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| Sponsor: | IMPAX Laboratories, Inc. |
|---|---|
| Information provided by: | IMPAX Laboratories, Inc. |
| ClinicalTrials.gov Identifier: | NCT00880620 |
Purpose
This study examines the efficacy of IPX066 as compared to placebo in Parkinson's disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson's Disease |
Drug: placebo Drug: IPX066 |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Placebo-Controlled Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease |
| Estimated Enrollment: | 350 |
| Study Start Date: | April 2009 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 1
Placebo
|
Drug: placebo
placebo
|
|
Experimental: 2
IPX066 dose level 1
|
Drug: IPX066
dose level 1
Other Name: CD-LD ER
|
|
Experimental: 3
IPX066 dose level 2
|
Drug: IPX066
dose level 2
Other Name: CD-LD ER
|
|
Experimental: 4
IPX066 dose level 3
|
Drug: IPX066
dose level 3
Other Name: CD-LD ER
|
A randomized, placebo controlled, fixed dose, parallel arm study of three doses of IPX066 versus placebo.
Approximately 350 subjects are equally randomized to receive one of 3 doses of IPX066, or matching placebo, orally.
Study duration is approximately 30 weeks for each subject.
The UPDRS is the primary outcome measure.
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 60 Study Locations| Study Director: | Impax Study Director | Impax Pharmaceuticals, a division of Impax Laboratories |
More Information
| Responsible Party: | Jeff Mulchahey, PhD/Sr. Director Regualtory Affairs, IMPAX Laboratories |
| ClinicalTrials.gov Identifier: | NCT00880620 History of Changes |
| Other Study ID Numbers: | IPX066-B08-05 |
| Study First Received: | April 3, 2009 |
| Last Updated: | December 3, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Parkinson's disease |
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |