Efficacy and Safety Study of Aplindore in Patients With Restless Legs Syndrome

NCT00834327 | Terminated Phase 2

• 1 other identifier: Aplindore-250
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 24

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.

Conditions

Restless Legs Syndrome

Keywords

Restless Legs Syndrome

Outcome Measures

Primary Outcomes (1)

• The change from baseline (Day 1) to final (Day 28) on the International Restless Legs Scale (IRLS).

  Day 1, Day 14, and Day 28

Study Arms (5)

1

EXPERIMENTAL

aplindore 0.05 mg MR total daily dose

Drug: aplindore MR tablets or Placebo

2

EXPERIMENTAL

aplindore 0.1 mg MR total daily dose

Drug: aplindore MR tablets or Placebo

3

EXPERIMENTAL

aplindore 0.25 mg MR total daily dose (to include short titration)

Drug: aplindore MR tablets or Placebo

4

EXPERIMENTAL

aplindore 0.5 mg MR total daily dose (to include short titration)

Drug: aplindore MR tablets or Placebo

5

PLACEBO COMPARATOR

Placebo

Drug: aplindore MR tablets or Placebo

Interventions

aplindore MR tablets or Placebo DRUG

aplindore MR tablets administered QD for about 4 weeks

1; 2; 3; 4; 5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Patients must be able to read, understand, and provide written/dated informed consent before enrolling in the study, and must be willing to comply with all study procedures.

You may not qualify if:

• 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);
• Any condition that may affect oral drug absorption;
• Travel across more than three time zones, have an expected change in sleep schedules of 6 hours or more, or have involvement in night shift work within seven days prior to screening through to study completion;
• Any clinically significant abnormal finding at the Screening Visit on physical examination, vital signs, or ECG, as determined by the Investigator; (The QTcF interval must be ≤ 450 msec for males and ≤ 470 msec for females);
• History of allergies, or known sensitivity, hypersensitivity, or adverse reaction to aplindore or structurally similar compounds such as flesinomax, ropinirole or ziprasadone;
• Pregnant or lactating females;

Sponsors & Collaborators

• Neurogen Corporation: lead

Study Sites (24)

HOPE Research Institute

Phoenix, Arizona, 85050, United States

Location

Genova Clinical Research

Tuscon, Arizona, 85741, United States

Location

Excell Research, Inc.

Oceanside, California, 92056, United States

Location

Lynn Institute of Pueblo

Pueblo, Colorado, 81001, United States

Location

Gaylord Sleep Medicine

Wallingford, Connecticut, 06492, United States

Location

Tampa Bay Medical Research

Clearwater, Florida, 33761, United States

Location

University Clinical Research Deland, LLC

DeLand, Florida, 32720, United States

Location

MD Clinical

Hallandale, Florida, 33009, United States

Location

University Clinical Research

Pembroke Pines, Florida, 33024, United States

Location

Broward Research Group

Pembroke Pines, Florida, 33026, United States

Location

Miami Research Associates

South Miami, Florida, 33013, United States

Location

Neurotrials Research, Inc.

Atlanta, Georgia, 30342, United States

Location

Sleep & Behavior Medicine Institute

Vernon Hills, Illinois, 60061, United States

Location

Community Research & Sleep Management Institute

Crestview Hills, Kentucky, 41017, United States

Location

Quest Research Institute

Bingham Farms, Michigan, 48025, United States

Location

Sleep Medicine and Research Center - St Luke's Hospital

Chesterfield, Missouri, 63017, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Comunity Reasearch

Cincinnati, Ohio, 45227, United States

Location

Tri-State Sleep Disorders Center

Cincinnati, Ohio, 45246, United States

Location

North Star Medical Research, LLC

Middleburg Heights, Ohio, 44130, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

Sleep Medicine Associates of Texas, P.A.

Dallas, Texas, 75231, United States

Location

Paragon Research Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Restless Legs Syndrome

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 30, 2009
• First Posted: February 3, 2009
• Study Start: February 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: December 1, 2009
• Last Updated: October 14, 2009

Record last verified: 2009-10

Locations

US (24)