Clinical trial NCT00558467: Pramipexole Pilot Phase II Study in Children and Adolescents With Tourette Disorder According to DSM-IV Criteria
Official title: A Randomized, Double-blind, Placebo-controlled, Flexible Dose Study to Evaluate Efficacy and Safety of Pramipexole Immediate Release (0.125-0.5mg/Day) Versus Placebo for 6 Weeks in Children and Adolescents (Age 6-17 Inclusive) Diagnosed With Tourette Disorder According to DSM IV Criteria.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tourette Syndrome
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2007-11-15
Enrollment: 63
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale
timeFrame: baseline 6 weeks
Secondary outcomes:
measure: Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 1
timeFrame: baseline 1 week
measure: Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 2
timeFrame: baseline and 2 weeks
measure: Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 3
timeFrame: baseline and 3 weeks
measure: Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 4
timeFrame: baseline and 4 weeks
measure: Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 6
timeFrame: baseline and 6 weeks
measure: Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 1
timeFrame: baseline 1 week
measure: Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 2
timeFrame: baseline and 2 weeks
measure: Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 3
timeFrame: baseline and 3 weeks
measure: Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 4
timeFrame: baseline 4 weeks
measure: Clinical Global Impressions - Improvement at 1 Week
timeFrame: baseline and Week 1
measure: Clinical Global Impressions - Improvement at Week 2
timeFrame: baseline and Week 2
measure: Clinical Global Impressions - Improvement at Week 3
timeFrame: baseline and Week 3
measure: Clinical Global Impressions - Improvement at Week 4
timeFrame: baseline and Week 4
measure: Clinical Global Impressions - Improvement at Week 6
timeFrame: baseline and Week 6
measure: Clinical Global Impressions - Severity of Illness at Week 1
timeFrame: baseline and Week 1
measure: Clinical Global Impressions - Severity of Illness at Week 2
timeFrame: baseline and Week 2
measure: Clinical Global Impressions - Severity of Illness at Week 3
timeFrame: baseline and Week 3
measure: Clinical Global Impressions - Severity of Illness at Week 4
timeFrame: baseline and Week 4
measure: Clinical Global Impressions - Severity of Illness at Week 6
timeFrame: baseline and Week 6
measure: Patient Global Impression at Week 1
timeFrame: baseline and Week 1
measure: Patient Global Impression at Week 2
timeFrame: baseline and Week 2
measure: Patient Global Impression at Week 3
timeFrame: baseline and Week 3
measure: Patient Global Impression at Week 4
timeFrame: baseline and Week 4
measure: Patient Global Impression at Week 6
timeFrame: baseline and Week 6
measure: Clinically Significant Abnormalities in Vital Signs (Orthostatic Reaction and Pulse Rate), and Serum Chemistry.
timeFrame: baseline and Week 6
Other outcomes:
Locations:
city: Bradenton
country: United States
facility: 248.644.0026 Boehringer Ingelheim Investigational Site
state: Florida
city: Tampa
country: United States
facility: 248.644.0025 Boehringer Ingelheim Investigational Site
state: Florida
city: Columbus
country: United States
facility: 248.644.0006 Boehringer Ingelheim Investigational Site
state: Georgia
city: Chicago
country: United States
facility: 248.644.0012 Boehringer Ingelheim Investigational Site
state: Illinois
city: Cambridge
country: United States
facility: 248.644.0005 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Manhasset
country: United States
facility: 248.644.0003 Boehringer Ingelheim Investigational Site
state: New York
city: New York
country: United States
facility: 248.644.0009 Boehringer Ingelheim Investigational Site
state: New York
city: New York
country: United States
facility: 248.644.0018 Boehringer Ingelheim Investigational Site
state: New York
city: Orangeburg
country: United States
facility: 248.644.0013 Boehringer Ingelheim Investigational Site
state: New York
city: Oklahoma City
country: United States
facility: 248.644.0029 Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Providence
country: United States
facility: 248.644.0010 Boehringer Ingelheim Investigational Site
state: Rhode Island
city: Memphis
country: United States
facility: 248.644.0030 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Houston
country: United States
facility: 248.644.0008 Boehringer Ingelheim Investigational Site
state: Texas
city: Norfolk
country: United States
facility: 248.644.0023 Boehringer Ingelheim Investigational Site
state: Virginia
city: Hannover
country: Germany
facility: 248.644.49001 Boehringer Ingelheim Investigational Site
city: Ulm
country: Germany
facility: 248.644.49004 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: