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

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®

Timeline

Start

2007-05

Primary completion

2011-12

Completion

2012-03

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Trimethobenzamide (Tigan®) vs Placebo; p = 0.09; Odds Ratio (OR) 0.43 (95% CI 0.17 to 1.11); Cochran-Mantel-Haenszel NCT00489255 ↗

Drugs

Indications