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    The EU Clinical Trials Register currently displays   35479   clinical trials with a EudraCT protocol, of which   5824   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2007-003293-25
    Sponsor's Protocol Code Number:DIM05
    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:2007-07-26
    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 number2007-003293-25
    A.3Full title of the trial
    A MULTI-CENTER, PHASE 2 RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED STUDY OF DIMEBON IN SUBJECTS WITH HUNTINGTON’S DISEASE
    A.3.2Name or abbreviated title of the trial where available
    DIMOND
    A.4.1Sponsor's protocol code numberDIM05
    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 SponsorMedivation, 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 nameDimebon
    D.3.2Product code Dimebon
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 3613-73-8
    D.3.9.2Current sponsor codeDimebon
    D.3.9.3Other descriptive nameDimebon Dihydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number18% to 22%
    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) 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 No
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Huntington's disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10020469
    E.1.2Term Huntington's chorea
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety and tolerability of Dimebon, 20 mg three times a day (TID), during 90 days of treatment in subjects with Huntington’s disease (HD).
    E.2.2Secondary objectives of the trial
    To assess the impact of Dimebon, 20 mg TID, during 90 days of treatment on cognitive, motor, and overall function in subjects with HD. To assess the pharmacokinetics (PK) of Dimebon following multiple-dose administration.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Clinical features of HD and a confirmatory family history of HD, or a Cytosine Adenine Guanine (CAG) polyglutamate repeat expansion ≥ 36;
    • Stage I, II, or III of HD and Total Functional Capacity (TFC) ≥ 5 by the UHDRS ’99;
    • Ambulatory and must not require skilled nursing care;
    • Age of 29 years or older;
    • Women who are not of child-bearing potential as a result of menopause or surgical steralization;
    • Males participating in the study must agree to use a condom plus a spermicidal gel or foam for contraception throughout the duration of the study and for an additional one month post-study;
    • If currently taking psychotropic medications (including antidepressants and neuroleptics) or other non-excluded medications to treat the symptoms of HD (e.g. Coenzyme Q10, and minocycline) must be on stable dosages for at least 30 days prior to the Baseline/Day 1 visit and be maintained on a constant treatment regimen throughout the study;
    • Willing to abstain from driving or operating heavy or hazardous machinery during the course of the study and agree to abide by the other instructions on seizure precautions provided by the site;
    • Capable of providing informed consent and complying with trial procedures, including being able to swallow capsules the size of the Study Drug;
    • A caregiver must oversee Study Drug administration.
    E.4Principal exclusion criteria
    • Use of cholinesterase inhibitors (e.g., donepezil, rivastigmine, and galantamine), anticholinergics (e.g., trihexyphenidyl hydrochloride, scopalamine, atropine, benztropine, and ipratropium bromide), and N methyl-D-aspartate (NMDA) antagonists (e.g., amantadine and memantine) within 60 days of the Baseline/Day 1 visit;
    • Use of centrally active H1 antihistamines or dextromethorphan within seven days of the Baseline/Day 1 visit;
    • Use of lithium or clonidine (oral or transdermal) within 30 days of the Baseline/Day 1 visit;
    • Use of narcotic analgesics more frequently than two times per week within 30 days of the Baseline/Day 1 visit;
    • ECG corrected QT interval by the Fridericia correction formula (QTcF) of greater than 450 milliseconds (msec) at the Screening visit;
    • Exposure to any investigational drug within 30 days of the Baseline/Day 1 visit;
    • Clinical evidence of unstable medical illness;
    • Known history of cardiovascular disease including coronary artery disease, myocardial infarction, unstable angina, congestive heart failure, atrial or ventricular arrhythmia, left bundle branch block (LBBB), or stroke;
    • Active peptic ulcer within 90 days prior to the Baseline/Day 1 visit;
    • Known history of a seizure disorder, including any past history of a single seizure such as a febrile seizure;
    • Known history of bladder outlet obstruction or benign prostatic hypertrophy requiring treatment;
    • Known positive human immunodeficiency virus (HIV) antibodies or suspected Acquired Immunodeficiency Syndrome (AIDS) or history of Hepatitis B (HBV) or Hepatitis C (HCV) viral infection. NOTE: Mandatory HIV, HCV, and HBV testing not required;
    • Clinically serious abnormalities in the screening laboratory studies including screening creatinine greater than 2.0 milligrams per deciliter (mg/dL) (177 micromoles per liter [µmol/L]), alanine aminotransferase (ALT) or total bilirubin greater than three times the upper limit of normal, absolute neutrophil count of less than or equal to 1000/microliters (L), platelet concentration of less than 100,000/L, or hematocrit (Hct) level of less than 33% for female or 35% for male;
    • Unstable psychiatric illness defined as psychosis (hallucinations or delusions), untreated or inadequately treated major depression, panic disorder, or suicidal ideation within 90 days of the Baseline/Day 1 visit;
    • Current or history of substance (alcohol or drug) abuse within 1 year of the Baseline/Day 1 visit;
    • Females who are pregnant, lactating, or of child bearing potential.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome variable is the ability of the subject to complete the 90-day dosing period on the assigned dosage of study medication.
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) 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 Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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
    The end of trial is defined as 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 years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months12
    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 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 90
    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 Decision2007-08-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-06-30
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