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NCT01920945 · ClinicalTrials.gov registry record · Phase 2
OnabotulinumtoxinA for the Treatment of New Daily Persistent Headache: an Open Label Study
A Phase 2 study, sponsored by St. Luke's-Roosevelt Hospital Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT01920945 is a Phase 2 study that was terminated before completion, run by St. Luke's-Roosevelt Hospital Center. The registered enrollment target is 6 participants.
The verdict
NCT01920945, a Phase 2 study, was terminated before completion, sponsored by St. Luke's-Roosevelt Hospital Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effect of BOTOX® (OnabotulinumtoxinA) on the number of headache days in patients with New Daily Persistent Headache (NDPH). NDPH is a benign form of chronic daily headache that comes in two forms: one that resolves on its own after months to years, or one that is difficult to treat and does not respond to preventive or abortive medications. Some patients experience migrainous features such as nausea, vomiting, photophobia, or phonophobia. BOTOX®, a treatment approved for chronic migraine, will be injected into specific muscles of the head and neck area by your study doctor, to evaluate its effectiveness in reducing or relieving NDPH days or severity. BOTOX has not been approved for NDPH and this is the first time it will be used for treatment of NDPH. All participants in this study will only receive BOTOX® and no other study drug.
Interventions
- DRUG OnabotulinumtoxinA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2014-09 |
| Est. Completion | 2016-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01920945
The ClinicalTrials.gov registry entry for NCT01920945 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Luke's-Roosevelt Hospital Center, which has 57 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which OnabotulinumtoxinA is the first listed.
NCT01920945 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01920945 about?
NCT01920945 is a clinical study titled "OnabotulinumtoxinA for the Treatment of New Daily Persistent Headache: an Open Label Study". The purpose of this study is to evaluate the effect of BOTOX® (OnabotulinumtoxinA) on the number of headache days in patients with New Daily Persistent Headache (NDPH). NDPH is a benign form of chronic daily headache that comes in two forms: one that resolves on its own after months to years, or one...
What is the current status of trial NCT01920945?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2014-09. Estimated completion is 2016-10.
What interventions are being tested in trial NCT01920945?
The interventions under investigation include: OnabotulinumtoxinA (DRUG).
Who is sponsoring clinical trial NCT01920945?
This trial is sponsored by St. Luke's-Roosevelt Hospital Center, which has 57 total clinical trials registered on ClinicalTrials.gov.
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