Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06261528
Study type Interventional
Source University of Texas Southwestern Medical Center
Contact Ana Raicu
Phone 214-645-0292
Email ana.raicu@utsouthwestern.edu
Status Recruiting
Phase Phase 1
Start date April 18, 2024
Completion date December 1, 2025

See also
  Status Clinical Trial Phase
Completed NCT02282826 - A First-in-human, Single Ascending Dose Study of GZ402668 in Patients With Progressive Multiple Sclerosis Phase 1
Completed NCT02804594 - A Study of Oxidative Pathways in MS Fatigue Phase 2
Completed NCT04120675 - Efficacy of Early Harvest Olive Oil in Cognition of Primary (PPMS) or Secondary (SPMS) Progressive Multiple Sclerosis N/A
Completed NCT01719159 - Intrathecal Therapy With Monoclonal Antibodies in Progressive Multiple Sclerosis Phase 2
Enrolling by invitation NCT03552211 - Evaluation of the Incidence of Relapses in Patients With Biotin-treated Progressive Multiple Sclerosis
Recruiting NCT05740722 - Nicotinamide Riboside Supplementation In Progressive Multiple Sclerosis Phase 2
Completed NCT03980145 - G-EO Gait Rehabilitation Training in Progressive Multiple Sclerosis N/A
Completed NCT03269071 - Neural Stem Cell Transplantation in Multiple Sclerosis Patients Phase 1
Not yet recruiting NCT05811013 - Effects of Transcranial Static Magnetic Field Stimulation (tSMS) in Progressive Multiple Sclerosis N/A
Not yet recruiting NCT04289909 - Identification of Retinal Perivascular Inflammation in Patients With Multiple Sclerosis Using Adaptive Optics (RETIMUS) N/A
Recruiting NCT05685784 - Multiple Sclerosis Prediction and Monitoring of Progression Study N/A
Completed NCT03493841 - Comparing Tolerability and Absorption of Racemic and R-lipoic Acid in Progressive Multiple Sclerosis Phase 1
Completed NCT03302806 - Study to Assess Effect and Safety of High Dose of Biotin (Qizenday®) in Progressive Multiple Sclerosis
Recruiting NCT05441488 - Masitinib in the Treatment of Patients With Primary Progressive or Non-active Secondary Progressive Multiple Sclerosis Phase 3
Recruiting NCT04695080 - ChariotMS - Cladribine to Halt Deterioration in People With Advanced Multiple Sclerosis Phase 2/Phase 3
Recruiting NCT06451159 - A Study of KYV-101, a CD19 CAR T Cell Therapy, in Participants With Treatment Refractory Progressive Multiple Sclerosis Phase 1
Completed NCT03423121 - A Trial of Bile Acid Supplementation in Patients With Multiple Sclerosis Phase 1/Phase 2
Terminated NCT02580669 - Study by Magnetic Resonance Imaging in the Progressive Forms of Multiple Sclerosis N/A
Enrolling by invitation NCT05706220 - Visual Processing Speed and Objective Analysis of Ocular Movements in Multiple Sclerosis
Recruiting NCT01815632 - Assessment of Bone Marrow-derived Cellular Therapy in Progressive Multiple Sclerosis (ACTiMuS) Phase 2