NL-OMON50021
Recruiting
Not Applicable
Establishing biomarkers and clinical endpoints in myotonic dystrophy type 1 (END-DM1) - Establishing biomarkers and clinical endpoints in DM type 1
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- DM1
- Sponsor
- Radboud Universitair Medisch Centrum
- Enrollment
- 20
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Age 18 to 70 years (inclusive)
- •\- Competent to provide informed consent
- •\- Clinical diagnosis of DM1 based on research criteria or positive genetic test
Exclusion Criteria
- •\- Symptomatic renal or liver disease, uncontrolled diabetes or thyroid
- •disorder, or active malignancy other than skin cancer
- •\- Current alcohol or substance abuse
- •\- Concurrent enrollment in clinical trial for DM1, pr participation in trial
- •within 6 months of entry
- •\- Concurrent pregnancy or planned pregnancy during the course of the study
- •\- Concurrent medical condition that would, in the opinion of the investigator
- •or clinical evaluator, compromise performance on study measures
- •\- Use of mexiletine or other anti\-myotonia agents within 72 hours of baseline
- •Note: non\-ambulatory participants are not excluded but are limited to \<15% of
Outcomes
Primary Outcomes
Not specified
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