guanfacine and Disorders of Excessive Somnolence studies

Guanfacine: A centrally acting antihypertensive agent with specificity towards ADRENERGIC ALPHA-2 RECEPTORS.

Disorders of Excessive Somnolence: Disorders characterized by hypersomnolence during normal waking hours that may impair cognitive functioning. Subtypes include primary hypersomnia disorders (e.g., IDIOPATHIC HYPERSOMNOLENCE; NARCOLEPSY; and KLEINE-LEVIN SYNDROME) and secondary hypersomnia disorders where excessive somnolence can be attributed to a known cause (e.g., drug affect, MENTAL DISORDERS, and SLEEP APNEA SYNDROME). (From J Neurol Sci 1998 Jan 8;153(2):192-202; Thorpy, Principles and Practice of Sleep Medicine, 2nd ed, p320)

Research Excerpts

Excerpt	Relevance	Reference
"To determine whether treatment with guanfacine extended release (GXR) in subjects with attention-deficit/hyperactivity disorder (ADHD) disrupted psychomotor functioning and alertness, or impacted daytime sleepiness."	5.15	Psychomotor functioning and alertness with guanfacine extended release in subjects with attention-deficit/hyperactivity disorder. ( Farrand, K; Kollins, SH; López, FA; Lyne, A; Roth, T; Turnbow, JM; Vince, BD; Wigal, SB, 2011)
"Guanfacine is a noradrenergic agonist that is believed to improve symptoms of attention-deficit/hyperactivity disorder (ADHD) through selective actions at alpha2A-adrenoceptors in the prefrontal cortex."	2.73	Long-term, open-label extension study of guanfacine extended release in children and adolescents with ADHD. ( Biederman, J; Donahue, J; Lyne, A; McBurnett, K; Melmed, RD; Patel, A, 2008)
"Only daytime sleepiness was more common for those receiving α2-adrenergic agonists vs stimulants (38% vs 3%); several adverse effects were reported more commonly for those receiving stimulants vs α2-adrenergic agonists, including moodiness/irritability (50% vs 29%), appetite suppression (38% vs 7%), and difficulty sleeping (21% vs 11%)."	1.62	α2-Adrenergic Agonists or Stimulants for Preschool-Age Children With Attention-Deficit/Hyperactivity Disorder. ( Barbaresi, W; Bax, A; Blum, NJ; Cacia, J; Deavenport-Saman, A; Friedman, S; Harstad, E; LaRosa, A; Loe, IM; Mittal, S; Shults, J; Tulio, S; Vanderbilt, D, 2021)

Research

Studies (3)

Authors

Clinical Trials (2)

Trial Overview

Trial Outcomes

Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at 6 Weeks

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	1 (33.33)	29.6817
2010's	1 (33.33)	24.3611
2020's	1 (33.33)	2.80

Authors	Studies
Harstad, E	1
Shults, J	1
Barbaresi, W	1
Bax, A	1
Cacia, J	1
Deavenport-Saman, A	1
Friedman, S	1
LaRosa, A	1
Loe, IM	1
Mittal, S	1
Tulio, S	1
Vanderbilt, D	1
Blum, NJ	1
Biederman, J	1
Melmed, RD	1
Patel, A	1
McBurnett, K	1
Donahue, J	1
Lyne, A	2
Kollins, SH	1
López, FA	1
Vince, BD	1
Turnbow, JM	1
Farrand, K	1
Wigal, SB	1
Roth, T	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Efficacy of Pharmacologic Management of ADHD in Children and Youth With Autism Spectrum Disorder[NCT05916339]	Phase 4	500 participants (Anticipated)	Interventional	2023-10-01	Not yet recruiting
A Phase II Study to Assess the Safety, Tolerability and Efficacy of SPD503 Administered to Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)[NCT00150592]	Phase 2	182 participants (Actual)	Interventional	2005-05-12	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. (NCT00150592)
Timeframe: Baseline and 6 weeks

Change From Baseline in Choice Reaction Time (CRT) at 6 Weeks

Intervention	Units on a Scale (Mean)
SPD503	-8.8
Placebo	-5.5

Choice reaction time (CRT) is a computerized assessment that trains the subject in holding down a press-pad and releasing the press-pad in response to stimuli presented on the screen. The task requires the subject to react as soon as a yellow dot appears in one of five locations, and the subject must respond by lifting their hand from the press-pad. This is the reaction time (RT) and ranges from 100 to 5000 msec. Lower scores indicate better performance. (NCT00150592)
Timeframe: Baseline and 6 weeks

Change From Baseline in Digital Symbol Substitution Task/Coding Test (DSST/Coding) Scores at 6 Weeks in Age Category 8-17 Years

Intervention	msec (Mean)
SPD503	20.7
Placebo	21.9

The Digital Symbol Substitution Task/Coding Test (DSST/Coding) assesses relative contributions of speed, memory, and visual scanning. Subjects are required to copy symbols that are paired with simple geometric shapes or numbers within a specific time. Scores range from 0-65 in age category 6-7 years and 0-199 in age category 8-17 years. Higher scores indicate better performance. (NCT00150592)
Timeframe: Baseline and 6 weeks

Change From Baseline in DSST/Coding Scores at 6 Weeks in Age Category 6-7 Years

Intervention	Units on a scale (Mean)
SPD503	18.3
Placebo	20.7

Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Scores at 6 Weeks

Intervention	Units on a scale (Mean)
SPD503	1.9
Placebo	9.7

The Pediatric Daytime Sleepiness Scale (PDSS) is an 8 question questionnaire scored on a scale from 0 (never) to 4 (always). Total scores range from 0 to 32, with increasing score reflecting greater sleepiness. (NCT00150592)
Timeframe: Baseline and 6 weeks

Change From Baseline in Pictorial Sleepiness Scale (PSS) Scores at 6 Weeks

Intervention	Units on a Scale (Mean)
SPD503	-1.3
Placebo	0.9

The Pictorial Sleepiness Scale (PSS) scores range from 1 (far left wide awake face) to 5 (far right very sleepy face). Increasing score reflects greater sleepiness. (NCT00150592)
Timeframe: Baseline and 6 weeks

Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I) at 6 Weeks

Intervention	Units on a Scale (Mean)
SPD503	0.0
Placebo	0.1

Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. (NCT00150592)
Timeframe: 6 weeks

Change From Baseline in Spatial Working Memory (SWM) Scores at 6 Weeks

Intervention	Participants (Number)
SPD503	67
Placebo	20

"The Spatial Working Memory (SWM) Test is a computerized assessment of working memory and strategy performance. The subject is required to find blue tokens in various displayed boxes and use the tokens to fill a column on the right side of the screen. Subjects can only find tokens in new boxes, therefore they must remember where previous tokens were found. SWM scores including number of between errors, number of within errors, and number of double errors range 0-800 and SWM strategy scores range 8-56. Lower scores indicate better performance." (NCT00150592)
Timeframe: Baseline and 6 weeks

Intervention	Units on a scale (Mean)
	Between errors	Within errors	Double errors	Strategy
Placebo	-3.2	-0.1	0.1	-0.1
SPD503	-4.4	0.0	-0.0	-0.9

Article	Year
Long-term, open-label extension study of guanfacine extended release in children and adolescents with ADHD. CNS spectrums, 2008, Volume: 13, Issue:12 Topics: Adolescent; Adrenergic alpha-Agonists; Attention Deficit Disorder with Hyperactivity; Blood Pressure	2008
Psychomotor functioning and alertness with guanfacine extended release in subjects with attention-deficit/hyperactivity disorder. Journal of child and adolescent psychopharmacology, 2011, Volume: 21, Issue:2 Topics: Adolescent; Adrenergic alpha-2 Receptor Agonists; Attention Deficit Disorder with Hyperactivity; Chi	2011

guanfacine and Disorders of Excessive Somnolence