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

Ipsen

Status and phase

Completed

Phase 4

Conditions

Parkinson's Disease

Treatments

Drug: Placebo

Drug: Tigan®

Study type

Interventional

Funder types

Industry

Identifiers

NCT00489255

APO-4PD-01

Y-47-52844-003

Details and patient eligibility

About

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®

Full description

Initial randomization is Tigan or Placebo (3:1) with phased withdrawal of Tigan to Placebo after 4 and 8 weeks. Subjects completing 4 weeks Tigan re-randomized to Tigan or Placebo (2:1) with patients completing 8 weeks Tigan re-randomized to receive Tigan or Placebo (1:1). Subjects randomized to Placebo over the previous 4 weeks assigned to continue on Placebo for the remainder of the study.

Enrollment

117 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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