RECRUITING

Assessment of Clemastine Fumarate as a Remyelinating Agent in Acute Optic Neuritis (ReCOVER)

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Conditions

Optic Neuritismultiple sclerosiseye painvision loss

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The main purpose of this study is to assess clemastine as a remyelinating agent in patients with acute optic neuritis.The study will also evaluate the tolerability of clemastine, originally approved as first-generation antihistamine, in patients with optic neuritis. Study procedures will include assessments for evidence of remyelination in the anterior visual pathway and in the brain using electrophysiologic techniques and magnetic resonance imaging. If they are on one, patients in this study can remain on their standard disease modifying treatment during the course of the study. However, patients cannot participate in any other investigational new drug research study concurrently.

Official Title

A Randomized, Double-Blind, Parallel-Group, Placebo Controlled Trial to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of Clemastine Fumarate as a Remyelinating Agent in Acute Optic Neuritis

Quick Facts

Study Start:2017-02-28
Study Completion:2026-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02521311

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients diagnosed or suspected to have an acute demyelinating optic neuritis in at least one eye within 3 weeks from the onset of any visual symptom other than pain
  2. * Use of disease-modifying therapies is not a contraindication
  3. * Use of appropriate contraception during the period of trial (women)
  4. * Understand and sign the informed consent
  1. * Other major ophthalmologic diseases / concomitant ophthalmologic disorders (e.g. diabetes, macular degeneration, glaucoma, severe myopia, etc)
  2. * Disc hemorrhages in the qualifying eye
  3. * No light perception in qualifying eye
  4. * Simultaneous bilateral optic neuritis
  5. * Cotton wool spots in the qualifying eye
  6. * Macular star in the qualifying eye
  7. * History of significant cardiac conduction block
  8. * History of cancer
  9. * Suicidal ideation or behavior in 6 months prior to baseline
  10. * Pregnancy, breastfeeding or planning to become pregnant
  11. * Involved with other study protocols simultaneously without prior approval
  12. * Concomitant use of any other putative remyelinating therapy as determined by the investigator
  13. * Serum creatinine \> 1.5 mg/dL; aspartate transaminase (AST), alanine transaminase (ALT), or alkaline phosphatase \> 2 times the upper limit of normal
  14. * History of drug or alcohol abuse within the past year
  15. * Untreated B12 deficiency (as determined by B12 serological assessments and metabolites including methylmalonic acid (MMA) and homocysteine) or untreated hypothyroidism
  16. * Clinically significant cardiac, metabolic, hematologic, hepatic, immunologic, urologic, endocrinologic, neurologic, pulmonary, psychiatric, dermatologic, allergic, renal, or other major diseases that, in the PI's judgment, may affect the interpretation of study results or patient safety
  17. * History or presence of clinically significant medical illness or laboratory abnormality that, in the opinion of the investigator would preclude participation in the study.
  18. * Positive for NMO antibody discovered within the first 2 weeks after randomization.

Contacts and Locations

Study Contact

Harkeerat Halait
CONTACT
415.353.2707
Harkeerat.Halait@ucsf.edu
Angelica Montevirgen, BS
CONTACT
415.745.1304
Angelica.Montevirgen@ucsf.edu

Principal Investigator

Ari Green, MD, MCR
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

University of California San Francisco
San Francisco, California, 94158
United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

  • Ari Green, MD, MCR, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-02-28
Study Completion Date2026-08

Study Record Updates

Study Start Date2017-02-28
Study Completion Date2026-08

Terms related to this study

Keywords Provided by Researchers

  • multiple sclerosis
  • eye pain
  • vision loss

Additional Relevant MeSH Terms

  • Optic Neuritis