Trial Outcomes & Findings for A Study Using Botulinum Toxin Type A as Headache Prophylaxis in Adolescents With Chronic Migraine (NCT NCT01662492)
NCT ID: NCT01662492
Last Updated: 2017-09-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
125 participants
Primary outcome timeframe
Baseline, 12 Weeks
Results posted on
2017-09-05
Participant Flow
Participant milestones
| Measure |
Botulinum Toxin Type A 155 U
Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.
|
Botulinum Toxin Type A 74 U
Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.
|
Placebo (Normal Saline)
Placebo (Normal Saline) intramuscular injections into specified muscles.
|
|---|---|---|---|
|
Overall Study
STARTED
|
45
|
43
|
37
|
|
Overall Study
COMPLETED
|
42
|
42
|
31
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
6
|
Reasons for withdrawal
| Measure |
Botulinum Toxin Type A 155 U
Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.
|
Botulinum Toxin Type A 74 U
Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.
|
Placebo (Normal Saline)
Placebo (Normal Saline) intramuscular injections into specified muscles.
|
|---|---|---|---|
|
Overall Study
Other miscellaneous reasons.
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
2
|
Baseline Characteristics
A Study Using Botulinum Toxin Type A as Headache Prophylaxis in Adolescents With Chronic Migraine
Baseline characteristics by cohort
| Measure |
Botulinum Toxin Type A 155 U
n=45 Participants
Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.
|
Botulinum Toxin Type A 74 U
n=43 Participants
Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.
|
Placebo (Normal Saline)
n=37 Participants
Placebo (Normal Saline) intramuscular injections into specified muscles.
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
15.1 years
STANDARD_DEVIATION 1.4 • n=5 Participants
|
15.0 years
STANDARD_DEVIATION 1.5 • n=7 Participants
|
15.2 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
15.1 years
STANDARD_DEVIATION 1.5 • n=4 Participants
|
|
Sex/Gender, Customized
Male
|
8 participants
n=5 Participants
|
11 participants
n=7 Participants
|
8 participants
n=5 Participants
|
27 participants
n=4 Participants
|
|
Sex/Gender, Customized
Female
|
37 participants
n=5 Participants
|
32 participants
n=7 Participants
|
29 participants
n=5 Participants
|
98 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 WeeksPopulation: Intent-to-Treat (ITT) Population: All randomized subjects.
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.
Outcome measures
| Measure |
Placebo (Normal Saline)
n=37 Participants
Placebo (Normal Saline) intramuscular injections into specified muscles.
|
Botulinum Toxin Type A 155 U
n=45 Participants
Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.
|
Botulinum Toxin Type A 74 U
n=43 Participants
Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.
|
|---|---|---|---|
|
Change From Baseline in the Frequency of Headache Days
Baseline
|
25.3 Headache days
Standard Deviation 3.9
|
23.2 Headache days
Standard Deviation 4.4
|
23.4 Headache days
Standard Deviation 4.8
|
|
Change From Baseline in the Frequency of Headache Days
Change from Baseline at Week 12
|
-6.8 Headache days
Standard Deviation 8.2
|
-6.3 Headache days
Standard Deviation 7.0
|
-6.4 Headache days
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: Baseline, 12 WeeksPopulation: Intent-to-Treat (ITT) Population: All randomized subjects.
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.
Outcome measures
| Measure |
Placebo (Normal Saline)
n=37 Participants
Placebo (Normal Saline) intramuscular injections into specified muscles.
|
Botulinum Toxin Type A 155 U
n=45 Participants
Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.
|
Botulinum Toxin Type A 74 U
n=43 Participants
Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.
|
|---|---|---|---|
|
Change From Baseline in the Frequency of Severe Headache Days
Baseline
|
9.1 Severe Headache Days
Standard Deviation 8.3
|
7.0 Severe Headache Days
Standard Deviation 5.0
|
7.8 Severe Headache Days
Standard Deviation 6.2
|
|
Change From Baseline in the Frequency of Severe Headache Days
Change from Baseline at Week 12
|
-0.9 Severe Headache Days
Standard Deviation 7.4
|
-1.3 Severe Headache Days
Standard Deviation 4.7
|
-2.3 Severe Headache Days
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: Baseline, 12 WeeksPopulation: Intent-to-Treat (ITT) Population: All randomized subjects.
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.
Outcome measures
| Measure |
Placebo (Normal Saline)
n=37 Participants
Placebo (Normal Saline) intramuscular injections into specified muscles.
|
Botulinum Toxin Type A 155 U
n=45 Participants
Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.
|
Botulinum Toxin Type A 74 U
n=43 Participants
Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.
|
|---|---|---|---|
|
Change From Baseline in the Total Cumulative Hours of Headache on Headache Days
Baseline
|
212.68 Cumulative hours of headache
Standard Deviation 184.37
|
170.69 Cumulative hours of headache
Standard Deviation 151.60
|
175.98 Cumulative hours of headache
Standard Deviation 139.76
|
|
Change From Baseline in the Total Cumulative Hours of Headache on Headache Days
Change from Baseline at Week 12
|
-50.04 Cumulative hours of headache
Standard Deviation 87.36
|
-36.52 Cumulative hours of headache
Standard Deviation 53.19
|
-19.03 Cumulative hours of headache
Standard Deviation 113.73
|
SECONDARY outcome
Timeframe: Baseline, 12 WeeksPopulation: Intent-to-Treat (ITT) Population: All randomized subjects.
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.
Outcome measures
| Measure |
Placebo (Normal Saline)
n=37 Participants
Placebo (Normal Saline) intramuscular injections into specified muscles.
|
Botulinum Toxin Type A 155 U
n=45 Participants
Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.
|
Botulinum Toxin Type A 74 U
n=43 Participants
Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.
|
|---|---|---|---|
|
Percentage of Patients With ≥ 50% Decrease From Baseline in the Frequency of Headache Days
|
29.7 Percentage of participants
|
28.9 Percentage of participants
|
32.6 Percentage of participants
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Intent-to-Treat (ITT) Population: All randomized subjects.
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.
Outcome measures
| Measure |
Placebo (Normal Saline)
n=37 Participants
Placebo (Normal Saline) intramuscular injections into specified muscles.
|
Botulinum Toxin Type A 155 U
n=45 Participants
Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.
|
Botulinum Toxin Type A 74 U
n=43 Participants
Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.
|
|---|---|---|---|
|
Percentage of Patients Who Are Prescribed Oral Rescue Migraine Prophylactic Treatment
Week 4
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Patients Who Are Prescribed Oral Rescue Migraine Prophylactic Treatment
Week 8
|
2.7 Percentage of participants
|
4.4 Percentage of participants
|
9.3 Percentage of participants
|
|
Percentage of Patients Who Are Prescribed Oral Rescue Migraine Prophylactic Treatment
Week 12
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
Adverse Events
Botulinum Toxin Type A 155 U
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Botulinum Toxin Type A 74 U
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo (Normal Saline)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Botulinum Toxin Type A 155 U
n=43 participants at risk
Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.
|
Botulinum Toxin Type A 74 U
n=43 participants at risk
Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.
|
Placebo (Normal Saline)
n=37 participants at risk
Placebo (Normal Saline) intramuscular injections into specified muscles.
|
|---|---|---|---|
|
Infections and infestations
Cellulitis
|
2.3%
1/43 • Up to Week 12
|
0.00%
0/43 • Up to Week 12
|
0.00%
0/37 • Up to Week 12
|
|
Infections and infestations
Appendicitis
|
0.00%
0/43 • Up to Week 12
|
2.3%
1/43 • Up to Week 12
|
0.00%
0/37 • Up to Week 12
|
|
Nervous system disorders
Migraine
|
0.00%
0/43 • Up to Week 12
|
2.3%
1/43 • Up to Week 12
|
0.00%
0/37 • Up to Week 12
|
Other adverse events
| Measure |
Botulinum Toxin Type A 155 U
n=43 participants at risk
Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.
|
Botulinum Toxin Type A 74 U
n=43 participants at risk
Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.
|
Placebo (Normal Saline)
n=37 participants at risk
Placebo (Normal Saline) intramuscular injections into specified muscles.
|
|---|---|---|---|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/43 • Up to Week 12
|
7.0%
3/43 • Up to Week 12
|
10.8%
4/37 • Up to Week 12
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
7.0%
3/43 • Up to Week 12
|
11.6%
5/43 • Up to Week 12
|
0.00%
0/37 • Up to Week 12
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
2.3%
1/43 • Up to Week 12
|
7.0%
3/43 • Up to Week 12
|
0.00%
0/37 • Up to Week 12
|
|
Nervous system disorders
Dizziness
|
7.0%
3/43 • Up to Week 12
|
0.00%
0/43 • Up to Week 12
|
2.7%
1/37 • Up to Week 12
|
|
Nervous system disorders
Migraine
|
2.3%
1/43 • Up to Week 12
|
7.0%
3/43 • Up to Week 12
|
2.7%
1/37 • Up to Week 12
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/43 • Up to Week 12
|
0.00%
0/43 • Up to Week 12
|
5.4%
2/37 • Up to Week 12
|
|
Infections and infestations
Bronchitis
|
2.3%
1/43 • Up to Week 12
|
0.00%
0/43 • Up to Week 12
|
5.4%
2/37 • Up to Week 12
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER