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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: Completed Phase 2 study, sponsored by Dent Neuroscience Research Center.
NCT01813591 is a Phase 2 study that has completed, run by Dent Neuroscience Research Center. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Comparison of the average total number of headache days after 30 days of Acthar treatment (both 40IU and 80IU groups)with the average number of headache days at baseline screening period
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 |
What the finished NCT01813591 record still lists
NCT01813591 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which H.P. Acthar Gel is the first listed.
NCT01813591 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01813591's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 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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