NCT03698409

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: State University of New York - Upstate Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Migraine, Headache

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-01-01
• Primary completion: 2019-08-01
• Completion: 2019-08-01
• First posted: 2018-10-09
• Last updated: 2022-06-01
• Results posted: 2022-06-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study