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

Restless Legs Syndrome Clinical Trial

Official title:

Randomized Double-Blind, 12-Week Study Of Pregabalin In Subjects With Restless Legs Syndrome

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01061372
• Other study ID #: A0081184
• Status: Withdrawn
• Phase: Phase 3
• Start date: May 2010
• Est. completion date: August 2011

Study information

• Verified date: June 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs Syndrome
• Syndrome

Intervention

Drug:
• Placebo
Placebo, orally administered once a day, 1-3 hours before bedtime for 12 weeks
• pregabalin
pregabalin 150 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 weeks
• pregabalin
pregabalin 300 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	The proportion of subjects responding to treatment using the Clinical Global Impression - Improvement (CGI-I) scale for efficacy assessment		up to 12 weeks
Secondary	Subjective Sleep Questionnaire (SSQ - Subjective WASO)		up to 12 weeks
Secondary	RLS Next Day Impact (RLS-NDI)		up to 12 weeks
Secondary	Limb pain rating using a numerical rating scale (Limb Pain - NRS)		up to 12 weeks
Secondary	Clinical Global Impressions - Severity (CGI-S)		up to 12 weeks
Secondary	Medical Outcomes Study - Sleep Scale (MOS - SS)		up to 12 weeks
Secondary	Impact on Life (IRLS symptom impact sub-score)		up to 12 weeks
Secondary	RLS-Quality of Life Scale (RLS-QoL)		up to 12 weeks
Secondary	Medical Outcomes Study - Short Form 36 (SF-36)		up to 12 weeks
Secondary	Work Productivity and Activity Impairment - Specific Health Problem (WPAI-SHP)		up to 12 weeks
Secondary	Profile of Mood States (POMS)		up to 12 weeks
Secondary	Adverse events from spontaneous reports will be monitored throughout the trial and summarized by treatment group		up to 12 weeks
Secondary	Sheehan Suicidality Tracking Scale (S-STS) will be utilized to assess the risk of suicide		up to 12 weeks
Secondary	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

External Links

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