Onabotulinumtoxin Type A Reconstitution With Preserved Versus Preservative-free Saline in Chronic Migraine. (B-RECON)

Onabotulinumtoxin Type A Reconstitution With Preserved Versus Preservative-free Saline in Chronic Migraine. A Randomized, Double-blind Trial.

A growing body of literature on the cosmetic use of OnabotulinumtoxinA has suggested that the use of preserved saline exerts a local anesthetic effect, and reduces the procedure discomfort when used in reconstitution in lieu of preservative-free saline. However, this has never been studied in chronic migraine.

While reducing discomfort is a desirable target in all procedures, it has a special importance in the use of OnabotulinumtoxinA for chronic migraine due to the numerous injection locations each session (31 sites) and the ubiquity of scalp tenderness in this population. In addition, the pain during procedure is a known migraine trigger for many of these patients.

We hypothesize that preserved saline (known as bacteriostatic saline) produces lower procedure-related discomfort when used as a dissolving solution for OnabotulinumtoxinA in individuals with chronic migraine as opposed to using preservative-free saline.

In addition, we hypothesize that reduction of procedure-relate pain during the injections will also result in reduced migraine/headache attacks in the week immediately following the procedure.

Study Overview

• Status: Completed
• Conditions: Chronic Migraine, Headache
• Intervention / Treatment: Drug: Preserved saline in reconstitution of Botox

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with diagnosis of chronic migraine receiving FDA-approved treatment with OnabotulinumtoxinA injection as per standard protocol. Standard protocol consists of 31 injection sites, with total dose ranging from 155 u to 195u.

Exclusion Criteria:

• Subjects whom OnabotulinumtoxinA injections deviate from standard protocol for any reason, such as head/neck infection, head deformity, recent surgery…etc.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Botox in preservative-free saline; OnabotulinumtoxinA (Botox) 200u will be reconstituted using 4 ml of preservative-free saline, as recommended by the manufacturer. 155-195 u of Onabotulinumtoxin A (Botox) will be injected in subjects with chronic migraine, consistent with FDA-approval indications, following the standard injection protocol (31 sites)
Active Comparator: Botox in preserved saline; OnabotulinumtoxinA (Botox) 200u will be reconstituted using 4 ml of preservative saline (i.e. bacteriostatic saline). 155-195 u of Onabotulinumtoxin A (Botox) will be injected in subjects with chronic migraine, consistent with FDA-approval indications, following the standard injection protocol (31 sites).	Drug: Preserved saline in reconstitution of Botox; The intervention consists of using 4 ml of preserved saline for the reconstitution of OnabotuliniumtoxinA prior to its use in subjects with chronic migraine.; Other Names: Bacteriostatic saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Verbal Pain Scale	Difference in verbal pain scale (0 to 10, 0 indicates no pain, and 10 indicates most severe pain)	Immediately after intervention, an average of 2 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache-day Frequency	Difference in headache-days in the first week following the procedure	1 week

Collaborators and Investigators

• Sponsor: State University of New York - Upstate Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: October 4, 2018
• First Submitted That Met QC Criteria: October 4, 2018
• First Posted (Actual): October 9, 2018

Study Record Updates

• Last Update Posted (Actual): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 8, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Migraine; Saline; Botox; Onabotulinumtoxin A; Reconstitution
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache
• Other Study ID Numbers: 1318956

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No