Efficacy and Safety Study of Aplindore in Patients With Restless Legs Syndrome
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00834327 |
Recruitment Status
:
Terminated
(Neurogen acquired by Ligand Pharmaceuticals - no further support for the study. No safety concerns identified.)
First Posted
: February 3, 2009
Last Update Posted
: October 14, 2009
|
Sponsor:
Neurogen Corporation
Information provided by:
Neurogen Corporation
Tracking Information | |||
---|---|---|---|
First Submitted Date ICMJE | January 30, 2009 | ||
First Posted Date ICMJE | February 3, 2009 | ||
Last Update Posted Date | October 14, 2009 | ||
Study Start Date ICMJE | February 2009 | ||
Estimated Primary Completion Date | November 2009 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
The change from baseline (Day 1) to final (Day 28) on the International Restless Legs Scale (IRLS). [ Time Frame: Day 1, Day 14, and Day 28 ] | ||
Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | Complete list of historical versions of study NCT00834327 on ClinicalTrials.gov Archive Site | ||
Current Secondary Outcome Measures ICMJE | Not Provided | ||
Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Outcome Measures ICMJE | Not Provided | ||
Original Other Outcome Measures ICMJE | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Efficacy and Safety Study of Aplindore in Patients With Restless Legs Syndrome | ||
Official Title ICMJE | 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 | 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. | ||
Study Type ICMJE | Interventional | ||
Study Phase | Phase 2 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
||
Condition ICMJE | Restless Legs Syndrome | ||
Intervention ICMJE | Drug: aplindore MR tablets or Placebo
aplindore MR tablets administered QD for about 4 weeks |
||
Study Arms |
|
||
Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||
Recruitment Information | |||
Recruitment Status ICMJE | Terminated | ||
Estimated Enrollment ICMJE |
230 | ||
Original Estimated Enrollment ICMJE | Same as current | ||
Estimated Study Completion Date | December 2009 | ||
Estimated Primary Completion Date | November 2009 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||
Sex/Gender |
|
||
Ages | 18 Years and older (Adult, Senior) | ||
Accepts Healthy Volunteers | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00834327 | ||
Other Study ID Numbers ICMJE | Aplindore-250 | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | Ken Sprenger, MD, MBBCh, Vice President, Clinical Development and Operations, Neurogen Corporation | ||
Study Sponsor ICMJE | Neurogen Corporation | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Neurogen Corporation | ||
Verification Date | October 2009 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |