Phase 2
N=63
Pramipexole Pilot Phase II Study in Children and Adolescents With Tourette Disorder According to DSM-IV Criteria
Tourette Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00558467 ↗Enrolled (actual)
63
Serious AEs
1.6%
Results posted
Oct 2010
Primary outcome: Primary: Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale — -7.17; -7.16 score on a scale — p=0.996
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- pramipexole immediate release (IR) (Drug); Placebo (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale |
-7.17; -7.16 | 0.996 |
| SECONDARY Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 1 |
-3.7; -4.1 | — |
| SECONDARY Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 2 |
-5.3; -5 | — |
| SECONDARY Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 3 |
-6.2; -5.4 | — |
| SECONDARY Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 4 |
-6; -6.4 | — |
| SECONDARY Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 6 |
-15.43; -15.58 | 0.9780 |
| SECONDARY Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 1 |
-6.2; -8.8 | — |
| SECONDARY Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 2 |
-9.5; -10.6 | — |
| SECONDARY Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 3 |
-14.1; -12.2 | — |
| SECONDARY Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 4 |
-15.5; -13.9 | — |
| SECONDARY Clinical Global Impressions - Improvement at 1 Week |
0; 5; 20; 37 | 0.1052 |
| SECONDARY Clinical Global Impressions - Improvement at Week 2 |
1; 6; 19; 36 | 0.2274 |
| SECONDARY Clinical Global Impressions - Improvement at Week 3 |
2; 5; 18; 37 | 0.7691 |
| SECONDARY Clinical Global Impressions - Improvement at Week 4 |
7; 6; 13; 36 | 0.0674 |
| SECONDARY Clinical Global Impressions - Improvement at Week 6 |
7; 11; 13; 31 | 0.4944 |
| SECONDARY Clinical Global Impressions - Severity of Illness at Week 1 |
0; 4; 20; 38; 0; 0 | 0.162 |
| SECONDARY Clinical Global Impressions - Severity of Illness at Week 2 |
1; 4; 19; 37; 0; 1 | 0.6375 |
| SECONDARY Clinical Global Impressions - Severity of Illness at Week 3 |
3; 4; 17; 37; 0; 1 | 0.6625 |
| SECONDARY Clinical Global Impressions - Severity of Illness at Week 4 |
4; 4; 16; 38; 0; 0 | 0.2664 |
| SECONDARY Clinical Global Impressions - Severity of Illness at Week 6 |
4; 10; 16; 32; 0; 0 | 0.7302 |
| SECONDARY Patient Global Impression at Week 1 |
4; 7; 16; 35 | 0.7723 |
| SECONDARY Patient Global Impression at Week 2 |
6; 9; 14; 33 | 0.4852 |
| SECONDARY Patient Global Impression at Week 3 |
5; 7; 15; 35 | 0.4607 |
| SECONDARY Patient Global Impression at Week 4 |
4; 7; 16; 35 | 0.7723 |
| SECONDARY Patient Global Impression at Week 6 |
6; 12; 14; 30 | 0.9389 |
| SECONDARY Clinically Significant Abnormalities in Vital Signs (Orthostatic Reaction and Pulse Rate), and Serum Chemistry. |
2; 5; 0; 1; 0; 1 | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT00558467). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.