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Oral Guanabenz for Multiple Sclerosis

NCT02423083 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2019-12-12

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Guanabenz

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    lead NIH

Principal Investigators

  • Irene CM Cortese, M.D. · National Institute of Neurological Disorders and Stroke (NINDS)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-21
Primary Completion
2017-10-30
Completion
2017-10-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02423083 on ClinicalTrials.gov