A Study Using Botulinum Toxin Type A as Headache Prophylaxis in Adolescents With Chronic Migraine

191622-103 BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex as Headache Prophylaxis in Adolescents (Children 12 to < 18 Years of Age) With Chronic Migraine

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01662492

Enrollment

125

Registered

2012-08-10

Start date

2012-10-31

Completion date

2016-08-31

Last updated

2017-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine Disorders

Brief summary

To evaluate the efficacy and safety of Botulinum Toxin Type A versus placebo (normal saline) as headache prophylaxis in adolescents (children 12 to 17) with chronic migraine.

Interventions

BIOLOGICALBotulinum toxin type A Dose 1

Botulinum toxin type A Dose 1 intramuscular injections into specified muscles.

BIOLOGICALBotulinum toxin type A Dose 2

Botulinum toxin type A Dose 2 intramuscular injections into specified muscles.

DRUGPlacebo (Normal Saline)

Placebo (Normal Saline) intramuscular injections into specified muscles.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Years to 17 Years

Healthy volunteers

Inclusion criteria

* Medical history of chronic migraine for at least 6 months * 15 or more headache days during a 4 week period

Exclusion criteria

* Previous use of any botulinum toxin of any serotype for any reason * Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis * Treatment of headache using acupuncture, transcutaneous electrical stimulation (TENS), cranial traction, dental splints, or injection of anesthetics/steroids within 4 weeks prior to the week -4 screening visit * Use of any headache prophylaxis medication within 4 weeks prior to the week -4 screening visit

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in the Frequency of Headache Days	Baseline, 12 Weeks	Change from baseline in the frequency of headache days during the 28-day period, ending with Week 12 in the Intent-to-Treat population. A headache day for a patient is defined as a calendar day with 1 or more total hours of headache as recorded by the patient in the electronic diary.

Secondary

Measure	Time frame	Description
Percentage of Patients Who Are Prescribed Oral Rescue Migraine Prophylactic Treatment	12 Weeks	Percentage of patients who are prescribed oral rescue migraine prophylactic treatment during the 28-day period ending with Week 12 in the Intent-to-Treat population.
Change From Baseline in the Frequency of Severe Headache Days	Baseline, 12 Weeks	Change from baseline in the frequency of severe headache days during the 28-day period, ending with Week 12 in the Intent-to-Treat population. A severe headache day is defined as a calendar day with 1 or more total hours of headache and with maximum severity reported as 'severe' for the day as recorded by the patient in the electronic diary.
Change From Baseline in the Total Cumulative Hours of Headache on Headache Days	Baseline, 12 Weeks	Change From Baseline in the Total Cumulative Hours of Headache on Headache Days during the 28-day period ending with Week 12 in the Intent-to-Treat Population. Total cumulative hours is defined as the sum of total duration of headaches on headache days.
Percentage of Patients With ≥ 50% Decrease From Baseline in the Frequency of Headache Days	Baseline, 12 Weeks	Percentage of patients with ≥ 50% decrease from baseline in the frequency of headache days during the 28-day period ending with Week 12 in the Intent-to-Treat Population. A responder for headache days was defined as a patient with a 50% decrease in change from baseline in the frequency of headache days.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Botulinum Toxin Type A 155 U Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.	45
Botulinum Toxin Type A 74 U Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.	43
Placebo (Normal Saline) Placebo (Normal Saline) intramuscular injections into specified muscles.	37
Total	125

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Lack of Efficacy	1	1	2
Overall Study	Lost to Follow-up	0	0	2
Overall Study	Other miscellaneous reasons.	1	0	1
Overall Study	Protocol Violation	1	0	0
Overall Study	Withdrawal by Subject	0	0	1

Baseline characteristics

Characteristic	Botulinum Toxin Type A 155 U	Botulinum Toxin Type A 74 U	Placebo (Normal Saline)	Total
Age, Continuous	15.1 years STANDARD_DEVIATION 1.4	15.0 years STANDARD_DEVIATION 1.5	15.2 years STANDARD_DEVIATION 1.5	15.1 years STANDARD_DEVIATION 1.5
Sex/Gender, Customized Female	37 participants	32 participants	29 participants	98 participants
Sex/Gender, Customized Male	8 participants	11 participants	8 participants	27 participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	8 / 43	14 / 43	8 / 37
serious Total, serious adverse events	1 / 43	2 / 43	0 / 37

Outcome results

Primary

Change From Baseline in the Frequency of Headache Days

Change from baseline in the frequency of headache days during the 28-day period, ending with Week 12 in the Intent-to-Treat population. A headache day for a patient is defined as a calendar day with 1 or more total hours of headache as recorded by the patient in the electronic diary.

Time frame: Baseline, 12 Weeks