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NCT06261528

Study of Circadian Focused Light Therapy in Progressive Multiple Sclerosis

Enrolling by Invitation
PHASE1Ages 18+InterventionalTreatment
University of Texas Southwestern Medical Center
~20 participants
Updated 2025-12-31 on ClinicalTrials.gov
What's tested:Light therapy

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Treatment Emergent Adverse Events (TEAEs)
Measured over 2.5 months

Conditions

Progressive Multiple Sclerosis

Explore related trials

Progressive multiple sclerosis

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Peter Sguigna, MD · PRINCIPAL_INVESTIGATOR · UTSW

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

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

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

What this trial measures

  • Treatment Emergent Adverse Events (TEAEs)2.5 months

    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.