thalidomide and Algodystrophic Syndrome

thalidomide has been researched along with Algodystrophic Syndrome in 3 studies

Thalidomide: A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects. It has been reintroduced and used for a number of immunological and inflammatory disorders. Thalidomide displays immunosuppressive and anti-angiogenic activity. It inhibits release of TUMOR NECROSIS FACTOR-ALPHA from monocytes, and modulates other cytokine action.
thalidomide : A racemate comprising equimolar amounts of R- and S-thalidomide.
2-(2,6-dioxopiperidin-3-yl)-1H-isoindole-1,3(2H)-dione : A dicarboximide that is isoindole-1,3(2H)-dione in which the hydrogen attached to the nitrogen is substituted by a 2,6-dioxopiperidin-3-yl group.

Research

Studies (3)

Authors

Clinical Trials (1)

Trial Overview

Trial Outcomes

"Change From Baseline in Mechanically Evoked (Allodynia) Numeric Rating Scale (NRS) Score at Week 12"

The investigator rated the degree of allodynia on both the CRPS-affected limb on an eleven-point scale where 0=no pain and 10=worst pain imaginable. This outcome compares the baseline values for the CRPS affected-limb to the values at week 12. Negative change values indicate improvement. (NCT00109772)
Timeframe: Day 0, week 12

Change From Baseline in Activity Level Rating Using a Numeric Rating Scale (NRS) at Week 12

Participants rated how the activity level on a given day compares with their activity level prior to the start of treatment. A seven-point scale is used with -3=much worse and +3=much better. Positive change values indicate improvement. (NCT00109772)
Timeframe: Day 0, week 12

Change From Baseline in Daily Sleep Assessment Average Score at Week 12

Participants rated how much CRPS pain interfered with their sleep each day in a diary. The Sleep Assessment uses an eleven point scale for four questions. Questions concern ability to fall asleep, ability to stay asleep, how refreshed the participant feels upon waking and how alert the participant is during the day. All use a scale of 0-10, where the higher number is the positive response (e.g. 0=Pain completely interferes with sleep and 10=Pain does not interfere). The mean of all four responses was calculated if at least 3 of the 4 questions had a value. Week 12 values are compared to baseline values. Positive change values indicate improvement. (NCT00109772)
Timeframe: Day 0, week 12

Change From Baseline in Participant Assessment of CRPS Symptoms Total Score at Week 12

Participants rated twelve CRPS symptoms using a four-point rating scale in which 1=the most positive outcome and 4= the most negative outcome for a total scale of 12-48. Week 12 values are compared to baseline values. Negative change values indicate improvement. (NCT00109772)
Timeframe: Day 0, week 12

Change From Baseline in the Brief Pain Inventory (BPI) Total Score at Week 12

Participants completed the Brief Pain Inventory which asks twelve questions that are rated on an eleven-point scale in which 0=most positive outcome and 10=the most negative outcome for a total scale of 0-120. BPI contains questions that concern the level of pain over the last week and the level of pain right now, the extent to which pain interfered with sleep, normal activities, ability to work, relationships, walking etc. Week 12 values are compared to baseline values. Negative change values indicate improvement. (NCT00109772)
Timeframe: Day 0, week 12

Change From Baseline in the Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score Using Averaged Morning and Evening Readings at Week 12

Participants rated the intensity of pain in the CRPS-affected limb twice each day in a diary. Morning and evening scores are averaged. The PI-NRS is an eleven point scale with 0=no pain and 10=worst pain imaginable. Week 12 values are compared to baseline values. Negative changes indicate improvement in level of pain. (NCT00109772)
Timeframe: Day 0, week 12

Change From Baseline in the Evening Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score at Week 12

Participants rated the intensity of pain in the CRPS-affected limb twice each day in a diary. The PI-NRS is an eleven point scale with 0=no pain and 10=worst pain imaginable. The evening pain ratings at baseline and Week 12 are compared. Negative changes indicate improvement in level of pain. (NCT00109772)
Timeframe: Day 0, week 12

Change From Baseline in the Maximal Composite Motor Nerve Conduction Velocity at Week 12

An electrophysiological evaluation using standard electrophysiological and electromyography to measure the speed and extent of nerve conduction. Week 12 values are compared to baseline values for maximal motor nerve conduct velocity. (NCT00109772)
Timeframe: Day 0, week 12

Change From Baseline in the Maximal Composite Sensory Nerve Conduction Velocity at Week 12

An electrophysiological evaluation using standard electrophysiological and electromyography to measure the speed and extent of nerve conduction. Week 12 values are compared to baseline values for maximal sensory nerve conduct velocity. (NCT00109772)
Timeframe: Day 0, week 12

Change From Baseline in the Morning Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score at Week 12

Participants rated the intensity of pain in the CRPS-affected limb twice each day in a diary. The PI-NRS is an eleven point scale with 0=no pain and 10=worst pain imaginable. The morning pain ratings at baseline and Week 12 are compared. Negative changes indicate improvement in level of pain. (NCT00109772)
Timeframe: Day 0, week 12

Change From Baseline in the Profile of Mood States (POMS) at Week 12

Participants completed the Profile of Mood States questionnaire that asks participants to rate how each of 65 words reflected their mood in the past week on a 5-point scale with 0=not at all and 4=extremely for a total scale of 0-260. Week 12 values are compared to baseline values. Negative change values indicate improvement. (NCT00109772)
Timeframe: Day 0, week 12

Change From Baseline in the Total Score of the Short Form McGill Pain Questionnaire (SF-MPQ) at Week 12

Short Form McGill Pain Questionnaire (SF-MPQ) is comprised of 15 pain qualities that are rated by the participant on a 4 point scale with 0=none and 3=severe. The scale for the Total Score is 0-45. Week 12 values are compared to baseline values. Negative changes indicate improvement in level of pain. (NCT00109772)
Timeframe: Day 0, week 12

Difference in Allodynia Rating Between the CRPS-affected Limb and the Normal Limb at Week 12

The investigator rated the degree of allodynia on both the CRPS-affected limb and the normal (or less-affected) limb on an eleven-point scale where 0=no pain and 10=worst pain imaginable. This outcome compares the values for the CRPS affected-limb to the normal limb at week 12. (NCT00109772)
Timeframe: Week 12

Patient Global Impression of Change (PGIC) at Week 12

The Patient Global Impression of Change asks the question: Overall, how would you rate your CRPS condition since the start of study drug? Answers are represented on a seven-point scale with -3=much worst and +3=much better. (NCT00109772)
Timeframe: Week 12

Participants Who Had a Change to CRPS Pain Medication During the Treatment Period

Participants who had any change in CRPS medication during the double-blind treatment period (up to week 12) are summarized. Changes include additions, discontinuations or dosage change of CRPS medication(s). (NCT00109772)
Timeframe: Day 1 to week 12

Participants With Treatment-Emergent Adverse Events in the Double-Blind Period or the Extension Period

"Counts of study participants who had adverse events (AEs) while treated in either the Double-blind or Extension Periods. The NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 was used by the investigator to grade the severity of the AEs: Grade 1=Mild AE, Grade 2=Moderate AE, Grade 3=Severe AE, Grade 4=Life-threatening or disabling AE, Grade 5=Death related to AE.~AEs are also summarized by whether they were serious, related to treatment and whether the AE caused treatment to be altered.~A serious AE (SAE) was any event that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect or was an important medical event could have jeopardized the patient's safety or required medical or surgical intervention to prevent one of the outcomes listed above." (NCT00109772)
Timeframe: Day 1 up to week 158

Percentage of Participants Who Have a >= 30% Reduction (Improvement) in the Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score From Baseline to the Last Assessment

Participants rated the intensity of pain in the CRPS-affected limb twice each day in a diary. The PI-NRS is an eleven point scale with 0=no pain and 10=worst pain imaginable. Responders are participants who completed 12 weeks of treatment and their week 12 PI-NRS score showed at least a 30% improvement from baseline. Participants who did not complete 12 weeks of treatment are considered non-responders. (NCT00109772)
Timeframe: Day 0, Week 12

Trials

1 trial available for thalidomide and Algodystrophic Syndrome

Other Studies

2 other studies available for thalidomide and Algodystrophic Syndrome