Multiple Sclerosis Clinical Trial
Study of Circadian Focused Light Therapy in Progressive Multiple Sclerosis
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.
Full Description
This will be an open label, single arm, single center, phase 1 research study designed to determinate the safety and mechanism of action of targeted light therapy as a treatment for fatigue in people with progressive multiple sclerosis (PMS).
Participants will undergo a 2-week screening that includes an at home sleep monitor, saliva collection, and completion of surveys. Once screening is complete, participants will complete a light therapy program that will require visits to UT Southwestern Medical Center each day for 3 days, and then every 2-3 weeks for three visits, for a total of 7 visits. Each visit will take about 3 hours. Participants will also be asked to collect saliva, wear the home sleep monitor, and complete surveys. The total study duration is about 2.5 months.
The risks of this study include the possibility of eye irritation during the light therapy, and loss of confidentiality.
The primary outcome will be the treatment emergent adverse events. There is a number of exploratory efficacy and mechanism of action outcomes for future study design.
Eligibility 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
Must be on a stable dose of an FDA-approved disease modifying therapy for at least 3 months prior to screening
Exclusion Criteria:
Pharmacological and non-pharmacological mood and fatigue treatment 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 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
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
Travel across two time zones within 3 months of study screening
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There is 1 Location for this study
Dallas Texas, 75247, United States More Info
Principal Investigator
Sub-Investigator
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