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

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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®

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen
• Collaborator: INC Research Limited
• Treatments: Trimethobenzamide

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