OnabotulinumtoxinA for the Treatment of New Daily Persistent Headache: an Open Label Study
| Status: | Recruiting |
|---|---|
| Conditions: | Migraine Headaches |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2014 |
| End Date: | September 2016 |
| Contact: | Iris R Harris, BS |
| Email: | iharris@chpnet.org |
| Phone: | 212-523-2381 |
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.
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.
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:
1. 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).
2. Diagnosis of other primary/secondary headache disorder.
3. Psychiatric disorders that could interfere with study participation.
4. Subjects who abuse drugs, including headache treatments and alcohol (DSM IV
criteria).
5. Those allergic to compounds similar to the study medication.
6. Those who are pregnant or breastfeeding, or who do not use adequate contraceptive
methods.
7. Those who have had any prior exposure to any botulinum toxin serotype.
We found this trial at
1
site
New York, New York 10019
Principal Investigator: Adelene E Jann, MD
Phone: 212-523-2381
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