Back to resultsOnabotulinumtoxinA for the Treatment of New Daily Persistent Headache: an Open Label Study
Primary Purpose
New Daily Persistent Headache
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
OnabotulinumtoxinA
Sponsored by
About this trial
This is an interventional treatment trial for New Daily Persistent Headache
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
- 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.
Sites / Locations
- Roosevelt Hospital Headache Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
OnabotulinumtoxinA
Arm Description
Outcomes
Primary Outcome Measures
change from baseline in frequency of headache days
Secondary Outcome Measures
Full Information
NCT ID
NCT01920945
First Posted
August 7, 2013
Last Updated
October 24, 2016
Sponsor
St. Luke's-Roosevelt Hospital Center
Collaborators
Allergan
1. Study Identification
Unique Protocol Identification Number
NCT01920945
Brief Title
OnabotulinumtoxinA for the Treatment of New Daily Persistent Headache: an Open Label Study
Official Title
OnabotulinumtoxinA for the Treatment of New Daily Persistent Headache: an Open Label Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
Difficult enrollment
Study Start Date
September 2014 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Luke's-Roosevelt Hospital Center
Collaborators
Allergan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
New Daily Persistent Headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OnabotulinumtoxinA
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
OnabotulinumtoxinA
Other Intervention Name(s)
Botox
Intervention Description
155 units of OnabotulinumtoxinA, will be injected into 31 sites in the head and neck every 12 weeks for a total of 24 weeks using a sterile 30-gauge, 0.5 inch needle as 0.1 mL (5 Units) injections per each site. Injections will be divided across seven specific head/neck muscle areas (corrugator, procerus, frontalis, temporalis, suboccipital, splenius capitus and medial/lateral occipital, and trapezius).
Primary Outcome Measure Information:
Title
change from baseline in frequency of headache days
Time Frame
29 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Facility Information:
Facility Name
Roosevelt Hospital Headache Institute
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
12. IPD Sharing Statement
Learn more about this trial
OnabotulinumtoxinA for the Treatment of New Daily Persistent Headache: an Open Label Study
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