A MULTI-CENTER, PHASE 2 RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED STUDY OF DIMEBON IN SUBJECTS WITH HUNTINGTON’S DISEASE - DIMOND

• Register: EUCTR
• Last refreshed on: 25 November 2019
• Main ID: EUCTR2007-003293-25-GB
• Date of registration: 26/07/2007
• Prospective Registration: Yes
• Primary sponsor: Medivation, Inc.
• Public title: A MULTI-CENTER, PHASE 2 RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED STUDY OF DIMEBON IN SUBJECTS WITH HUNTINGTON’S DISEASE - DIMOND
• Scientific title: A MULTI-CENTER, PHASE 2 RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED STUDY OF DIMEBON IN SUBJECTS WITH HUNTINGTON’S DISEASE - DIMOND
• Date of first enrolment: 20/11/2007
• Target sample size: 90
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-003293-25
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

United Kingdom

Key inclusion & exclusion criteria

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Huntington's disease
MedDRA version: 9.1 Level: LLT Classification code 10020469 Term: Huntington's chorea

Intervention(s)

Product Name: Dimebon
Product Code: Dimebon
Pharmaceutical Form: Tablet
CAS Number: 3613-73-8
Current Sponsor code: Dimebon
Other descriptive name: Dimebon Dihydrochloride
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 18%-22%
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: 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).

Primary 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.

Secondary Objective: 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.

Secondary ID(s)

DIM05

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 05/01/2017
• Date Completed: 30/06/2008
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2007-003293-25/results