Progressive Multiple SclerosisPhase 1NO-FATIGUENCT06261528
Study of Circadian Focused Light Therapy in Progressive Multiple Sclerosis
A Phase 1 study testing Light therapy in people with Progressive Multiple Sclerosis, run by University of Texas Southwestern Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Progressive Multiple Sclerosis
- What is being tested?
- Light therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2024to 1 Jul 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official 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.
Read the detailed 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.
- Conditions
- Progressive Multiple Sclerosis
- Being tested
- Light therapy
- Keywords
- Fatigue, Sleepiness, Circadian
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive, Fatigue, Sleepiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light therapyDevice
Light therapy aimed at alleviating fatigue through circadian rhythm synchronization
| Study group | Role | What they receive |
|---|---|---|
| Circadian Focused Light Therapy for Fatigue Reduction in Progressive Multiple Sclerosis (NO-FATIGUE) | Experimental | 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 Receives: Device: Light therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start18 Apr 2024
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Sguigna, University of Texas Southwestern Medical Center
- Investigators
- Peter Sguigna, MD, Principal investigator, UTSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261528
- Sponsor's protocol ID
- STU-2023-1289
- Acronym
- NO-FATIGUE
- Status last verified
- Dec 2025
- First submitted
- 7 Feb 2024
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All individual patient data that supports a publication as reported in the article after deidentification will be available to qualified investigators with reasonable requests.
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Circadian Focused Light Therapy for Fatigue Reduction in Progressive Multiple Sclerosis (NO-FATIGUE)
- ClinicalTrials.gov ID
- NCT06261528
- Acronym / sponsor ID
- NO-FATIGUE / STU-2023-1289
- Conditions
- Progressive Multiple Sclerosis
- Keywords
- Fatigue, Sleepiness, Circadian
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 15 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Circadian Focused Light Therapy for Fatigue Reduction in Progressive Multiple Sclerosis (NO-FATIGUE) | Experimental | Device: Light therapyThis 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Light therapyLight therapy aimed at alleviating fatigue through circadian rhythm synchronization | Device | Circadian Focused Light Therapy for Fatigue Reduction in Progressive Multiple Sclerosis (NO-FATIGUE) |
Primary outcome
Treatment Emergent Adverse Events (TEAEs)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: Yes. All individual patient data that supports a publication as reported in the article after deidentification will be available to qualified investigators with reasonable requests.
Related trials for Progressive Multiple Sclerosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Sguigna, MD principal investigator
UTSW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Light therapy in people with Progressive Multiple Sclerosis, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Emergent Adverse Events (TEAEs) (time frame: 2.5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.