Study of Circadian Focused Light Therapy in Progressive Multiple Sclerosis

Progressive Multiple Sclerosis Clinical Trial

— NO-FATIGUE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06261528
• Other study ID #: STU-2023-1289
• Status: Recruiting
• Phase: Phase 1
• Start date: April 18, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: April 2024
• Source: University of Texas Southwestern Medical Center
• Contact: Ana Raicu
• Phone: 214-645-0292
• Email: ana.raicu[@]utsouthwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Progressive Multiple Sclerosis
• Sclerosis

Intervention

Device:
• Light therapy
Light therapy aimed at alleviating fatigue through circadian rhythm synchronization

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (3)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	International Progressive Multiple Sclerosis Alliance, National Multiple Sclerosis Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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