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

Boehringer Ingelheim

Status and phase

Completed

Phase 2

Conditions

Tourette Syndrome

Treatments

Drug: pramipexole immediate release (IR)

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00558467

248.644

Details and patient eligibility

About

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.

Enrollment

63 patients

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

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.