12-Week Efficacy And Safety Of Pregabalin In Treating Restless Legs Syndrome (RLS) Subjects
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ClinicalTrials.gov Identifier: NCT01061372 |
Recruitment Status
:
Withdrawn
First Posted
: February 3, 2010
Last Update Posted
: June 29, 2010
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Restless Legs Syndrome | Drug: Placebo Drug: pregabalin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Randomized Double-Blind, 12-Week Study Of Pregabalin In Subjects With Restless Legs Syndrome |
Study Start Date : | May 2010 |
Estimated Primary Completion Date : | August 2011 |
Estimated Study Completion Date : | August 2011 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo |
Drug: Placebo
Placebo, orally administered once a day, 1-3 hours before bedtime for 12 weeks
|
Experimental: Pregabalin 150 mg/day |
Drug: pregabalin
pregabalin 150 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 weeks
Other Name: Lyrica
|
Experimental: Pregabalin 300 mg/day |
Drug: pregabalin
pregabalin 300 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 weeks
Other Name: Lyrica
|
- Changes from baseline in RLS symptom severity using the International Restless Leg Group Rating Scale (IRLS) total score for efficacy assessment [ Time Frame: up to 12 weeks ]
- The proportion of subjects responding to treatment using the Clinical Global Impression - Improvement (CGI-I) scale for efficacy assessment [ Time Frame: up to 12 weeks ]
- Subjective Sleep Questionnaire (SSQ - Subjective WASO) [ Time Frame: up to 12 weeks ]
- RLS Next Day Impact (RLS-NDI) [ Time Frame: up to 12 weeks ]
- Limb pain rating using a numerical rating scale (Limb Pain - NRS) [ Time Frame: up to 12 weeks ]
- Clinical Global Impressions - Severity (CGI-S) [ Time Frame: up to 12 weeks ]
- Medical Outcomes Study - Sleep Scale (MOS - SS) [ Time Frame: up to 12 weeks ]
- Impact on Life (IRLS symptom impact sub-score) [ Time Frame: up to 12 weeks ]
- RLS-Quality of Life Scale (RLS-QoL) [ Time Frame: up to 12 weeks ]
- Medical Outcomes Study - Short Form 36 (SF-36) [ Time Frame: up to 12 weeks ]
- Work Productivity and Activity Impairment - Specific Health Problem (WPAI-SHP) [ Time Frame: up to 12 weeks ]
- Profile of Mood States (POMS) [ Time Frame: up to 12 weeks ]
- Adverse events from spontaneous reports will be monitored throughout the trial and summarized by treatment group [ Time Frame: up to 12 weeks ]
- Sheehan Suicidality Tracking Scale (S-STS) will be utilized to assess the risk of suicide [ Time Frame: 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 [ Time Frame: week 13 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Idiopathic Restless Legs Syndrome with the presence of all four clinical manifestations of RLS:
- RLS symptoms occur predominantly in the evening
- RLS history at least 6 months
- International Restless Legs Study Group Rating Scale (IRLS) greater than or equal to 15 at the beginning and the end of placebo run-in
- Have greater than or equal to 15 nights with RLS symptoms in the month prior to screening
Exclusion Criteria:
- Any secondary RLS
- Current augmentation due to RLS treatment
- Placebo responders identified during the placebo run-in

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01061372
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
ClinicalTrials.gov Identifier: | NCT01061372 History of Changes |
Other Study ID Numbers: |
A0081184 |
First Posted: | February 3, 2010 Key Record Dates |
Last Update Posted: | June 29, 2010 |
Last Verified: | June 2010 |
Keywords provided by Pfizer:
RLS |
Additional relevant MeSH terms:
Syndrome Psychomotor Agitation Restless Legs Syndrome Disease Pathologic Processes Dyskinesias Neurologic Manifestations Nervous System Diseases Psychomotor Disorders Neurobehavioral Manifestations Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Parasomnias |
Mental Disorders Pregabalin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs |