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

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ClinicalTrials.gov Identifier: NCT01662492
Recruitment Status : Completed
First Posted : August 10, 2012
Results First Posted : September 5, 2017
Last Update Posted : September 5, 2017
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Migraine Disorders
Interventions Biological: Botulinum toxin type A Dose 1
Biological: Botulinum toxin type A Dose 2
Drug: Placebo (Normal Saline)
Enrollment 125
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Botulinum Toxin Type A 155 U Botulinum Toxin Type A 74 U Placebo (Normal Saline)
Hide Arm/Group Description Botulinum toxin type A, 155 U, intramuscular injections into specified muscles. Botulinum toxin type A, 74 U, intramuscular injections into specified muscles. Placebo (Normal Saline) intramuscular injections into specified muscles.
Period Title: Overall Study
Started 45 43 37
Completed 42 42 31
Not Completed 3 1 6
Reason Not Completed
Other miscellaneous reasons.             1             0             1
Withdrawal by Subject             0             0             1
Protocol Violation             1             0             0
Lost to Follow-up             0             0             2
Lack of Efficacy             1             1             2
Arm/Group Title Botulinum Toxin Type A 155 U Botulinum Toxin Type A 74 U Placebo (Normal Saline) Total
Hide Arm/Group Description Botulinum toxin type A, 155 U, intramuscular injections into specified muscles. Botulinum toxin type A, 74 U, intramuscular injections into specified muscles. Placebo (Normal Saline) intramuscular injections into specified muscles. Total of all reporting groups
Overall Number of Baseline Participants 45 43 37 125
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 43 participants 37 participants 125 participants
15.1  (1.4) 15.0  (1.5) 15.2  (1.5) 15.1  (1.5)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 45 participants 43 participants 37 participants 125 participants
Male 8 11 8 27
Female 37 32 29 98
1.Primary Outcome
Title Change From Baseline in the Frequency of Headache Days
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: All randomized subjects.
Arm/Group Title Botulinum Toxin Type A 155 U Botulinum Toxin Type A 74 U Placebo (Normal Saline)
Hide Arm/Group Description:
Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.
Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.
Placebo (Normal Saline) intramuscular injections into specified muscles.
Overall Number of Participants Analyzed 45 43 37
Mean (Standard Deviation)
Unit of Measure: Headache days
Baseline 23.2  (4.4) 23.4  (4.8) 25.3  (3.9)
Change from Baseline at Week 12 -6.3  (7.0) -6.4  (7.8) -6.8  (8.2)
2.Secondary Outcome
Title Change From Baseline in the Frequency of Severe Headache Days
Hide Description 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.
Time Frame Baseline, 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: All randomized subjects.
Arm/Group Title Botulinum Toxin Type A 155 U Botulinum Toxin Type A 74 U Placebo (Normal Saline)
Hide Arm/Group Description:
Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.
Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.
Placebo (Normal Saline) intramuscular injections into specified muscles.
Overall Number of Participants Analyzed 45 43 37
Mean (Standard Deviation)
Unit of Measure: Severe Headache Days
Baseline 7.0  (5.0) 7.8  (6.2) 9.1  (8.3)
Change from Baseline at Week 12 -1.3  (4.7) -2.3  (6.3) -0.9  (7.4)
3.Secondary Outcome
Title Change From Baseline in the Total Cumulative Hours of Headache on Headache Days
Hide Description 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.
Time Frame Baseline, 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: All randomized subjects.
Arm/Group Title Botulinum Toxin Type A 155 U Botulinum Toxin Type A 74 U Placebo (Normal Saline)
Hide Arm/Group Description:
Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.
Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.
Placebo (Normal Saline) intramuscular injections into specified muscles.
Overall Number of Participants Analyzed 45 43 37
Mean (Standard Deviation)
Unit of Measure: Cumulative hours of headache
Baseline 170.69  (151.60) 175.98  (139.76) 212.68  (184.37)
Change from Baseline at Week 12 -36.52  (53.19) -19.03  (113.73) -50.04  (87.36)
4.Secondary Outcome
Title Percentage of Patients With ≥ 50% Decrease From Baseline in the Frequency of Headache Days
Hide Description 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.
Time Frame Baseline, 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: All randomized subjects.
Arm/Group Title Botulinum Toxin Type A 155 U Botulinum Toxin Type A 74 U Placebo (Normal Saline)
Hide Arm/Group Description:
Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.
Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.
Placebo (Normal Saline) intramuscular injections into specified muscles.
Overall Number of Participants Analyzed 45 43 37
Measure Type: Number
Unit of Measure: Percentage of participants
28.9 32.6 29.7
5.Secondary Outcome
Title Percentage of Patients Who Are Prescribed Oral Rescue Migraine Prophylactic Treatment
Hide Description 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.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: All randomized subjects.
Arm/Group Title Botulinum Toxin Type A 155 U Botulinum Toxin Type A 74 U Placebo (Normal Saline)
Hide Arm/Group Description:
Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.
Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.
Placebo (Normal Saline) intramuscular injections into specified muscles.
Overall Number of Participants Analyzed 45 43 37
Measure Type: Number
Unit of Measure: Percentage of participants
Week 4 0 0 0
Week 8 4.4 9.3 2.7
Week 12 0 0 0
Time Frame Up to Week 12
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Botulinum Toxin Type A 155 U Botulinum Toxin Type A 74 U Placebo (Normal Saline)
Hide Arm/Group Description Botulinum toxin type A, 155 U, intramuscular injections into specified muscles. Botulinum toxin type A, 74 U, intramuscular injections into specified muscles. Placebo (Normal Saline) intramuscular injections into specified muscles.
All-Cause Mortality
Botulinum Toxin Type A 155 U Botulinum Toxin Type A 74 U Placebo (Normal Saline)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Botulinum Toxin Type A 155 U Botulinum Toxin Type A 74 U Placebo (Normal Saline)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/43 (2.33%)   2/43 (4.65%)   0/37 (0.00%) 
Infections and infestations       
Cellulitis † 1  1/43 (2.33%)  0/43 (0.00%)  0/37 (0.00%) 
Appendicitis † 1  0/43 (0.00%)  1/43 (2.33%)  0/37 (0.00%) 
Nervous system disorders       
Migraine † 1  0/43 (0.00%)  1/43 (2.33%)  0/37 (0.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA, version 19.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Botulinum Toxin Type A 155 U Botulinum Toxin Type A 74 U Placebo (Normal Saline)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/43 (18.60%)   14/43 (32.56%)   8/37 (21.62%) 
Infections and infestations       
Upper Respiratory Tract Infection † 1  0/43 (0.00%)  3/43 (6.98%)  4/37 (10.81%) 
Bronchitis † 1  1/43 (2.33%)  0/43 (0.00%)  2/37 (5.41%) 
Musculoskeletal and connective tissue disorders       
Neck Pain † 1  3/43 (6.98%)  5/43 (11.63%)  0/37 (0.00%) 
Musculoskeletal Pain † 1  1/43 (2.33%)  3/43 (6.98%)  0/37 (0.00%) 
Nervous system disorders       
Dizziness † 1  3/43 (6.98%)  0/43 (0.00%)  1/37 (2.70%) 
Migraine † 1  1/43 (2.33%)  3/43 (6.98%)  1/37 (2.70%) 
Respiratory, thoracic and mediastinal disorders       
Oropharyngeal Pain † 1  0/43 (0.00%)  0/43 (0.00%)  2/37 (5.41%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA, version 19.0
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head
Organization: Allergan, Inc
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01662492    
Other Study ID Numbers: 191622-103
First Submitted: August 8, 2012
First Posted: August 10, 2012
Results First Submitted: August 3, 2017
Results First Posted: September 5, 2017
Last Update Posted: September 5, 2017