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 @ 4:26 PM
Ignite Modification Date:
2025-12-24 @ 4:26 PM
NCT ID:
NCT01585766
Eligibility Criteria:
Inclusion Criteria:
* Confirmed relapsing form of MS (ie, RRMS, SPMS, PRMS, or CIS) according to revised 2010 McDonald criteria and MRI brain lesions consistent with MS on screening
* At least 1 documented relapse within the past 3 years prior to screening
* EDSS between 0.0 and 6.5 at screening
* Have no more than 20 Gd-enhancing T1 brain lesions detected by cranial MRI scan
Exclusion Criteria:
* Subjects with impaired renal function
* Major surgery within 8 weeks of the screening visit
* Subjects who are unable to undergo cranial MRI scan
* A history of hypersensitivity to Gd-containing MRI contrast agents
* Has received within 1 year prior to screening: monoclonal antibodies, experimental B-cell depleting agents, or treatment with natalizumab (Tysabri) for greater than 3 months
* Receiving monthly methylprednisone or equivalent glucocorticoid for disease modification of a relapsing form of MS
* Known sensitivity to acetaminophen/paracetamol, diphenhydramine or equivalent antihistamine, methylprednisolone or equivalent glucocorticoid, or to any component of the investigational drug
* Diagnosis of PPMS, neuromyelitis optica, or other non-MS variant of neuro-inflammatory or demyelinating diseases
* Any history of opportunistic infection or the presence of active infection within two months prior to screening or any herpes zoster infection that has not resolved within 12 weeks prior to screening
* Any clinically significant findings during the screening phase, including physical, neurological, laboratory, or ECG examination as per protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01585766
Study Brief:
Protocol Section:
NCT01585766