12-Week Efficacy And Safety Of Pregabalin In Treating Restless Legs Syndrome (RLS) Subjects

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Restless Legs Syndrome	Drug: Placebo; Drug: pregabalin	Phase 3

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Primary Outcome Measures :

1. 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 ]
2. 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 ]

Secondary Outcome Measures :

1. Subjective Sleep Questionnaire (SSQ - Subjective WASO) [ Time Frame: up to 12 weeks ]
2. RLS Next Day Impact (RLS-NDI) [ Time Frame: up to 12 weeks ]
3. Limb pain rating using a numerical rating scale (Limb Pain - NRS) [ Time Frame: up to 12 weeks ]
4. Clinical Global Impressions - Severity (CGI-S) [ Time Frame: up to 12 weeks ]
5. Medical Outcomes Study - Sleep Scale (MOS - SS) [ Time Frame: up to 12 weeks ]
6. Impact on Life (IRLS symptom impact sub-score) [ Time Frame: up to 12 weeks ]
7. RLS-Quality of Life Scale (RLS-QoL) [ Time Frame: up to 12 weeks ]
8. Medical Outcomes Study - Short Form 36 (SF-36) [ Time Frame: up to 12 weeks ]
9. Work Productivity and Activity Impairment - Specific Health Problem (WPAI-SHP) [ Time Frame: up to 12 weeks ]
10. Profile of Mood States (POMS) [ Time Frame: up to 12 weeks ]
11. Adverse events from spontaneous reports will be monitored throughout the trial and summarized by treatment group [ Time Frame: up to 12 weeks ]
12. Sheehan Suicidality Tracking Scale (S-STS) will be utilized to assess the risk of suicide [ Time Frame: up to 12 weeks ]
13. 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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

Pfizer

Investigators

Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

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
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