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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00489255
First Posted: June 21, 2007
Last Update Posted: May 23, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
INC Research Limited
Information provided by (Responsible Party):
Ipsen
Results First Submitted: December 24, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Parkinson's Disease
Interventions: Drug: Tigan®
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited at 24 investigational sites in the United States (US).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Number of participants “STARTED” does not match “Enrollment, Actual” (in protocol section) due to re-randomization design of the study & phased withdrawal of subjects from Tigan to placebo. Some subjects were included on one treatment in one period and re-randomized to a different treatment in a later period.

Reporting Groups
  Description
Trimethobenzamide (Tigan®) Tigan® : Oral capsule, 300mg three times daily.
Tigan:Placebo Placebo : Oral capsule, three times daily.

Participant Flow for 4 periods

Period 1:   Screening and Initial Randomization
    Trimethobenzamide (Tigan®)   Tigan:Placebo
STARTED   145 [1]   49 [2] 
COMPLETED   136   46 
NOT COMPLETED   9   3 
Discontinued prior to taking study drug                9                3 
[1] Total randomized subjects to receive Tigan
[2] Total randomized subjects to receive placebo

Period 2:   Period 1: Days 1 to 28
    Trimethobenzamide (Tigan®)   Tigan:Placebo
STARTED   136   46 
Completed and Follow Period 2   94   29 
Completed But Discontinued Study   13   5 
COMPLETED   107   34 
NOT COMPLETED   29   12 
Adverse Event                21                8 
Withdrawal by Subject                5                0 
Physician Decision                1                4 
Noncompliance                2                0 

Period 3:   Period 2: Days 29 to 56
    Trimethobenzamide (Tigan®)   Tigan:Placebo
STARTED   64   59 [1] 
Completed and Follow Period 3   58   52 [1] 
Completed But Discontinued Study   3   3 [2] 
COMPLETED   61   55 [1] 
NOT COMPLETED   3   4 
Adverse Event                3                1 
Withdrawal by Subject                0                3 
[1] Re-randomized participants is 26.Sample sizes differed due to withdrawal&re-randomization design.
[2] Re-randomized participants is 2.Sample sizes differed due to withdrawal&re-randomization design.

Period 4:   Period 3: Days 57 to 84
    Trimethobenzamide (Tigan®)   Tigan:Placebo
STARTED   28   82 [1] 
COMPLETED   24   78 [2] 
NOT COMPLETED   4   4 
Adverse Event                3                3 
Withdrawal by Subject                1                0 
Lost to Follow-up                0                1 
[1] Re-randomized participants is 30.Sample sizes differed due to withdrawal&re-randomization design.
[2] Re-randomized participants is 27.Sample sizes differed due to withdrawal&re-randomization design.



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Trimethobenzamide (Tigan®) Tigan® : Oral capsule, 300mg three times daily.
Placebo Placebo : Oral capsule, three times daily.
Total Total of all reporting groups

Baseline Measures
   Trimethobenzamide (Tigan®)   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 134   46   180 
Age [1] 
[Units: Years]
Median (Full Range)
 65.5 
 (24.0 to 93.0) 
 63.5 
 (49.0 to 79.0) 
 65.0 
 (24.0 to 93.0) 
[1]

Period 1:

Overall Number of Baseline Participants in 'Trimethobenzamide (Tigan®)' arm is 134.

Overall Number of Baseline Participants in 'Placebo' arm is 46.

Age [1] 
[Units: Years]
Median (Full Range)
 64.0 
 (33.0 to 86.0) 
 65.5 
 (24.0 to 85.0) 
 64.0 
 (24.0 to 86.0) 
[1]

Period 2 (Re-randomized patients):

Overall Number of Baseline Participants in 'Trimethobenzamide (Tigan®)' arm is 64.

Overall Number of Baseline Participants in 'Placebo' arm is 30 (re-randomized) and 59 (all placebo).

Age [1] 
[Units: Years]
Median (Full Range)
 66.5 
 (41.0 to 86.0) 
 63.0 
 (33 to 84.0) 
 64.0 
 (24.0 to 86.0) 
[1]

Period 3 (Re-randomized patients):

Overall Number of Baseline Participants in 'Trimethobenzamide (Tigan®)' arm is 28.

Overall Number of Baseline Participants in 'Placebo' arm is is 30 (re-randomized) and 82 (all placebo).

Gender [1] 
[Units: Participants]
     
Female   42   13   55 
Male   92   33   125 
[1]

Data for Period 1.

Period 2 & 3 are as follows:

Period 2, Re-randomized patients

Female: 19 participants in 'Trimethobenzamide (Tigan®)' arm and 11 participants in 'Placebo' arm.

Male: 45 participants in 'Trimethobenzamide (Tigan®)' arm and 19 participants in 'Placebo' arm.

Period 3, Re-randomized patients

Female: 7 participants in 'Trimethobenzamide (Tigan®)' arm and 8 participants in 'Placebo' arm.

Male: 21 participants in 'Trimethobenzamide (Tigan®)' arm and 22 participants in 'Placebo' arm.

Unified Parkinson's Disease Rating Scale (UPDRS) total score for Period 1 [1] 
[Units: Score on a scale]
Mean (Standard Deviation)
 49.2  (21.26)   47.8  (17.83)   48.8  (20.40) 
[1] The UPDRS is a 4-part rating tool to follow the longitudinal course of Parkinson’s disease. The four sections in the scale are 1. Mentation, Behavior and Mood, 2. Activities of Daily Living (ADL), 3. Motor Exam and 4. Complications of Therapy. UPDRS total score range from 0 to 199, with 199 indicative of the worst and 0 no disability.
UPDRS motor score for Period 1 [1] 
[Units: Score on a scale]
Mean (Standard Deviation)
 25.7  (15.07)   25.2  (12.25)   25.6  (14.37) 
[1] Part III (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.
UPDRS total score for Period 2 [1] 
[Units: Score on a scale]
Mean (Standard Deviation)
 46.7  (21.32)   47.6  (18.83)   47.1  (20.09) 
[1] The UPDRS is a 4-part rating tool to follow the longitudinal course of Parkinson’s disease. The four sections in the scale are 1. Mentation, Behavior and Mood, 2. Activities of Daily Living (ADL), 3. Motor Exam and 4. Complications of Therapy. UPDRS total score range from 0 to 199, with 199 indicative of the worst and 0 no disability.
UPDRS motor score for Period 2 [1] 
[Units: Score on a scale]
Mean (Standard Deviation)
 24.3  (15.50)   25.5  (12.60)   24.9  (14.14) 
[1] Part III (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.
UPDRS total score for Period 3 [1] 
[Units: Score on a scale]
Mean (Standard Deviation)
 48.1  (17.84)   47.5  (20.87)   47.6  (20.06) 
[1] The UPDRS is a 4-part rating tool to follow the longitudinal course of Parkinson’s disease. The four sections in the scale are 1. Mentation, Behavior and Mood, 2. Activities of Daily Living (ADL), 3. Motor Exam and 4. Complications of Therapy. UPDRS total score range from 0 to 199, with 199 indicative of the worst and 0 no disability.
UPDRS motor score for Period 3 [1] 
[Units: Score on a scale]
Mean (Standard Deviation)
 25.5  (13.58)   25.1  (14.69)   25.2  (14.35) 
[1] Part III (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.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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) ]

2.  Secondary:   Incidence of Nausea and/or Vomiting for Period 1   [ Time Frame: Days 1-28 ]

3.  Secondary:   Incidence of Nausea and/or Vomiting for Period 2   [ Time Frame: Days 29-56 ]

4.  Secondary:   Incidence of Nausea and/or Vomiting for Period 3   [ Time Frame: Days 57-84 ]

5.  Secondary:   Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 1   [ Time Frame: Days 1-28 ]

6.  Secondary:   Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 2   [ Time Frame: Days 29-56 ]

7.  Secondary:   Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 3   [ Time Frame: Days 57-84 ]

8.  Secondary:   Subject Global Evaluation of Randomized Study Medication for Period 1   [ Time Frame: Day 28 (Visit 3) ]

9.  Secondary:   Subject Global Evaluation of Randomized Study Medication for Period 2   [ Time Frame: Day 56 (Visit 4) ]

10.  Secondary:   Subject Global Evaluation of Randomized Study Medication for Period 3   [ Time Frame: Day 84 (Visit 5) ]

11.  Secondary:   Median Time to 'on' for Visit 2/Period 1 Injection 1   [ Time Frame: Day 1 (Visit 2) ]

12.  Secondary:   Median Time to 'on' for Visit 2/Period 1 Injection 2   [ Time Frame: Day 1 (Visit 2) ]

13.  Secondary:   Median Time to 'on' for Visit 3/End of Period 1 Injection   [ Time Frame: Day 28 ]

14.  Secondary:   Median Time to 'on' for Visit 4/End of Period 2 Injection   [ Time Frame: Day 56 (Visit 4) ]

15.  Secondary:   Median Time to 'on' for Visit 5/End of Period 3 Injection   [ Time Frame: Day 84 (Visit 5) ]

16.  Secondary:   Unified Parkinson’s Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 2, Pre Apokyn Dose, Period 1   [ Time Frame: Day 1 (Visit 2) ]

17.  Secondary:   Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 3, Pre Apokyn Dose, Period 1   [ Time Frame: Day 28 ]

18.  Secondary:   Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 3, Post Apokyn Dose, Period 1   [ Time Frame: Day 28 ]

19.  Secondary:   Unified Parkinson’s Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 4, Pre Apokyn Dose, Period 2   [ Time Frame: Day 56 (Visit 4) ]

20.  Secondary:   Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 4, Post Apokyn Dose, Period 2   [ Time Frame: Day 56 (Visit 4) ]

21.  Secondary:   Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 5, Pre Apokyn Dose, Period 3   [ Time Frame: Day 84 (Visit 5) ]

22.  Secondary:   Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 5, Post Apokyn Dose, Period 3   [ Time Frame: Day 56 (Visit 4) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Medical Director, Neurology
Organization: Ipsen
phone: clinical.trials@ipsen.com
e-mail: clinical.trials@ipsen.com



Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00489255     History of Changes
Other Study ID Numbers: Y-47-52844-003
APO-4PD-01
First Submitted: June 20, 2007
First Posted: June 21, 2007
Results First Submitted: December 24, 2012
Results First Posted: May 20, 2013
Last Update Posted: May 23, 2014