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

Emory University

201 Dowman Dr
Atlanta, Georgia 30303

(404) 727-6123