Background:
- People with multiple sclerosis (MS) get lesions in their brain and spinal cord. These cause
neurological symptoms and sometimes disability. Researchers want to see if a blood pressure
drug called guanabenz can repair lesions and help people with MS.
Objective:
- To see if guanabenz is safe and well tolerated in people with MS.
Eligibility:
- People 18 55 years old with MS who have taken glatiramer acetate for the past year.
Design:
- Participants will be screened in a separate protocol. For 2 months, they will be
examined and have magnetic resonance imaging (MRI) scans. This will decide if they are
in the Stable or Active MS study group.
- The study will last 5 months. There will be up to 11 visits, 5 overnight.
- Visit 1: overnight stay at the clinic:
- Medical history and physical exam.
- Health questionnaire
- Bladder ultrasound scan
- Brain MRI
- Electrocardiogram (EKG) to measure heart electrical activity
- Blood will be drawn through an intravenous (IV) line.
- Participants may have tests of strength, muscle tone, and movement.
- They will get their first dose of the study drug, a tablet taken once a day.
- Participants will take the study drug at home and keep a medicine diary.
- The dose will slowly increase. Each time, participants will stay overnight at the
clinic. They will have a physical exam, EKG, MRI, and IV blood draw.
- Visit 6: Participants will have a physical exam, MRI, and blood drawn. They will get a
schedule to slowly lower their drug dose and stop taking guanabenz.
- Participants will have 2 final visits. They will have a physical exam, EKG, MRI, and IV
blood draw.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)