Abobotulinumtoxina Efficacy in Post-Traumatic Headache

NCT03928496 | Completed Phase 4 FDA Drug

• 1 other identifier: Zirovich0002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the efficacy of abobotulinumtoxina on Veterans with post-traumatic headache

Conditions

Post-Traumatic Headache

Outcome Measures

Primary Outcomes (1)

• Incidence of headaches from baseline

  Evaluation in weekly incidence of headaches from baseline based on headache diary or weekly phone follow-up

  evaluation from time of injection until completion of 12 week follow-up

Secondary Outcomes (2)

• Intensity of headache pain

  evaluation from time of injection until completion of 12 week follow-up

• Number of headache days per week

  evaluation from time of injection until completion of 12 week follow-up

Study Arms (2)

Abobotulinumtoxina

EXPERIMENTAL

300 units of abobotulinumtoxinA was reconstituted with 2.4 ml of 0.9% preservative free sterile saline so that each 0.1 ml contained 12.5 units of Abobotulinumtoxina 0.1 ml were injected into 31 sites of the head and neck

Drug: AbobotulinumtoxinA

Placebo

PLACEBO COMPARATOR

0.9% preservative free sterile saline. 0.1 ml were injected into 31 sites of the head and neck

Drug: Normal saline

Interventions

AbobotulinumtoxinA DRUG

Subjects were injected with 0.1 ml (12.5 units of Abobotulinumtoxina) into 31 distinct muscle locations in the head and neck

Also known as: Dysport

Abobotulinumtoxina

Normal saline DRUG

Subjects were injected with 0.1 ml of preservative free normal saline into 31 distinct muscle locations in the head and neck

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male or female
• age 18-65
• meets International Classification Headache Disorders II (ICHD-II) criteria for post-traumatic headache
• average pain score of greater than 4/10 in severity on the numerical rating system
• Rancho Los Amigos cognitive scale score greater than seven.

You may not qualify if:

• Uncontrolled medical condition other than PTH
• Severe additional chronic pain complaint which could not be distinguished from headache pain
• pregnancy, breast feeding,
• prior treatment with botulinum toxin within one year of enrollment
• current substance abuse/dependence
• medical condition that would increase risk of neuromuscular junction blockade with botulinum toxin (myasthenia gravis, Eaton Lambert, amyotrophic lateral sclerosis)
• poorly controlled psychiatric
• initiation of a new anti-depressant or anti-seizure medication within three months of enrolling in study
• ongoing disability or litigation claim.

Sponsors & Collaborators

• VA Greater Los Angeles Healthcare System: lead
• Ipsen: collaborator

Study Sites (1)

VA Greater Los Angeles Healthcare System

Los Angeles, California, 90073, United States

Location

MeSH Terms

Conditions

Post-Traumatic Headache

Interventions

abobotulinumtoxinA; Saline Solution

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Milena Zirovich, MD

  VA Greater Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The project statistician used a computer-based random number generator to create a randomized treatment allocation schedule that was provided to the pharmacist and nurse practitioner who did not disclose this information. The pharmacist provided the nurse practitioner with the medication in an unlabeled bag, which either included BoNT-A or Normal Saline. Patients were randomized to receive BoNT-A or Normal Saline as first injection. The nurse practitioner reconstituted the medication in a separate room and then provided the investigator with unlabeled syringes.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: April 26, 2019
• Study Start: August 1, 2013
• Primary Completion: February 2, 2017
• Study Completion: February 2, 2017
• Last Updated: April 26, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Starting at 3 months following publication and up to 3 years after publication
• Access Criteria: Data access requests will be reviewed and requestors will sign a data access agreement

Locations

US (1)