Trial Outcomes & Findings for Onabotulinumtoxin Type A Reconstitution With Preserved Versus Preservative-free Saline in Chronic Migraine. (NCT NCT03698409)

NCT ID: NCT03698409

Last Updated: 2022-06-01

Results Overview

Difference in verbal pain scale (0 to 10, 0 indicates no pain, and 10 indicates most severe pain)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 68 participants
• Primary outcome timeframe: Immediately after intervention, an average of 2 minutes
• Results posted on: 2022-06-01

Participant Flow

Subjects were recruited from the headache clinic of SUNY Upstate Medical University which is a tertiary care center in central New York. Two of the authors performed the randomization through a simulated "coin flipper" website (www.random.org). Following the randomization, same authors prepared the syringes. Two different authors performed the injections.

Participant milestones

Measure	Botox in Preservative-free Saline OnabotulinumtoxinA (Botox) 200u will be reconstituted 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)	Botox in Preserved Saline 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). 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.
Overall Study STARTED	39	29
Overall Study COMPLETED	39	29
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Botox in Preservative-free Saline n=39 Participants OnabotulinumtoxinA (Botox) 200u will be reconstituted 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)	Botox in Preserved Saline n=29 Participants 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). 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.	Total n=68 Participants Total of all reporting groups
Age, Continuous	42.5 years STANDARD_DEVIATION 13.5 • n=5 Participants	43 years STANDARD_DEVIATION 14.3 • n=7 Participants	43 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	27 Participants n=7 Participants	57 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	2 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	39 Participants n=5 Participants	29 Participants n=7 Participants	68 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Botox in Preservative-free Saline n=39 Participants OnabotulinumtoxinA (Botox) 200u will be reconstituted 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)	Botox in Preserved Saline n=29 Participants 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). 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.
Verbal Pain Scale	5.3 score on a scale Interval 4.8 to 6.1	3.3 score on a scale Interval 2.5 to 4.1

SECONDARY outcome

Timeframe: 1 week

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

Outcome measures

Measure	Botox in Preservative-free Saline n=39 Participants OnabotulinumtoxinA (Botox) 200u will be reconstituted 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)	Botox in Preserved Saline n=29 Participants 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). 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.
Headache-day Frequency	4.6 days Standard Deviation 2.3	4.1 days Standard Deviation 1.7

Adverse Events

Botox in Preservative-free Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Botox in Preserved Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Assistant Profressor

SUNY Upstate medical University

Phone: 3154644243

Email: zidan@upstate.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place