Pramipexole Pilot Phase II Study in Children and Adolescents With Tourette Disorder According to DSM-IV Criteria
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00558467
First received: November 14, 2007
Last updated: May 18, 2012
Last verified: May 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Tourette Syndrome |
Drug: pramipexole IR Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-blind, Placebo-controlled, Flexible Dose Study to Evaluate Efficacy and Safety of Pramipexole IR (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. |
Resource links provided by NLM:
Genetics Home Reference related topics:
Tourette syndrome
MedlinePlus related topics:
Tourette Syndrome
U.S. FDA Resources
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale [ Time Frame: baseline 6 weeks ] [ Designated as safety issue: No ]
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:
- Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 1 [ Time Frame: baseline 1 week ] [ Designated as safety issue: No ]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 [ Time Frame: baseline and 2 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: baseline and 3 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: baseline 1 week ] [ Designated as safety issue: No ]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 [ Time Frame: baseline and 2 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: baseline and 3 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: baseline 4 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: baseline and Week 1 ] [ Designated as safety issue: No ]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 2 [ Time Frame: baseline and Week 2 ] [ Designated as safety issue: No ]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 [ Time Frame: baseline and Week 3 ] [ Designated as safety issue: No ]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 [ Time Frame: baseline and Week 4 ] [ Designated as safety issue: No ]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 [ Time Frame: baseline and Week 6 ] [ Designated as safety issue: No ]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 [ Time Frame: baseline and Week 1 ] [ Designated as safety issue: No ]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 [ Time Frame: baseline and Week 2 ] [ Designated as safety issue: No ]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 [ Time Frame: baseline and Week 3 ] [ Designated as safety issue: No ]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 [ Time Frame: baseline and Week 4 ] [ Designated as safety issue: No ]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 [ Time Frame: baseline and Week 6 ] [ Designated as safety issue: No ]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 [ Time Frame: baseline and Week 1 ] [ Designated as safety issue: No ]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 [ Time Frame: baseline and Week 2 ] [ Designated as safety issue: No ]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 [ Time Frame: baseline and Week 3 ] [ Designated as safety issue: No ]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 [ Time Frame: baseline and Week 4 ] [ Designated as safety issue: No ]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 [ Time Frame: baseline and Week 6 ] [ Designated as safety issue: No ]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).
| Enrollment: | 63 |
| Study Start Date: | January 2008 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Pramipexole | Drug: pramipexole IR |
| Placebo Comparator: Placebo | Drug: Placebo |
Eligibility| Ages Eligible for Study: | 6 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00558467
Locations
| United States, Florida | |
| 248.644.0026 Boehringer Ingelheim Investigational Site | |
| Bradenton, Florida, United States | |
| 248.644.0025 Boehringer Ingelheim Investigational Site | |
| Tampa, Florida, United States | |
| United States, Georgia | |
| 248.644.0006 Boehringer Ingelheim Investigational Site | |
| Columbus, Georgia, United States | |
| United States, Illinois | |
| 248.644.0012 Boehringer Ingelheim Investigational Site | |
| Chicago, Illinois, United States | |
| United States, Massachusetts | |
| 248.644.0005 Boehringer Ingelheim Investigational Site | |
| Cambridge, Massachusetts, United States | |
| United States, New York | |
| 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 | |
| United States, Oklahoma | |
| 248.644.0029 Boehringer Ingelheim Investigational Site | |
| Oklahoma City, Oklahoma, United States | |
| United States, Rhode Island | |
| 248.644.0010 Boehringer Ingelheim Investigational Site | |
| Providence, Rhode Island, United States | |
| United States, Tennessee | |
| 248.644.0030 Boehringer Ingelheim Investigational Site | |
| Memphis, Tennessee, United States | |
| United States, Texas | |
| 248.644.0008 Boehringer Ingelheim Investigational Site | |
| Houston, Texas, United States | |
| United States, Virginia | |
| 248.644.0023 Boehringer Ingelheim Investigational Site | |
| Norfolk, Virginia, United States | |
| Germany | |
| 248.644.49001 Boehringer Ingelheim Investigational Site | |
| Hannover, Germany | |
| 248.644.49004 Boehringer Ingelheim Investigational Site | |
| Ulm, Germany | |
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
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: | May 18, 2012 |
| Health Authority: | Germany: BfArM-Federal Authorities for Drugs and Medical Devices United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Tourette Syndrome Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Tic Disorders Movement Disorders Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Genetic Diseases, Inborn Mental Disorders Diagnosed in Childhood Mental Disorders Pramipexol |
Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Dopamine Agonists Dopamine Agents Neurotransmitter Agents |
ClinicalTrials.gov processed this record on May 16, 2013