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

NCT01281189

NCT01281189
Completed Phase 3 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You must be between 18 and 80 years old at the start of the trial.
  • You must have been diagnosed with ALS, either the sporadic (no family history) or familial (runs in the family) type.
  • Your first ALS symptoms must have started within the last 24 months before joining the trial.
  • Your ALS diagnosis must meet certain recognised medical standards for a possible, probable, or definite diagnosis (confirm with trial site).
  • Your lung breathing capacity when sitting upright must be 65% or more of what is considered normal.
  • You may or may not be taking the ALS medication Riluzole, but if you are currently taking it, you must have been on the same dose for at least 60 days; if you recently stopped taking it, you must have stopped at least 30 days ago.
  • You must be able to swallow tablets when you enter the study.

Who may not be able to join:

  • You have another serious medical illness alongside ALS.
  • Your routine blood or other lab test results show significant abnormalities.
  • You are currently pregnant or breastfeeding.
  • You have previously taken a drug called dexpramipexole.
  • You are currently taking a medication called pramipexole or any similar type of drug known as a dopamine agonist (confirm with trial site if unsure about your current medications).

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 3: approximately ~65% 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 3
Sponsor
Knopp Biosciences
Registry
clinicaltrials_gov
Start date
1 March 2011
Est. completion
1 November 2012

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇨🇦 Canada 🇫🇷 France 🇩🇪 Germany 🇮🇪 Ireland 🇳🇱 Netherlands 🇪🇸 Spain 🇸🇪 Sweden 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Composite Assessment of Function and Survival (CAFS) at 12 Months; Death up to 12 Months (CAFs Individual Component); Change From Baseline in ALSFRS-R at 12 Months (CAFs Individual Component)

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