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

Completed · Phase 4 · Has a placebo group

Conditions studied: Parkinson's Disease

In brief

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®

Key facts

Study ID

NCT00489255

Run by

Ipsen

People needed

117

Starts

2007-05-01

Expected to finish

2012-03-01

Last updated by the study team

2019-01-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Barrow Neurological Movement Disorder Clinic — Phoenix, Arizona, United States
• Mayo Clinic — Scottsdale, Arizona, United States
• Coastal Neurological Medical Group Inc. — La Jolla, California, United States
• Neurosearch, Inc. — Reseda, California, United States
• Neurosearch II, Inc. — Ventura, California, United States
• Parkinson's Disease and Movement Disorders Center of Boca Raton — Boca Raton, Florida, United States
• Neurology at Shands Medical Center — Gainesville, Florida, United States
• University of Florida at Jacksonville — Jacksonville, Florida, United States
• Neurology Associates of Ormond Beach — Ormond Beach, Florida, United States
• Charlotte Neurological Services — Port Charlotte, Florida, United States
• Suncoast Neuroscience Associates, Inc. — St. Petersburg, Florida, United States
• USF Parkinson's Disease and Movement Disorders Center of Excellence — Tampa, Florida, United States
• Emory University — Atlanta, Georgia, United States
• NorthShore University Health System — Glenview, Illinois, United States
• Iowa Health Physicians — Des Moines, Iowa, United States
• Parkinson's & Movements Disorders Center of Maryland — Elkridge, Maryland, United States
• Quest Research Institute — Bingham Farms, Michigan, United States
• Henry Ford Health System - Franklin Point — Southfield, Michigan, United States
• Parkinson's Disease and Movement Disorders Center of Long Island — Commack, New York, United States
• Kingston Neurological Associates — Kingston, New York, United States
• Raleigh Neurology Associates — Raleigh, North Carolina, United States
• Neurological Institute, Cleveland Clinic — Cleveland, Ohio, United States
• Neurology Specialist of Dallas P.A — Dallas, Texas, United States
• Parkinson's Disease and Movement Disorders Center, Baylor College of Medicine — Houston, Texas, United States
• Neurology Associates, P.A. — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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