Phase 2 Motor Neurone Disease Trial, Recruiting NCT06527222 Sponsor: Swathy Chandrashekhar, MBBS Condition: Motor Neurone Disease
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Phase 2 Motor Neurone Disease Trial, Recruiting

NCT06527222
Recruiting Phase 2

Who may 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 might be able to join this trial:

  • People aged 18 or older
  • People who have been diagnosed with ALS (also called Lou Gehrig's disease), confirmed using established medical guidelines known as the revised El Escorial criteria
  • People whose lungs are working at 50% capacity or more, based on a breathing test called forced vital capacity (FVC)
  • People who are able to swallow pills at the start of the study and are expected to continue to be able to do so throughout the study
  • People who are taking ALS medications and have been on a stable, unchanged dose for at least 30 days before joining
  • People who experience 4 or more muscle cramps per week during a 2-week check-in period before the study begins

Who may not be able to join:

  • People who have had ALS for less than 5 years
  • People who have had a tracheostomy, use a breathing machine inserted through the throat, or rely on a non-invasive breathing machine for more than 12 hours per day
  • People who are pregnant or breastfeeding, people who are unable to give their own consent to participate, or people who are currently imprisoned
  • People who are currently taking a medication called ranolazine, or who are taking or have recently taken any experimental (investigational) drug within the past 30 days or longer (confirm with trial site)
  • People who have heart, liver, or kidney disease that is not well managed medically
  • People who have a specific type of irregular heart rhythm finding on an ECG (called QTc interval prolongation above certain thresholds), a history of a condition called long QT syndrome, or who take medications known to affect heart rhythm in this way (confirm with trial site)
  • People who have participated in an experimental drug trial within 30 days before the screening period
  • People who are not on a stable dose of any muscle cramp medications — either the dose must have been unchanged for at least 30 days, or the person must have stopped taking those medications at least 30 days before joining the study

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 23 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Jeffrey Statland, MD, University of Kansas Medical Center

Phone: 913-945-9932

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Swathy Chandrashekhar, MBBS
Registry
ClinicalTrials.gov
Start date
29 April 2025
Est. completion
1 July 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Frequency of Treatment-Emergent Adverse Events; Tolerability of treatment assignment; Muscle cramp frequency; Muscle cramp severity; Muscle cramps impact on quality of life; Safety Lab Cystatin C; Safety Lab Estimated Glomerular Filtration Rate (eGFR); Safety Lab Alanine Transaminase (ALT); Safety Lab Aspartate Transferase (AST); Safety Lab Alkaline Phosphatase (ALP); Safety Lab Total Bilirubin

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: 23 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