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

Status:	Completed
Conditions:	Parkinsons Disease
Therapuetic Areas:	Neurology
Healthy:	No
Age Range:	18 - Any
Updated:	2/1/2019
Start Date:	May 2007
End Date:	March 2012

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

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®

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.

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

We found this trial at

sites

Neurology at Shands Medical Center

2000 Southwest Archer Road
Gainesville, Florida 32608

714

from 43215

Gainesville, FL