Progressive Multiple Sclerosis Clinical Trial
— NO-FATIGUEOfficial title:
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 1, 2025 |
Est. primary completion date | May 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | UT Southwestern Medical Center | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center | International Progressive Multiple Sclerosis Alliance, National Multiple Sclerosis Society |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Treatment Emergent Adverse Events (TEAEs) | 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. | 2.5 months |
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 |