Study of Circadian Focused Light Therapy in Progressive Multiple Sclerosis

Description

The study is being done to determine if treatment with a novel form of light therapy is tolerated in patients with progressive multiple sclerosis. The goal of this trial to establish the safety profile of this light therapy while generating data on its impact on fatigue, as well as its mechanism of action. Fatigue is often a complex symptom in multiple sclerosis, without any FDA-approved direct therapy. Fatigue is traditionally treated with symptom management through a multidisciplinary team.

Conditions

Progressive Multiple Sclerosis

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Study Overview

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Study Details

Study overview

The study is being done to determine if treatment with a novel form of light therapy is tolerated in patients with progressive multiple sclerosis. The goal of this trial to establish the safety profile of this light therapy while generating data on its impact on fatigue, as well as its mechanism of action. Fatigue is often a complex symptom in multiple sclerosis, without any FDA-approved direct therapy. Fatigue is traditionally treated with symptom management through a multidisciplinary team.

A Phase I Study of Circadian Focused Light Therapy for Fatigue Reduction in Progressive Multiple Sclerosis (NO-FATIGUE)

Study of Circadian Focused Light Therapy in Progressive Multiple Sclerosis

Condition
Progressive Multiple Sclerosis
Intervention / Treatment

-

Contacts and Locations

Dallas

UT Southwestern Medical Center, Dallas, Texas, United States, 75247

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age ≥ 18 years old
  • * Diagnosis of PPMS or SPMS according to the 2017, or 2010 Revised McDonald Criteria
  • * In the opinion of the investigator, able to complete study procedures
  • * Must be on a stable dose of an FDA-approved disease modifying therapy for at least 3 months prior to screening
  • * Pharmacological and non-pharmacological mood and fatigue treatment changes within the previous three months prior to screening
  • * Based on the Investigator's judgement, patients with a history of significant other medical condition that may interfere with the conduct of the study, or interpretation of the study results
  • * History of any clinically significant abnormality in hematology, blood chemistry, or examination not resolved by the baseline visit which according to the investigator can interfere with study participation
  • * Positive drug screen for cocaine, or phencyclidine, or known alcohol abuse within 30 days of the trial
  • * Females who are pregnant, have a positive pregnancy test, are nursing, or who plan to get pregnant during the course of this clinical trial
  • * Patient taking melatonin analogues without appropriate washout, defined as five half-lives of the medication, or within 14 days of screening, whichever is longer
  • * New or adjusted prescription medication within 14 days of the baseline
  • * An investigator verified MS relapse within the previous year
  • * Presence of a gadolinium-enhancing demyelinating lesion within the last year
  • * Optic neuritis within the previous 3 months
  • * Travel across two time zones within 3 months of study screening

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Texas Southwestern Medical Center,

Peter Sguigna, MD, PRINCIPAL_INVESTIGATOR, UTSW

Study Record Dates

2025-12-01