XP13512 vs. Placebo in Patients With Restless Legs Syndrome.

XenoPort

Status and phase: Completed; Phase 3

Conditions: Restless Legs Syndrome

Treatments: Drug: PLACEBO; Drug: XP13512 1200MG; Drug: XP13512 600MG

Study type: Interventional

Funder types: Industry

Identifiers

NCT00365352

111460

XP053 (Other Identifier)

Details and patient eligibility

About

The primary objective of this trial is to assess the efficacy of XP13512 taken once daily compared to placebo for the treatment of patients suffering from Restless Legs Syndrome (RLS).

Full description

This was a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of XP13512 in subjects with Restless Legs Syndrome (RLS). Eligible subjects were randomized to receive 1 of 3 once daily oral doses of XP13512 1200 mg, XP13512 600 mg, or placebo. The primary study objective was to compare the efficacy of XP13512 1200 mg taken once daily for 12 weeks versus placebo. The secondary study objectives were to assess the efficacy of XP13512 600 mg taken once daily for the reatment of RLS and to assess the onset of treatment benefits and improvement in sleep, pain, mood, quality of life, and safety and tolerability of both XP13512 1200 mg and 600 mg.

Enrollment: 325 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with primary RLS, based on the International RLS Study Diagnostic Criteria.

Exclusion criteria

• A sleep disorder (e.g., sleep apnea) that may significantly affect the assessment of RLS;
• Neurologic disease or movement disorder (e.g., diabetic neuropathy, Parkinson's Disease, Multiple Sclerosis, dyskinesias, and dystonias);
• Abnormal laboratory results, electrocardiogram (ECG) or physical findings;
• Pregnant or lactating women;
• Women of childbearing potential who are not practicing an acceptable method of birth control.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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325 participants in 3 patient groups, including a placebo group

XP13512 600MG

Experimental group

Description:

XP13512 600MG ONCE DAILY

Treatment:

Drug: XP13512 600MG

XP13512 1200MG

Experimental group

Description:

XP13512 1200MG ONCE DAILY

Treatment:

Drug: XP13512 1200MG

Placebo

Placebo Comparator group

Description:

PLACEBO ONCE DAILY

Treatment:

Drug: PLACEBO