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Pramipexole Pilot Phase II Study in Children and Adolescents With Tourette Disorder According to DSM-IV Criteria
This study has been completed.
Study NCT00558467   Information provided by Boehringer Ingelheim Pharmaceuticals

First Received on November 14, 2007.   Last Updated on July 4, 2011   History of Changes
Results First Received: June 18, 2010  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
Condition: Tourette Syndrome
Interventions: Drug: pramipexole IR
Drug: Placebo

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

Participant Flow:   Overall Study
    Placebo     Pramipexole  
STARTED     20     43  
COMPLETED     19     39  
NOT COMPLETED     1     4  
Adverse Event                 1                 2  
Lack of Efficacy                 0                 1  
Patient moving out of state                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Placebo No text entered.
Pramipexole No text entered.

Baseline Measures
    Placebo     Pramipexole     Total  
Number of Participants  
[units: participants]
 		  20     43     63  
Age  
[units: Years]
Mean ± Standard Deviation 		  11.1  ± 3.2     12.2  ± 2.4     11.8  ± 2.7  
Gender  
[units: participants]
 		     
Female     2     8     10  
Male     18     35     53  
Attention Deficit Hyperactive Disorder [1]
[units: Number of Patients]
 		     
Intermediate     3     6     9  
Negative     9     22     31  
Positive     8     15     23  
Duration of Tourettes syndrome  
[units: participants]
 		     
1-5 years     10     19     29  
Less than 1 years     6     12     18  
More than 5 years     4     12     16  
Ethnicity, Customized  
[units: Number of Patients]
 		     
Hispanic/Latino     2     5     7  
Not Hispanic/Latino     18     38     56  
Obsessive Compulsive Disorder [2]
[units: participants]
 		     
Intermediate     1     3     4  
Negative     16     37     53  
Positive     3     3     6  
Race, Customized  
[units: participants]
 		     
Black/African American     2     4     6  
White     18     39     57  
Body Mass Index  
[units: kilograms/(meters squared)]
Mean ± Standard Deviation 		  20.085  ± 5.324     22.575  ± 5.656     21.784  ± 5.632  
Height  
[units: centimeters]
Mean ± Standard Deviation 		  150.7  ± 21.6     155.3  ± 16.2     153.8  ± 18  
Weight  
[units: kilograms]
Mean ± Standard Deviation 		  47.48  ± 21.29     55.87  ± 20.64     53.21  ± 21.05  
[1] Diagnosis of disorder was performed using National Institute of Mental Health Diagnostic Interview Schedule for Children (NIMH DISC IV) and resulted in patients being classified as negative diagnosis, intermediate diagnosis and positive diagnosis for disorder.
[2] Diagnosis of disorder was performed using National Institute of Mental Health Diagnostic Interview Schedule for Children (NIMH DISC IV) and resulted in patients being classified as negative, intermediate and positive for disorder.



  Outcome Measures
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1.  Primary:   Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale   [ Time Frame: baseline 6 weeks ]
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2.  Secondary:   Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 1   [ Time Frame: baseline 1 week ]
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3.  Secondary:   Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 2   [ Time Frame: baseline and 2 weeks ]
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4.  Secondary:   Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 3   [ Time Frame: baseline and 3 weeks ]
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5.  Secondary:   Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 4   [ Time Frame: baseline and 4 weeks ]
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6.  Secondary:   Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 6   [ Time Frame: baseline and 6 weeks ]
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7.  Secondary:   Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 1   [ Time Frame: baseline 1 week ]
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8.  Secondary:   Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 2   [ Time Frame: baseline and 2 weeks ]
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9.  Secondary:   Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 3   [ Time Frame: baseline and 3 weeks ]
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10.  Secondary:   Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 4   [ Time Frame: baseline 4 weeks ]
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11.  Secondary:   Clinical Global Impressions - Improvement at 1 Week   [ Time Frame: baseline and Week 1 ]
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12.  Secondary:   Clinical Global Impressions - Improvement at Week 2   [ Time Frame: baseline and Week 2 ]
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13.  Secondary:   Clinical Global Impressions - Improvement at Week 3   [ Time Frame: baseline and Week 3 ]
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14.  Secondary:   Clinical Global Impressions - Improvement at Week 4   [ Time Frame: baseline and Week 4 ]
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15.  Secondary:   Clinical Global Impressions - Improvement at Week 6   [ Time Frame: baseline and Week 6 ]
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16.  Secondary:   Clinical Global Impressions - Severity of Illness at Week 1   [ Time Frame: baseline and Week 1 ]
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17.  Secondary:   Clinical Global Impressions - Severity of Illness at Week 2   [ Time Frame: baseline and Week 2 ]
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18.  Secondary:   Clinical Global Impressions - Severity of Illness at Week 3   [ Time Frame: baseline and Week 3 ]
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19.  Secondary:   Clinical Global Impressions - Severity of Illness at Week 4   [ Time Frame: baseline and Week 4 ]
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20.  Secondary:   Clinical Global Impressions - Severity of Illness at Week 6   [ Time Frame: baseline and Week 6 ]
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21.  Secondary:   Patient Global Impression at Week 1   [ Time Frame: baseline and Week 1 ]
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22.  Secondary:   Patient Global Impression at Week 2   [ Time Frame: baseline and Week 2 ]
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23.  Secondary:   Patient Global Impression at Week 3   [ Time Frame: baseline and Week 3 ]
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24.  Secondary:   Patient Global Impression at Week 4   [ Time Frame: baseline and Week 4 ]
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25.  Secondary:   Patient Global Impression at Week 6   [ Time Frame: baseline and Week 6 ]
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  Serious Adverse Events
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  Other Adverse Events
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  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.


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.  


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, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00558467     History of Changes
Other Study ID Numbers: 248.644
Study First Received: November 14, 2007
Results First Received: June 18, 2010
Last Updated: July 4, 2011
Health Authority: Germany: BfArM-Federal Authorities for Drugs and Medical Devices;   United States: Food and Drug Administration





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