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:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-25 @ 4:55 AM
NCT ID:
NCT06089018
Eligibility Criteria:
Inclusion Criteria:
* Ability to provide informed consent
* Age 12-90 years old at the time of informed consent
* Genetic confirmation of DM1 or DM2
* Ability to comply with study assessments
* Clinically apparent myotonia equivalent to hand opening time of at least 2 seconds, in the opinion of the Investigator
* Ambulatory (orthoses allowed, canes and walkers not allowed) and able to walk at least 25 meters at screening
Exclusion Criteria:
* Ongoing medical condition (e.g. wasting or cachexia, severe anemia) that would, in the opinion of the Investigator, interfere with the conduct or assessments of the study
* Significant cognitive impairment, clinical dementia, or unstable psychiatric illness, including psychosis, suicidal ideation, suicide attempt, or untreated major depression ≤ 90 days of screening, which in the opinion of the Investigator may interfere with the study procedures
* Treatment with an investigational drug, biologic agent, or device within one month of screening, or 5 half-lives of investigational agent, whichever is longer
* Inability to comply with study requirements
* Other unspecified reasons that, in the opinion of the Investigator or the Sponsor, make the participant unsuitable for enrolment
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
90 Years
Study:
NCT06089018
Study Brief:
Protocol Section:
NCT06089018