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Sponsored by: |
Neurogen Corporation |
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Information provided by: | Neurogen Corporation |
ClinicalTrials.gov Identifier: | NCT00809302 |
This is a clinical trial to be conducted at multiple Parkinson Study Group (PSG) sites in the USA. Patients with early Parkinson disease will be randomly allocated to one of 4 arms in the study. The 4 arms include 3 arms with different doses of aplindore MR tablets and 1 placebo arm. The study drug will be taken twice a day (BID). The study is blinded and neither subjects, nor the investigators, will know what treatment the subject is receiving. Investigational study drug will be adjusted to the assigned dosage and then maintained at that dosage for the balance of the 12 week follow-up period. The entire study will take about 13 weeks. The study will assess the safety and tolerability of aplindore and measure how effective aplindore is in improving movement and other effects of Parkinson disease.
Condition | Intervention | Phase |
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Early Parkinson Disease |
Drug: aplindore MR tablets or Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Three Doses of Aplindore MR (1, 3, and 6 mg Twice Daily) in Patients With Early Parkinson Disease (APLIED) |
Estimated Enrollment: | 168 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
aplindore 2 mg MR total daily dose
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Drug: aplindore MR tablets or Placebo
aplindore MR tablets administered BID for about 13 weeks
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2: Experimental
aplindore 6 mg MR total daily dose
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Drug: aplindore MR tablets or Placebo
aplindore MR tablets administered BID for about 13 weeks
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3: Experimental
aplindore 12 mg MR total daily dose
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Drug: aplindore MR tablets or Placebo
aplindore MR tablets administered BID for about 13 weeks
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4: Placebo Comparator
Placebo
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Drug: aplindore MR tablets or Placebo
aplindore MR tablets administered BID for about 13 weeks
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One hundred and sixty eight patients will be randomly assigned to one of four investigational treatment regimens in this outpatient study. For active treatment arms, study drug will be titrated to the assigned dosage and then maintained for up to a 12 week follow-up period before receiving tapered doses in advance of study completion. Dosing will take place over a total of about 13 weeks.
Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Neurogen Corporation ( Ken Sprenger, MD, MBBCh, Vice President, Clinical Development and Operations ) |
Study ID Numbers: | Aplindore-211 |
Study First Received: | December 15, 2008 |
Last Updated: | December 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00809302 |
Health Authority: | United States: Food and Drug Administration |
Ganglion Cysts Movement Disorders Parkinson Disease Basal Ganglia Diseases |
Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases |
Nervous System Diseases |