NCT02423083

Oral Guanabenz for Multiple Sclerosis

Terminated Phase 1 Last updated 12 December 2019

What this trial tests

Phase 1 trial testing Guanabenz in Multiple Sclerosis, Relapsing-Remitting in 2 participants. Terminated before completion.

Timeline

21 April 2015

Primary endpoint
30 October 2017

30 October 2017

Quick facts

Lead sponsor	National Institute of Neurological Disorders and Stroke (NINDS)
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	2
Start date	21 April 2015
Primary completion	30 October 2017
Estimated completion	30 October 2017
Sites	1 location across United States

Drugs / interventions tested

• Guanabenz — full drug profile →

Conditions studied

• Multiple Sclerosis, Relapsing-Remitting — all drugs for Multiple Sclerosis, Relapsing-Remitting →
• Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Who can join

Adults 18 to 55, any sex, with Multiple Sclerosis, Relapsing-Remitting or Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Oligodendroglia: metabolic supporters of neurons.
   Philips T, Rothstein JD. · · 2017 · cited 254× · PMID 28862639 · DOI 10.1172/jci90610
2. Sephin1, which prolongs the integrated stress response, is a promising therapeutic for multiple sclerosis.
   Chen Y, Podojil JR, Kunjamma RB, Jones J, et al · · 2019 · cited 78× · PMID 30657878 · DOI 10.1093/brain/awy322
3. Endoplasmic reticulum stress and the unfolded protein response in disorders of myelinating glia.
   Clayton BLL, Popko B. · · 2016 · cited 71× · PMID 27055915 · DOI 10.1016/j.brainres.2016.03.046
4. Harnessing the integrated stress response for the treatment of multiple sclerosis.
   Way SW, Popko B. · · 2016 · cited 61× · PMID 26873788 · DOI 10.1016/s1474-4422(15)00381-6
5. Unfolded protein response in myelin disorders.
   Lin W, Stone S. · · 2020 · cited 45× · PMID 31638085 · DOI 10.4103/1673-5374.266903
6. Mammalian integrated stress responses in stressed organelles and their functions.
   Lu HJ, Koju N, Sheng R. · · 2024 · cited 29× · PMID 38267546 · DOI 10.1038/s41401-023-01225-0
7. Endoplasmic reticulum stress in diseases.
   Liu Y, Xu C, Gu R, Han R, et al · · 2024 · cited 23× · PMID 39188936 · DOI 10.1002/mco2.701
8. Endoplasmic Reticulum Stress and Its Role in Homeostasis and Immunity of Central and Peripheral Neurons.
   Perner C, Krüger E. · · 2022 · cited 19× · PMID 35572517 · DOI 10.3389/fimmu.2022.859703