Phase 1 Multiple Sclerosis Trial, By Invitation NCT06261528 Sponsor: University of Texas Southwestern Medical Center Condition: Multiple Sclerosis
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Phase 1 Multiple Sclerosis Trial, By Invitation

NCT06261528
By Invitation Phase 1

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • People aged 18 or older.
  • People who have been diagnosed with primary progressive MS (PPMS) or secondary progressive MS (SPMS) based on recognised diagnostic guidelines (the 2017 or 2010 Revised McDonald Criteria).
  • People who, in the opinion of the trial investigator, are able to complete the study procedures.
  • People who score 9 or higher on the Epworth Sleepiness Scale, a standard questionnaire used to measure daytime sleepiness.
  • People who have been taking an approved disease-modifying therapy for MS at the same dose for at least 3 months before the screening visit.
  • People whose treatments for mood and fatigue — both medication-based and non-medication-based — have remained unchanged for the 3 months before screening, and who intend to keep them unchanged for the duration of the trial.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People who fall asleep in under 15 minutes when trying to (sleep onset latency under 15 minutes).
  • People whose mood or fatigue treatments — whether medication-based or non-medication-based — have changed in the 3 months before screening.
  • People who, in the investigator's judgement, have a history of another significant medical condition that could interfere with the study or its results.
  • People who have had a clinically significant abnormal blood test or physical finding that had not resolved by the baseline visit and that the investigator believes could affect study participation.
  • People who test positive for cocaine or phencyclidine on a drug screen, or who have had known alcohol misuse within 30 days of the trial.
  • People who are pregnant, have recently had a positive pregnancy test, are breastfeeding, or plan to become pregnant during the trial.
  • People who are taking melatonin-related medications and have not completed an appropriate washout period, defined as either five half-lives of the medication or 14 days before screening, whichever is longer.
  • People who have had a new or adjusted prescription medication within 14 days of the baseline visit.
  • People who have had an MS relapse confirmed by an investigator within the past year.
  • People in whom a gadolinium-enhancing demyelinating lesion (a type of active MS lesion visible on a specific type of MRI scan) has been found within the past year.
  • People who have experienced optic neuritis (inflammation of the optic nerve) within the past 3 months.
  • People whose work requires them to change their sleep schedule, such as those who work night shifts.
  • People who have travelled across two or more time zones within 3 months of the screening visit.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 9 July 2026

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Trial details

Status
By Invitation
Phase
Phase 1
Registry
ClinicalTrials.gov
Start date
18 April 2024
Est. completion
1 July 2026

This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Treatment Emergent Adverse Events (TEAEs)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 9 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov