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NCT03068754 · ClinicalTrials.gov registry record · Phase 2
Study of Acthar® Gel (Acthar) for Amyotrophic Lateral Sclerosis (ALS)
A Phase 2 study, sponsored by Mallinckrodt.
- Terminated
- Registry status
- Phase 2
- Development phase
- 143
- Enrollment target
NCT03068754: Clinical Trial Phase 2 study, sponsored by Mallinckrodt.
NCT03068754 is a Phase 2 study that was terminated before completion, run by Mallinckrodt. The registered enrollment target is 143 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03068754, a Phase 2 study, was terminated before completion, sponsored by Mallinckrodt.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 143 participants
- Enrollment target
Study Summary
About 213 people with ALS will participate in this study. There will be locations in North and South America. During the first part, participants will be randomly assigned to a group (like by flipping a coin). Out of every 3: * 2 will get the study drug * 1 will get a look-alike with no drug in it (placebo) During the second part, everyone will get the study drug. Participation will help doctors find out if Acthar can help or slow down the symptoms of ALS better than placebo.
Primary Outcome
The ALSFRS-R is a validated questionnaire-based scale used extensively as a primary outcome measure in ALS clinical trials and is considered a predictor of survival. ALSFRS-R is a 12-item scale that measures 4 domains relevant for ALS (gross motor, fine motor, bulbar and respiratory) A trained, independent rater calls each participant (or the caregiver) to administer the questionnaire. The 12 functions are rated on a scale from 0 to 4, with a highest possible (summed) score of 48. Higher score
Interventions
- DRUG Placebo
- DRUG Acthar
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 143 participants |
| Start Date | 2017-06-22 |
| Est. Completion | 2019-11-25 |
| Phase | Phase 2 |
Why NCT03068754 stopped before completion
NCT03068754 is an interventional study that assigns participants to a tested intervention. The registered 143 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03068754 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03068754 about?
NCT03068754 is a clinical study titled "Study of Acthar® Gel (Acthar) for Amyotrophic Lateral Sclerosis (ALS)". About 213 people with ALS will participate in this study. There will be locations in North and South America. During the first part, participants will be randomly assigned to a group (like by flipping a coin). Out of every 3: * 2 will get the study drug * 1 will get a look-alike with no drug in it...
What is the current status of trial NCT03068754?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 143 participants. The study started on 2017-06-22. Estimated completion is 2019-11-25.
What interventions are being tested in trial NCT03068754?
The interventions under investigation include: Placebo (DRUG), Acthar (DRUG).
Who is sponsoring clinical trial NCT03068754?
This trial is sponsored by Mallinckrodt, which has 69 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03068754's enrollment target sits among peer trials
143 507th of 2000 higher than 1,494 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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