Safety/Efficacy of Tigan® to Control Nausea/Vomiting Experienced During Apokyn® Initiation and Treatment - Full Text View

Sponsor:	Ipsen
Collaborator:	INC Research Limited
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00489255

Purpose

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

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Movement Disorders Nausea and Vomiting Parkinson's Disease

Drug Information available for: Apomorphine Apomorphine hydrochloride Trimethobenzamide Trimethobenzamide hydrochloride

U.S. FDA Resources

Further study details as provided by Ipsen:

Primary Outcome Measures:

Percentage of Apokyn® injections with nausea/vomiting between Days 1-28, 29-56 and 57-84 [ Time Frame: over 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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. [ Time Frame: Over 12 weeks. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	180
Study Start Date:	May 2007
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Trimethobenzamide	Drug: Tigan® Oral capsule, 300mg three times daily
2: Placebo Comparator Inactive substance	Drug: Placebo Oral capsule, three times daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 dolasetron)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00489255

Locations

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

Sponsors and Collaborators

Ipsen

INC Research Limited

Investigators

Principal Investigator:

Robert A Hauser, MD

USF Parkinson's Disease and Movement Disorders Center

More Information

No publications provided

Responsible Party:	USF Parkinson's Disease and Movement Disorders Center ( Dr Robert Hauser )
Study ID Numbers:	Y-47-52844-003, APO-4PD-01
Study First Received:	June 20, 2007
Last Updated:	August 11, 2009
ClinicalTrials.gov Identifier:	NCT00489255 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Ipsen:

Parkinson's disease
Anti-emetic
Nausea
Vomiting

Additional relevant MeSH terms:

Vomiting
Signs and Symptoms, Digestive
Physiological Effects of Drugs
Basal Ganglia Diseases
Nervous System Diseases
Gastrointestinal Agents
Central Nervous System Diseases
Antiemetics
Brain Diseases
Neurodegenerative Diseases

Trimethobenzamide
Pharmacologic Actions
Signs and Symptoms
Autonomic Agents
Parkinson Disease
Movement Disorders
Therapeutic Uses
Peripheral Nervous System Agents
Parkinsonian Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 20, 2009