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The purpose of this study is to assess efficacy and safety of pregabalin in treating moderate to severe Restless Legs Syndrome in comparison to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Pregabalin 150 mg/day | Experimental |
| |
| Pregabalin 300 mg/day | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo, orally administered once a day, 1-3 hours before bedtime for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in RLS symptom severity using the International Restless Leg Group Rating Scale (IRLS) total score for efficacy assessment | up to 12 weeks | |
| The proportion of subjects responding to treatment using the Clinical Global Impression - Improvement (CGI-I) scale for efficacy assessment | up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Sleep Questionnaire (SSQ - Subjective WASO) | up to 12 weeks | |
| RLS Next Day Impact (RLS-NDI) | up to 12 weeks | |
| Limb pain rating using a numerical rating scale (Limb Pain - NRS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| pregabalin |
| Drug |
pregabalin 150 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 weeks |
|
|
| pregabalin | Drug | pregabalin 300 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 weeks |
|
|
| up to 12 weeks |
| Clinical Global Impressions - Severity (CGI-S) | up to 12 weeks |
| Medical Outcomes Study - Sleep Scale (MOS - SS) | up to 12 weeks |
| Impact on Life (IRLS symptom impact sub-score) | up to 12 weeks |
| RLS-Quality of Life Scale (RLS-QoL) | up to 12 weeks |
| Medical Outcomes Study - Short Form 36 (SF-36) | up to 12 weeks |
| Work Productivity and Activity Impairment - Specific Health Problem (WPAI-SHP) | up to 12 weeks |
| Profile of Mood States (POMS) | up to 12 weeks |
| Adverse events from spontaneous reports will be monitored throughout the trial and summarized by treatment group | up to 12 weeks |
| Sheehan Suicidality Tracking Scale (S-STS) will be utilized to assess the risk of suicide | up to 12 weeks |
| Changes in RLS symptoms following the discontinuation of study drug at the end of treatment will be evaluated by collection of the IRLS scores at the end of the drug taper period at Week 13 | week 13 |
| D020447 |
| Parasomnias |
| D001523 | Mental Disorders |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |