A Study to Explore the Safety and Tolerability of Acthar in Patients With Amyotrophic Lateral Sclerosis
Public ClinicalTrials.gov record NCT01906658. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01906658
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 43 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2013
- Primary completion
- Oct 31, 2014
- Completion
- Nov 30, 2014
- Last update posted
- Jan 5, 2017
2013 – 2014
United States locations
- U.S. sites
- 17
- U.S. states
- 11
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Questcor Investigational Site | Birmingham | Alabama | 35233 | — |
| Questcor Investigational Site | Phoenix | Arizona | 85018 | — |
| Questcor Investigational Site | San Francisco | California | 94115 | — |
| Questcor Investigational Site | Stanford | California | 94305 | — |
| Questcor Investigational Site | Jacksonville | Florida | 32224 | — |
| Questcor Investigational Site | Miami | Florida | 33136 | — |
| Questcor Investigational Site | Tampa | Florida | 33612 | — |
| Questcor Investigational Site | Atlanta | Georgia | 30322 | — |
| Questcor Investigational Site | Kansas City | Kansas | 66160 | — |
| Questcor Investigational Site | Rochester | Minnesota | 55905 | — |
| Questcor Investigational Site | Lincoln | Nebraska | 68506 | — |
| Questcor Investigational Site | Hershey | Pennsylvania | 17033 | — |
| Questcor Investigational Site | Pittsburgh | Pennsylvania | 15212 | — |
| Questcor Investigational Site | Memphis | Tennessee | 38104 | — |
| Questcor Investigational Site | Dallas | Texas | 75214 | — |
| Questcor Investigational Site | Houston | Texas | 77030 | — |
| Questcor Investigational Site | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01906658, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 5, 2017 · Synced Sep 5, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01906658 live on ClinicalTrials.gov.