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NCT02423083 · ClinicalTrials.gov registry record · Phase 1
Oral Guanabenz for Multiple Sclerosis
A Phase 1 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT02423083 is a Phase 1 study that was terminated before completion, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 2 participants.
The verdict
NCT02423083, a Phase 1 study, was terminated before completion, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
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.
Interventions
- DRUG Guanabenz
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2015-04-21 |
| Est. Completion | 2017-10-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02423083
The ClinicalTrials.gov registry entry for NCT02423083 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Guanabenz is the first listed.
NCT02423083 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02423083 about?
NCT02423083 is a clinical study titled "Oral Guanabenz for Multiple Sclerosis". 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 guanaben...
What is the current status of trial NCT02423083?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2015-04-21. Estimated completion is 2017-10-30.
What interventions are being tested in trial NCT02423083?
The interventions under investigation include: Guanabenz (DRUG).
Who is sponsoring clinical trial NCT02423083?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
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