Pramipexole Pilot Phase II Study in Children and Adolescents With Tourette Disorder According to DSM-IV Criteria

Phase 2

Completed

Conditions: Tourette Syndrome

Interventions: Drug: Placebo
Drug: pramipexole immediate release (IR)

Registration Number: NCT00558467

Lead Sponsor: Boehringer Ingelheim

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 63

Inclusion Criteria

Male of female patients 6-17 yrs.
Written informed consent.
Diagnosed with Tourette's Disorder with a > or equal to 22 on the Total Tic Score at baseline.
Diagnosed with Tourette's Disorder when administering the Diagnostic Interview Schedule for Children.
Having at least 1 tic/day.
Women of childbearing age must have a negative serum pregnancy test at screening and must use a medically accepted contraceptive method.
Either a newly diagnosed patient or a patient diagnosed with Tourette's Disorder who can safely discontinue treatment.
Having a body weight of > or equal to 20 kg (44 lbs).

Exclusion Criteria

Any women of childbearing age having a positive serum pregnancy test at screening.
Patients who have clinically significant renal disease or serum creatinine greater than 1.0 mg/dL at screening.
Lab results at screening: hemoglobin below lower limit of normal which is determined to be clinically significant; Thyroid Stimulating Hormone (TSH), triiodothyronine (T3) or thyroxine (T4) clinically significant; clinically significant abnormalities in labs.
Other clinically significant metabolic-endocrine, hematological, gastrointestinal disease, pulmonary disease which would preclude the patient from participating in this study.
History of Schizophrenia or any psychotic disorder, history of mental disorders or any present Axis I psychiatric disorder according to Diagnostic and Statistic Manual of Mental Disorders Fourth Edition (DSM-IV) requiring any medical therapy except for patients with a diagnosis of attention deficit hyperactivity disorder (ADHD) or obsessive-compulsive disorder (OCD) who are not on therapy.
History of/or clinical signs of epilepsy or seizures other than fever related seizures in early childhood.
History of/or clinical signs of any malignant neoplasm.
Allergic response to pramipexole.
Had previous treatment with dopamine agonists other than pramipexole within 14 days prior to baseline visit.
Had any other medical treatment for Tourette's Disorder besides the study medication within 28 days prior to baseline visit.
Had withdrawal symptoms of any medication at screening or at the baseline visit.
Having a Kaufman Brief Intelligence Test (KBIT IQ) score <70 at screening.
Having a children's Yale-Brown obsessive-compulsive scale (CY-BOCS) score of >15 at baseline.
Patients who meet criteria for Restless Legs Syndrome and or Periodic Limb Movement disorder.
Patients with severe asthma.
Patients that have initiated psychotherapy for Tourette's Disorder, OCD or ADHD within 3 mths of starting the trial.
Patients receiving psychological, cognitive and/or behavioral treatments greater than 3 mths prior to start of trial for Tourette's Disorder, OCD, and/or ADHD who will have changes in treatment plan.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Pramipexole	pramipexole immediate release (IR)	-

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale	baseline 6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impressions - Improvement at Week 2	baseline and 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.
Clinical Global Impressions - Improvement at Week 3	baseline and 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.
Clinical Global Impressions - Improvement at Week 4	baseline and 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.
Clinical Global Impressions - Improvement at Week 6	baseline and 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.
Clinical Global Impressions - Severity of Illness at Week 1	baseline and 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.
Clinical Global Impressions - Severity of Illness at Week 2	baseline and 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.
Clinical Global Impressions - Severity of Illness at Week 3	baseline and 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.
Clinical Global Impressions - Severity of Illness at Week 4	baseline and 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.
Clinical Global Impressions - Severity of Illness at Week 6	baseline and 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.
Patient Global Impression at Week 1	baseline and 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).
Patient Global Impression at Week 2	baseline and 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).
Patient Global Impression at Week 3	baseline and 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).
Patient Global Impression at Week 4	baseline and 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).
Patient Global Impression at Week 6	baseline and 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).
Clinically Significant Abnormalities in Vital Signs (Orthostatic Reaction and Pulse Rate), and Serum Chemistry.	baseline and Week 6
Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 1	baseline 1 week	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
Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 2	baseline and 2 weeks	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
Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 3	baseline and 3 weeks	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
Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 4	baseline and 4 weeks	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
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 6	baseline and 6 weeks	Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe)
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 1	baseline 1 week	Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe)
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 2	baseline and 2 weeks	Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe)
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 3	baseline and 3 weeks	Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe)
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 4	baseline 4 weeks	Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe)
Clinical Global Impressions - Improvement at 1 Week	baseline and Week 1	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.

Trial Locations

Locations (16): 248.644.0012 Boehringer Ingelheim Investigational Site
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Chicago, Illinois, United States
248.644.0026 Boehringer Ingelheim Investigational Site
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Bradenton, Florida, United States
248.644.0005 Boehringer Ingelheim Investigational Site
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Cambridge, Massachusetts, United States
248.644.0013 Boehringer Ingelheim Investigational Site
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Orangeburg, New York, United States
248.644.0029 Boehringer Ingelheim Investigational Site
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Oklahoma City, Oklahoma, United States
248.644.0025 Boehringer Ingelheim Investigational Site
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Tampa, Florida, United States
248.644.0006 Boehringer Ingelheim Investigational Site
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Columbus, Georgia, United States
248.644.0003 Boehringer Ingelheim Investigational Site
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Manhasset, New York, United States
248.644.0009 Boehringer Ingelheim Investigational Site
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New York, New York, United States
248.644.0018 Boehringer Ingelheim Investigational Site
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New York, New York, United States
248.644.0010 Boehringer Ingelheim Investigational Site
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Providence, Rhode Island, United States
248.644.0030 Boehringer Ingelheim Investigational Site
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Memphis, Tennessee, United States
248.644.0008 Boehringer Ingelheim Investigational Site
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Houston, Texas, United States
248.644.0023 Boehringer Ingelheim Investigational Site
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Norfolk, Virginia, United States
248.644.49001 Boehringer Ingelheim Investigational Site
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Hannover, Germany
248.644.49004 Boehringer Ingelheim Investigational Site
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Ulm, Germany