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

New Daily Persistent Headache Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headache
• New Daily Persistent Headache

• NCT number: NCT01920945
• Study type: Interventional
• Source: St. Luke's-Roosevelt Hospital Center
• Status: Terminated
• Phase: Phase 2
• Start date: September 2014
• Completion date: October 2016