Trial Outcomes & Findings for "Follow the Sutures". A New Procedure for Injection of Botulinum Toxin for Chronic Migraine (NCT NCT03543254)

NCT ID: NCT03543254

Last Updated: 2024-01-30

Results Overview

adverse events (other than clearly related to migraine) will be recorded in the diary by the patients and reviewed during the scheduled visits

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2024-01-30

Participant Flow

Participant milestones

Measure	BoNT-A Injected BoNT-A (Botulinum toxin A) injected in the head on specific sites and in half the usual concentration BoNT-A: 90U BoNT-A, given in one treatment as 18 injections of 5u (0.2 ml) each, on specific preselected sites along the sutures of the skull. First 100 U of Botox® is solved in 4 ml (cc) of isotone saline water (9 mg/ml), distributed in 4 syringes. This is half the usual concentration, allowing for better diffusion in order to reach the target structures.
Overall Study STARTED	20
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure

BoNT-A Injected BoNT-A (Botulinum toxin A) injected in the head on specific sites and in half the usual concentration BoNT-A: 90U BoNT-A, given in one treatment as 18 injections of 5u (0.2 ml) each, on specific preselected sites along the sutures of the skull. First 100 U of Botox® is solved in 4 ml (cc) of isotone saline water (9 mg/ml), distributed in 4 syringes. This is half the usual concentration, allowing for better diffusion in order to reach the target structures.

Overall Study Lost to Follow-up

1

Baseline Characteristics

"Follow the Sutures". A New Procedure for Injection of Botulinum Toxin for Chronic Migraine

Baseline characteristics by cohort

Measure	BoNT-A Injected n=20 Participants BoNT-A (Botulinum toxin A) injected in the head on specific sites and in half the usual concentration BoNT-A: 90U BoNT-A, given in one treatment as 18 injections of 5u (0.2 ml) each, on specific preselected sites along the sutures of the skull. First 100 U of Botox® is solved in 4 ml (cc) of isotone saline water (9 mg/ml), distributed in 4 syringes. This is half the usual concentration, allowing for better diffusion in order to reach the target structures.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	40 Years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: All included got injection of botulinum toxin. One out of 19 (5.3%) had reduced power of chewing

adverse events (other than clearly related to migraine) will be recorded in the diary by the patients and reviewed during the scheduled visits

Outcome measures

Measure

BoNT-A Injected n=19 Participants BoNT-A (Botulinum toxin A) injected in the head on specific sites and in half the usual concentration BoNT-A: 90U BoNT-A, given in one treatment as 18 injections of 5u (0.2 ml) each, on specific preselected sites along the sutures of the skull. First 100 U of Botox® is solved in 4 ml (cc) of isotone saline water (9 mg/ml), distributed in 4 syringes. This is half the usual concentration, allowing for better diffusion in order to reach the target structures.

Number of Adverse Events

1 Participants

SECONDARY outcome

Timeframe: Week 1

Population: Time used for injection of Medicine measured by stopwatch (not measured in 3 patients)

Time used for injection of Medicine measured by stopwatch

Outcome measures

Measure

BoNT-A Injected n=16 Participants BoNT-A (Botulinum toxin A) injected in the head on specific sites and in half the usual concentration BoNT-A: 90U BoNT-A, given in one treatment as 18 injections of 5u (0.2 ml) each, on specific preselected sites along the sutures of the skull. First 100 U of Botox® is solved in 4 ml (cc) of isotone saline water (9 mg/ml), distributed in 4 syringes. This is half the usual concentration, allowing for better diffusion in order to reach the target structures.

Injection Time

5.47 Minutes Standard Deviation 1.02

Adverse Events

BoNT-A Injected

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure

BoNT-A Injected n=19 participants at risk BoNT-A (Botulinum toxin A) injected in the head on specific sites and in half the usual concentration BoNT-A: 90U BoNT-A, given in one treatment as 18 injections of 5u (0.2 ml) each, on specific preselected sites along the sutures of the skull. First 100 U of Botox® is solved in 4 ml (cc) of isotone saline water (9 mg/ml), distributed in 4 syringes. This is half the usual concentration, allowing for better diffusion in order to reach the target structures.

Musculoskeletal and connective tissue disorders Power of chewing

5.3% 1/19 • Number of events 1 • 12 weeks Adverse events (serious and not serious)

Additional Information

Knut Hagen

St. Olavs Hospital HF

Phone: +4795401579

Email: knut.hagen@ntnu.no

Results disclosure agreements

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