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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tigan®
Placebo
Sponsored by
Ipsen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Anti-emetic, Nausea, Vomiting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Barrow Neurological Movement Disorder Clinic
  • Mayo Clinic
  • Coastal Neurological Medical Group Inc.
  • Neurosearch, Inc.
  • Neurosearch II, Inc.
  • Parkinson's Disease and Movement Disorders Center of Boca Raton
  • Neurology at Shands Medical Center
  • University of Florida at Jacksonville
  • Neurology Associates of Ormond Beach
  • Charlotte Neurological Services
  • Suncoast Neuroscience Associates, Inc.
  • USF Parkinson's Disease and Movement Disorders Center of Excellence
  • Emory University
  • NorthShore University Health System
  • Iowa Health Physicians
  • Parkinson's & Movements Disorders Center of Maryland
  • Quest Research Institute
  • Henry Ford Health System - Franklin Point
  • Parkinson's Disease and Movement Disorders Center of Long Island
  • Kingston Neurological Associates
  • Raleigh Neurology Associates
  • Neurological Institute, Cleveland Clinic
  • Neurology Specialist of Dallas P.A
  • Parkinson's Disease and Movement Disorders Center, Baylor College of Medicine
  • Neurology Associates, P.A.
  • East Texas Medical Center
  • Sentara Neurological Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Trimethobenzamide (Tigan®)

Inactive substance

Arm Description

Outcomes

Primary Outcome Measures

Incidence of Nausea and/or Vomiting During the Initial Titration of Apokyn® at the Visit on Day 1

Secondary Outcome Measures

Incidence of Nausea and/or Vomiting for Period 1
Incidence of Nausea and/or Vomiting for Period 2
Incidence of Nausea and/or Vomiting for Period 3
Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 1
The INVR is an 8-item, 5 point Likert-type measurement of the patient's perceived experience of nausea, vomiting and retching. Modified INVR scores collected once daily, rather than twice a day. INVR total score range from 0 to 32, with 32 indicative of the worst and 0 no symptom.
Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 2
The INVR is an 8-item, 5 point Likert-type measurement of the patient's perceived experience of nausea, vomiting and retching. Modified INVR scores collected once daily, rather than twice a day. INVR total score range from 0 to 32, with 32 indicative of the worst and 0 no symptom.
Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 3
The INVR is an 8-item, 5 point Likert-type measurement of the patient's perceived experience of nausea, vomiting and retching. Modified INVR scores collected once daily, rather than twice a day. INVR total score range from 0 to 32, with 32 indicative of the worst and 0 no symptom.
Subject Global Evaluation of Randomized Study Medication for Period 1
The subject global evaluation of Tigan/placebo was completed by the subject at the visits in response to the question "Overall, how would you rate the study medication you received for nausea/vomiting?" Response choices were excellent, very good, good, fair, or poor.
Subject Global Evaluation of Randomized Study Medication for Period 2
The subject global evaluation of Tigan/placebo was completed by the subject at the visits in response to the question "Overall, how would you rate the study medication you received for nausea/vomiting?" Response choices were excellent, very good, good, fair, or poor.
Subject Global Evaluation of Randomized Study Medication for Period 3
The subject global evaluation of Tigan/placebo was completed by the subject at the visits in response to the question "Overall, how would you rate the study medication you received for nausea/vomiting?" Response choices were excellent, very good, good, fair, or poor.
Median Time to 'on' for Visit 2/Period 1 Injection 1
Time to "on" (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of "on" and time of injection.
Median Time to 'on' for Visit 2/Period 1 Injection 2
Time to "on" (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of "on" and time of injection.
Median Time to 'on' for Visit 3/End of Period 1 Injection
Time to "on" (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of "on" and time of injection.
Median Time to 'on' for Visit 4/End of Period 2 Injection
Time to "on" (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of "on" and time of injection.
Median Time to 'on' for Visit 5/End of Period 3 Injection
Time to "on" (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of "on" and time of injection.
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 2, Pre Apokyn Dose, Period 1
Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 3, Pre Apokyn Dose, Period 1
Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 3, Post Apokyn Dose, Period 1
Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 4, Pre Apokyn Dose, Period 2
Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 4, Post Apokyn Dose, Period 2
Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 5, Pre Apokyn Dose, Period 3
Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 5, Post Apokyn Dose, Period 3
Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.

Full Information

First Posted
June 20, 2007
Last Updated
January 11, 2019
Sponsor
Ipsen
Collaborators
INC Research Limited
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1. Study Identification

Unique Protocol Identification Number
NCT00489255
Brief Title
Safety/Efficacy of Tigan® to Control Nausea/Vomiting Experienced During Apokyn® Initiation and Treatment
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen
Collaborators
INC Research Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

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®
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, Anti-emetic, Nausea, Vomiting

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trimethobenzamide (Tigan®)
Arm Type
Experimental
Arm Title
Inactive substance
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Tigan®
Intervention Description
Oral capsule, 300mg three times daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral capsule, three times daily
Primary Outcome Measure Information:
Title
Incidence of Nausea and/or Vomiting During the Initial Titration of Apokyn® at the Visit on Day 1
Time Frame
Day 1 (Period 1, Visit 2)
Secondary Outcome Measure Information:
Title
Incidence of Nausea and/or Vomiting for Period 1
Time Frame
Days 1-28
Title
Incidence of Nausea and/or Vomiting for Period 2
Time Frame
Days 29-56
Title
Incidence of Nausea and/or Vomiting for Period 3
Time Frame
Days 57-84
Title
Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 1
Description
The INVR is an 8-item, 5 point Likert-type measurement of the patient's perceived experience of nausea, vomiting and retching. Modified INVR scores collected once daily, rather than twice a day. INVR total score range from 0 to 32, with 32 indicative of the worst and 0 no symptom.
Time Frame
Days 1-28
Title
Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 2
Description
The INVR is an 8-item, 5 point Likert-type measurement of the patient's perceived experience of nausea, vomiting and retching. Modified INVR scores collected once daily, rather than twice a day. INVR total score range from 0 to 32, with 32 indicative of the worst and 0 no symptom.
Time Frame
Days 29-56
Title
Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 3
Description
The INVR is an 8-item, 5 point Likert-type measurement of the patient's perceived experience of nausea, vomiting and retching. Modified INVR scores collected once daily, rather than twice a day. INVR total score range from 0 to 32, with 32 indicative of the worst and 0 no symptom.
Time Frame
Days 57-84
Title
Subject Global Evaluation of Randomized Study Medication for Period 1
Description
The subject global evaluation of Tigan/placebo was completed by the subject at the visits in response to the question "Overall, how would you rate the study medication you received for nausea/vomiting?" Response choices were excellent, very good, good, fair, or poor.
Time Frame
Day 28 (Visit 3)
Title
Subject Global Evaluation of Randomized Study Medication for Period 2
Description
The subject global evaluation of Tigan/placebo was completed by the subject at the visits in response to the question "Overall, how would you rate the study medication you received for nausea/vomiting?" Response choices were excellent, very good, good, fair, or poor.
Time Frame
Day 56 (Visit 4)
Title
Subject Global Evaluation of Randomized Study Medication for Period 3
Description
The subject global evaluation of Tigan/placebo was completed by the subject at the visits in response to the question "Overall, how would you rate the study medication you received for nausea/vomiting?" Response choices were excellent, very good, good, fair, or poor.
Time Frame
Day 84 (Visit 5)
Title
Median Time to 'on' for Visit 2/Period 1 Injection 1
Description
Time to "on" (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of "on" and time of injection.
Time Frame
Day 1 (Visit 2)
Title
Median Time to 'on' for Visit 2/Period 1 Injection 2
Description
Time to "on" (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of "on" and time of injection.
Time Frame
Day 1 (Visit 2)
Title
Median Time to 'on' for Visit 3/End of Period 1 Injection
Description
Time to "on" (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of "on" and time of injection.
Time Frame
Day 28
Title
Median Time to 'on' for Visit 4/End of Period 2 Injection
Description
Time to "on" (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of "on" and time of injection.
Time Frame
Day 56 (Visit 4)
Title
Median Time to 'on' for Visit 5/End of Period 3 Injection
Description
Time to "on" (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of "on" and time of injection.
Time Frame
Day 84 (Visit 5)
Title
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 2, Pre Apokyn Dose, Period 1
Description
Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.
Time Frame
Day 1 (Visit 2)
Title
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 3, Pre Apokyn Dose, Period 1
Description
Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.
Time Frame
Day 28
Title
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 3, Post Apokyn Dose, Period 1
Description
Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.
Time Frame
Day 28
Title
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 4, Pre Apokyn Dose, Period 2
Description
Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.
Time Frame
Day 56 (Visit 4)
Title
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 4, Post Apokyn Dose, Period 2
Description
Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.
Time Frame
Day 56 (Visit 4)
Title
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 5, Pre Apokyn Dose, Period 3
Description
Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.
Time Frame
Day 84 (Visit 5)
Title
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 5, Post Apokyn Dose, Period 3
Description
Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.
Time Frame
Day 56 (Visit 4)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Barrow Neurological Movement Disorder Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Coastal Neurological Medical Group Inc.
City
La Jolla
State/Province
California
ZIP/Postal Code
78258
Country
United States
Facility Name
Neurosearch, Inc.
City
Reseda
State/Province
California
ZIP/Postal Code
91335
Country
United States
Facility Name
Neurosearch II, Inc.
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Parkinson's Disease and Movement Disorders Center of Boca Raton
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Neurology at Shands Medical Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
University of Florida at Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Neurology Associates of Ormond Beach
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Charlotte Neurological Services
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Suncoast Neuroscience Associates, Inc.
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
USF Parkinson's Disease and Movement Disorders Center of Excellence
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
NorthShore University Health System
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60026
Country
United States
Facility Name
Iowa Health Physicians
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Parkinson's & Movements Disorders Center of Maryland
City
Elkridge
State/Province
Maryland
ZIP/Postal Code
21075
Country
United States
Facility Name
Quest Research Institute
City
Bingham Farms
State/Province
Michigan
ZIP/Postal Code
48025
Country
United States
Facility Name
Henry Ford Health System - Franklin Point
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
Facility Name
Parkinson's Disease and Movement Disorders Center of Long Island
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Kingston Neurological Associates
City
Kingston
State/Province
New York
ZIP/Postal Code
12401
Country
United States
Facility Name
Raleigh Neurology Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Neurological Institute, Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Neurology Specialist of Dallas P.A
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Parkinson's Disease and Movement Disorders Center, Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Neurology Associates, P.A.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
East Texas Medical Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Sentara Neurological Associates
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23456
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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