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Safety and Efficacy Study of IPX159 in Restless Legs Syndrome (RLS)

NCT01521663 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2017-02-01

No results posted yet for this study

Summary

The purpose of this study is to determine whether IPX159 is safe and effective in treating symptoms of RLS in subjects with Restless Legs Syndrome.

Conditions

  • Restless Legs Syndrome

Interventions

DRUG

IPX159

DRUG

Placebo

Sponsors & Collaborators

  • Impax Laboratories, LLC

    lead INDUSTRY

Principal Investigators

  • Impax Study Director · Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-02-28
Completion
2013-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01521663 on ClinicalTrials.gov