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

NCT00489255 | Completed Phase 4 Results

• 2 other identifiers: Y-47-52844-003APO-4PD-01
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 27

Brief Summary

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®

Conditions

Parkinson's Disease

Keywords

Parkinson's disease; Anti-emetic; Nausea; Vomiting

Outcome Measures

Primary Outcomes (1)

• Incidence of Nausea and/or Vomiting During the Initial Titration of Apokyn® at the Visit on Day 1

  Day 1 (Period 1, Visit 2)

Secondary Outcomes (21)

• Incidence of Nausea and/or Vomiting for Period 1

  Days 1-28

• Incidence of Nausea and/or Vomiting for Period 2

  Days 29-56

• Incidence of Nausea and/or Vomiting for Period 3

  Days 57-84

• Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 1

  Days 1-28

• Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 2

  Days 29-56

Study Arms (2)

Trimethobenzamide (Tigan®)

EXPERIMENTAL

Drug: Tigan®

Inactive substance

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Tigan® DRUG

Oral capsule, 300mg three times daily

Trimethobenzamide (Tigan®)

Placebo DRUG

Oral capsule, three times daily

Inactive substance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Ipsen: lead
• INC Research Limited: collaborator

Study Sites (27)

Barrow Neurological Movement Disorder Clinic

Phoenix, Arizona, 85013, United States

Location

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

Coastal Neurological Medical Group Inc.

La Jolla, California, 78258, United States

Location

Neurosearch, Inc.

Reseda, California, 91335, United States

Location

Neurosearch II, Inc.

Ventura, California, 93003, United States

Location

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, 33486, United States

Location

Neurology at Shands Medical Center

Gainesville, Florida, 32608, United States

Location

University of Florida at Jacksonville

Jacksonville, Florida, 32209, United States

Location

Neurology Associates of Ormond Beach

Ormond Beach, Florida, 32174, United States

Location

Charlotte Neurological Services

Port Charlotte, Florida, 33952, United States

Location

Suncoast Neuroscience Associates, Inc.

St. Petersburg, Florida, 33701, United States

Location

USF Parkinson's Disease and Movement Disorders Center of Excellence

Tampa, Florida, 33606, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

NorthShore University Health System

Glenview, Illinois, 60026, United States

Location

Iowa Health Physicians

Des Moines, Iowa, 50309, United States

Location

Parkinson's & Movements Disorders Center of Maryland

Elkridge, Maryland, 21075, United States

Location

Quest Research Institute

Bingham Farms, Michigan, 48025, United States

Location

Henry Ford Health System - Franklin Point

Southfield, Michigan, 48034, United States

Location

Parkinson's Disease and Movement Disorders Center of Long Island

Commack, New York, 11725, United States

Location

Kingston Neurological Associates

Kingston, New York, 12401, United States

Location

Raleigh Neurology Associates

Raleigh, North Carolina, 27607, United States

Location

Neurological Institute, Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Neurology Specialist of Dallas P.A

Dallas, Texas, 75231, United States

Location

Parkinson's Disease and Movement Disorders Center, Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Neurology Associates, P.A.

San Antonio, Texas, 78258, United States

Location

East Texas Medical Center

Tyler, Texas, 75701, United States

Location

Sentara Neurological Associates

Virginia Beach, Virginia, 23456, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Nausea; Vomiting

Interventions

trimethobenzamide

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Medical Director, Neurology
• Organization: Ipsen

clinical.trials@ipsen.com

clinical.trials@ipsen.com

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2007
• First Posted: June 21, 2007
• Study Start: May 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: March 1, 2012
• Last Updated: January 30, 2019
• Results First Posted: May 20, 2013

Record last verified: 2019-01

Locations

US (27)