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NCT01813591 · ClinicalTrials.gov registry record · Phase 2
A Two-Arm Study Evaluation H.P. Acthar Injection Gel in Treatment of Chronic Migraines
A Phase 2 study, sponsored by Dent Neuroscience Research Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT01813591 is a Phase 2 study that has completed, run by Dent Neuroscience Research Center. The registered enrollment target is 20 participants.
The verdict
NCT01813591, a Phase 2 study, has completed, sponsored by Dent Neuroscience Research Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
This small study is to investigate the efficacy of Acthar in the treatment of chronic migraine in patients who have failed multiple treatments, including Botox (which is defined as having \<30% reduction from baseline in the number of headache days per month). Despite the widespread use of anti-seizure medications, there remain a significant number of patient whose migraines are refractory to these agents. The pathophysiology of migraine is such that the neural substances calcitonin G related protein (CGRP), substance P, and neurokinin A are released at the trigeminal nerve endings innervating the large cranial and dura mater blood vessels and this neurotrasmission generates migraine associated pain. Because of this, treatment for migraine can be directed towards down regulating those receptor sites accordingly. Acthar may provide pain relief through this mechanist, as ACTH has been shown to inhibit the release of CGRP and may also provide relief through a negative feedback loop as exogenous ACTH inhibits CRH release and mast cell degranulation.
Interventions
- DRUG H.P. Acthar Gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2013-04 |
| Est. Completion | 2015-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01813591
The ClinicalTrials.gov registry entry for NCT01813591 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dent Neuroscience Research Center, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which H.P. Acthar Gel is the first listed.
NCT01813591 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01813591 about?
NCT01813591 is a clinical study titled "A Two-Arm Study Evaluation H.P. Acthar Injection Gel in Treatment of Chronic Migraines". This small study is to investigate the efficacy of Acthar in the treatment of chronic migraine in patients who have failed multiple treatments, including Botox (which is defined as having \<30% reduction from baseline in the number of headache days per month). Despite the widespread use of anti-seiz...
What is the current status of trial NCT01813591?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2013-04. Estimated completion is 2015-11.
What interventions are being tested in trial NCT01813591?
The interventions under investigation include: H.P. Acthar Gel (DRUG).
Who is sponsoring clinical trial NCT01813591?
This trial is sponsored by Dent Neuroscience Research Center, which has 4 total clinical trials registered on ClinicalTrials.gov.
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