A randomized, double-blind, placebo-controlled, flexible dose study to evaluate efficacy and safety of Pramipexole versus placebo for 6 weeks in children (age 6-17) diagnosed with Tourette Disorder according to DSM IV criteria. The primary efficacy measure will be the Total Tic Score (TTS) of the Yale Global Tic Severity Scale (YGTSS) at 6 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
63
248.644.0026 Boehringer Ingelheim Investigational Site
Bradenton, Florida, United States
248.644.0025 Boehringer Ingelheim Investigational Site
Tampa, Florida, United States
Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale
Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50. Analysis was adjusted for baseline total tic score and age as linear covariates.
Time frame: baseline 6 weeks
Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 1
Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50
Time frame: baseline 1 week
Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 2
Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50
Time frame: baseline and 2 weeks
Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 3
Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50
Time frame: baseline and 3 weeks
Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 4
Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50
Time frame: baseline and 4 weeks
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 6
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248.644.0006 Boehringer Ingelheim Investigational Site
Columbus, Georgia, United States
248.644.0012 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
248.644.0005 Boehringer Ingelheim Investigational Site
Cambridge, Massachusetts, United States
248.644.0003 Boehringer Ingelheim Investigational Site
Manhasset, New York, United States
248.644.0009 Boehringer Ingelheim Investigational Site
New York, New York, United States
248.644.0018 Boehringer Ingelheim Investigational Site
New York, New York, United States
248.644.0013 Boehringer Ingelheim Investigational Site
Orangeburg, New York, United States
248.644.0029 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma, United States
...and 6 more locations
Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe)
Time frame: baseline and 6 weeks
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 1
Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe)
Time frame: baseline 1 week
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 2
Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe)
Time frame: baseline and 2 weeks
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 3
Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe)
Time frame: baseline and 3 weeks
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 4
Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe)
Time frame: baseline 4 weeks
Clinical Global Impressions - Improvement at 1 Week
Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.
Time frame: baseline and Week 1
Clinical Global Impressions - Improvement at Week 2
Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.
Time frame: baseline and Week 2
Clinical Global Impressions - Improvement at Week 3
Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.
Time frame: baseline and Week 3
Clinical Global Impressions - Improvement at Week 4
Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.
Time frame: baseline and Week 4
Clinical Global Impressions - Improvement at Week 6
Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.
Time frame: baseline and Week 6
Clinical Global Impressions - Severity of Illness at Week 1
Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater.
Time frame: baseline and Week 1
Clinical Global Impressions - Severity of Illness at Week 2
Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater.
Time frame: baseline and Week 2
Clinical Global Impressions - Severity of Illness at Week 3
Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater.
Time frame: baseline and Week 3
Clinical Global Impressions - Severity of Illness at Week 4
Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater.
Time frame: baseline and Week 4
Clinical Global Impressions - Severity of Illness at Week 6
Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater.
Time frame: baseline and Week 6
Patient Global Impression at Week 1
Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
Time frame: baseline and Week 1
Patient Global Impression at Week 2
Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
Time frame: baseline and Week 2
Patient Global Impression at Week 3
Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
Time frame: baseline and Week 3
Patient Global Impression at Week 4
Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
Time frame: baseline and Week 4
Patient Global Impression at Week 6
Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
Time frame: baseline and Week 6
Clinically Significant Abnormalities in Vital Signs (Orthostatic Reaction and Pulse Rate), and Serum Chemistry.
Time frame: baseline and Week 6