HD-med: A longitudinal, observational study to assess medication use, medication efficacy and the role of pharmacogenetics in Huntington*s Disease.
- Conditions
- Huntington's DiseaseHuntington's chorea (outdated terminology)1008362410028037
- Registration Number
- NL-OMON55123
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 391
- A capacitated individual, aged >= 18 years.
- Genetically confirmed CAG-repeat expansion of >= 36 in the Huntingtin gene.
- Either about to start with prescribed medication related to HD or already
using one or more HD related drugs. HD-related drugs are drugs considered to
treat symptoms that either are related to manifest HD or are prescribed in
pre-motor manifest or prodromal HD stage for symptoms that may be attributed to
HD.
- Sufficient knowledge of the Dutch language to understand the subject
information letter and sign the IC.
Any medical condition, in the view of the investigator, which might endanger
subject*s safety and/or satisfactory participation in the study.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Percentage definite prescription changes in HD gene carriers with a divergent<br /><br>PGx CYP2C19 or CYP2D6 phenotype (poor and ultra-rapid metabolizers) versus<br /><br>those with a PGx phenotype in more normal range (extensive and intermediate<br /><br>metabolizers). </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary study parameters/endpoints:<br /><br>- Overview of medication use by HD gene carriers in one year.<br /><br>- Accuracy of a one-year medication diary compared to pharmacy medication<br /><br>history surveys.<br /><br><br /><br>Exploratory study parameters/endpoints<br /><br>- Identify potentially new genetic polymorphisms with pharmacogenetic action in<br /><br>HD gene carriers.</p><br>