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Sponsors and Collaborators: |
Ipsen INC Research Limited |
---|---|
Information provided by: | Ipsen |
ClinicalTrials.gov Identifier: | NCT00489255 |
The purposes of the study are to determine:
i. The rate of Apokyn®-related nausea and vomiting in subjects treated with oral Tigan® compared to those treated with oral placebo (inactive substance).
ii. The need for continued use of Tigan® for control of nausea and vomiting with on-going Apokyn® treatment for up to 12 weeks
iii. Possible side effects of Tigan® when used in combination with Apokyn® in subjects with Parkinson's Disease
iv. If Tigan® slows or hastens the body's metabolism (clearance) of Apokyn®.
Condition | Intervention | Phase |
---|---|---|
Parkinson's Disease |
Drug: Tigan® Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Trimethobenzamide (Tigan®) in the Control of Nausea and Vomiting During Initiation and Continued Treatment With Subcutaneous Apomorphine (Apokyn®) in Apomorphine-naïve Patients With Parkinson's Disease Suffering From Acute Intermittent "Off" Episodes, With Phased Withdrawal of Patients From Tigan® to Placebo |
Estimated Enrollment: | 60 |
Study Start Date: | May 2007 |
Study Completion Date: | August 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Trimethobenzamide
|
Drug: Tigan®
Apokyn, Dose, Freq PRN and Tigan, Oral Tablet, Freq
|
2: Placebo Comparator
Inactive substance
|
Drug: Placebo |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Coastal Neurological Medical Group INC. | |
La Jolla, California, United States, 78258 | |
United States, Florida | |
USF Parkinson's Disease and Movement Disorders Center | |
Tampa, Florida, United States, 33606 | |
Charlotte Neurological Services | |
Port Charlotte, Florida, United States, 33952 | |
United States, Iowa | |
Iowa Health Physicians | |
Des Moins, Iowa, United States, 50309 | |
United States, Maryland | |
Parkinson's & Movements Disorders Center of Maryland | |
Elkridge, Maryland, United States, 21075 | |
United States, Michigan | |
Quest Research Institute | |
Bingham Farms, Michigan, United States, 48025 | |
United States, North Carolina | |
Raleigh Neurology Associates, P.A. | |
Raleigh, North Carolina, United States, 27607 | |
United States, Texas | |
Neurology Associates, P.A. | |
San Antonio, Texas, United States, 78258 | |
Baylor College of Medicine | |
Houston, Texas, United States, 77030 | |
Baylor College of Medicine | |
Houston, Texas, United States, 77030-2744 |
Principal Investigator: | Robert A Hauser, MD | USF Parkinson's Disease and Movement Disorders Center |
Responsible Party: | USF Parkinson's Disease and Movement Disorders Center ( Dr Robert Hauser ) |
Study ID Numbers: | APO-4PD-01 |
Study First Received: | June 20, 2007 |
Last Updated: | October 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00489255 |
Health Authority: | United States: Food and Drug Administration |
Parkinson's disease Anti-emetic Nausea Vomiting |
Ganglion Cysts Vomiting Movement Disorders Parkinson Disease Basal Ganglia Diseases Central Nervous System Diseases |
Nausea Parkinsonian Disorders Trimethobenzamide Neurodegenerative Diseases Brain Diseases Apomorphine |
Autonomic Agents Therapeutic Uses Physiological Effects of Drugs Nervous System Diseases Gastrointestinal Agents |
Antiemetics Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions |