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NCT01049451 · ClinicalTrials.gov registry record · Phase 1
Pulse ACTH vs. MP for MS
A Phase 1 study, sponsored by University of Southern California.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT01049451 is a Phase 1 study that has completed, run by University of Southern California. The registered enrollment target is 23 participants.
The verdict
NCT01049451, a Phase 1 study, has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
We hypothesize that corticotropin or adrenocorticotrophic hormone (ACTH), administered as Acthar Gel® (MANUFACTURER NAME) is effective in the control of clinical disease activity as a pulse therapy for relapsing-remitting MS when added to standard treatment with beta-interferon. We wish to determine whether ACTH, when administered as clustered monthly intramuscular injections (monthly pulse therapy) as add-on to beta-interferons, may be a safe and effective alternative to monthly pulse therapy with MP. In addition, we hypothesize that pulse therapy with ACTH alters immune function to favor a regulatory, rather than a pro-inflammatory T cell environment.
Interventions
- DRUG Methylprednisolone
- DRUG ACTH
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2009-11 |
| Est. Completion | 2013-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01049451
The ClinicalTrials.gov registry entry for NCT01049451 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Methylprednisolone is the first listed.
NCT01049451 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01049451 about?
NCT01049451 is a clinical study titled "Pulse ACTH vs. MP for MS". We hypothesize that corticotropin or adrenocorticotrophic hormone (ACTH), administered as Acthar Gel® (MANUFACTURER NAME) is effective in the control of clinical disease activity as a pulse therapy for relapsing-remitting MS when added to standard treatment with beta-interferon. We wish to determin...
What is the current status of trial NCT01049451?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2009-11. Estimated completion is 2013-07.
What interventions are being tested in trial NCT01049451?
The interventions under investigation include: Methylprednisolone (DRUG), ACTH (DRUG).
Who is sponsoring clinical trial NCT01049451?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
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