NCT06261528Enrolling by invitationPhase 1
Study of Circadian Focused Light Therapy in Progressive Multiple Sclerosis
A Phase I Study of Circadian Focused Light Therapy for Fatigue Reduction in Progressive Multiple Sclerosis (NO-FATIGUE)
Source: ClinicalTrials.gov · Last updated 31 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 7 Feb 2024
- Start date
- 18 Apr 2024
- Primary completion date
- 1 Jul 2026
- Lead sponsor
- University of Texas Southwestern Medical Center
- Diseases
- Multiple sclerosis
- NCT number
- NCT06261528
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 20
- From 18 Apr 2024 to the primary completion date, 1 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UT Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.