Clinical trial NCT00681863: Open-label Extension Study of Pramipexole in the Treatment of Children and Adolescents With Tourette Syndrome
Official title: Open Label Extension Study With Pramipexole (PPX) in Children With Tourette Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Tourette Syndrome
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-05-21
Enrollment: 45
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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 Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria and who have completed either Study 248.641 (NCT 00681863) or 248.644 (NCT 00558467).


Eligibility 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 International Conference on Harmonization (ICH) Good Clinical Practice (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 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 Tourette Syndrome (TS), Attention Deficit Hyperactivity Disorder (ADHD) or Obsessive Compulsive Disorder (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.

Primary outcomes:
measure: Patients With Adverse Events Leading to Discontinuation of Trial Drug
timeFrame: 24 Weeks
Secondary outcomes:
measure: Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale
timeFrame: baseline and week 24
measure: Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
timeFrame: baseline and Week 24 (end of treatment visit)
measure: Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale
timeFrame: baseline and Week 1
measure: Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale
timeFrame: baseline and Week 2
measure: Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale
timeFrame: baseline and Week 3
measure: Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale
timeFrame: baseline and week 4
measure: Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale
timeFrame: baseline and Week 8
measure: Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale
timeFrame: baseline and Week 12
measure: Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale
timeFrame: baseline and Week 16
measure: Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale
timeFrame: baseline and Week 20
measure: Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
timeFrame: baseline and Week 1
measure: Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
timeFrame: baseline and Week 2
measure: Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
timeFrame: baseline and Week 3
measure: Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
timeFrame: baseline and Week 4
measure: Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
timeFrame: baseline and Week 8
measure: Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
timeFrame: baseline and Week 12
measure: Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
timeFrame: baseline and Week 16
measure: Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
timeFrame: baseline and Week 20
measure: Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
timeFrame: baseline and Week 24
measure: Clinical Global Impressions - Severity of Illness
timeFrame: week 24
measure: Clinical Global Impressions - Severity of Illness, Categorized
timeFrame: week 24
measure: Clinical Global Impressions - Improvement
timeFrame: week 1
measure: Clinical Global Impressions - Improvement
timeFrame: week 2
measure: Clinical Global Impressions - Improvement
timeFrame: week 3
measure: Clinical Global Impressions - Improvement
timeFrame: week 4
measure: Clinical Global Impressions - Improvement
timeFrame: week 8
measure: Clinical Global Impressions - Improvement
timeFrame: week 12
measure: Clinical Global Impressions - Improvement
timeFrame: week 16
measure: Clinical Global Impressions - Improvement
timeFrame: week 20
measure: Clinical Global Impressions - Improvement
timeFrame: week 24
measure: Patient Global Impression - Improvement
timeFrame: week 1
measure: Patient Global Impression - Improvement
timeFrame: week 2
measure: Patient Global Impression - Improvement
timeFrame: week 3
measure: Patient Global Impression - Improvement
timeFrame: week 4
measure: Patient Global Impression - Improvement
timeFrame: week 8
measure: Patient Global Impression - Improvement
timeFrame: week 12
measure: Patient Global Impression - Improvement
timeFrame: week 16
measure: Patient Global Impression - Improvement
timeFrame: week 20
measure: Patient Global Impression - Improvement
timeFrame: week 24
measure: Frequency of Patients With Possible Clinically Significant Abnormalities for Laboratory Parameters
timeFrame: Baseline and 24 weeks
Other outcomes:
Locations:
city: Bradenton
country: United States
facility: 248.642.0026 Boehringer Ingelheim Investigational Site
state: Florida
city: Tampa
country: United States
facility: 248.642.0025 Boehringer Ingelheim Investigational Site
state: Florida
city: Columbus
country: United States
facility: 248.642.0006 Boehringer Ingelheim Investigational Site
state: Georgia
city: Cambridge
country: United States
facility: 248.642.0005 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Manhasset
country: United States
facility: 248.642.0003 Boehringer Ingelheim Investigational Site
state: New York
city: New York
country: United States
facility: 248.642.0009 Boehringer Ingelheim Investigational Site
state: New York
city: New York
country: United States
facility: 248.642.0018 Boehringer Ingelheim Investigational Site
state: New York
city: Orangeburg
country: United States
facility: 248.642.0013 Boehringer Ingelheim Investigational Site
state: New York
city: Oklahoma City
country: United States
facility: 248.642.0029 Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Providence
country: United States
facility: 248.642.0010 Boehringer Ingelheim Investigational Site
state: Rhode Island
city: Memphis
country: United States
facility: 248.642.0030 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Houston
country: United States
facility: 248.642.0008 Boehringer Ingelheim Investigational Site
state: Texas
city: Norfolk
country: United States
facility: 248.642.0023 Boehringer Ingelheim Investigational Site
state: Virginia
city: Ulm
country: Germany
facility: 248.642.49004 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: