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

• ClinicalTrials.gov Identifier: NCT03698409
• Recruitment Status: Not yet recruiting
• First Posted: October 9, 2018
• Last Update Posted: October 9, 2018
• Sponsor: State University of New York - Upstate Medical University
• Information provided by (Responsible Party): Awss Zidan, MD, State University of New York - Upstate Medical University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Migraine, Headache	Other: Preserved saline in reconstitution of Botox	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Onabotulinumtoxin Type A Reconstitution With Preserved Versus Preservative-free Saline in Chronic Migraine. A Randomized, Double-blind Trial.
• Estimated Study Start Date: January 1, 2019
• Estimated Primary Completion Date: June 1, 2019
• Estimated Study Completion Date: July 1, 2019

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Botox in preservative-free saline; OnabotulinumtoxinA (Botox) 200u will be reconstituited 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 reconstituited 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).	Other: 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 Name: Bacteriostatic saline

Outcome Measures

Primary Outcome Measures :

1. Verbal Pain Scale [ Time Frame: Immediately after intervention ]
   Difference in verbal pain scale (0 to 10, 0 indicates no pain, and 10 indicates most severe pain)

Secondary Outcome Measures :

1. Headache-day frequency [ Time Frame: 1 week ]
   Difference in headache-days in the first week following the procedure

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Awss Zidan, MD, Clinical Instructor, State University of New York - Upstate Medical University
• ClinicalTrials.gov Identifier: NCT03698409
• Other Study ID Numbers: 1318956
• First Posted: October 9, 2018
• Last Update Posted: October 9, 2018
• Last Verified: October 2018

• 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

Keywords provided by Awss Zidan, MD, State University of New York - Upstate Medical University:

Migraine; Onabotulinumtoxin A; Botox; Reconstitution; Saline

Additional relevant MeSH terms:

Migraine Disorders; Headache; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations