Onabotulinumtoxin Type A Reconstitution With Preserved Versus Preservative-free Saline in Chronic Migraine. (B-RECON)
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|ClinicalTrials.gov Identifier: NCT03698409|
Recruitment Status : Not yet recruiting
First Posted : October 8, 2018
Last Update Posted : October 8, 2018
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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
- 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)
- Headache-day frequency [ Time Frame: 1 week ]Difference in headache-days in the first week following the procedure