Study of Circadian Focused Light Therapy in Progressive Multiple Sclerosis

NCT06261528 | Enrolling By Invitation Phase 1 DMC FDA Device

• 1 other identifier: STU-2023-1289
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Progressive Multiple Sclerosis

Keywords

Fatigue; Sleepiness; Circadian

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Circadian Focused Light Therapy for Fatigue Reduction in Progressive Multiple Sclerosis (NO-FATIGUE)

EXPERIMENTAL

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

Interventions

Light therapy DEVICE

Light therapy aimed at alleviating fatigue through circadian rhythm synchronization

Circadian Focused Light Therapy for Fatigue Reduction in Progressive Multiple Sclerosis (NO-FATIGUE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Epworth Sleepiness Scale (ESS) ≥ 9
• 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 treatments must be stable for the previous three months prior to screening and must have intent to keep these stable for the duration of study treatment

You may not qualify if:

• Sleep onset latency under 15 minutes
• Pharmacological and non-pharmacological mood and fatigue treatments 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 provided recent 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
• No 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
• Sleep schedule changes as required by employment (night shifts)
• Travel across two time zones within 3 months of study screening

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75247, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive; Fatigue; Sleepiness

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Peter Sguigna, MD

  UTSW

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor - Department of Neurology

Model Details: 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

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 15, 2024
• Study Start: April 18, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.

Locations

US (1)