OnabotulinumtoxinA for the Treatment of New Daily Persistent Headache: an Open Label Study
Keywords
Abstract
Dates
| Last Verified: | 09/30/2016 |
| First Submitted: | 08/06/2013 |
| Estimated Enrollment Submitted: | 08/08/2013 |
| First Posted: | 08/11/2013 |
| Last Update Submitted: | 10/23/2016 |
| Last Update Posted: | 10/25/2016 |
| Actual Study Start Date: | 08/31/2014 |
| Estimated Primary Completion Date: | 09/30/2016 |
| Estimated Study Completion Date: | 09/30/2016 |
Condition or disease
Intervention/treatment
Drug: OnabotulinumtoxinA
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: OnabotulinumtoxinA | Drug: OnabotulinumtoxinA 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). |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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: 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. |
Outcome
Primary Outcome Measures
1. change from baseline in frequency of headache days [29 weeks]
