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 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT01900093
Eligibility Criteria:
Inclusion Criteria:
* Ages 18-65
* EDSS of 2.0 - 7.5 (inclusive)
* Sustained a significant MS exacerbation affecting vision, brainstem, motor, or cerebellar function AND were initially treated with a 5 day course of IVMP within 10 days of the onset of symptoms.
* Failed to make adequate improvement and must initiate Acthar Gel therapy within two weeks (+/- 72 hours) after the first day of 5 treatments with 1000 mg IVMP, as judged by their treating neurologist.
* Must be able to comply with the requirements of the protocol as determined by the investigator.
* Ability to understand the purpose and risks of the study and provide signed and date informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
Exclusion Criteria:
* Patients whose relapse consists of pure sensory or bowel/bladder symptoms
* History of ACTHAR gel use or other forms of ACTH with failure to improve or with occurrence of significant adverse experiences.
* Diagnosis of scleroderma, systemic fungal infections, ocular herpes simplex, congestive heart failure, and/or uncontrolled hypertension, and/or any clinically relevant medical disease that would put the patient at risk by participating in the study
* Persistent significant or severe infection
* Recent history of drug or alcohol abuse
* Concomitant use or prior use in the preceding 6 months of any investigational drug.
* Pregnant or nursing
* Recent surgery (up to the investigator's discretion what constitutes recent)
* History of, or the presence of, a peptic ulcer
* Known sensitivity to proteins of porcine origin
* Received a live or live attenuated vaccine in the last 30 days before baseline
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01900093
Study Brief:
Protocol Section:
NCT01900093