NCT00489255

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

A Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Trimethobenzamide (Tigan®) in the Control of Nausea and Vomiting During Initiation and Continued Treatment With Subcutaneous Apomorphine (Apokyn®) in Apomorphine-naïve Subjects With Parkinson's Disease Suffering From Acute Intermittent "Off" Episodes, With Phased Withdrawal of Subjects From Tigan® to Placebo

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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®

Detailed 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.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Tigan®	Oral capsule, 300mg three times daily
DRUG	Placebo	Oral capsule, three times daily

Timeline

• Start date: 2007-05-01
• Primary completion: 2011-12-01
• Completion: 2012-03-01
• First posted: 2007-06-21
• Last updated: 2019-01-30
• Results posted: 2013-05-20

Locations

27 sites across 1 country: United States