An open-label, flexible dose, follow-up study to evaluate safety and effectiveness of oral pramipexole (0.0625 – 0.5mg/day) for 24-weeks in children and adolescents (age 6-17 years) who have been diagnosed with Tourette Syndrome and who have completed the previous trials 248.641 or 248.644

• Conditions: Tourette's Syndrome; MedDRA version: 14.0Level: LLTClassification code 10044127Term: Tourette's syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2008-000342-32-Outside-EU/EEA
• Lead Sponsor: Boehringer Ingelheim Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-04
• Last Update Posted: 24 July 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 120

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 ß-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 (spermacide + diaphragm), or abstinence at the discretion of the investigator.
Are the trial subjects under 18? yes
Number of subjects for this age range: 120
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 6-12 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 theinvestigator that would preclude the patient from participating in this study. Patients with asthma that is well-controlled are not excluded.
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 suspiciousundiagnosed skin lesion (which may be melanoma), melanoma, or a history ofmelanoma. Albinotic patients.
9. Pharmacological, herbal and / or alternative treatments for TS, ADHD and / or OCD are not allowed during the trial. See Section 4.2.2 of Prtocol for complete details and washout information.
10. Patients receiving psychological, cognitive and / or behavioral treatments for TS, OCD and / or ADHD are excluded unless they started the treatment at least 3 months prior to randomisation and no changes in treatment are planned for the duration of this 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.
15. History of alcohol abuse, substance abuse or any prescribed or over-the-counter medication usage in a manner which, in the opinion of the investigator, indicates abuse.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified