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Open-label Extension Study of Pramipexole in the Treatment of Children and Adolescents With Tourette Syndrome

Primary Purpose

Tourette Syndrome

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
pramipexole 0.125 mg BID
pramipexole 0.0625 mg QD
pramipexole 0.125 mg TID
pramipexole 0.25 mg BID
pramipexole 0.0625 mg BID
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tourette Syndrome

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • 248.642.0026 Boehringer Ingelheim Investigational Site
  • 248.642.0025 Boehringer Ingelheim Investigational Site
  • 248.642.0006 Boehringer Ingelheim Investigational Site
  • 248.642.0005 Boehringer Ingelheim Investigational Site
  • 248.642.0003 Boehringer Ingelheim Investigational Site
  • 248.642.0009 Boehringer Ingelheim Investigational Site
  • 248.642.0018 Boehringer Ingelheim Investigational Site
  • 248.642.0013 Boehringer Ingelheim Investigational Site
  • 248.642.0029 Boehringer Ingelheim Investigational Site
  • 248.642.0010 Boehringer Ingelheim Investigational Site
  • 248.642.0030 Boehringer Ingelheim Investigational Site
  • 248.642.0008 Boehringer Ingelheim Investigational Site
  • 248.642.0023 Boehringer Ingelheim Investigational Site
  • 248.642.49004 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

pramipexole 0.0625 mg BID (twice daily)

pramipexole 0.0625 mg QD (once daily)

pramipexole 0.125 mg BID

pramipexole 0.125 mg TID (three times daily)

pramipexole 0.25 mg BID

Arm Description

all patients to receive one tablet of pramipexole 0.0625 mg BID for first 4 weeks (flexible dosing for all other arms)

patients to receive one tablet of pramipexole 0.0625 mg QD

patients to receive one tablet of pramipexole 0.125 mg BID

patients to receive one tablet of pramipexole 0.125 mg TID

patients to receive one tablet of pramipexole 0.25 mg BID

Outcomes

Primary Outcome Measures

Patients With Adverse Events Leading to Discontinuation of Trial Drug
Number of patients with Adverse Events leading to discontinuation of trial drug

Secondary Outcome Measures

Mean Change From Baseline in Total Tic Score (TTS) 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.
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).
Mean Change From Baseline in Total Tic Score (TTS) 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.
Mean Change From Baseline in Total Tic Score (TTS) 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.
Mean Change From Baseline in Total Tic Score (TTS) 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.
Mean Change From Baseline in Total Tic Score (TTS) 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.
Mean Change From Baseline in Total Tic Score (TTS) 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.
Mean Change From Baseline in Total Tic Score (TTS) 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.
Mean Change From Baseline in Total Tic Score (TTS) 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.
Mean Change From Baseline in Total Tic Score (TTS) 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.
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).
Clinical Global Impressions - Severity of Illness
Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.
Clinical Global Impressions - Severity of Illness, Categorized
Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (among the most extremely ill patients). Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.
Clinical Global Impressions - Improvement
Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).
Clinical Global Impressions - Improvement
Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).
Clinical Global Impressions - Improvement
Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).
Clinical Global Impressions - Improvement
Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).
Clinical Global Impressions - Improvement
Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).
Clinical Global Impressions - Improvement
Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).
Clinical Global Impressions - Improvement
Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).
Clinical Global Impressions - Improvement
Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).
Clinical Global Impressions - Improvement
Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).
Patient Global Impression - Improvement
Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
Patient Global Impression - Improvement
Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
Patient Global Impression - Improvement
Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
Patient Global Impression - Improvement
Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
Patient Global Impression - Improvement
Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
Patient Global Impression - Improvement
Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
Patient Global Impression - Improvement
Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
Patient Global Impression - Improvement
Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
Patient Global Impression - Improvement
Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
Frequency of Patients With Possible Clinically Significant Abnormalities for Laboratory Parameters
Frequency of patients with possible clinically significant abnormalities for laboratory parameters (blood hematology and electrolyte assessments, serum chemistry, including follicle-stimulating hormone (FSH), luteinizing hormone (LH) and estradiol for pubertal female patients, prolactin in all patients, testosterone in pubertal male patients, urine analysis)

Full Information

First Posted
May 19, 2008
Last Updated
May 7, 2014
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00681863
Brief Title
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

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Terminated
Why Stopped
Terminated for slow enrollment.
Study Start Date
May 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pramipexole 0.0625 mg BID (twice daily)
Arm Type
Active Comparator
Arm Description
all patients to receive one tablet of pramipexole 0.0625 mg BID for first 4 weeks (flexible dosing for all other arms)
Arm Title
pramipexole 0.0625 mg QD (once daily)
Arm Type
Active Comparator
Arm Description
patients to receive one tablet of pramipexole 0.0625 mg QD
Arm Title
pramipexole 0.125 mg BID
Arm Type
Active Comparator
Arm Description
patients to receive one tablet of pramipexole 0.125 mg BID
Arm Title
pramipexole 0.125 mg TID (three times daily)
Arm Type
Active Comparator
Arm Description
patients to receive one tablet of pramipexole 0.125 mg TID
Arm Title
pramipexole 0.25 mg BID
Arm Type
Active Comparator
Arm Description
patients to receive one tablet of pramipexole 0.25 mg BID
Intervention Type
Drug
Intervention Name(s)
pramipexole 0.125 mg BID
Intervention Description
titrated dose for those patients whose symptoms were not controlled on the 0.0625 mg BID dose
Intervention Type
Drug
Intervention Name(s)
pramipexole 0.0625 mg QD
Intervention Description
dose down titrated for those patients unable to tolerate the 0.0625 mg BID dosing
Intervention Type
Drug
Intervention Name(s)
pramipexole 0.125 mg TID
Intervention Description
titrated up for those patients whose symptoms were not adequately controlled on 0.125 mg BID dose
Intervention Type
Drug
Intervention Name(s)
pramipexole 0.25 mg BID
Intervention Description
titrated for those patients whose symptoms were not adequately controlled on 0.125 mg TID dose
Intervention Type
Drug
Intervention Name(s)
pramipexole 0.0625 mg BID
Intervention Description
0.0625 mg BID given for first 4 wks of treatment
Primary Outcome Measure Information:
Title
Patients With Adverse Events Leading to Discontinuation of Trial Drug
Description
Number of patients with Adverse Events leading to discontinuation of trial drug
Time Frame
24 Weeks
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale
Description
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.
Time Frame
baseline and week 24
Title
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
Description
Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).
Time Frame
baseline and Week 24 (end of treatment visit)
Title
Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale
Description
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.
Time Frame
baseline and Week 1
Title
Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale
Description
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.
Time Frame
baseline and Week 2
Title
Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale
Description
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.
Time Frame
baseline and Week 3
Title
Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale
Description
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.
Time Frame
baseline and week 4
Title
Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale
Description
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.
Time Frame
baseline and Week 8
Title
Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale
Description
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.
Time Frame
baseline and Week 12
Title
Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale
Description
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.
Time Frame
baseline and Week 16
Title
Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale
Description
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.
Time Frame
baseline and Week 20
Title
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
Description
Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).
Time Frame
baseline and Week 1
Title
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
Description
Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).
Time Frame
baseline and Week 2
Title
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
Description
Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).
Time Frame
baseline and Week 3
Title
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
Description
Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).
Time Frame
baseline and Week 4
Title
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
Description
Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).
Time Frame
baseline and Week 8
Title
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
Description
Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).
Time Frame
baseline and Week 12
Title
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
Description
Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).
Time Frame
baseline and Week 16
Title
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
Description
Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).
Time Frame
baseline and Week 20
Title
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
Description
Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).
Time Frame
baseline and Week 24
Title
Clinical Global Impressions - Severity of Illness
Description
Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.
Time Frame
week 24
Title
Clinical Global Impressions - Severity of Illness, Categorized
Description
Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (among the most extremely ill patients). Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.
Time Frame
week 24
Title
Clinical Global Impressions - Improvement
Description
Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).
Time Frame
week 1
Title
Clinical Global Impressions - Improvement
Description
Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).
Time Frame
week 2
Title
Clinical Global Impressions - Improvement
Description
Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).
Time Frame
week 3
Title
Clinical Global Impressions - Improvement
Description
Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).
Time Frame
week 4
Title
Clinical Global Impressions - Improvement
Description
Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).
Time Frame
week 8
Title
Clinical Global Impressions - Improvement
Description
Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).
Time Frame
week 12
Title
Clinical Global Impressions - Improvement
Description
Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).
Time Frame
week 16
Title
Clinical Global Impressions - Improvement
Description
Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).
Time Frame
week 20
Title
Clinical Global Impressions - Improvement
Description
Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).
Time Frame
week 24
Title
Patient Global Impression - Improvement
Description
Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
Time Frame
week 1
Title
Patient Global Impression - Improvement
Description
Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
Time Frame
week 2
Title
Patient Global Impression - Improvement
Description
Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
Time Frame
week 3
Title
Patient Global Impression - Improvement
Description
Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
Time Frame
week 4
Title
Patient Global Impression - Improvement
Description
Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
Time Frame
week 8
Title
Patient Global Impression - Improvement
Description
Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
Time Frame
week 12
Title
Patient Global Impression - Improvement
Description
Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
Time Frame
week 16
Title
Patient Global Impression - Improvement
Description
Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
Time Frame
week 20
Title
Patient Global Impression - Improvement
Description
Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
Time Frame
week 24
Title
Frequency of Patients With Possible Clinically Significant Abnormalities for Laboratory Parameters
Description
Frequency of patients with possible clinically significant abnormalities for laboratory parameters (blood hematology and electrolyte assessments, serum chemistry, including follicle-stimulating hormone (FSH), luteinizing hormone (LH) and estradiol for pubertal female patients, prolactin in all patients, testosterone in pubertal male patients, urine analysis)
Time Frame
Baseline and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria 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. 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. Ability and willingness to comply with study treatment regimen and to complete study assessments. Females of childbearing potential having a negative serum pregnancy test at Visit 1. 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 Breastfeeding females. Development of any clinical condition in the preceding trial that in the investigator's opinion could be worsened by treatment with pramipexole. 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. 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. 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. 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. History or presence of clinical signs of epilepsy or seizures other than fever-related seizures in early childhood. 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. 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). 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. Allergic response to pramipexole or the inactive ingredients in its tablet formulation. Non-compliance with study medication (defined as less than 80% or more than 120%) during the preceding Study 248.641 or 248.644. Concurrent participation in another clinical trial using any investigational drug since completion of the preceding Study 248.641 or 248.644. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
248.642.0026 Boehringer Ingelheim Investigational Site
City
Bradenton
State/Province
Florida
Country
United States
Facility Name
248.642.0025 Boehringer Ingelheim Investigational Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
248.642.0006 Boehringer Ingelheim Investigational Site
City
Columbus
State/Province
Georgia
Country
United States
Facility Name
248.642.0005 Boehringer Ingelheim Investigational Site
City
Cambridge
State/Province
Massachusetts
Country
United States
Facility Name
248.642.0003 Boehringer Ingelheim Investigational Site
City
Manhasset
State/Province
New York
Country
United States
Facility Name
248.642.0009 Boehringer Ingelheim Investigational Site
City
New York
State/Province
New York
Country
United States
Facility Name
248.642.0018 Boehringer Ingelheim Investigational Site
City
New York
State/Province
New York
Country
United States
Facility Name
248.642.0013 Boehringer Ingelheim Investigational Site
City
Orangeburg
State/Province
New York
Country
United States
Facility Name
248.642.0029 Boehringer Ingelheim Investigational Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
248.642.0010 Boehringer Ingelheim Investigational Site
City
Providence
State/Province
Rhode Island
Country
United States
Facility Name
248.642.0030 Boehringer Ingelheim Investigational Site
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
248.642.0008 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
248.642.0023 Boehringer Ingelheim Investigational Site
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
248.642.49004 Boehringer Ingelheim Investigational Site
City
Ulm
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/248/248.642_U10-3215.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/248/248.642_Statement.pdf
Description
Related Info

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Open-label Extension Study of Pramipexole in the Treatment of Children and Adolescents With Tourette Syndrome

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