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

Launched by IPSEN · Jun 20, 2007

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility 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