amphetamine has been researched along with Sleep Initiation and Maintenance Disorders in 15 studies
Amphetamine: A powerful central nervous system stimulant and sympathomimetic. Amphetamine has multiple mechanisms of action including blocking uptake of adrenergics and dopamine, stimulation of release of monamines, and inhibiting monoamine oxidase. Amphetamine is also a drug of abuse and a psychotomimetic. The l- and the d,l-forms are included here. The l-form has less central nervous system activity but stronger cardiovascular effects. The d-form is DEXTROAMPHETAMINE.
1-phenylpropan-2-amine : A primary amine that is isopropylamine in which a hydrogen attached to one of the methyl groups has been replaced by a phenyl group.
amphetamine : A racemate comprising equimolar amounts of (R)-amphetamine (also known as levamphetamine or levoamphetamine) and (S)-amphetamine (also known as dexamfetamine or dextroamphetamine.
Sleep Initiation and Maintenance Disorders: Disorders characterized by impairment of the ability to initiate or maintain sleep. This may occur as a primary disorder or in association with another medical or psychiatric condition.
| Excerpt | Relevance | Reference |
|---|---|---|
| "Cataplexy was not affected by amphetamine treatment, but was abolished in two patients when clomipramine was given together with either amphetamine." | 6.64 | Levo(-) amphetamine and dextro(+) amphetamine in the treatment of narcolepsy. ( Fenton, GW; Parkes, JD, 1973) |
| "Cataplexy was not affected by amphetamine treatment, but was abolished in two patients when clomipramine was given together with either amphetamine." | 2.64 | Levo(-) amphetamine and dextro(+) amphetamine in the treatment of narcolepsy. ( Fenton, GW; Parkes, JD, 1973) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 11 (73.33) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 0 (0.00) | 29.6817 |
| 2010's | 3 (20.00) | 24.3611 |
| 2020's | 1 (6.67) | 2.80 |
| Authors | Studies |
|---|---|
| Levine, LA | 1 |
| Betcher, HK | 1 |
| Ziegelmann, MJ | 1 |
| Bajic, P | 1 |
| Chierrito de Oliveira, D | 1 |
| Guerrero de Sousa, P | 1 |
| Borges Dos Reis, C | 1 |
| Tonin, FS | 1 |
| Maria Steimbach, L | 1 |
| Virtuoso, S | 1 |
| Fernandez-Llimos, F | 1 |
| Pontarolo, R | 1 |
| Cristina Conegero Sanches, A | 1 |
| Fulde, GW | 1 |
| Forster, SL | 1 |
| Meyers, N | 1 |
| Fromm, S | 1 |
| Luckenbaugh, DA | 1 |
| Drevets, WC | 1 |
| Hasler, G | 1 |
| BATTERMAN, RC | 1 |
| MENDELS, J | 1 |
| KORNETSKY, C | 1 |
| MIRSKY, AF | 1 |
| KESSLER, EK | 1 |
| DORFF, JE | 1 |
| Jouvet, M | 1 |
| Zarcone, V | 1 |
| Parkes, JD | 1 |
| Fenton, GW | 1 |
| Rubinskaia, NL | 1 |
| Pearlman, CA | 1 |
| Greenberg, R | 1 |
| Arnold, LE | 1 |
| Wender, PH | 1 |
| McCloskey, K | 1 |
| Snyder, SH | 1 |
| Goldstein, BJ | 1 |
| Brauzer, B | 1 |
| Voronka, GSh | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| Pharmacological Treatment of Rett Syndrome by Stimulation of Synaptic Maturation With Recombinant Human IGF-1(Mecasermin [rDNA] Injection)[NCT01777542] | Phase 2 | 30 participants (Actual) | Interventional | 2013-01-31 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
"The ABC-C is a global behavior checklist implemented for the measurement of drug and other treatment effects in populations with intellectual disability. Behavior based on 58 items that describe various behavioral problems.~Each item is rated on the parents perceived severity of the behavior. The answer options for each item are:~0 = Not a problem~= Problem but slight in degree~= Moderately serious problem~= Severe in degree~The measure is broken down into the following subscales with individual ranges as follows:~Subscale I (Irritability): 15 items, score range = 0-45 Subscale II (Lethargy): 16 items, score range = 0-48 Subscale III (Stereotypy): 7 items, score range = 0-21 Subscale IV (Hyperactivity): 16 items, score range = 0-48 Subscale V (Inappropriate Speech) was not included in the breakdown because it was not applicable (no participants in the study had verbal language)." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends
| Intervention | units on a scale (Median) | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 1 - First Intervention: Subscale I | Visit 3 - First Intervention: Subscale I | Visit 5 - First Intervention: Subscale I | Visit 6 - Second Intervention: Subscale I | Visit 8 - Second Intervention: Subscale I | Visit 10 - Second Intervention: Subscale I | Follow-up: Subscale I (Irritability) | Visit 1 - First Intervention: Subscale II | Visit 3 - First Intervention: Subscale II | Visit 5 - First Intervention: Subscale II | Visit 6 - Second Intervention: Subscale II | Visit 8 - Second Intervention: Subscale II | Visit 10 - Second Intervention: Subscale II | Follow-up: Subscale II (Lethargy) | Visit 1 - First Intervention: Subscale III | Visit 3 - First Intervention: Subscale III | Visit 5 - First Intervention: Subscale III | Visit 6 - Second Intervention: Subscale III | Visit 8 - Second Intervention: Subscale III | Visit 10 - Second Intervention: Subscale III | Follow-up: Subscale III (Stereotypy) | Visit 1 - First Intervention: Subscale IV | Visit 3 - First Intervention: Subscale IV | Visit 5 - First Intervention: Subscale IV | Visit 6 - Second Intervention: Subscale IV | Visit 8 - Second Intervention: Subscale IV | Visit 10 - Second Intervention: Subscale IV | Follow-up: Subscale IV (Hyperactivity) | |
| Placebo First, Then rhIGF-1 | 9.00 | 9.00 | 7.00 | 7.00 | 4.00 | 5.00 | 3.00 | 13.00 | 11.00 | 9.00 | 11.00 | 8.00 | 6.00 | 6.00 | 13.00 | 10.00 | 11.00 | 11.00 | 10.00 | 8.00 | 8.00 | 13.00 | 12.00 | 11.00 | 11.00 | 7.00 | 10.00 | 9.00 |
| rhIGF-1 First, Then Placebo | 6.00 | 4.00 | 2.00 | 4.00 | 3.00 | 5.00 | 2.00 | 8.00 | 7.00 | 6.00 | 5.00 | 5.00 | 4.00 | 5.00 | 12.00 | 10.00 | 9.00 | 11.00 | 9.00 | 9.00 | 9.00 | 8.00 | 8.00 | 6.00 | 7.00 | 4.00 | 5.00 | 5.00 |
"Remaining subscales of the ADAMS that are not primary outcome measures include: Manic/hyperactive, Depressed mood, General anxiety, Obsessive/compulsive behavior.~The range for each subscale is as follows:~Manic/Hyperactive Behavior: 0-15 Depressed Mood: 0-21 General Anxiety: 0-21 Obsessive/Compulsive Behavior: 0-9~The higher the score for each subscale, the more problematic the behavior." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends
| Intervention | units on a scale (Median) | |||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 1- First Intervention: Manic/Hyperactive | Visit 2- First Intervention: Manic/Hyperactive | Visit 3- First Intervention: Manic/Hyperactive | Visit 4- First Intervention: Manic/Hyperactive | Visit 5- First Intervention: Manic/Hyperactive | Visit 6- Second Intervention: Manic/Hyperactive | Visit 7- Second Intervention: Manic/Hyperactive | Visit 8- Second Intervention: Manic/Hyperactive | Visit 9- Second Intervention: Manic/Hyperactive | Visit 10- First Intervention: Manic/Hyperactive | Follow-up: Manic/Hyperactive Subscale | Visit 1- First Intervention: Depressed Mood | Visit 2- First Intervention: Depressed Mood | Visit 3- First Intervention: Depressed Mood | Visit 4- First Intervention: Depressed Mood | Visit 5- First Intervention: Depressed Mood | Visit 6- Second Intervention: Depressed Mood | Visit 7- Second Intervention: Depressed Mood | Visit 8- Second Intervention: Depressed Mood | Visit 9- Second Intervention: Depressed Mood | Visit 10- Second Intervention: Depressed Mood | Follow-up: Depressed Mood Subscale | Visit 1- First Intervention: General Anxiety | Visit 2- First Intervention: General Anxiety | Visit 3- First Intervention: General Anxiety | Visit 4- First Intervention: General Anxiety | Visit 5- First Intervention: General Anxiety | Visit 6- Second Intervention: General Anxiety | Visit 7- Second Intervention: General Anxiety | Visit 8- Second Intervention: General Anxiety | Visit 9- Second Intervention: General Anxiety | Visit 10- Second Intervention: General Anxiety | Follow-up: General Anxiety Subscale | Visit 1- First Intervention: Obsessive Compulsive | Visit 2- First Intervention: Obsessive Compulsive | Visit 3- First Intervention: Obsessive Compulsive | Visit 4- First Intervention: Obsessive Compulsive | Visit 5- First Intervention: Obsessive Compulsive | Visit 6- Second Intervention: Obsessive Compulsive | Visit 7- Second Intervention: Obsessive Compulsive | Visit 8- Second Intervention: Obsessive Compulsive | Visit 9- Second Intervention: Obsessive Compulsive | Visit 10- First Intervention: Obsessive Compulsive | Follow-up: Obsessive Compulsive Behavior Subscale | |
| Placebo First, Then rhIGF-1 | 8.00 | 7.00 | 7.00 | 7.00 | 7.00 | 8.00 | 6.50 | 6.00 | 6.00 | 5.00 | 5.00 | 2.00 | 4.00 | 3.00 | 2.00 | 2.00 | 2.00 | 3.00 | 2.00 | 3.00 | 2.00 | 2.00 | 8.00 | 6.00 | 6.00 | 5.00 | 5.00 | 6.00 | 6.00 | 6.00 | 4.00 | 4.00 | 5.50 | 4.00 | 4.00 | 4.00 | 3.00 | 3.00 | 3.00 | 3.00 | 3.00 | 3.00 | 2.00 | 3.50 |
| rhIGF-1 First, Then Placebo | 7.00 | 7.00 | 6.00 | 5.00 | 4.00 | 6.00 | 5.00 | 5.00 | 4.00 | 4.50 | 5.00 | 4.00 | 5.00 | 3.00 | 3.00 | 4.00 | 4.00 | 3.00 | 3.00 | 2.00 | 3.00 | 3.50 | 6.00 | 7.00 | 6.00 | 5.00 | 5.00 | 7.00 | 5.00 | 4.00 | 3.00 | 4.00 | 4.00 | 3.00 | 4.00 | 4.00 | 3.00 | 3.00 | 3.00 | 3.00 | 3.00 | 2.00 | 2.50 | 3.00 |
"The ADAMS is completed by the parent/caregiver/LAR and consists of 29 items which are scored on a 4-point rating scale that combines frequency and severity ratings. The instructions ask the rater to describe the individual's behavior over the last six months on the following scale: 0 if the behavior has not occurred, 1 if the behavior occurs occasionally or is a mild problem, 2 if the behavior occurs quite often or is moderate problem, or 3 if the behavior occurs a lot or is a severe problem.~The Social Avoidance subscale of the ADAMS will be used as a primary outcome measure for this trial. The range for this subscale is 0-21. The higher the subscale score, the more problematic the behavior." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends
| Intervention | units on a scale (Median) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 1 - First Intervention | Visit 2 - First Intervention | Visit 3 - First Intervention | Visit 4 - First Intervention | Visit 5 - First Intervention | Visit 6 - Second Intervention | Visit 7 - Second Intervention | Visit 8 - Second Intervention | Visit 9 - Second Intervention | Visit 10 - Second Intervention | Follow-up | |
| Placebo First, Then rhIGF-1 | 6.00 | 5.00 | 5.00 | 6.00 | 5.00 | 4.00 | 4.00 | 4.00 | 3.00 | 3.50 | 4.00 |
| rhIGF-1 First, Then Placebo | 4.00 | 5.00 | 4.00 | 4.00 | 3.00 | 4.00 | 4.00 | 4.00 | 3.00 | 3.50 | 3.00 |
"Each time the patient was seen after the study intervention was initiated, the clinician compared the patient's overall clinical condition to the CGI-S score obtained at the baseline (visit 1) visit. Based on information collected, the clinician determined if any improvement occurred on the following 7-point scale: 1=Very much improved since the initiation of treatment; 2=Much improved; 3=Minimally improved; 4=No change from baseline (the initiation of treatment); 5=Minimally worse; 6=Much worse; 7=Very much worse since the initiation of treatment.~The possible range for reported scores is 1-7." (NCT01777542)
Timeframe: Every 10 weeks during each of the two 20-week treatment periods
| Intervention | units on a scale (Median) | ||||
|---|---|---|---|---|---|
| Visit 3 - First Intervention | Visit 5 - First Intervention | Visit 6 - Second Intervention | Visit 8 - Second Intervention | Visit 10 - Second Intervention | |
| Placebo First, Then rhIGF-1 | 4.00 | 4.00 | 4.00 | 4.00 | 4.00 |
| rhIGF-1 First, Then Placebo | 4.00 | 4.00 | 4.00 | 4.00 | 4.00 |
"This scale is used to judge the severity of the subject's disease prior to entry into the study. The clinician will rate the severity of behavioral symptoms at baseline on a 7-point scale from not impaired to the most impaired.~The scores that correspond to each possible grouping are as follows: 1=Normal, not at all impaired; 2=Borderline impaired; 3=Mildly impaired; 4=Moderately impaired; 5=Markedly impaired; 6=Severely impaired; 7=The most impaired.~The possible range for reported scores is 1-7." (NCT01777542)
Timeframe: Every 10 weeks during each of the two 20-week treatment periods
| Intervention | units on a scale (Median) | |||||
|---|---|---|---|---|---|---|
| Visit 1 - First Intervention | Visit 3 - First Intervention | Visit 5 - First Intervention | Visit 6 - Second Intervention | Visit 8 - Second Intervention | Visit 10 - Second Intervention | |
| Placebo First, Then rhIGF-1 | 4.00 | 4.00 | 4.00 | 4.00 | 4.00 | 4.00 |
| rhIGF-1 First, Then Placebo | 4.00 | 4.00 | 4.00 | 4.00 | 4.00 | 4.50 |
"The CSBS-DP was designed to measure early communication and symbolic skills in infants and young children (that is, functional communication skills of 6 month to 2 year olds). The CSBS-DP measures skills from three composites: (a) Social (emotion, eye gaze, and communication); (b) Speech (sounds and words); and (c) Symbolic (understanding and object use) and asks about developmental milestones. The data reported are the composite scores for these three categories.~The possible scores for the three composite categories are as follows:~Social Composite = 0-48; Speech Composite = 0-40; Symbolic Composite = 0-51.~A higher score indicates more advanced abilities in that area." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends
| Intervention | units on a scale (Median) | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 1 - First Intervention: Social | Visit 2: Social Composite Score | Visit 3: Social Composite Score | Visit 4: Social Composite Score | Visit 5: Social Composite Score | Visit 6 - Second Intervention: Social | Visit 7 - Second Intervention: Social | Visit 8 - Second Intervention: Social | Visit 9 - Second Intervention: Social | Visit 10 - Second Intervention: Social | Follow-up: Social Composite Score | Visit 1 - First Intervention: Speech | Visit 2 - First Intervention: Speech | Visit 3 - First Intervention: Speech | Visit 4 - First Intervention: Speech | Visit 5 - First Intervention: Speech | Visit 6 - Second Intervention: Speech | Visit 7 - Second Intervention: Speech | Visit 8 - Second Intervention: Speech | Visit 9 - Second Intervention: Speech | Visit 10 - Second Intervention: Speech | Follow-up: Speech Composite Score | Visit 1 - First Intervention: Symbolic | Visit 2 - First Intervention: Symbolic | Visit 3 - First Intervention: Symbolic | Visit 4 - First Intervention: Symbolic | Visit 5 - First Intervention: Symbolic | Visit 6 - Second Intervention: Symbolic | Visit 7 - Second Intervention: Symbolic | Visit 8 - Second Intervention: Symbolic | Visit 9 - Second Intervention: Symbolic | Visit 10 - Second Intervention: Symbolic | Follow-up: Symbolic Composite Score | |
| Placebo First, Then rhIGF-1 | 19.00 | 20.00 | 18.00 | 18.00 | 20.00 | 18.00 | 20.00 | 21.00 | 21.00 | 22.50 | 22.50 | 4.00 | 3.00 | 5.00 | 5.50 | 6.50 | 4.00 | 4.00 | 5.00 | 5.00 | 5.00 | 6.00 | 9.50 | 10.50 | 10.50 | 12.00 | 11.50 | 13.00 | 10.25 | 11.50 | 11.50 | 13.75 | 14.25 |
| rhIGF-1 First, Then Placebo | 22.00 | 24.00 | 24.00 | 24.00 | 23.00 | 28.00 | 25.00 | 27.00 | 29.00 | 27.00 | 28.00 | 7.00 | 5.00 | 8.00 | 5.00 | 8.00 | 8.50 | 7.00 | 6.50 | 5.00 | 7.25 | 6.00 | 14.00 | 14.50 | 15.00 | 14.00 | 16.50 | 18.50 | 17.00 | 17.00 | 18.00 | 17.00 | 18.00 |
"The Kerr clinical severity scale (Kerr scale) is a quantitative measure of global disease severity. The Kerr scale is a summation of individual items related to Rett syndrome phenotypic characteristics. The items are based on the severity or degree of abnormality of each characteristic on a discrete scale (0, 1, 2) with the highest level corresponding to the most severe or most abnormal presentations.~The possible range of scores is 0-48. The higher the score, the more severe the symptoms." (NCT01777542)
Timeframe: At the start and end of each 20-week treatment period
| Intervention | units on a scale (Median) | |||
|---|---|---|---|---|
| Visit 1 - First Intervention | Visit 5 - First Intervention | Visit 6 - Second Intervention | Visit 10 - Second Intervention | |
| Placebo First, Then rhIGF-1 | 16.50 | 15.00 | 15.00 | 14.00 |
| rhIGF-1 First, Then Placebo | 18.00 | 18.00 | 19.00 | 20.00 |
"The MSEL is a standardized developmental test for children ages 3 to 68 months consisting of five subscales: gross motor, fine motor, visual reception, expressive language, and receptive language.~The raw score is reported for each subscale domain. The potential score ranges are as follows:~Visual Reception: 33 items, score range=0-50, Fine Motor: 30 items, score range= 0-49, Receptive Language: 33 items, score range= 0-48, Expressive Language: 28 items, score range= 0-50. The gross motor subscale was not included in this population.~A higher raw score indicates more advanced abilities in that section." (NCT01777542)
Timeframe: At the start and end of each 20-week treatment period
| Intervention | units on a scale (Median) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 1- First Intervention: Visual Reception | Visit 5- First Intervention: Visual Reception | Visit 6- Second Intervention: Visual Reception | Visit 10: Visual Reception Raw Score | Visit 1- First Intervention: Fine Motor | Visit 5- First Intervention: Fine Motor | Visit 6- Second Intervention: Fine Motor | Visit 10- Second Intervention: Fine Motor | Visit 1- First Intervention: Receptive Language | Visit 5- First Intervention: Receptive Language | Visit 6- Second Intervention: Receptive Language | Visit 10- Second Intervention: Receptive Language | Visit 1- First Intervention: Expressive Language | Visit 5- First Intervention: Expressive Language | Visit 6- Second Intervention: Expressive Language | Visit 10- Second Intervention: Expressive Language | |
| Placebo First, Then rhIGF-1 | 17.00 | 26.00 | 23.00 | 28.00 | 10.00 | 9.00 | 11.00 | 9.00 | 20.00 | 30.00 | 31.00 | 31.00 | 8.00 | 9.00 | 6.00 | 8.00 |
| rhIGF-1 First, Then Placebo | 26.00 | 39.50 | 42.00 | 44.00 | 7.00 | 7.00 | 10.00 | 8.50 | 25.50 | 32.00 | 38.00 | 36.50 | 9.00 | 8.00 | 10.00 | 8.00 |
"The parent or caretaker identifies the three most troublesome, RTT-specific, target symptoms, such as inattention or breath-holding. This allows the problems that are of concern to parents and the family to be targeted in the trial. In this study the caregiver will choose three target symptoms at baseline and then rate changes in severity of each target symptom on a visual analog scale (VAS).~The VAS is a 10 cm line, where a target symptom is anchored on one end with the description the best it has ever been and on the other with the description the worst it has ever been. The parent was asked to marked on the line where they felt their child's symptoms currently fit best. This mark was measured as recorded as a numeric value from 0.00-10.00 cm. The higher the value, the worse the symptom." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends
| Intervention | units on a scale (Median) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 1 - First Intervention | Visit 2 - First Intervention | Visit 3 - First Intervention | Visit 4 - First Intervention | Visit 5 - First Intervention | Visit 6 - Second Intervention | Visit 7 - Second Intervention | Visit 8 - Second Intervention | Visit 9 - Second Intervention | Visit 10 - Second Intervention | Follow-up | |
| Placebo First, Then rhIGF-1 | 6.50 | 4.70 | 5.65 | 5.05 | 4.80 | 4.95 | 4.55 | 5.65 | 4.15 | 4.80 | 5.60 |
| rhIGF-1 First, Then Placebo | 8.80 | 4.80 | 5.35 | 5.10 | 5.15 | 5.20 | 4.65 | 5.00 | 5.15 | 5.05 | 5.08 |
"The parent or caretaker identifies the three most troublesome, RTT-specific, target symptoms, such as inattention or breath-holding. This allows the problems that are of concern to parents and the family to be targeted in the trial. In this study the caregiver will choose three target symptoms at baseline and then rate changes in severity of each target symptom on a visual analog scale (VAS).~The VAS is a 10 cm line, where a target symptom is anchored on one end with the description the best it has ever been and on the other with the description the worst it has ever been. The parent was asked to marked on the line where they felt their child's symptoms currently fit best. This mark was measured as recorded as a numeric value from 0.00-10.00 cm. The higher the value, the worse the symptom." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends
| Intervention | units on a scale (Median) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 1 - First Intervention | Visit 2 - First Intervention | Visit 3 - First Intervention | Visit 4 - First Intervention | Visit 5 - First Intervention | Visit 6 - Second Intervention | Visit 7 - Second Intervention | Visit 8 - Second Intervention | Visit 9 - Second Intervention | Visit 10 - Second Intervention | Follow-up | |
| Placebo First, Then rhIGF-1 | 7.75 | 4.50 | 5.85 | 5.00 | 5.00 | 5.35 | 5.50 | 5.15 | 3.80 | 4.90 | 5.15 |
| rhIGF-1 First, Then Placebo | 6.35 | 5.25 | 5.95 | 5.40 | 5.45 | 7.10 | 5.85 | 5.00 | 5.13 | 4.95 | 5.20 |
"The parent or caretaker identifies the three most troublesome, RTT-specific, target symptoms, such as inattention or breath-holding. This allows the problems that are of concern to parents and the family to be targeted in the trial. In this study the caregiver will choose three target symptoms at baseline and then rate changes in severity of each target symptom on a visual analog scale (VAS).~The VAS is a 10 cm line, where a target symptom is anchored on one end with the description the best it has ever been and on the other with the description the worst it has ever been. The parent was asked to marked on the line where they felt their child's symptoms currently fit best. This mark was measured as recorded as a numeric value from 0.00-10.00 cm. The higher the value, the worse the symptom." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends
| Intervention | units on a scale (Median) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 1 - First Intervention | Visit 2 - First Intervention | Visit 3 - First Intervention | Visit 4 - First Intervention | Visit 5 - First Intervention | Visit 6 - Second Intervention | Visit 7 - Second Intervention | Visit 8 - Second Intervention | Visit 9 - Second Intervention | Visit 10 - Second Intervention | Follow-up | |
| Placebo First, Then rhIGF-1 | 7.85 | 4.70 | 5.65 | 4.15 | 5.00 | 6.20 | 4.80 | 4.85 | 4.60 | 4.13 | 4.55 |
| rhIGF-1 First, Then Placebo | 5.70 | 5.00 | 5.20 | 5.35 | 5.10 | 5.35 | 4.95 | 5.15 | 5.25 | 4.55 | 5.10 |
"As part of each visit after the study intervention was initiated, the parent/caregiver was asked to compare the patient's overall clinical condition to the score obtained at the baseline (visit 1) visit. Based on information collected, the clinician determined if any improvement occurred on the following 7-point scale: 1=Very much improved since the initiation of treatment; 2=Much improved; 3=Minimally improved; 4=No change from baseline (the initiation of treatment); 5=Minimally worse; 6=Much worse; 7=Very much worse since the initiation of treatment.~The possible range for reported scores is 1-7." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends
| Intervention | units on a scale (Median) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Visit 2 - First Intervention | Visit 3 - First Intervention | Visit 4 - First Intervention | Visit 5 - First Intervention | Visit 6 - Second Intervention | Visit 7 - Second Intervention | Visit 8 - Second Intervention | Visit 9 - Second Intervention | Visit 10 - Second Intervention | Follow-up | |
| Placebo First, Then rhIGF-1 | 4.00 | 3.00 | 3.00 | 3.00 | 4.00 | 3.00 | 3.00 | 3.00 | 3.00 | 3.00 |
| rhIGF-1 First, Then Placebo | 4.00 | 4.00 | 4.00 | 3.00 | 3.00 | 3.00 | 3.00 | 3.00 | 3.00 | 3.00 |
"The PGI-S is the parent version of the CGI-S. Parents/caregivers/LAR are asked to rate the severity of their child's symptoms at baseline on a 7-point scale from not at all impaired to the most impaired. The parents/caregivers/LAR will complete the PGI-S at each study visit.~The scores that correspond to each possible grouping are as follows:~1=Normal, not at all impaired; 2=Borderline impaired; 3=Mildly impaired; 4=Moderately impaired; 5=Markedly impaired; 6=Severely impaired; 7=The most impaired.~The possible range for reported scores is 1-7." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends
| Intervention | units on a scale (Median) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 1 - First Intervention | Visit 2 - First Intervention | Visit 3 - First Intervention | Visit 4 - First Intervention | Visit 5 - First Intervention | Visit 6 - Second Intervention | Visit 7 - Second Intervention | Visit 8 - Second Intervention | Visit 9 - Second Intervention | Visit 10 - Second Intervention | Follow-up | |
| Placebo First, Then rhIGF-1 | 4.00 | 4.00 | 4.00 | 4.00 | 4.00 | 4.00 | 4.00 | 4.00 | 4.00 | 4.00 | 4.00 |
| rhIGF-1 First, Then Placebo | 6.00 | 4.00 | 4.00 | 4.00 | 4.00 | 4.00 | 4.00 | 6.00 | 6.00 | 5.00 | 4.00 |
"Respiratory data was collected using non-invasive respiratory inductance plethysmography from a BioCapture® recording device. BioCapture® is a child-friendly measurement device that can record from 1 to 12 physiological signal transducers in a time-locked manner. It can be configured with the pediatric chest and abdominal plethysmography bands and the 3 lead ECG signals we plan to use for monitoring cardiac safety throughout the study. Each transducer is placed on the patient independently to provide a customized fit that yields the highest signal quality for each patient irrespective of body shape and proportion. The transducer signals captured by the BioCapture® are transmitted wirelessly to a laptop computer where all signals are displayed in real-time.~The apnea index is given as apneas/hour. Data on apneas greater than or equal to 10 seconds are displayed below. The higher the frequency of apnea, the more severe the breathing abnormality." (NCT01777542)
Timeframe: Every 10 weeks during each of the two 20-week treatment periods
| Intervention | Apneas/Hour (Median) | |||||
|---|---|---|---|---|---|---|
| Visit 1 - First Intervention: Apnea Index | Visit 3 - First Intervention: Apnea Index | Visit 5 - First Intervention: Apnea Index | Visit 6 - Second Intervention: Apnea Index | Visit 8 - Second Intervention: Apnea Index | Visit 10 - Second Intervention: Apnea Index | |
| Placebo First, Then rhIGF-1 | 7.58 | 4.80 | 6.93 | 7.90 | 7.28 | 8.91 |
| rhIGF-1 First, Then Placebo | 4.05 | 3.48 | 3.07 | 3.62 | 5.55 | 5.56 |
"The RSBQ is a parent-completed measure of abnormal behaviors typically observed in individuals with RTT. Each item, grouped into eight subscales, is scored on a Likert scale of 0-2, according to how well the item describes the individual's behavior. A score of 0 indicates the described item is not true, a score of 1 indicates the described item is somewhat or sometimes true, and a score of 2 indicates the described item is very true or often true.~The total sum of each subscale is reported. The higher the score, the more severe the symptoms of that subscale in the participant.~The range for each subscale is as follows:~General Mood: 0-16 Body rocking and expressionless face: 0-14 Hand behaviors: 0-12 Breathing Problems: 0-10 Repetitive Face Movements: 0-8 Night-time behaviors: 0-6 Walking Standing: 0-4~The fear/anxiety subscale was used as a primary outcome measure in this study and results can be found in that section." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends
| Intervention | units on a scale (Median) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 1- First Intervention: General Mood | Visit 2- First Intervention: General Mood | Visit 3- First Intervention: General Mood | Visit 4- First Intervention: General Mood | Visit 5- First Intervention: General Mood | Visit 6- Second Intervention: General Mood | Visit 7- Second Intervention: General Mood | Visit 8- Second Intervention: General Mood | Visit 9- Second Intervention: General Mood | Visit 10- Second Intervention: General Mood | Follow-up: General Mood | Visit 1- First Intervention: Body Rocking | Visit 2- First Intervention: Body Rocking | Visit 3- First Intervention: Body Rocking | Visit 4- First Intervention: Body Rocking | Visit 5- First Intervention: Body Rocking | Visit 6- Second Intervention: Body Rocking | Visit 7- Second Intervention: Body Rocking | Visit 8- Second Intervention: Body Rocking | Visit 9- Second Intervention: Body Rocking | Visit 10- Second Intervention: Body Rocking | Followup: Body Rocking | Visit 1- First Intervention: Hand Behaviors | Visit 2- First Intervention: Hand Behaviors | Visit 3- First Intervention: Hand Behaviors | Visit 4- First Intervention: Hand Behaviors | Visit 5- First Intervention: Hand Behaviors | Visit 6- Second Intervention: Hand Behaviors | Visit 7- Second Intervention: Hand Behaviors | Visit 8- Second Intervention: Hand Behaviors | Visit 9- Second Intervention: Hand Behaviors | Visit 10- Second Intervention: Hand Behaviors | Follow-up: Hand Behaviors | Visit 1- First Intervention: Breathing Problems | Visit 2- First Intervention: Breathing Problems | Visit 3- First Intervention: Breathing Problems | Visit 4- First Intervention: Breathing Problems | Visit 5- First Intervention: Breathing Problems | Visit 6- Second Intervention: Breathing Problems | Visit 7- Second Intervention: Breathing Problems | Visit 8- Second Intervention: Breathing Problems | Visit 9- Second Intervention: Breathing Problems | Visit 10- Second Intervention: Breathing Problems | Follow-up: Breathing Problems | Visit 1- First Intervention: Repetitive Face Movem | Visit 2- First Intervention: Repetitive Face Movem | Visit 3- First Intervention: Repetitive Face Movem | Visit 4- First Intervention: Repetitive Face Movem | Visit 5- First Intervention: Repetitive Face Movem | Visit 6- Second Intervention: Repetitive Face Mov | Visit 7- Second Intervention: Repetitive Face Mov | Visit 8- Second Intervention: Repetitive Face Mov | Visit 9- Second Intervention: Repetitive Face Mov | Visit 10- Second Intervention: Repetitive Face Mov | Follow-up: Repetitive Face Movements | Visit 1- First Intervention: Night time Behaviors | Visit 2- First Intervention: Night time Behaviors | Visit 3- First Intervention: Night time Behaviors | Visit 4- First Intervention: Night time Behaviors | Visit 5- First Intervention: Night time Behaviors | Visit 6- Second Intervention: Night time Behavior | Visit 7- Second Intervention: Night time Behavior | Visit 8- Second Intervention: Night time Behavior | Visit 9- Second Intervention: Night time Behavior | Visit 10- Second Intervention: Night time Behavior | Follow-up: Night time Behaviors | Visit 1- First Intervention: Walking/Standing | Visit 2- First Intervention: Walking/Standing | Visit 3- First Intervention: Walking/Standing | Visit 4- First Intervention: Walking/Standing | Visit 5- First Intervention: Walking/Standing | Visit 6- Second Intervention: Walking/Standing | Visit 7- Second Intervention: Walking/Standing | Visit 8- Second Intervention: Walking/Standing | Visit 9- Second Intervention: Walking/Standing | Visit 10- Second Intervention: Walking/Standing | Follow-up: Walking/Standing | |
| Placebo First, Then rhIGF-1 | 7.00 | 5.00 | 6.00 | 5.00 | 5.00 | 4.00 | 5.50 | 5.00 | 6.00 | 4.00 | 5.50 | 6.00 | 5.00 | 5.00 | 6.00 | 5.00 | 4.00 | 5.00 | 5.00 | 4.00 | 5.00 | 4.50 | 8.00 | 9.00 | 8.00 | 8.00 | 8.00 | 9.00 | 8.00 | 8.00 | 8.00 | 7.00 | 7.50 | 6.00 | 4.00 | 5.00 | 5.00 | 5.00 | 6.00 | 4.50 | 6.00 | 5.00 | 6.00 | 5.00 | 2.00 | 2.00 | 3.00 | 2.00 | 3.00 | 3.00 | 3.00 | 3.00 | 3.00 | 3.00 | 2.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 1.00 | 0.00 | 0.00 | 0.00 | 2.00 | 2.00 | 2.00 | 2.00 | 2.00 | 2.00 | 2.00 | 2.00 | 3.00 | 1.50 | 2.00 |
| rhIGF-1 First, Then Placebo | 4.00 | 3.00 | 2.00 | 2.00 | 3.00 | 4.00 | 2.00 | 2.00 | 1.00 | 2.50 | 2.00 | 4.00 | 4.00 | 3.00 | 4.00 | 4.00 | 4.00 | 3.00 | 4.00 | 3.00 | 4.00 | 4.00 | 8.00 | 8.00 | 8.00 | 9.00 | 9.00 | 8.00 | 9.00 | 9.00 | 7.00 | 9.00 | 8.50 | 4.00 | 4.00 | 4.00 | 5.00 | 4.00 | 4.00 | 3.00 | 3.00 | 3.00 | 4.00 | 3.00 | 2.00 | 2.00 | 3.00 | 2.00 | 2.00 | 3.00 | 2.00 | 2.00 | 2.00 | 1.50 | 2.00 | 1.00 | 1.00 | 0.00 | 0.00 | 1.00 | 1.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 2.00 | 2.00 | 2.00 | 2.00 | 2.00 | 2.00 | 2.00 | 2.00 | 2.00 | 2.00 | 2.00 |
"The RSBQ is an informant/parent-completed measure of abnormal behaviors typically observed in individuals with RTT, which is completed by a parent/caregiver/LAR. Each item, grouped into eight domains/factors: General mood, Breathing problems, Body rocking and expressionless face, Hand behaviors, Repetitive face movements, Night-time behaviors, Fear/anxiety and Walking/standing), is scored on a Likert scale of 0-2, according to how well the item describes the individual's behavior. A score of 0 indicates the described item is not true, a score of 1 indicates the described item is somewhat or sometimes true, and a score of 2 indicates the described item is very true or often true.~The total sum of items in each subscale is reported.~For the fear/anxiety subscale, the sum total could be between 0-8. The higher the sum total score, the greater the frequency of fear/anxiety behaviors." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends
| Intervention | units on a scale (Median) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 1 - First Intervention | Visit 2 - First Intervention | Visit 3 - First Intervention | Visit 4 - First Intervention | Visit 5 - First Intervention | Visit 6 - Second Intervention | Visit 7 - Second Intervention | Visit 8 - Second Intervention | Visit 9 - Second Intervention | Visit 10 - Second Intervention | Follow-up | |
| Placebo First, Then rhIGF-1 | 4.00 | 5.00 | 4.00 | 4.00 | 3.00 | 4.00 | 4.00 | 3.00 | 3.00 | 4.00 | 3.50 |
| rhIGF-1 First, Then Placebo | 5.00 | 3.00 | 3.00 | 3.00 | 3.00 | 4.00 | 3.00 | 4.00 | 3.00 | 3.00 | 3.50 |
"The VABS-II is a survey designed to assess personal and social functioning. Within each domain (Communication, Daily Living Skills, Socialization, and Motor Skills), items can given a score of 2 if the participant successfully performs the activity usually; a 1 if the participant successfully performs the activity sometimes, or needs reminders; a 0 if the participant never performs the activity, and a DK if the parent/caregiver is unsure of the participant's ability for an item.~The raw scores in each sub-domain are reported and the ranges for these are as follows: [Communication Domain], Receptive Language=0-40, Expressive Language=0-108, Written Language=0-50; [Daily Living Skills Domain], Personal=0-82, Domestic=0-48, Community=0-88; [Socialization Domain], Interpersonal Relationships=0-76, Play and Leisure Time=0-62, Coping Skills=0-60; [Motor Skills Domain]: Gross Motor Skills=0-80, Fine Motor Skills=0-72.~A higher score indicates more advanced abilities." (NCT01777542)
Timeframe: At the start and end of each 20-week treatment period
| Intervention | units on a scale (Median) | |||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 1 - First Intervention: Receptive | Visit 5 - First Intervention: Receptive | Visit 6 - Second Intervention: Receptive Language | Visit 10 - Second Intervention: Receptive Language | Visit 1 - First Intervention: Expressive | Visit 5 - First Intervention: Expressive | Visit 6 - Second Intervention: Expressive Lang. | Visit 10 - Second Intervention: Expressive Lang. | Visit 1 - First Intervention: Written | Visit 5 - First Intervention: Written | Visit 6: - Second Intervention Written Language | Visit 10 - Second Intervention: Written Language | Visit 1 - First Intervention: Personal | Visit 5 - First Intervention: Personal | Visit 6 - Second Intervention: Personal | Visit 10 - Second Intervention: Personal | Visit 1 - First Intervention: Domestic | Visit 5 - First Intervention: Domestic | Visit 6 - Second Intervention: Domestic | Visit 10 - Second Intervention: Domestic | Visit 1 - First Intervention: Community | Visit 5 - First Intervention: Community | Visit 6 - Second Intervention: Community | Visit 10 - Second Intervention: Community | Visit 1 - First Intervention: Interpersonal Rel. | Visit 5 - First Intervention: Interpersonal Rel. | Visit 6 - Second Intervention: Interpersonal Rel. | Visit 10 - Second Intervention: Interpersonal Rel. | Visit 1 - First Intervention: Play and Leisure | Visit 5 - First Intervention: Play and Leisure | Visit 6 - Second Intervention: Play and Leisure | Visit 10 - Second Intervention: Play and Leisure | Visit 1 - First Intervention: Coping Skills | Visit 5 - First Intervention: Coping Skills | Visit 6 - Second Intervention: Coping Skills | Visit 10 - Second Intervention: Coping Skills | Visit 1 - First Intervention: Gross Motor | Visit 5 - First Intervention: Gross Motor | Visit 6 - Second Intervention: Gross Motor | Visit 10 - Second Intervention: Gross Motor | Visit 1 - First Intervention: Fine Motor | Visit 5 - First Intervention: Fine Motor | Visit 6 - Second Intervention: Fine Motor | Visit 10 - Second Intervention: Fine Motor | |
| Placebo First, Then rhIGF-1 | 13.00 | 15.00 | 18.00 | 20.00 | 16.00 | 17.00 | 18.00 | 20.00 | 0.00 | 0.00 | 4.00 | 6.00 | 9.00 | 10.00 | 9.00 | 10.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 1.00 | 1.00 | 2.00 | 18.00 | 18.00 | 19.00 | 20.00 | 8.00 | 11.00 | 12.00 | 11.00 | 3.00 | 2.00 | 3.00 | 4.00 | 31.00 | 34.00 | 27.00 | 27.00 | 6.00 | 6.00 | 7.00 | 5.00 |
| rhIGF-1 First, Then Placebo | 18.00 | 21.00 | 22.00 | 24.50 | 18.00 | 22.00 | 25.00 | 24.00 | 4.00 | 5.00 | 7.00 | 7.00 | 8.00 | 9.00 | 8.50 | 9.50 | 0.00 | 0.00 | 0.00 | 0.00 | 3.00 | 3.00 | 5.00 | 5.00 | 21.00 | 22.00 | 21.00 | 22.50 | 13.00 | 12.00 | 13.00 | 12.50 | 3.00 | 4.00 | 6.00 | 4.50 | 10.00 | 10.00 | 11.50 | 10.50 | 2.00 | 3.00 | 4.00 | 4.00 |
5 reviews available for amphetamine and Sleep Initiation and Maintenance Disorders
| Article | Year |
|---|---|
Safety of Treatments for ADHD in Adults: Pairwise and Network Meta-Analyses.
Topics: Adrenergic Uptake Inhibitors; Adult; Amphetamine; Atomoxetine Hydrochloride; Attention Deficit Disor | 2019 |
The impact of amphetamine-type stimulants on emergency services.
Topics: Acute Disease; Aggression; Amphetamine; Amphetamine-Related Disorders; Anxiety; Central Nervous Syst | 2015 |
Narcolepsy.
Topics: Adolescent; Adult; Amphetamine; Cataplexy; Child; Diagnosis, Differential; Female; Hallucinations; H | 1973 |
Medical-psychological implications of recent sleep research.
Topics: Adaptation, Psychological; Amphetamine; Barbiturates; Central Nervous System Stimulants; Chloral Hyd | 1970 |
Pharmacologic considerations in the treatment of anxiety and depression in medical practice.
Topics: Adult; Amphetamine; Antidepressive Agents; Anxiety; Autonomic Nervous System; Cardiovascular System; | 1971 |
3 trials available for amphetamine and Sleep Initiation and Maintenance Disorders
| Article | Year |
|---|---|
Neural correlates of sleepiness induced by catecholamine depletion.
Topics: Adolescent; Adult; Amphetamine; Brain; Brain Mapping; Catecholamines; Central Nervous System Stimula | 2011 |
Levo(-) amphetamine and dextro(+) amphetamine in the treatment of narcolepsy.
Topics: Adult; Amphetamine; Antidepressive Agents; Cataplexy; Dextroamphetamine; Electroencephalography; Eva | 1973 |
Levoamphetamine and dextroamphetamine: comparative efficacy in the hyperkinetic syndrome. Assessment by target symptoms.
Topics: Aggression; Amphetamine; Attention; Body Weight; Child; Clinical Trials as Topic; Dextroamphetamine; | 1972 |
7 other studies available for amphetamine and Sleep Initiation and Maintenance Disorders
| Article | Year |
|---|---|
Amphetamine/Dextroamphetamine Salts for Delayed Orgasm and Anorgasmia in Men: A Pilot Study.
Topics: Aged; Amphetamine; Central Nervous System Stimulants; Ejaculation; Humans; Male; Middle Aged; Orgasm | 2020 |
SUSTAINED-ACTION AMPHETAMINE-MEPROBAMATE COMBINATION FOR THE TREATMENT OF OBESITY.
Topics: Amphetamine; Amphetamines; Appetite Depressants; Biomedical Research; Delayed-Action Preparations; D | 1964 |
SIDE-EFFECTS OF TRANYLCYPROMINE.
Topics: Amphetamine; Blood Pressure; Chlordiazepoxide; Drug Therapy; Electric Countershock; Hypertension; Hy | 1965 |
The effects of dextro-amphetamine on behavioral deficits produced by sleep loss in humans.
Topics: Amphetamine; Amphetamines; Dextroamphetamine; Humans; Sleep; Sleep Initiation and Maintenance Disord | 1959 |
[Recent data on experimental insomnia in the cat].
Topics: Amphetamine; Animals; Catecholamines; Cats; Humans; Medulla Oblongata; Nialamide; Reticular Formatio | 1966 |
[RNA in neurons and their glial cell-satellites in the rat red nucleus during natural sleep, deprivation of its paradoxical phase and phenamine insomnia].
Topics: Amphetamine; Animals; Humans; Male; Neuroglia; Rats; Red Nucleus; RNA; Sleep; Sleep Deprivation; Sle | 1973 |
[Effect of prolonged phenamine-induced insomnia and subsequent sleep on the protein content of neurons and their glial cell-satellites of the brain supraoptic and red nuclei].
Topics: Amphetamine; Animals; Humans; Hypothalamus; Male; Nerve Tissue Proteins; Neuroglia; Neurons; Rats; R | 1971 |