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 (Responsible Party):	Ipsen
ClinicalTrials.gov Identifier:	NCT00489255

Purpose

The purposes of the study are to determine:

i. To assess the efficacy of Tigan® (trimethobenzamide) in preventing nausea and vomiting when initiating therapy with Apokyn® (apomorphine)

ii. To determine the optimal duration for continuation of Tigan® following initiation of Apokyn® therapy

iii. To assess the safety of Tigan® in combination with Apokyn®

iv. To characterize the pharmacokinetic (PK) profile of apomorphine in subjects treated concomitantly with and without Tigan®

Condition	Intervention	Phase
Parkinson's Disease	Drug: Tigan® Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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 Subjects With Parkinson's Disease Suffering From Acute Intermittent "Off" Episodes, With Phased Withdrawal of Subjects From Tigan® to Placebo

Resource links provided by NLM:

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

MedlinePlus related topics: Nausea and Vomiting Parkinson's Disease

Drug Information available for: Apomorphine Apomorphine hydrochloride Trimethobenzamide Apomorphine hydrochloride anhydrous Trimethobenzamide hydrochloride

U.S. FDA Resources

Further study details as provided by Ipsen:

Primary Outcome Measures:

Incidence of nausea and/or vomiting during the initial titration of Apokyn® at the visit [ Time Frame: 1 day (Visit 2) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Incidence of nausea and/or vomiting [ Time Frame: For each period between Days 1-28, 29-56 and 57-84. ] [ Designated as safety issue: Yes ]
Modified Index of Nausea, Vomiting and Retching (INVR) scores (total, symptom experience, symptom occurrence and symptom distress) [ Time Frame: For each period between Days 1-28, 29-56 and 57-84. ] [ Designated as safety issue: Yes ]
Adverse event monitoring [ Time Frame: over 12 weeks ] [ Designated as safety issue: Yes ]
Subject global evaluation of randomized study medication [ Time Frame: At each visit on Day 28, 56 and 84 (Visits 3, 4 and 5). ] [ Designated as safety issue: No ]
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (motor section) [ Time Frame: At visit on Days 1, 28, 56 and 84 (Visits 2, 3, 4 and 5). ] [ Designated as safety issue: No ]
Time to 'on' for each injection [ Time Frame: At each visit on Days 1, 28, 56 and 84 (Visits 2, 3, 4, and 5). ] [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	May 2007
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

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

Subjects aged 18 years or over
Subjects with advanced Parkinson's disease with disabling hypomobility ("off" episodes) who are to be initiated with Apokyn® by intermittent subcutaneous injection
Able to swallow Tigan®/placebo capsules
Subjects willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
Women of child bearing potential must have a negative serum pregnancy test (beta hCG) prior to receiving study drug and must be using an appropriate form of contraception
Willing and able to provide informed consent

Exclusion Criteria:

Hypersensitive to apomorphine hydrochloride or any of the ingredients of Apokyn® (notably sodium metabisulfite)
Hypersensitive to trimethobenzamide or any of the ingredients of Tigan®
Previous treatment with Apokyn®
Participation in any other clinical trial within 14 days of the present trial
Contraindications to Apokyn® or Tigan®
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)
Malignant melanoma or a history of previously treated malignant melanoma
Pregnancy or breast feeding
Receipt of any investigational (i.e. unapproved) medication within 30 days of starting the present trial
Any significant medical disorder, condition, concomitant medication or psychiatric disorder according to DSM-IV criteria which would, in the opinion of the investigator, represent a hazard to the subject or prevent the subject from completing the trial

Contacts and Locations

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

Contacts

Contact: Ipsen Enquiries

clinical.trials@ipsen.com

Show 27 Study Locations

Sponsors and Collaborators

Ipsen

INC Research Limited

Investigators

Study Director:

Stephen Revell, MD

Ipsen

More Information

No publications provided

Responsible Party:	Ipsen
ClinicalTrials.gov Identifier:	NCT00489255 History of Changes
Other Study ID Numbers:	Y-47-52844-003, APO-4PD-01
Study First Received:	June 20, 2007
Last Updated:	November 2, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Ipsen:

Parkinson's disease
Anti-emetic
Nausea
Vomiting

Additional relevant MeSH terms:

Nausea
Parkinson Disease
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders

Neurodegenerative Diseases
Trimethobenzamide
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents

ClinicalTrials.gov processed this record on February 09, 2012