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NCT01906658 · ClinicalTrials.gov registry record · Phase 2
A Study to Explore the Safety and Tolerability of Acthar in Patients With Amyotrophic Lateral Sclerosis
A Phase 2 study, sponsored by Mallinckrodt.
- Completed
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
NCT01906658: Completed Phase 2 study, sponsored by Mallinckrodt.
NCT01906658 is a Phase 2 study that has completed, run by Mallinckrodt. The registered enrollment target is 43 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01906658, a Phase 2 study, has completed, sponsored by Mallinckrodt.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
Study Summary
This 8-week randomized, open-label evaluation will examine the acute safety and tolerability of 4 different dosing regimens of Acthar to inform dose selection for future studies of Acthar in patients with Amyotrophic Lateral Sclerosis (ALS). The study will also investigate the mean rate of change in the ALSFRS-R total score as an exploratory endpoint to help design future studies. This study will enroll up to 40 patients and include an optional 28-week open-label extension period plus a 3-week treatment taper and 1-week follow up period. After completion of Week 8, patients enrolled in a treatment group that is considered safe and tolerable at that time have the option to continue into the open-label extension period. A 3-week treatment taper and a follow-up visit are planned for all patients enrolled in the study, beginning either at Week 8 or at Week 36 if a patient continues into the optional open-label extension period.
Interventions
- DRUG Repository corticotropin injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2013-07 |
| Est. Completion | 2014-12 |
| Phase | Phase 2 |
What the finished NCT01906658 record still lists
NCT01906658 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 1 intervention - of which Repository corticotropin injection is the first listed.
NCT01906658 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01906658 about?
NCT01906658 is a clinical study titled "A Study to Explore the Safety and Tolerability of Acthar in Patients With Amyotrophic Lateral Sclerosis". This 8-week randomized, open-label evaluation will examine the acute safety and tolerability of 4 different dosing regimens of Acthar to inform dose selection for future studies of Acthar in patients with Amyotrophic Lateral Sclerosis (ALS). The study will also investigate the mean rate of change in...
What is the current status of trial NCT01906658?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2013-07. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01906658?
The interventions under investigation include: Repository corticotropin injection (DRUG).
Who is sponsoring clinical trial NCT01906658?
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 NCT01906658's enrollment target sits among peer trials
43 1332nd of 2000 higher than 662 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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