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    Summary
    EudraCT Number:2008-000342-32
    Sponsor's Protocol Code Number:248.642
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2011-11-04
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2008-000342-32
    A.3Full title of the trial
    An open-label, flexible dose, follow-up study to evaluate safety and
    efficacy of oral pramipexole (0.0625-0.5 mg/day) for 24 weeks in
    children and adolescents (age 6-17 years) diagnosed with Tourette
    Syndrome according to DSM-IV criteria and who have completed the
    double-blind phase of either study 248.641 or 248.644
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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
    A.4.1Sponsor's protocol code number248.642
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/27/2010
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBoehringer Ingelheim Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBoehringer Ingelheim Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim Pharma GmbH & Co. KG
    B.5.2Functional name of contact pointQRPE PSC CT Information Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressBinger Strasse 173
    B.5.3.2Town/ cityIngelheim am Rhein
    B.5.3.3Post code55216
    B.5.3.4CountryGermany
    B.5.4Telephone number0018002430127
    B.5.5Fax number0018008217119
    B.5.6E-mailclintriage.rdg@boehringer-ingelheim.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePramipexole dihydrochloride monohydrate
    D.3.2Product code SND 919 CL2 Y
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNpramipexole
    D.3.9.2Current sponsor codeSND 919 CL2 Y
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.0625
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Sifrol
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNpramipexole
    D.3.9.2Current sponsor codeSND 919 CL2 Y
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.125
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Sifrol
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNpramipexole
    D.3.9.2Current sponsor codeSND 919 CL2 Y
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Tourette's Syndrome
    E.1.1.1Medical condition in easily understood language
    Tourette Syndrome is a neurological disorder that is commonly characterized by childhood onset of motor and phonic/verbal tics
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10044127
    E.1.2Term Tourette's syndrome
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    The safety of pramipexole will be evaluated collectively for the incidence of adverse events and elicited adverse events, proportion of withdrawals due to adverse events, and the assessment of the following scales:
    • Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS);
    • Child Behavior Checklist (CBCL) ;
    • DuPaul Attention-Deficit / Hyperactivity Disorder (ADHD) Rating Scale-IV;
    • Child Depression Inventory-Short Version (CDI-S);
    • Columbia Suicide Severity Rating Scale (C-SSRS);
    • Multidimensional Anxiety Scale for Children (MASC);
    • Tanner Staging.
    E.2.2Secondary objectives of the trial
    Secondary efficacy measures:
    • Total Tic Score (TTS) of the Yale Global Tic Severity Scale (YGTSS);
    • Total Score of the YGTSS;
    • Clinical Global Impressions-Severity of Illness (CGI-S);
    • Clinical Global Impressions-Global Improvement (CGI-I) response;
    • Patient Global Impression-Improvement (PGI-I) response.
    Secondary safety measures will include height, weight, vital signs (pulse rate, respiration rate, blood pressure, temperature), ECG assessments and laboratory parameters (blood haematology and electrolyte assessments, serum chemistry, including FSH, LH and estradiol for pubertal female patients, prolactin in all patients, testosterone in pubertal male patients, urine analysis), as well as an eye and skin examinations.
    E.2.3Trial contains a sub-study No
    E.3Principal 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 β-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.
    E.4Principal 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.
    E.5 End points
    E.5.1Primary end point(s)
    The safety of pramipexole will be evaluated collectively for the incidence of adverse events and elicited adverse events, proportion of withdrawals due to adverse events, and the assessment of the following scales:
    •Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) at Week 24 relativeto baseline of Study 248.641 or 248.644;
    •Child Behavior Checklist (CBCL) at Week 24 relative to baseline of Study 248.641 or248.644;
    •DuPaul Attention-Deficit / Hyperactivity Disorder (ADHD) Rating Scale-IV atWeek 24 relative to baseline of Study 248.641 or 248.644;
    •Child Depression Inventory-Short Version (CDI-S) at Weeks 12 and 24 relative to baseline of Study 248.641 or 248.644;
    •Columbia Suicide Severity Rating Scale (C-SSRS) at Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, and 28 relative tobaseline of Study 248.641 or 248.644;
    •Multidimensional Anxiety Scale for Children (MASC) at Weeks 12 and 24 relative tobaseline of Study 248.641 or 248.644; and
    •Tanner Staging at Week 24 relative to baseline of Study 248.641 or 248.644.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The prim. endpoints were evaluated over a treatmet period of 24
    weeks
    E.5.2Secondary end point(s)
    •Total Tic Score (TTS) of the Yale Global Tic Severity Scale (YGTSS)
    •Total Score of the YGTSS
    •TTS of the YGTSS at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24
    •Total Score of the YGTSS at Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24
    •Clinical Global Impressions-Severity of Illness (CGI-S) at the last visit
    •Clinical Global Impressions-Global Improvement (CGI-I) response
    ("much improved" or "very much improved") at Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24
    •Patient Global Impression-Improvement (PGI-I) response ("much
    better" or "very much better") at Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24

    Vital signs, ECG, lab parameters (incl FSH, LH and estradiol for
    pubertal females, prolactin in all patients, testosterone in pubertal
    males, urine analysis), eye and skin examination at the first and last visit of the study period.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety was evaluated over a treatment period of 24 weeks
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    End of the trial will be the last visit of the last subject undergoing the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 120
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 25
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 20
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    children, 6 to 17 years of age
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 120
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    expected normal treatment
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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