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

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Brief Title

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.

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.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale

Secondary Outcome

 Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 1

Condition

Tourette Syndrome

Intervention

pramipexole immediate release (IR)

Study Arms / Comparison Groups

 Pramipexole
Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

63

Start Date

January 2008

Primary Completion Date

June 2009

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.

Gender

All

Ages

6 Years - 17 Years

Accepts Healthy Volunteers

No

Contacts

Boehringer Ingelheim, ,

Location Countries

Germany

Location Countries

Germany

Administrative Informations

NCT ID

NCT00558467

Organization ID

248.644

Responsible Party

Sponsor

Study Sponsor

Boehringer Ingelheim

Study Sponsor

Boehringer Ingelheim, Study Chair, Boehringer Ingelheim

Verification Date

March 2014