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    Summary
    EudraCT Number:2009-011800-44
    Sponsor's Protocol Code Number:DIM20
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-11-04
    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
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2009-011800-44
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients with Mild-to-Moderate Huntington Disease Version 2.0 08 May 2009
    A.3.2Name or abbreviated title of the trial where available
    DIM20
    A.4.1Sponsor's protocol code numberDIM20
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/08/597
    D.3 Description of the IMP
    D.3.1Product nameDimebon
    D.3.4Pharmaceutical form Film-coated 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 97657-92-6
    D.3.9.2Current sponsor codeDimebon
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/08/597
    D.3 Description of the IMP
    D.3.1Product nameDimebon
    D.3.4Pharmaceutical form Film-coated 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.3.8INN - Proposed INNDimebon dihydrochloride
    D.3.9.1CAS number 97657-92-6
    D.3.9.2Current sponsor codeDimebon
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    Patients with Mild-to-Moderate Huntington Disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    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 determine the effect of Dimebon as compared to placebo on cognition as measured by the Mini-Mental State Examination (MMSE); and - To determine the effect of Dimebon as compared to placebo on the primary measure of global function, the Clinician s Interview-Based Impression of Change, plus caregiver input (CIBIC-plus).
    E.2.2Secondary objectives of the trial
    - To determine the effect of Dimebon as compared to placebo on a measure of behavior, the Neuropsychiatric Inventory (NPI); - To determine the effect of Dimebon as compared to placebo on a measure of self-care and daily function, the Alzheimer s Disease Cooperative Study Activities of Daily Living (ADCS-ADL); - To determine the effect of Dimebon as compared to placebo on a measure of motor impairment, the Unified Huntington Disease Rating Scale (UHDRS 99) Total Motor Score; - To determine the safety of treatment with Dimebon as compared to placebo; and - To examine the relationship between Dimebon plasma concentrations and efficacy and safety outcomes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Have clinical features of HD and a CAG polyglutammate repeat expansion >=36 2.Have Stage 1, 2, or 3 HD with a UHDRS 99 TFC between 5 and 13 (inclusive) at the Screening visit; 3.Have cognitive impairment as noted by the following: a.A Screening MMSE AND a baseline (pre-dose) MMSE score between 10 and 26 (inclusive); and b.A subjective assessment of cognitive impairment with decline from pre-HD levels by the Investigator after interviewing the subject and caregiver; 4.Are willing and able to give informed consent for study participation and cytochrome P450 (CYP) 2D6 genotyping. If the subject is not competent, a mentally-competent legally-acceptable representative must provide informed consent on his/her behalf, and the subject must provide assent; 5.Are ambulatory and do not require skilled nursing care; 6.Are aged 30 years or older; 7.If female, are either a) of reproductive potential and compliant in using adequate birth control or b) not of reproductive potential. Adequate birth control is defined as consistent practice of an effective and accepted method of contraception (hormone-based, intrauterine device, or double barrier contraception, i.e., condom and diaphragm, diaphragm and spermicidal gel or foam) throughout the duration of the study. Abstinence is an acceptable method of contraception. Female subjects not of reproductive potential may have undergone menopause, hysterectomy, bilateral oophorectomy, or tubal ligation. Menopause is defined as one year without menses. If the subject s menopausal status is in question, a follicle-stimulating hormone (FSH) level of > 40 milli-international units per milliliter (mIU/mL) must be documented. Hysterectomy, bilateral oophorectomy, or tubal ligation must be documented; 8.If male, are either a) of reproductive potential and compliant in using adequate birth control or are b) not of reproductive potential. Surgical sterilization must be documented. Adequate birth control for males is defined as a condom and spermicidal gel or foam, or abstinence throughout the duration of the study; 9.If currently taking psychotropic medications (including antidepressants and neuroleptics) or other medications to treat the symptoms of HD (with the exception of tetrabenazine) must be on stable doses for at least 30 days prior to randomization; 10.If currently taking tetrabenazine must be tolerating it well, on a stable dose for at least 60 days prior to randomization, and have the intent to continue the current dose throughout the study duration. For subjects who have previously taken tetrabenazine, subjects must be off therapy for at least 60 days prior to randomization and have the intent to remain off therapy throughout the study duration. Note: Subjects will not be allowed to initiate tetrabenazine during the study period; 11.Have at least nine years of prior education and should have previously (in pre-HD condition) been capable of reading, writing, and communicating effectively with others; 12.Have a caregiver who assists/spends time with the subject at least five days per week for at least three hours per day and has intimate knowledge of the subject s cognitive, functional, and emotional states, and of the subject s personal care. The caregiver must be willing to accompany the subject to all study visits, and must be willing to supervise study drug administration.
    E.4Principal exclusion criteria
    1. Had onset of HD symptoms prior to age 18; 2. Have active suicidality as measured by a suicide ideation score of 4 or 5 on the Columbia Suicide Severity Rating Scale (Baseline version); Exclusion Criteria Subjects ineligible to participate in this study are persons who: 1. Had onset of HD symptoms prior to age 18; 2. Have active suicidality as measured by a suicide ideation score of 4 or 5 on the Columbia Suicide Severity Rating Scale (Baseline version); 3. Have any major medical illness or unstable medical condition within 180 days of screening that may interfere with the subject s ability to comply with study procedures and abide by study restrictions, or with the ability to interpret safety data, including: a. Any physical disability that would prevent completion of study procedures or assessments (e.g., blindness or significant visual impairment, deafness or significant hearing impairment, non-HD-related speech impairment); b. A diagnosis of diabetes mellitus requiring treatment with insulin; c. A history of cancer within five years of randomization with the exception of non-melanoma skin cancers or prostate cancer that has been stable for six months; 4. Have any of the following cardiovascular parameters: a. Hypotension (systolic blood pressure < 86 millimeters of mercury [mmHg]) or bradycardia with heart rate less than 45 beats per minute at Screening or on more than one occasion within three months prior to Screening; b. Uncontrolled hypertension as indicated by a resting systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg at Screening or on more than one occasion within three months prior to Screening; c. Active cardiovascular disease including any of the following: unstable angina, decompensated congestive heart failure, clinically relevant arrhythmias. NOTE: A history of these conditions is acceptable, if stable under medical management. Subjects with pacemakers, subjects on anticoagulant therapy, and subjects who are stable with a prior history if MI may be included; d. A corrected QT interval by the Fridericia correction formula (QTcF) of greater than 470 milliseconds (msec), second degree or higher heart block, or left bundle branch block on an ECG at the Screening visit; 5. Have a history of traumatic brain injury with residual neurological deficit or stroke; 6. Have another disease known to affect cognition other than HD (e.g., Parkinson disease, frontotemporal dementia, normal pressure hydrocephalus); 7. Have a history of a seizure disorder requiring ongoing treatment, febrile seizures, or any seizure including loss of consciousness within 180 days preceding randomization. NOTE: Use of anti-epileptic medication for non-seizure related treatment is allowed if the dose has remained stable for at least 30 days prior to randomization; 8. Have any current psychiatric diagnosis that may interfere with the subject s ability to perform the study and all assessments (e.g., alcohol or drug-related abuse or alcohol dependence, or alcohol or drug-related dementia, major depression, mental retardation, schizophrenia, bipolar disorder, etc.); NOTE: Depression arising in the context of HD is not an Exclusion Criterion if on stable pharmacologic and/or non-pharmacologic management for 30 days preceding randomization. Subjects who require anxiolytics, sedatives, sleeping medications, or antipsychotic medications prior to randomization are allowed if doses have remained stable for 30 days prior to randomization; 9. Are pregnant or lactating females; 10. Reside in a nursing home or assisted care facility with need for 24-hour care and supervision; 11. Have a paid caregiver who is not clinically trained that cares for more than two subjects; 12. Have been informed of their treatment assignment after participation in a previous blinded clinical study with Dimebon; 13. Have exper
    E.5 End points
    E.5.1Primary end point(s)
    Co-Primary Efficacy Outcomes &#61623; A comparison between the mean changes from baseline in the Dimebon 20 mg TID treatment group and the placebo group on the MMSE at Week 26; &#61623; A comparison of the distributions of the CIBIC-plus (ADCS-CGIC) at Week 26 in the Dimebon 20 mg TID treatment group and the placebo group.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    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 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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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
    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 months6
    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 months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    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 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
    soggetti incapaci di intendere e di volere assistiti da un rappresentante
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 350
    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 Decision2009-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-10-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-02-15
    The status of studies in GB is no longer updated from 1.1.2021
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