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NCT00626418 · ClinicalTrials.gov registry record · Phase 2
The Effects of Aplindore on the Treatment of Signs and Symptoms of Restless Legs Syndrome
A Phase 2 study, sponsored by Ligand Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT00626418 is a Phase 2 study that has completed, run by Ligand Pharmaceuticals. The registered enrollment target is 24 participants.
The verdict
NCT00626418, a Phase 2 study, has completed, sponsored by Ligand Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the efficacy and tolerability of single doses of aplindore compared to placebo in RLS. Patients will be required to spend 5-8 nights in a sleep laboratory. This includes 1 adaptation night, 1 placebo night, and 3-6 drug treatment nights. Ascending doses of active drug will be administered on study nights 3 through 5 to determine the maximum well tolerated efficacious dose (defined as a decrease in Periodic Limb Movement Index (PLMI) of at least 50% from placebo baseline). If an efficacious dose cannot be identified the Investigator in consultation with the sponsor may decide to examine higher doses in up to 3 additional PSG nights in an attempt to identify a tolerable efficacious dose. This study will utilize up to 24 evaluable patients, each meeting International Classification of Sleep Disorders (ICSD-2) diagnostic criteria for primary RLS who are not currently taking any RLS medication including DAs ( and L-dopa) or who are able to discontinue their RLS medication at least 5 half-lives prior to the adaptation night.
Interventions
- DRUG Placebo
- DRUG Aplindore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2008-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00626418
The ClinicalTrials.gov registry entry for NCT00626418 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ligand Pharmaceuticals, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00626418 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00626418 about?
NCT00626418 is a clinical study titled "The Effects of Aplindore on the Treatment of Signs and Symptoms of Restless Legs Syndrome". The purpose of this study is to assess the efficacy and tolerability of single doses of aplindore compared to placebo in RLS. Patients will be required to spend 5-8 nights in a sleep laboratory. This includes 1 adaptation night, 1 placebo night, and 3-6 drug treatment nights. Ascending doses of acti...
What is the current status of trial NCT00626418?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2008-02.
What interventions are being tested in trial NCT00626418?
The interventions under investigation include: Placebo (DRUG), Aplindore (DRUG).
Who is sponsoring clinical trial NCT00626418?
This trial is sponsored by Ligand Pharmaceuticals, which has 15 total clinical trials registered on ClinicalTrials.gov.
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