Safety/Efficacy of Tigan® to Control Nausea/Vomiting Experienced During Apokyn® Initiation and Treatment
Public ClinicalTrials.gov record NCT00489255. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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 Parkinson's Disease Suffering From Acute Intermittent "Off" Episodes, With Phased Withdrawal of Subjects From Tigan® to Placebo
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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®
Study identification
- NCT ID
- NCT00489255
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 117 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 2007 (Type not available)
- Primary completion
- Dec 2011 (Actual)
- Completion
- Mar 2012 (Actual)
- Last update posted
- Jan 30, 2019
2007 – 2012
United States locations
- U.S. sites
- 27
- U.S. states
- 13
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Barrow Neurological Movement Disorder Clinic | Phoenix | Arizona | 85013 | — |
| Mayo Clinic | Scottsdale | Arizona | 85259 | — |
| Coastal Neurological Medical Group Inc. | La Jolla | California | 78258 | — |
| Neurosearch, Inc. | Reseda | California | 91335 | — |
| Neurosearch II, Inc. | Ventura | California | 93003 | — |
| Parkinson's Disease and Movement Disorders Center of Boca Raton | Boca Raton | Florida | 33486 | — |
| Neurology at Shands Medical Center | Gainesville | Florida | 32608 | — |
| University of Florida at Jacksonville | Jacksonville | Florida | 32209 | — |
| Neurology Associates of Ormond Beach | Ormond Beach | Florida | 32174 | — |
| Charlotte Neurological Services | Port Charlotte | Florida | 33952 | — |
| Suncoast Neuroscience Associates, Inc. | St. Petersburg | Florida | 33701 | — |
| USF Parkinson's Disease and Movement Disorders Center of Excellence | Tampa | Florida | 33606 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| NorthShore University Health System | Glenview | Illinois | 60026 | — |
| Iowa Health Physicians | Des Moines | Iowa | 50309 | — |
| Parkinson's & Movements Disorders Center of Maryland | Elkridge | Maryland | 21075 | — |
| Quest Research Institute | Bingham Farms | Michigan | 48025 | — |
| Henry Ford Health System - Franklin Point | Southfield | Michigan | 48034 | — |
| Parkinson's Disease and Movement Disorders Center of Long Island | Commack | New York | 11725 | — |
| Kingston Neurological Associates | Kingston | New York | 12401 | — |
| Raleigh Neurology Associates | Raleigh | North Carolina | 27607 | — |
| Neurological Institute, Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Neurology Specialist of Dallas P.A | Dallas | Texas | 75231 | — |
| Parkinson's Disease and Movement Disorders Center, Baylor College of Medicine | Houston | Texas | 77030 | — |
| Neurology Associates, P.A. | San Antonio | Texas | 78258 | — |
| East Texas Medical Center | Tyler | Texas | 75701 | — |
| Sentara Neurological Associates | Virginia Beach | Virginia | 23456 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00489255, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 30, 2019 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00489255 live on ClinicalTrials.gov.