Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients (RLS)

Viatris

Status and phase: Completed; Phase 3

Conditions: Idiopathic Restless Legs Syndrome

Treatments: Drug: Pregabalin; Drug: placebo and pregabalin; Drug: pramipexol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00806026

A0081186

Details and patient eligibility

About

This purpose of this study is to investigate the efficacy and tolerability of pregabalin in treating idiopathic RLS patients for up to 12 months.

Enrollment: 731 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• idiopathic RLS with the presence of all four clinical manifestations of RLS
• RLS symptoms occur predominantly in the evening
• RLS history at least 6 months
• IRLS => 15 at the beginning and the end of placebo run-in
• Have =>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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731 participants in 6 patient groups

PBO/PGB 300 mg

Experimental group

Treatment:

Drug: placebo and pregabalin

PBO/PPX 0.25 mg

Active Comparator group

Treatment:

Drug: pramipexol

Drug: pramipexol

Drug: pramipexol

Drug: pramipexol

PBO/PPX 0.5 mg

Active Comparator group

Treatment:

Drug: pramipexol

Drug: pramipexol

Drug: pramipexol

Drug: pramipexol

PGB 300 mg

Experimental group

Treatment:

Drug: Pregabalin

PPX 0.25 mg

Active Comparator group

Treatment:

Drug: pramipexol

Drug: pramipexol

Drug: pramipexol

Drug: pramipexol

PPX 0.5 mg

Active Comparator group

Treatment:

Drug: pramipexol

Drug: pramipexol

Drug: pramipexol

Drug: pramipexol