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Completed

NCT Number: NCT03698409

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

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.

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Key information

Conditions

Chronic Migraine, Headache Brain Diseases Central Nervous System Diseases Headache Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Preserved saline in reconstitution of Botox

Drug

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

Primary outcomes

  1. Verbal Pain Scale

    Time frame: 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 outcomes

  1. Headache-day Frequency

    Time frame: 1 week

    Difference in headache-days in the first week following the procedure

Sponsors and collaborators

Lead sponsor

State University of New York - Upstate Medical University

Other

Registry information

Official study title

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

Acronym: B-RECON

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 9, 2018
Registry last updated
Jun 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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