Safety/Efficacy of Tigan® to Control Nausea/Vomiting Experienced During Apokyn® Initiation and Treatment
Information source: Vernalis Development
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Parkinson's Disease
Intervention: Tigan® (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Vernalis Development Official(s) and/or principal investigator(s):
Robert A Hauser, MD, Principal Investigator, Affiliation: USF Parkinson's Disease and Movement Disorders Center
Summary
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®.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: Percentage of Apokyn® injections with nausea/vomiting between Days 1-28, 29-56 and 57-84
Secondary outcome: Index of nausea, vomiting and retching (INVR) over the same time periods.
Unified Parkinson's disease Rating Scale (UDPRS) Safety will be assessed by vital signs measurements and adverse event monitoring.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients aged 18 years or over
- Patients with advanced Parkinson's disease with disabling hypomobility, "off" episodes
who are to be initiated with Apokyn® by intermittent subcutaneous injection
- Ability to swallow Tigan®/placebo
Exclusion Criteria:
- Hypersensitivity to apomorphine or any of the ingredients of Apokyn® (notably sodium
metabisulphite)
- Hypersensitivity to trimethobenzamide or any of the ingredients of Tigan®
- Previous treatment with Apokyn®
- Contraindications to Apokyn®
- Currently taking, or likely to need to take at any time during the course of the
study, any 5HT3 antagonist (ondansetron, alosetron, granisetron, palonosetron or
dolesetron)
Locations and Contacts
Coastal Neurological Medical Group INC., La Jolla, California 78258, United States
USF Parkinson's Disease and Movement Disorders Center, Tampa, Florida 33606, United States
Charlotte Neurological Services, Port Charlotte, Florida 33952, United States
Iowa Health Physicians, Des Moins, Iowa 50309, United States
Parkinson's & Movements Disorders Center of Maryland, Elkridge, Maryland 21075, United States
Quest Research Institute, Bingham Farms, Michigan 48025, United States
Raleigh Neurology Associates, P.A., Raleigh, North Carolina 27607, United States
Neurology Associates, P.A., San Antonio, Texas 78258, United States
Baylor College of Medicine, Houston, Texas 77030, United States
Baylor College of Medicine, Houston, Texas 77030-2744, United States
Additional Information
Starting date: May 2007
Ending date: July 2008
Last updated: May 22, 2008
|
