Trials / Terminated
TerminatedNCT01950234
ACTH in Progressive Forms of MS
Treatment of Progressive Forms of Multiple Sclerosis With Pulsed ACTH (Acthar Gel)
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 59 (actual)
- Sponsor
- University of Minnesota · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase II, randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety, tolerability, and efficacy of adrenocorticotropic hormone (ACTH, Acthar gel) administered as a pulsed regimen consisting of injections on three consecutive days per month in patients with progressive forms of Multiple Sclerosis (MS). Patients will be randomly assigned to either an ACTH arm or a placebo arm. The main hypotheses are that 1) pulsed ACTH will be safe and well-tolerated, and 2) pulsed ACTH will slow progression of clinical and paraclinical measures of MS progression compared to placebo.
Conditions
- Secondary Progressive Multiple Sclerosis
- Primary Progressive Multiple Sclerosis
- Progressive Relapsing Multiple Sclerosis
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ACTH | Acthar gel |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2014-04-17
- Primary completion
- 2022-12-31
- Completion
- 2022-12-31
- First posted
- 2013-09-25
- Last updated
- 2025-02-11
- Results posted
- 2025-02-11
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01950234. Inclusion in this directory is not an endorsement.