Efficacy and Safety Study of Aplindore in Patients With Restless Legs Syndrome
Public ClinicalTrials.gov record NCT00834327. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00834327
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 230 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 2009 (Type not available)
- Primary completion
- Nov 2009 (Estimated)
- Completion
- Dec 2009 (Estimated)
- Last update posted
- Oct 14, 2009
2009
United States locations
- U.S. sites
- 24
- U.S. states
- 15
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| HOPE Research Institute | Phoenix | Arizona | 85050 | — |
| Genova Clinical Research | Tuscon | Arizona | 85741 | — |
| Excell Research, Inc. | Oceanside | California | 92056 | — |
| Lynn Institute of Pueblo | Pueblo | Colorado | 81001 | — |
| Gaylord Sleep Medicine | Wallingford | Connecticut | 06492 | — |
| Tampa Bay Medical Research | Clearwater | Florida | 33761 | — |
| University Clinical Research Deland, LLC | DeLand | Florida | 32720 | — |
| MD Clinical | Hallandale | Florida | 33009 | — |
| University Clinical Research | Pembroke Pines | Florida | 33024 | — |
| Broward Research Group | Pembroke Pines | Florida | 33026 | — |
| Miami Research Associates | South Miami | Florida | 33013 | — |
| Neurotrials Research, Inc. | Atlanta | Georgia | 30342 | — |
| Sleep & Behavior Medicine Institute | Vernon Hills | Illinois | 60061 | — |
| Community Research & Sleep Management Institute | Crestview Hills | Kentucky | 41017 | — |
| Quest Research Institute | Bingham Farms | Michigan | 48025 | — |
| Sleep Medicine and Research Center - St Luke's Hospital | Chesterfield | Missouri | 63017 | — |
| Wake Research Associates | Raleigh | North Carolina | 27612 | — |
| Comunity Reasearch | Cincinnati | Ohio | 45227 | — |
| Tri-State Sleep Disorders Center | Cincinnati | Ohio | 45246 | — |
| North Star Medical Research, LLC | Middleburg Heights | Ohio | 44130 | — |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | — |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | — |
| Sleep Medicine Associates of Texas, P.A. | Dallas | Texas | 75231 | — |
| Paragon Research Center | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00834327, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 14, 2009 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00834327 live on ClinicalTrials.gov.