OnabotulinumtoxinA for the Treatment of New Daily Persistent Headache: an Open Label Study
Status:
Terminated
Trial end date:
2016-10-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
St. Luke's-Roosevelt Hospital Center
Collaborator:
Allergan
Treatments:
abobotulinumtoxinA Botulinum Toxins, Type A incobotulinumtoxinA onabotulinumtoxinA