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

Viatris

Status and phase: Withdrawn; Phase 3

Conditions: Restless Legs Syndrome

Treatments: Drug: pregabalin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01061372

A0081184

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Pregabalin 150 mg/day

Experimental group

Treatment:

Drug: pregabalin

Drug: pregabalin

Pregabalin 300 mg/day

Experimental group

Treatment:

Drug: pregabalin

Drug: pregabalin