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Open-Label Extension Study of Pramipexole in the Treatment of Children and Adolescents With Tourette Syndrome
This study is currently recruiting participants.
Verified by Boehringer Ingelheim Pharmaceuticals, December 2008
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00681863
  Purpose

The primary objective of this open-label, flexible dose study is to assess the safety and efficacy of pramipexole over a 24-week period in children and adolescents (age 6-17 years inclusive) diagnosed with Tourette Syndrome according to DSM-IV criteria and who have completed either Study 248.641 or 248.644.


Condition Intervention Phase
Tourette Syndrome
Drug: pramipexole
Phase III

Genetics Home Reference related topics: familial encephalopathy with neuroserpin inclusion bodies familial paroxysmal nonkinesigenic dyskinesia Tourette syndrome
MedlinePlus related topics: Tourette Syndrome
Drug Information available for: Pramipexol Pramipexole dihydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Safety/Efficacy Study
Official Title: OL Extension Study With PPX in Children With Tourette Syndrome

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Incidence of adverse events, proportion of withdrawals due to drug related adverse events, and assessment of the following scales: CYBOCS, CBCL, ADHD, CDI S, MASC. [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • Change from baseline in the Total Tic Score (TTS) of the YGTSS, in the Total Score of the YGTSS and GCI S. Change from baseline in the TTS and in Total Score of the YGTSS, in PGCI and CGI at Weeks 1, 2, 3, 4, 8, 12, 16, 20 and 24. [ Time Frame: 24 weeks ]

Estimated Enrollment: 148
Study Start Date: May 2008
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patients aged 6-17 years at the time of enrollment into study 248.641 or 248.644 and who have completed study 248.641 or 248.644.
  2. Written informed consent provided by the patient's parent (or legal guardian) and assent provided by the patient consistent with ICH GCP and local Institutional Review Board (IRB) requirements for children obtained prior to any study procedures being performed.
  3. Ability and willingness to comply with study treatment regimen and to complete study assessments.
  4. Females of childbearing potential having a negative serum beta-HCG pregnancy test at Visit 1.
  5. Females of childbearing potential must be using a medically accepted contraceptive method throughout the study. Acceptable methods of birth control are limited to: Intra-Uterine Device (IUD), oral, implantable, injectable contraceptives or estrogen patch, double barrier method (spermicide + diaphragm), or abstinence at the discretion of the investigator

Exclusion Criteria:

  1. Breastfeeding females.
  2. Development of any clinical condition in the preceding trial that in the investigator's opinion could be worsened by treatment with pramipexole.
  3. Clinically significant renal disease or serum creatinine out of this range: 0.3 1.0 mg/dL for patients aged 3-12 years and 0.5-1.4 mg/dL for patients aged 13+ years.
  4. Any of the following lab results at screening:

    Hemoglobin (Hgb) below lower limit of normal (LLN) which is determined to be clinically significant Basal thyroid stimulating hormone (TSH), triiodothyronine (T3) or thyroxine (T4) clinically significant (at the investigator's discretion) out of normal range at screening (if not caused by substitution therapy according the investigator's opinion) Patients with any clinically significant abnormalities in laboratory parameters at screening at the investigator's discretion.

  5. Other clinically significant metabolic-endocrine, hematological, gastrointestinal disease, or pulmonary disease (such as severe asthma) in the opinion of the investigator that would preclude the patient from participating in this study.
  6. History or presence of schizophrenia or any psychotic disorder. History or presence of any psychiatric disorder requiring medical therapy with the exception for patients with a diagnosis of TS, ADHD or OCD who are not on therapy other than pramipexole.
  7. History or presence of clinical signs of epilepsy or seizures other than fever-related seizures in early childhood.
  8. History or presence of clinical signs of any malignant neoplasm including suspicious undiagnosed skin lesion (which may be melanoma), melanoma, or a history of melanoma.
  9. History of any other medical treatment for TS besides the study medication within 28 days prior to the baseline visit (14 days prior to baseline for guanfacine, 14 days prior to baseline for dopamine agonists, 14 days prior to baseline for L-Dopa, 35 days prior to baseline for fluoxetine).
  10. Patients receiving psychotherapy are excluded unless they started the treatment at least 3 months prior to starting the trial and no changes in treatment are planned for the duration of the study.
  11. Allergic response to pramipexole or the inactive ingredients in its tablet formulation.
  12. Non-compliance with study medication (defined as less than 80% or more than 120%) during the preceding Study 248.641 or 248.644.
  13. Concurrent participation in another clinical trial using any investigational drug since completion of the preceding Study 248.641 or 248.644.
  14. Any other conditions, that in the opinion of the investigator, would interfere with the evaluation of the results or constitute a health hazard for the patient.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00681863

Contacts
Contact: Boehringer Ingelheim Study Coordinator 800-542-6257 ext Option 4 clintriage.rdg@boehringer-ingelheim.com

  Show 23 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 248.642, EUDRACT2008-000342-32
Study First Received: May 19, 2008
Last Updated: December 17, 2008
ClinicalTrials.gov Identifier: NCT00681863  
Health Authority: Argentina: A.N.M.A.T. (Administración Nacional de Medicamentos, Alimentos y Tecnologia Médica);   Brazil: Comitê Nacional de Ética em Pesquisa Clínica - CONEP;   Canada: Health Canada;   Germany: BfArM-Federal Authorities for Drugs and Medical Devices;   Great Britain: MHRA;   Italy: San Raffaele Hospital - Rome;   South Africa: MCC (Medicines Control Council);   Spain: Agencia Espanola del Medicamento y Productos Sanitarios;   United States: Food and Drug Administration

Study placed in the following topic categories:
Ganglion Cysts
Basal Ganglia Diseases
Central Nervous System Diseases
Tourette Syndrome
Tic Disorders
Brain Diseases
Neurodegenerative Diseases
Pramipexol
Tics
Dopamine
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Movement Disorders
Mental Disorders
Mental Disorders Diagnosed in Childhood
Gilles de la Tourette's syndrome

Additional relevant MeSH terms:
Neurotransmitter Agents
Disease
Antioxidants
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Nervous System Diseases
Physiological Effects of Drugs
Antiparkinson Agents
Dopamine Agonists
Protective Agents
Pharmacologic Actions
Pathologic Processes
Syndrome
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009