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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: Clinical Trial Phase 2 study, sponsored by St. Luke's-Roosevelt Hospital Center.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
Why NCT01920945 stopped before completion
NCT01920945 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which OnabotulinumtoxinA is the first listed.
NCT01920945 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01920945's enrollment target sits among peer trials
6 1996th of 2000 higher than 1 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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