HD-MED: Aiming to personalize drug treatment in Huntington’s Disease
- Conditions
- <p>Huntington's Disease</p>Pharmacogenetics, pharmacogenomics, drug type, medication use, medication efficacy, pharmacovigilance, Huntington’s Disease, rare disorder, protocol, biobank.10028037
- Registration Number
- NL-OMON23607
- Lead Sponsor
- eiden University Medical Center (investigator-initiated)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 391
In order to be eligible to participate in this study, a subject must meet all of the following criteria: - A capacitated individual, aged = 18 years. - Genetically confirmed CAG-repeat expansion of = 36 in the HTT 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 informed consent form.
A potential subject who meets any of the following criteria will be excluded from participation in this study: - 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 non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br><tr><br><td>Percentage per study protocol defined negative medication effects in HD gene expansion carriers with a CYP2C19 or CYP2D6 predicted poor and ultra-rapid metabolizer phenotype versus those with a predicted intermediate and normal metabolizer phenotype. </td><br></tr><br><br>
- Secondary Outcome Measures
Name Time Method <br><tr><br><td>o Overview of medication use by HD gene expansion carriers in one year.<br /><br><br /><br>o Number of prescription drug discrepancies between the official pharmacy medication verification scheme and the patient-reported medication diary for the HD-MED follow-up period.<br /><br><br /><br><br /><br><br /><br>Exploratory outcome:<br /><br><br /><br>o Genetic variants associated with extra-ordinary side effect profiles or lack of medication response.</td><br></tr><br>