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Behavioural Intervention

Circadian Focused Light Therapy for Fatigue Reduction in Progressive Multiple Sclerosis (NO-FATIGUE) for Multiple Sclerosis (NO-FATIGUE Trial)

Phase 1

Recruiting

Led By Peter Sguigna, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must be on a stable dose of an FDA-approved disease modifying therapy for at least 3 months prior to screening

Age ≥ 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2.5 months

Awards & highlights

NO-FATIGUE Trial Summary

This trial aims to see if a new type of light therapy is safe for patients with progressive multiple sclerosis. The study will look at how this therapy affects fatigue and how it works in the body. Fat

Who is the study for?

This trial is for adults over 18 with progressive multiple sclerosis (either primary or secondary), as diagnosed by specific medical criteria. Participants must be stable on an FDA-approved MS treatment for at least three months and able to complete study procedures.Check my eligibility

What is being tested?

The trial is testing a new form of light therapy to see if it's safe for patients with progressive multiple sclerosis and if it can help reduce fatigue, a common symptom without direct FDA-approved treatments.See study design

What are the potential side effects?

While the side effects of this novel light therapy are being studied, potential risks may include eye strain, headache, sleep disturbances, or mood changes.

NO-FATIGUE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been on a stable dose of approved medication for my condition for at least 3 months.

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I am 18 years old or older.

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I have been diagnosed with primary or secondary progressive MS.

NO-FATIGUE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2.5 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2.5 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2.5 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Treatment Emergent Adverse Events (TEAEs)

NO-FATIGUE Trial Design

1Treatment groups

Experimental Treatment

Group I: Circadian Focused Light Therapy for Fatigue Reduction in Progressive Multiple Sclerosis (NO-FATIGUE)Experimental Treatment1 Intervention

This will be an open label, single arm, single center phase 1 research study designed to generate safety data, biomarker data, and preliminary efficacy data to reduce fatigue in patients with progressive MS, to include PPMS and SPMS

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Light therapy

2004

N/A

~250

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Multiple Sclerosis SocietyOTHER

96 Previous Clinical Trials

9,485 Total Patients Enrolled

94 Trials studying Multiple Sclerosis

9,131 Patients Enrolled for Multiple Sclerosis

University of Texas Southwestern Medical CenterLead Sponsor

1,049 Previous Clinical Trials

1,054,284 Total Patients Enrolled

15 Trials studying Multiple Sclerosis

51,654 Patients Enrolled for Multiple Sclerosis

International Progressive Multiple Sclerosis AllianceUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment process currently open for this clinical trial?

"Indeed, data provided on clinicaltrials.gov highlights that this research is actively seeking volunteers. The study was initially listed on April 18th, 2024, and the most recent update occurred on the same date. The trial aims to enroll 20 participants at a single site."

Answered by AI

What is the number of participants currently enrolled in this clinical study?

"Affirmative. Information provided on clinicaltrials.gov confirms the ongoing recruitment for this study. This trial was first published on 4/18/2024 and underwent its most recent update on the same date. The research is seeking to enroll a total of 20 participants at a single designated site."

Answered by AI

What is the safety profile of Circadian Focused Light Therapy in reducing fatigue for individuals with Progressive Multiple Sclerosis as investigated in the NO-FATIGUE trial?

"The safety assessment for the Circadian Focused Light Therapy in managing fatigue related to Progressive Multiple sclerosis (NO-FATIGUE) is rated at 1 by our team due to its Phase 1 status, indicating restricted evidence supporting both safety and effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Circadian Focused Light Therapy in Progressive Multiple Sclerosis

Peter Sguigna 2024. "Study of Circadian Focused Light Therapy in Progressive Multiple Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06261528.

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