Onabotulinumtoxin Type A Reconstitution With Preserved Versus Preservative-free Saline in Chronic Migraine.

Phase 4

Completed

• Conditions: Chronic Migraine, Headache
• Interventions: Drug: Preserved saline in reconstitution of Botox

• Registration Number: NCT03698409
• Lead Sponsor: State University of New York - Upstate Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-04
• Study First Submitted QC: 2018-10-04
• Study First Posted: 2018-10-09
• Study Start: 2019-01-01
• Primary Completion: 2019-08-01
• Study Completion: 2019-08-01
• Results First Submitted: 2021-09-16
• Status Verified: 2022-05
• Results First Submitted QC: 2022-05-08
• Last Update Submitted: 2022-05-08
• Results First Posted: 2022-06-01
• Last Update Posted: 2022-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Botox in preserved saline	Preserved saline in reconstitution of Botox	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).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Headache-day Frequency	1 week	Difference in headache-days in the first week following the procedure

Trial Locations

Locations (1)

SUNY Upstate Medical University; 🇺🇸 Syracuse, New York, United States