Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2025-12-24 @ 10:16 PM
NCT ID:
NCT03867435
Eligibility Criteria:
* INCLUSION CRITERIA:
* Age 11 to 70 inclusive
* Competent to provide informed consent and assent (consent of a parent or guardian will be required for pediatric participants)
* Positive genetic test for DM1 or DM2 (Genetic testing for DM1 or DM2 may be determined after enrollment
EXCLUSION CRITERIA:
* Concurrent enrollment in a clinical trial or participation in an investigative drug trial within 6 months of study 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:
* Clinically significant infections or medical illness within 30 days from study entry.
* History of, or abnormal laboratory values indicative of, significant medical, neurologic (other than DM1 or DM2), or psychiatric disorders.
* A recent history (30 days prior to study entry) of any of the following conditions on routine blood screening: white blood cells \< 3000, platelets \< 100,000, hematocrit \< 30%, symptomatic liver disease with serum albumin \< 3 g/L, or creatinine \> 1.5 mg%.
* Any of the following medical conditions: uncontrolled or insulin-dependent diabetes mellitus, congestive heart failure, symptomatic cardiomyopathy, symptomatic coronary artery disease, cancer (other than skin cancer) within 5 years from study entry, multiple sclerosis, or other serious medical illness.
* Other diseases that mimic the signs or symptoms of DM1 or DM2. Coexistence of other neuromuscular disease.
* Thyroid dysfunction that is untreated (if on thyroid hormone replacement therapy, need to have adequate and stable replacement over the previous 6 months from study entry).
* Second or third degree heart block, atrial flutter, atrial fibrillation, ventricular tachycardia, or is receiving medication for the treatment of cardiac arrhythmia.
* Liver or kidney disease requiring ongoing treatment.
* Have a seizure disorder.
* Drug or alcohol abuse within 3 months of study entry (DSM-V criteria will be used for the diagnosis and level of a substance use disorder:
* Treatment with supplemental anabolic hormones (including testosterone, human recombinant growth hormone, human recombinant insulin like growth factor-1, other anabolic drug mixtures) during the previous 12 months from study entry.
Note: non-ambulatory participants are not excluded but are limited to \<15% of enrollment. Individuals using a cane or walker will not be examined for gait, balance and mobility.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
11 Years
Maximum Age:
70 Years
Study:
NCT03867435
Study Brief:
Protocol Section:
NCT03867435