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 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT00769860
Eligibility Criteria:
Inclusion Criteria:
* Meet the diagnostic criteria for definite or probable IBM (Griggs 1995)
* Muscle function adequate for quantitative muscle testing
* Age \> 50 years
* Women must be postmenopausal or status post hysterectomy
* For any patient currently taking medication for IBM, they must remain on current dosage for the extent of the study and last dosage change must be \> 30 days previous to enrollment
Exclusion Criteria:
* Presence of any one of the following medical conditions: diabetes mellitus or patients taking anti-diabetic medications, chronic infection, chronic renal insufficiency, cancer other than skin cancer less than 5 years previously, multiple sclerosis or prior episode or central nervous system demyelination, or other chronic serious medical illnesses
* Presence of any of the following on routine blood screening: WBC \< 3000, platelets \< 100,000, hematocrit \< 30%, BUN \> 30 mg%, creatine \> 1.5 mg%, symptomatic liver disease with serum albumin \< 3 g/dl, PT or PTT \> upper range of control values
* Women who are pregnant or lactating
* History of non-compliance with other therapies
* Coexistence of other neuromuscular disease
* Drug or alcohol abuse within the last 3 months
* Inability to give informed consent
* Known bleeding disorder
* Use of potentially renal toxic drugs
* Prior difficulties with local anesthetic
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT00769860
Study Brief:
Protocol Section:
NCT00769860