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

NCT01920945 | Terminated Phase 2 DMC

• 1 other identifier: ALLERGAN-13-002
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

New Daily Persistent Headache

Outcome Measures

Primary Outcomes (1)

• change from baseline in frequency of headache days

  29 weeks

Study Arms (1)

OnabotulinumtoxinA

EXPERIMENTAL

Drug: OnabotulinumtoxinA

Interventions

OnabotulinumtoxinA DRUG

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).

Also known as: Botox

OnabotulinumtoxinA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Luke's-Roosevelt Hospital Center: lead
• Allergan: collaborator

Study Sites (1)

Roosevelt Hospital Headache Institute

New York, New York, 10019, United States

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2013
• First Posted: August 12, 2013
• Study Start: September 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 26, 2016

Record last verified: 2016-10

Locations

US (1)