Open-label Extension Study of Pramipexole in the Treatment of Children and Adolescents With Tourette Syndrome

This study has been terminated.
(Terminated for slow enrollment.)
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00681863
First received: May 19, 2008
Last updated: May 7, 2014
Last verified: May 2014
Results First Received: October 13, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Tourette Syndrome
Interventions: Drug: pramipexole 0.125 mg BID
Drug: pramipexole 0.0625 mg QD
Drug: pramipexole 0.125 mg TID
Drug: pramipexole 0.25 mg BID
Drug: pramipexole 0.0625 mg BID

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pramipexole 4 weeks individual dose titration starting with 0.0625 mg BID (twice daily), down-titration to 0.0625 QD (once daily) if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID (three times daily) and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.

Participant Flow:   Overall Study
    Pramipexole  
STARTED     45  
COMPLETED     22  
NOT COMPLETED     23  
Adverse Event                 1  
Lost to Follow-up                 2  
Lack of Efficacy                 2  
not specified                 18  



  Baseline Characteristics
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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.
Treated Set (TS) included all patients who were entered, were dispensed study medication and were documented to have taken at least one dose of study medication.

Reporting Groups
  Description
Pramipexole 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.

Baseline Measures
    Pramipexole  
Number of Participants  
[units: participants]
  45  
Age  
[units: Years]
Mean ± Standard Deviation
  11.8  ± 2.8  
Gender  
[units: Participants]
 
Female     9  
Male     36  
Ethnicity (NIH/OMB)  
[units: Participants]
 
Hispanic or Latino     6  
Not Hispanic or Latino     38  
Unknown or Not Reported     1  
Race/Ethnicity, Customized  
[units: participants]
 
Black or African American     5  
White     40  
Duration of Tourettes Syndrome  
[units: Participants]
 
More than 5 years     10  
Less than 1 year     15  
1 to 5 years     20  
Height  
[units: centimeters]
Mean ± Standard Deviation
  152.6  ± 19.4  
Weight  
[units: kilograms]
Mean ± Standard Deviation
  53.01  ± 21.58  
Body mass index  
[units: kilograms/square¬†meter]
Mean ± Standard Deviation
  22.064  ± 5.930  
Body temperature  
[units: Degrees¬†centigrade]
Mean ± Standard Deviation
  36.752  ± 0.718  
Respiration  
[units: breaths/minute]
Mean ± Standard Deviation
  17.4  ± 2.0  
Obsessive Compulsive Disorder [1]
[units: Participants]
 
Positive     4  
Intermediate     4  
Negative     37  
Attention Deficit Hyperactive Disorder [1]
[units: participants]
 
Positive     17  
Intermediate     6  
Negative     22  
Treatment received in previous trial (NCT00558467)  
[units: Participants]
 
Received placebo     14  
Received pramipexole     31  
[1] Diagnosis of disorder was performed using National Institute of Mental Health Diagnostic Interview Schedule for Children (NIMH DISC-IV)



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Patients With Adverse Events Leading to Discontinuation of Trial Drug   [ Time Frame: 24 Weeks ]

2.  Secondary:   Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale   [ Time Frame: baseline and week 24 ]

3.  Secondary:   Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale   [ Time Frame: baseline and Week 24 (end of treatment visit) ]

4.  Secondary:   Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale   [ Time Frame: baseline and Week 1 ]

5.  Secondary:   Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale   [ Time Frame: baseline and Week 2 ]

6.  Secondary:   Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale   [ Time Frame: baseline and Week 3 ]

7.  Secondary:   Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale   [ Time Frame: baseline and week 4 ]

8.  Secondary:   Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale   [ Time Frame: baseline and Week 8 ]

9.  Secondary:   Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale   [ Time Frame: baseline and Week 12 ]

10.  Secondary:   Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale   [ Time Frame: baseline and Week 16 ]

11.  Secondary:   Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale   [ Time Frame: baseline and Week 20 ]

12.  Secondary:   Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale   [ Time Frame: baseline and Week 24 ]

13.  Secondary:   Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale   [ Time Frame: baseline and Week 1 ]

14.  Secondary:   Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale   [ Time Frame: baseline and Week 2 ]

15.  Secondary:   Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale   [ Time Frame: baseline and Week 3 ]

16.  Secondary:   Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale   [ Time Frame: baseline and Week 4 ]

17.  Secondary:   Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale   [ Time Frame: baseline and Week 8 ]

18.  Secondary:   Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale   [ Time Frame: baseline and Week 12 ]

19.  Secondary:   Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale   [ Time Frame: baseline and Week 16 ]

20.  Secondary:   Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale   [ Time Frame: baseline and Week 20 ]

21.  Secondary:   Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale   [ Time Frame: baseline and Week 24 ]

22.  Secondary:   Clinical Global Impressions - Severity of Illness   [ Time Frame: week 24 ]

23.  Secondary:   Clinical Global Impressions - Severity of Illness, Categorized   [ Time Frame: week 24 ]

24.  Secondary:   Clinical Global Impressions - Improvement   [ Time Frame: week 1 ]

25.  Secondary:   Clinical Global Impressions - Improvement   [ Time Frame: week 2 ]

26.  Secondary:   Clinical Global Impressions - Improvement   [ Time Frame: week 3 ]

27.  Secondary:   Clinical Global Impressions - Improvement   [ Time Frame: week 4 ]

28.  Secondary:   Clinical Global Impressions - Improvement   [ Time Frame: week 8 ]

29.  Secondary:   Clinical Global Impressions - Improvement   [ Time Frame: week 12 ]

30.  Secondary:   Clinical Global Impressions - Improvement   [ Time Frame: week 16 ]

31.  Secondary:   Clinical Global Impressions - Improvement   [ Time Frame: week 20 ]

32.  Secondary:   Clinical Global Impressions - Improvement   [ Time Frame: week 24 ]

33.  Secondary:   Patient Global Impression - Improvement   [ Time Frame: week 1 ]

34.  Secondary:   Patient Global Impression - Improvement   [ Time Frame: week 2 ]

35.  Secondary:   Patient Global Impression - Improvement   [ Time Frame: week 3 ]

36.  Secondary:   Patient Global Impression - Improvement   [ Time Frame: week 4 ]

37.  Secondary:   Patient Global Impression - Improvement   [ Time Frame: week 8 ]

38.  Secondary:   Patient Global Impression - Improvement   [ Time Frame: week 12 ]

39.  Secondary:   Patient Global Impression - Improvement   [ Time Frame: week 16 ]

40.  Secondary:   Patient Global Impression - Improvement   [ Time Frame: week 20 ]

41.  Secondary:   Patient Global Impression - Improvement   [ Time Frame: week 24 ]

42.  Secondary:   Frequency of Patients With Possible Clinically Significant Abnormalities for Laboratory Parameters   [ Time Frame: Baseline and 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
The sponsor cancelled this trial prematurely. Thus, enrollment for 248.642 (NCT00681863) was significantly less than what was planned (120 planned vs. 45 entered). Therefore, the objectives of this study could not be fully assessed.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided


Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00681863     History of Changes
Other Study ID Numbers: 248.642, 2008-000342-32
Study First Received: May 19, 2008
Results First Received: October 13, 2010
Last Updated: May 7, 2014
Health Authority: Brazil: Comitê Nacional de Ética em Pesquisa Clínica - CONEP
Germany: BfArM-Federal Authorities for Drugs and Medical Devices
United States: Food and Drug Administration