Tests light therapy for fatigue in progressive multiple sclerosis
Tests whether a light device is tolerated by adults with progressive multiple sclerosis.
Plain-language title generated from the registry record
Registry title: Study of Circadian Focused Light Therapy in Progressive Multiple Sclerosis
Key facts
- Where
- Dallas, United StatesSee the site
- Phase
- Phase 1
Where in United States
- UT Southwestern Medical CenterDallas, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Texas Southwestern Medical Center
- Trial code
- NCT06261528
- Record updated
- 31 December 2025
- Original 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.Read full original descriptionShow less
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.
Inclusion: 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: Pharmacological and non-pharmacological mood and fatigue treatments changes within the previous three months prior to screening; Positive drug screen for cocaine, or phencyclidine, or known alcohol abuse within 30 days of the 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; Optic neuritis within the previous 3 months; 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; Sleep onset latency under 15 minutes; 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; Presence of a gadolinium-enhancing demyelinating lesion within the last year; Sleep schedule changes as required by employment (night shifts); Travel across two time zones within 3 months of study screening.