Study of Circadian Focused Light Therapy in Progressive Multiple Sclerosis (NO-FATIGUE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Progressive Multiple Sclerosis
• Intervention / Treatment: Device: Light therapy

Detailed Description

This will be an open label, single arm, single center, phase 1 research study designed to determinate the safety and mechanism of action of targeted light therapy as a treatment for fatigue in people with progressive multiple sclerosis (PMS).

Participants will undergo a 2-week screening that includes an at home sleep monitor, saliva collection, and completion of surveys. Once screening is complete, participants will complete a light therapy program that will require visits to UT Southwestern Medical Center each day for 3 days, and then every 2-3 weeks for three visits, for a total of 7 visits. Each visit will take about 3 hours. Participants will also be asked to collect saliva, wear the home sleep monitor, and complete surveys. The total study duration is about 2.5 months.

The risks of this study include the possibility of eye irritation during the light therapy, and loss of confidentiality.

The primary outcome will be the treatment emergent adverse events. There is a number of exploratory efficacy and mechanism of action outcomes for future study design.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ana Raicu; Phone Number: 214-645-0292; Email: ana.raicu@utsouthwestern.edu

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75247
      • Recruiting
      • UT Southwestern Medical Center
      • Principal Investigator: Peter Sguigna, MD
      • Contact: Ana Raicu; Phone Number: 214-645-0292; Email: ana.raicu@utsouthwestern.edu
      • Contact: Ana Raicu; Phone Number: 214-645-0292
      • Sub-Investigator: Benjamin Greenberg, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Circadian Focused Light Therapy for Fatigue Reduction in Progressive Multiple Sclerosis (NO-FATIGUE); This will be an open label, single arm, single center phase 1 research study designed to generate safety data, biomarker data, and preliminary efficacy data to reduce fatigue in patients with progressive MS, to include PPMS and SPMS	Device: Light therapy; Light therapy aimed at alleviating fatigue through circadian rhythm synchronization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Emergent Adverse Events (TEAEs)	The primary objective is to characterize treatment emergent adverse events (TEAEs) following light therapy targeting circadian rhythm synchronization. Data will be summarized descriptively as incidence/prevalence relative to the study population.	2.5 months

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: National Multiple Sclerosis Society; International Progressive Multiple Sclerosis Alliance
• Investigators: Principal Investigator: Peter Sguigna, MD, UTSW

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 7, 2024
• First Submitted That Met QC Criteria: February 7, 2024
• First Posted (Actual): February 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Fatigue; Sleepiness; Circadian
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Disease Attributes; Chronic Disease; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
• Other Study ID Numbers: STU-2023-1289

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All individual patient data that supports a publication as reported in the article after deidentification will be available to qualified investigators with reasonable requests.
• IPD Sharing Time Frame: The data will be available within two years of publication of the results of the trial by qualified investigators for a defined period of time. This data will be available through institutional mechanisms.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No