Treatment of Chronic Post-Traumatic Headache With OnabotulinumtoxinA

NCT02160535 | Terminated Phase 3 Results DMC

• 1 other identifier: 46614
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This study will provide evidence on whether the use of an FDA-approved drug therapy for the treatment of chronic migraine (OnabotulinumtoxinA) shows similar efficacy for treatment of chronic headaches caused by traumatic injury to the brain (TBI) from a direct hit to the head, or a fall, or a motor vehicle accident, or some other traumatic event.

Conditions

Chronic Post Traumatic Headache

Keywords

Mild Traumatic Brain Injury; Concussion; Post Concussive Headache

Outcome Measures

Primary Outcomes (1)

• Change in Mean Percentage of Headache Days

  To measure average number of headache days three months after the last onaboltulinumtoxinA injection and compare to average number of headache days during screening month (and present as percentage of headache change).

  Baseline, 9 months

Secondary Outcomes (3)

• Change in SF-36 Assessment Scores

  Baseline and 9 month.

• Change in MIDAS Score

  Baseline and 9 month.

• Change in HIT-6 Score.

  Baseline and 9 month.

Study Arms (1)

Treatment with OnabotulinumtoxinA

EXPERIMENTAL

OnabotulinumtoxinA

Drug: OnabotulinumtoxinA

Interventions

OnabotulinumtoxinA DRUG

155 units of OnabotulinumtoxinA administered intramuscularly. Injections are divided across seven injection specific head/neck muscle areas every 12 weeks to prevent chronic migraine post traumatic headache

Also known as: BOTOX

Treatment with OnabotulinumtoxinA

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of mild traumatic brain injury (mTBI) within the past 15 months
• Suffer at least fifteen total headache days per month
• Ability to speak and read English

You may not qualify if:

• Subject with hypersensitivity reactions or other intolerance to OnabotulinumtoxinA
• Previous use of OnabotulinumtoxinA for treatment of headache
• Any medications commonly used as headache preventives started less than 3 months prior to enrollment
• Prior or current diagnosis of major psychiatric disorder or other central nervous system disorder
• Less than 80% compliance (recorded for less than 24 days) in the 30 day screening headache diary
• Subjects who are pregnant or trying to become pregnant within the timeframe of the study

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington Headache Clinic

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Brain Concussion

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

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

Results Point of Contact

• Title: Dr. Sylvia Lucas, MD, PhD
• Organization: University of Washington

lucass@uw.edu

206-598-9260

Study Officials

• Sylvia Lucas, MD, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 15, 2014
• First Posted: June 10, 2014
• Study Start: May 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: October 23, 2018
• Results First Posted: October 23, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)