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    The EU Clinical Trials Register currently displays   44173   clinical trials with a EudraCT protocol, of which   7329   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2004-000622-67
    Sponsor's Protocol Code Number:3147K2-101WW
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-02-10
    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
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2004-000622-67
    A.3Full title of the trial
    A Double-Blind, Placebo-Controlled, Randomized, Multiple Ascending Dose, Safety Study of MYO-029 Administered to Adult Patients with Becker, Facioscapulohumeral and Limb-Girdle Muscular Dystrophy.
    A.4.1Sponsor's protocol code number3147K2-101WW
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorWyeth Research Division of Wyeth 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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameMYO-029
    D.3.4Pharmaceutical form Powder for injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot Available
    D.3.9.2Current sponsor codeMYO-029
    D.3.9.3Other descriptive nameRecombinant human anti-GDF-8 antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeRecombinant human anti-GDF-8 antibody.
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for injection*
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Becker Muscular Dystrophy, Facioscapulohumeral Muscular Dystrophy, Limb-Girdle Muscular Dystrophy.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective is to evaluate safety of MYO-029 in adult subjects with muscular dystrophy.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to:
    1) evaluate the biological activity of MYO-029 by using the following measurements: muscle mass, volume, strength; histopathology findings; patient-reported outcomes; and functional measurements.
    2) explore associations between gene expression patterns, test article administration, and clinical parameters.
    3) evaluate the pharmacokinetics of MYO-029 in adult subjects with muscular dystrophy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age >=18 years.
    2. Confirmed clinical and molecular diagnosis of BMD, FSHD, or LGMD 2A, 2B, 2C, 2D, 2E, or 2I using the specific diagnostic criteria listed in Section 19, Muscular Dystrophy History
    3. Independent ambulation as assessed by completion of a 9-meter walking test. The use of an ankle foot orthosis is permitted if needed.
    4. Screening period- first strength evaluation: at least 8 of the following 16 muscle groups must have a MMT muscle grade >= 3- and <= 4+ on the modified Medical Research Council Scale:
    Shoulder flexors, Shoulder abductors, Shoulder external rotators, Shoulder internal rotators, Biceps, Elbow extensors, Brachioradialis (all bilateral), Neck Flexors, Neck Extensors.
    5. Screening period- second strength evaluation: at least 10 of the following 16 muscle groups must have an MMT grade that is within 2 steps of the grade assigned at the first screening evaluation:
    Shoulder flexors, Shoulder abductors, Shoulder external rotators, Shoulder internal rotators, Biceps, Elbow extensors, Brachioradialis (all bilateral), Neck flexors, Neck Extensors.
    6. Forced vital capacity (FVC) >= 60% of predicted (performed while seated) at Visit 1
    7. Ejection fraction > 40% as measured by echocardiogram at Visit 1.
    8. Male subjects who are not surgically sterile agree and commit to the use of 2 reliable methods of birth control for the duration of the study and for 12 weeks after the last dose of test article.
    9. Female subjects who are surgically sterile or postmenopausal.
    10. Able to comply with all study evaluations and return for all study visits.
    E.4Principal exclusion criteria
    1. Known history of congestive heart failure.
    2. Diagnosis of atherosclerotic heart disease.
    3. Use of anti-arrhythmic treatment during the 12 weeks before randomization.
    4. Use of chronic anti-coagulant treatment during the 12 weeks before randomization.
    5. Use of steroids such as, but not limited to, prednisone, prednisolone, deflazacort, and oxandrolone, during the 6 months before randomization and for the duration of the study with the exception of topical, inhaled and/or intranasal steroids used for a condition other than muscular dystrophy.
    6. Use of any other pharmacologic treatment with the potential to affect muscle function such as, but not limited to, albuterol and creatine during the 4 weeks before randomization and for the duration of the study.
    7. Initiation of, or significant change in, endurance and/or strengthening exercises with the potential to affect muscle function during the 8 weeks before randomization and for the duration of the study.
    8. Surgery performed during the 12 weeks before randomization or planned for the duration of the study.
    9. Concomitant co-morbidity that functionally limits the ability to perform required study procedures (eg, MMT, MRI, etc.).
    10. Any contraindication to MRI per site standard of care, including the presence of any metal implants.
    11. Significant concomitant intercurrent illness.
    12. History of sensitivity to monoclonal antibodies or protein pharmaceuticals.
    13. Lactating women.
    14. Women of childbearing potential
    15. Use of any experimental treatments or participation in a clinical trial during the 4 weeks before randomization and for the duration of the study.
    16. Any other major illness or reason that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in this study.
    17. Diagnosis of LGMD other than LGMD 2A, 2B, 2C, 2D, 2E, and 2I.
    E.5 End points
    E.5.1Primary end point(s)
    NA
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Evaluation of biological activity of MYO-029.
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months13
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months13
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    F.4.2.2In the whole clinical trial 136
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2005-04-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-06-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-01-31
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