Status:
TERMINATED
OnabotulinumtoxinA for the Treatment of New Daily Persistent Headache: an Open Label Study
Lead Sponsor:
St. Luke's-Roosevelt Hospital Center
Collaborating Sponsors:
Allergan
Conditions:
New Daily Persistent Headache
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 chroni...
Eligibility Criteria
Inclusion
- Subjects aged 18 or older, male or female of any race with the diagnosis of NDPH meeting International Classification of Headache Disorders (ICHD-2) criteria will be included in the study. The criteria is as follows:
- A. Persistent headache fulfilling criteria B and C B. Distinct and clearly remembered onset, with pain becoming continuous and unremitting within 24 hours C. Present for \>3 months D. Not better accounted for by another ICHD-3 diagnosis
Exclusion
- Those with relevant physical or psychological illness, particularly conditions that might put them at risk if exposed to OnabotulinumtoxinA (myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other neuromuscular disease).
- Diagnosis of other primary/secondary headache disorder.
- Psychiatric disorders that could interfere with study participation.
- Subjects who abuse drugs, including headache treatments and alcohol (DSM IV criteria).
- Those allergic to compounds similar to the study medication.
- Those who are pregnant or breastfeeding, or who do not use adequate contraceptive methods.
- Those who have had any prior exposure to any botulinum toxin serotype.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01920945
Start Date
September 1 2014
End Date
October 1 2016
Last Update
October 26 2016
Active Locations (1)
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1
Roosevelt Hospital Headache Institute
New York, New York, United States, 10019