Huntington's Disease Rilmenidine Safety Trial - Huntington's Disease Rilmenidine study
- Conditions
- Huntington's DiseaseMedDRA version: 14.1 Level: PT Classification code 10070668 Term: Huntington's disease System Organ Class: 10010331 - Congenital, familial and genetic disorders
- Registration Number
- EUCTR2009-018119-14-GB
- Lead Sponsor
- Cambridge University Hospitals NHS Foundation Trust and University of Cambridge
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 16
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: To investigate whether Rilmenidine (oral preparation) can safely be taken and is well tolerated by patients suffering from Huntington’s Disease (HD).<br> This will be achieved by regular, periodic assessments of the patients’ physical and mental health monitoring for adverse effects and disease progression.<br> ;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.;Primary end point(s): Patient safety
- Secondary Outcome Measures
Name Time Method