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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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30 June 2019 |
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Main ID: |
EUCTR2009-018119-14-GB |
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Date of registration:
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18/06/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Huntington's Disease Rilmenidine Safety Trial - Huntington's Disease Rilmenidine study
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Scientific title:
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Huntington's Disease Rilmenidine Safety Trial - Huntington's Disease Rilmenidine study |
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Date of first enrolment:
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23/07/2010 |
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Target sample size:
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16 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-018119-14 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Confirmed diagnosis of Huntington’s Disease on the basis of qualifying clinical signs and symptoms as well as a relevant family history, or a CAG repeat of >36 on exon 1 of the htt gene.
2. HD stage 1-3 with a total functioning capacity (TFC) on the Unified Huntington’s Disease Rating Scale 1999 (UHDRS) of at least 5.
3. Able to self care independently and are ambulant.
4. Aged from 18 and 70.
5. Women of childbearing age neither pregnant nor planning to conceive during the period of the study.
6. English speaking and able to provide written, informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0
Exclusion criteria:
1. An ongoing clinically significant and unstable General Medical Condition (including but not limited to; asthma, chronic obstructive pulmonary disease COPD, unstable ischaemic heart disease IHD, congestive cardiac failure CCF, left bundle branch block LBBB or a cerebral vascular accident CVA) confirmed via past medical history or baseline medical physical examination and investigations.
2. Prescribed anti-hypertensive medication or any drug known to be contraindicated or to have an adverse interaction with Rilmenidine (viz. a Monoamine Oxidase Inhibitor).
3. Known hypersensitivity to Rilmenidine.
4. Ongoing significant mental illness determined by evidence or a history of a psychotic or affective (depression or mania) episode in the six months prior to Baseline Interview assessed using the Diagnostic and Statistical Manual of Mental Disorders criteria (Fourth Edition with Text Revision; American Psychiatric Association).
5. Prescribed typical or atypical anti-psychotic medication (only if being prescribed explicitly for treatment of a psychotic illness).
6. Pregnant or breastfeeding female patients, including those planning to conceive during the period of the trial.
7. Substance (alcohol or illegal/prescription drug) misuse in the six months prior to the baseline assessment.
8. Known co-morbid major neurological disorder (incl. Parkinson’s Disease or dementia), HIV/AIDS or Hepatitis (HBV or HCV).
9. Previous neurosurgery to the brain.
10. Marked clinically adverse abnormalities on laboratory investigations including creatinine clearance <15mg/min or creatinine serum level >177 Umol/l.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Huntington's Disease
MedDRA version: 14.1
Level: PT
Classification code 10070668
Term: Huntington's disease
System Organ Class: 10010331 - Congenital, familial and genetic disorders
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Intervention(s)
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Trade Name: Hyperium
Product Name: Rilmenidine
Pharmaceutical Form: Tablet
INN or Proposed INN: Rilmenidine
CAS Number: 54187-04-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1mg-
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Primary Outcome(s)
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Secondary Objective: Secondary objectives are to assess if there are a) any efficacy effects; and b) any ability to change the biomarker profiles away from that predicted.
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Main Objective: To investigate whether Rilmenidine (oral preparation) can safely be taken and is well tolerated by patients suffering from Huntington’s Disease (HD).
This will be achieved by regular, periodic assessments of the patients’ physical and mental health monitoring for adverse effects and disease progression.
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Primary end point(s): Patient safety
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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