Light therapy for fatigue in progressive multiple sclerosis
A Phase I Study of Circadian Focused Light Therapy for Fatigue Reduction in Progressive Multiple Sclerosis (NO-FATIGUE)
PHASE1 · University of Texas Southwestern Medical Center · NCT06261528
This study is testing a new light therapy to see if it can help reduce fatigue in people with progressive multiple sclerosis.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center (other) |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT06261528 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and mechanism of action of a novel light therapy aimed at reducing fatigue in patients with progressive multiple sclerosis. It involves a 2-week screening period followed by a light therapy program that includes daily visits for three days and additional visits every 2-3 weeks for a total of seven visits. Participants will undergo assessments including sleep monitoring and surveys to gather data on the therapy's effects. The primary focus is on identifying any treatment-emergent adverse events while exploring the therapy's efficacy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of primary or secondary progressive multiple sclerosis who experience significant fatigue.
Not a fit: Patients with stable sleep patterns or those whose mood and fatigue treatments have changed recently may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for managing fatigue in patients with progressive multiple sclerosis.
How similar studies have performed: While light therapy has been explored in other contexts, this specific application for progressive multiple sclerosis fatigue is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * 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 Exclusion Criteria: * 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
Where this trial is running
Dallas, Texas
- UT Southwestern Medical Center — Dallas, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Peter Sguigna, MD — UTSW
- Study coordinator: Ana Raicu
- Email: ana.raicu@utsouthwestern.edu
- Phone: 214-645-0292
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Progressive Multiple Sclerosis, Fatigue, Sleepiness, Circadian