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 @ 4:49 PM
Ignite Modification Date:
2025-12-24 @ 4:49 PM
NCT ID:
NCT01649050
Eligibility Criteria:
Key Inclusion Criteria:
* Diagnosis of multiple sclerosis (MS) of any type.
* MS diagnosis at least 6 months prior to screening.
* Stable MS with no relapse within 3 months prior to screening.
* Treated or untreated spasticity due to MS for at least 3 months prior to screening, not wholly relieved with antispasticity medications.
Key exclusion criteria:
* Patients with symptoms of spasticity not due to MS.
* Patients taking three or more different anti-spasticity medications.
* Acute MS exacerbation requiring treatment within 3 months of the Screening Visit.
* Initiation of, or the discontinuation of interferon beta or any other disease modifying therapy for MS within 3 months of the Screening Visit.
* Use of baclofen pump at any time.
* Wheelchair or bed-bound patients.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01649050
Study Brief:
Protocol Section:
NCT01649050