Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00489255
Status:
COMPLETED
Last Update Posted:
2019-01-30
First Post:
2007-06-20
Brief Title:
SafetyEfficacy of Tigan to Control NauseaVomiting Experienced During Apokyn Initiation and Treatment
Sponsor:
Ipsen
Organization:
Ipsen
Study Overview
Official Title:
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 Parkinsons Disease Suffering From Acute Intermittent Off Episodes With Phased Withdrawal of Subjects From Tigan to Placebo
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 31 with phased withdrawal of Tigan to Placebo after 4 and 8 weeks Subjects completing 4 weeks Tigan re-randomized to Tigan or Placebo 21 with patients completing 8 weeks Tigan re-randomized to receive Tigan or Placebo 11 Subjects randomized to Placebo over the previous 4 weeks assigned to continue on Placebo for the remainder of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| APO-4PD-01 | None | None | None |