A Randomized, Double-Blind, Placebo-Controlled Four Week Study of the Efficacy and Safety of Four Doses (0.05 mg, 0.1 mg, 0.25 mg, 0.5 mg) of Aplindore MR Tablets vs. Placebo in Idiopathic Restless Legs Syndrome.

Neurogen Corporation24 sites in 1 country230 target enrollmentFebruary 2009

ConditionsRestless Legs Syndrome

Interventionsaplindore MR tablets or Placebo

Drugsaplindore MR tablets or Placebo

Overview

Phase: Phase 2
Intervention: aplindore MR tablets or Placebo
Conditions: Restless Legs Syndrome
Sponsor: Neurogen Corporation
Enrollment: 230
Locations: 24
Primary Endpoint: The change from baseline (Day 1) to final (Day 28) on the International Restless Legs Scale (IRLS).
Status: Terminated
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a clinical trial to be conducted at multiple sites in the USA. Patients diagnosed with moderate to severe Restless Legs Syndrome will be randomly allocated to one of 5 treatment arms in the study. The 5 arms include 4 arms with different doses of aplindore MR tablets and 1 placebo arm. The treatment will be taken once a day. The study is blinded and neither patients, nor the investigators, will know what treatment the patient is receiving. Patients will be assigned a dose and will be maintained at that dose for several weeks (2 treatment arms include a short titration period). The entire study will take about 6 weeks. The study will measure how effective aplindore is in decreasing symptoms of Restless Legs Syndrome, and will also assess the safety and tolerability of aplindore.

Detailed Description

Two hundred and thirty patients will be randomly assigned to one of five treatment arms in this outpatient study. Of the four aplindore arms, two arms will be titrated over a brief period until the targeted dose is achieved, and then as with the other arms, will be maintained for several weeks. Dosing will take place over a total of about 4 weeks.

Registry

clinicaltrials.gov

Start Date

February 2009

End Date

December 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Neurogen Corporation

Eligibility Criteria

Inclusion Criteria

•Male or female 18-85 years;
•Must have a score of ≥20 on the IRLS at Day 1 (Baseline) Visit;
•Have a history of moderate to severe RLS symptoms that disrupted sleep for at least 3 nights per week over at least a 3 month period either immediately before screening or prior to starting any RLS treatment;
•Patients must be off dopamine agonists or any other medications they are taking for RLS for a minimum of one week or 5 half lives of the RLS medication whichever is longer, prior to the Day 1 (Baseline) Visit;
•Patients must be in good general health as determined by a thorough medical history and physical examination (including vital signs), and 12-lead electrocardiogram (ECG);
•Patients must have clinical laboratory values within normal reference range or must not be clinically significantly abnormal as judged by the Investigator at screening;
•Females of childbearing potential must be using an acceptable method of contraception, have a negative serum pregnancy test at screening, and a negative urine pregnancy test at baseline. Acceptable methods of contraception include oral, intrauterine, implantable, injectable contraceptives, hormonal patch, double barrier methods or condoms impregnated with spermicide. After screening, patients using oral contraceptive methods of contraception must agree to add an additional method until 30 days following the last dose of study medication. Women on oral contraceptives must have been using them for at least one month prior to screening;
•Male patients with partners of childbearing potential must agree to use adequate contraception (use of a condom and a spermicidal) during the study and for 3 months after the study;
•Female patients who have been surgically sterilized are eligible if they have a negative pregnancy test at screening and at Baseline;
•If receiving hormone replacement therapy, patients must be on a stable regimen for minimum of 3 months prior to screening;

Exclusion Criteria

•Clinically significant unstable medical illness;
•Clinically significant allergic, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease;
•History of non-basal cell cancer or squamous cell cancers or carcinoma in situ of the cervix within 2 years before the screening visit are excluded; for all other cancer diagnoses, patients with a history within 5 years before the screening visit are excluded;
•Patients with plasma ferritin levels less than 10 ng/mL at screening;
•A supine blood pressure \> 140/90 mm/Hg at screening or baseline;
•Patients taking OTC or prescription medications that can, in the judgment of the investigator, exacerbate or are the cause of their RLS symptoms will be excluded from the study;
•Patients taking prescription drug therapy or over the counter (OTC) medication for chronic medical conditions other then RLS who are not on stable doses for at least two months prior to screening; patients who are not off any investigational drug for at least 30 days prior to screening;
•History of chronic use of dopamine antagonists for more than 6 months within the past 2 years;
•History or presence of chronic pain other than that associated with RLS. Patients should be excluded if the preponderance of the patient's complaints is related to pain and not associated with the urge to move;
•Clinically significant narcolepsy, parasomnia as an adult, significant circadian rhythm disorder, or secondary causes of RLS, (e.g., uremia or neuropathy);