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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT02870634

NCT02870634
Completed Phase 1 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You have signed a consent form before any study procedures begin
  • You have been diagnosed with ALS (also called Motor Neurone Disease), whether inherited or not, at any stage from "possible" to "definite" based on standard diagnostic guidelines
  • Your first ALS/MND symptoms appeared no more than 2 years before your screening appointment
  • Your lung function tests show your breathing capacity and nasal sniff pressure are at or above certain minimum levels (at least 70% and 50% of what is expected for someone your age and size)
  • You are either not taking riluzole, or you have been on a stable dose of riluzole for at least 4 weeks before screening (you cannot start riluzole during the study)
  • You are between 18 and 75 years old when you sign the consent form
  • You have a reliable caregiver who is able and willing to help you take the study medication
  • Your blood test results show your bone marrow, kidneys, and liver are functioning well enough (confirm specific numbers with trial site)
  • If you could become pregnant, you must use effective contraception during the study, not be breastfeeding, and have a negative pregnancy test at screening; this applies to male participants whose partners could become pregnant as well

Who may not be able to join:

  • You have difficulty swallowing tablets or have a gut condition that may stop the study drug from being properly absorbed
  • You rely on a breathing machine (invasive or non-invasive) for any part of the day or night
  • You have taken part in another clinical trial within the last 3 months, or two other trials within the last 6 months
  • You have had an active stomach or bowel condition (other than acid reflux) within 30 days of your screening visit
  • You have a condition or are receiving treatment that weakens your immune system
  • You have any of the following: drug or alcohol dependency, an unstable heart, lung, kidney, liver, hormone, or blood disorder, an active infection, HIV/AIDS, current cancer, an unstable psychiatric condition such as psychosis or untreated severe depression within 90 days of screening, or any other muscle or nerve disease besides ALS/MND
  • You have dementia that could affect the study results or your ability to understand and follow the study requirements
  • You have been using blood-thinning medication at treatment doses within 7 days before your screening visit
  • You are currently taking certain medications that strongly affect how the body processes drugs (confirm specific medications with trial site)

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.

Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 1
Sponsor
Collaborative Medicinal Development Pty Limited
Registry
clinicaltrials_gov
Start date
16 November 2016
Est. completion
30 October 2019

Where this trial is recruiting

🇦🇺 Australia

2 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

recommended phase 2 dose as determined by the number of participants at each dose level with dose limiting toxicities

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: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov