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

NCT00558467 | Completed Phase 2 Results

• 1 other identifier: 248.644
• Study Type: interventional
• Target: 63
• Locations: 2 countries
• Sites: 16

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.

Conditions

Tourette Syndrome

Outcome Measures

Primary Outcomes (1)

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

  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.

  baseline 6 weeks

Secondary Outcomes (25)

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

  baseline 1 week

• Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 2

  baseline and 2 weeks

• Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 3

  baseline and 3 weeks

• Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 4

  baseline and 4 weeks

• Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 6

  baseline and 6 weeks

Study Arms (2)

Pramipexole

OTHER

Drug: pramipexole immediate release (IR)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

pramipexole immediate release (IR) DRUG

Pramipexole

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (16)

248.644.0026 Boehringer Ingelheim Investigational Site

Bradenton, Florida, United States

Location

248.644.0025 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Location

248.644.0006 Boehringer Ingelheim Investigational Site

Columbus, Georgia, United States

Location

248.644.0012 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

248.644.0005 Boehringer Ingelheim Investigational Site

Cambridge, Massachusetts, United States

Location

248.644.0003 Boehringer Ingelheim Investigational Site

Manhasset, New York, United States

Location

248.644.0009 Boehringer Ingelheim Investigational Site

New York, New York, United States

Location

248.644.0018 Boehringer Ingelheim Investigational Site

New York, New York, United States

Location

248.644.0013 Boehringer Ingelheim Investigational Site

Orangeburg, New York, United States

Location

248.644.0029 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

Location

248.644.0010 Boehringer Ingelheim Investigational Site

Providence, Rhode Island, United States

Location

248.644.0030 Boehringer Ingelheim Investigational Site

Memphis, Tennessee, United States

Location

248.644.0008 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

248.644.0023 Boehringer Ingelheim Investigational Site

Norfolk, Virginia, United States

Location

248.644.49001 Boehringer Ingelheim Investigational Site

Hanover, Germany

Location

248.644.49004 Boehringer Ingelheim Investigational Site

Ulm, Germany

Location

MeSH Terms

Conditions

Tourette Syndrome

Interventions

Pramipexole

Condition Hierarchy (Ancestors)

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; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzothiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2007
• First Posted: November 15, 2007
• Study Start: January 1, 2008
• Primary Completion: June 1, 2009
• Last Updated: May 16, 2014
• Results First Posted: October 20, 2010

Record last verified: 2014-03

Locations

US (14); DE (2)