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 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
NCT03918356
Eligibility Criteria:
Inclusion Criteria:
* duration of weakness \>12 months.
* ages 18 to 80 years old.
* serum CK level no greater than 15 times the upper limit of normal.
* quadriceps weakness \>hip flexor weakness and/or finger flexor weakness \>shoulder abduction weakness.
* one or more of the following pathological findings:
* endomysial inflammatory infiltrate.
* rimmed vacuoles.
* protein accumulation or 15-18 mm filaments.
DM/PM inclusion criteria:
* ages 18 to 80
* Symmetric proximal weakness
* Elevated CK
* EMG suggestive of myopathy with evidence of muscle membrane irritation
* Muscle biopsy suggestive of inflammatory myositis (degeneration, regeneration, necrosis, and interstitial mononuclear infiltrates)
* Typical skin rashes of DM (Heliotrope rash or Gottron sign)
Key inclusion criteria for the control group:
* no active neuromuscular disorders or known history of neuromuscular disorders.
* no sign or symptoms of muscle weakness.
* no family history of muscular dystrophies or ALS.
* ages 18 to 80
Exclusion Criteria:
* Patients with decompensated congestive heart failure
* Patients with chronic kidney disease on hemodialysis
* Patients with active cancer on chemotherapy or radiotherapy
* Patients with severe disease who are already wheel chair bound
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03918356
Study Brief:
Protocol Section:
NCT03918356