Clinical Trial: OnabotulinumtoxinA for the Treatment of New Daily Persistent Headache: an Open Label Study

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: OnabotulinumtoxinA for the Treatment of New Daily Persistent Headache: an Open Label Study

Brief 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.

Detailed Summary:
Sponsor: St. Luke's-Roosevelt Hospital Center

Current Primary Outcome: change from baseline in frequency of headache days [ Time Frame: 29 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: St. Luke's-Roosevelt Hospital Center

Dates:
Date Received: August 7, 2013
Date Started: September 2014
Date Completion:
Last Updated: October 24, 2016
Last Verified: October 2016