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

NCT00681863 | Terminated Phase 3 Results

• 2 other identifiers: 248.6422008-000342-32
• Study Type: interventional
• Target: 45
• Locations: 2 countries
• Sites: 14

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).

Conditions

Tourette Syndrome

Outcome Measures

Primary Outcomes (1)

• Patients With Adverse Events Leading to Discontinuation of Trial Drug

  Number of patients with Adverse Events leading to discontinuation of trial drug

  24 Weeks

Secondary Outcomes (40)

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

  baseline and week 24

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

  baseline and Week 24 (end of treatment visit)

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

  baseline and Week 1

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

  baseline and Week 2

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

  baseline and Week 3

Study Arms (5)

pramipexole 0.0625 mg BID (twice daily)

ACTIVE COMPARATOR

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

Drug: pramipexole 0.0625 mg BID

pramipexole 0.0625 mg QD (once daily)

ACTIVE COMPARATOR

patients to receive one tablet of pramipexole 0.0625 mg QD

Drug: pramipexole 0.0625 mg QD

pramipexole 0.125 mg BID

ACTIVE COMPARATOR

patients to receive one tablet of pramipexole 0.125 mg BID

Drug: pramipexole 0.125 mg BID

pramipexole 0.125 mg TID (three times daily)

ACTIVE COMPARATOR

patients to receive one tablet of pramipexole 0.125 mg TID

Drug: pramipexole 0.125 mg TID

pramipexole 0.25 mg BID

ACTIVE COMPARATOR

patients to receive one tablet of pramipexole 0.25 mg BID

Drug: pramipexole 0.25 mg BID

Interventions

pramipexole 0.125 mg BID DRUG

titrated dose for those patients whose symptoms were not controlled on the 0.0625 mg BID dose

pramipexole 0.125 mg BID

pramipexole 0.0625 mg QD DRUG

dose down titrated for those patients unable to tolerate the 0.0625 mg BID dosing

pramipexole 0.0625 mg QD (once daily)

pramipexole 0.125 mg TID DRUG

titrated up for those patients whose symptoms were not adequately controlled on 0.125 mg BID dose

pramipexole 0.125 mg TID (three times daily)

pramipexole 0.25 mg BID DRUG

titrated for those patients whose symptoms were not adequately controlled on 0.125 mg TID dose

pramipexole 0.25 mg BID

pramipexole 0.0625 mg BID DRUG

0.0625 mg BID given for first 4 wks of treatment

pramipexole 0.0625 mg BID (twice daily)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (14)

248.642.0026 Boehringer Ingelheim Investigational Site

Bradenton, Florida, United States

Location

248.642.0025 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Location

248.642.0006 Boehringer Ingelheim Investigational Site

Columbus, Georgia, United States

Location

248.642.0005 Boehringer Ingelheim Investigational Site

Cambridge, Massachusetts, United States

Location

248.642.0003 Boehringer Ingelheim Investigational Site

Manhasset, New York, United States

Location

248.642.0009 Boehringer Ingelheim Investigational Site

New York, New York, United States

Location

248.642.0018 Boehringer Ingelheim Investigational Site

New York, New York, United States

Location

248.642.0013 Boehringer Ingelheim Investigational Site

Orangeburg, New York, United States

Location

248.642.0029 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

Location

248.642.0010 Boehringer Ingelheim Investigational Site

Providence, Rhode Island, United States

Location

248.642.0030 Boehringer Ingelheim Investigational Site

Memphis, Tennessee, United States

Location

248.642.0008 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

248.642.0023 Boehringer Ingelheim Investigational Site

Norfolk, Virginia, United States

Location

248.642.49004 Boehringer Ingelheim Investigational Site

Ulm, Germany

Location

MeSH Terms

Conditions

Tourette Syndrome

Interventions

Pramipexole; BID protein, human

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

Limitations and Caveats

The sponsor cancelled this trial prematurely. Thus, enrollment for 248.642 (NCT00681863) was significantly less than what was planned (120 planned vs. 45 entered). Therefore, the objectives of this study could not be fully assessed.

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 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2008
• First Posted: May 21, 2008
• Study Start: May 1, 2008
• Primary Completion: October 1, 2009
• Last Updated: May 23, 2014
• Results First Posted: December 17, 2010

Record last verified: 2014-05

Locations

DE (1); US (13)