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

Primary Purpose

Migraine Disorders

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Botulinum toxin type A Dose 1
Botulinum toxin type A Dose 2
Placebo (Normal Saline)
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Disorders

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Phoenix Children's Hospital
  • Fullerton Neurology and Headache Center
  • The Research Center of Southern California
  • San Francisco Clinical Research Center
  • Stanford Hospital and Clinics
  • Associated Neurologists of Southern CT, P.C.
  • New England Institute for Clinical Research
  • NW FL Clinical Research Group, LLC
  • Pediatric Neurology, PA
  • The Premiere Research Institute at Palm Beach Neurology
  • Advanced Clinical Research
  • Josephson Wallack Munshower Neurology, P.C.
  • CPFCC Neurology Research Department
  • Michigan Head Pain & Neurological Institute
  • CORE (Center for Outpatient Research)
  • Renown Institution for Neurosciences
  • Rochester Clinical Research, Inc
  • Lynn Health Science Institute
  • Jill Waldo, CCRC
  • Nashville Neuroscience Group
  • Texas Association of Pediatric Neurology/Road Runner Research
  • Wasatch Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Botulinum toxin type A Dose 1

Botulinum toxin type A Dose 2

Placebo (Normal Saline)

Arm Description

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

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

Placebo (Normal Saline) intramuscular injections into specified muscles.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change From Baseline in the Frequency of Severe Headache Days
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
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
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.
Percentage of Patients Who Are Prescribed Oral Rescue Migraine Prophylactic Treatment
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.

Full Information

First Posted
August 8, 2012
Last Updated
August 3, 2017
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT01662492
Brief Title
A Study Using Botulinum Toxin Type A as Headache Prophylaxis in Adolescents With Chronic Migraine
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Botulinum toxin type A Dose 1
Arm Type
Experimental
Arm Description
Botulinum toxin type A Dose 1 intramuscular injections into specified muscles.
Arm Title
Botulinum toxin type A Dose 2
Arm Type
Experimental
Arm Description
Botulinum toxin type A Dose 2 intramuscular injections into specified muscles.
Arm Title
Placebo (Normal Saline)
Arm Type
Placebo Comparator
Arm Description
Placebo (Normal Saline) intramuscular injections into specified muscles.
Intervention Type
Biological
Intervention Name(s)
Botulinum toxin type A Dose 1
Other Intervention Name(s)
onabotulinumtoxinA, BOTOX®
Intervention Description
Botulinum toxin type A Dose 1 intramuscular injections into specified muscles.
Intervention Type
Biological
Intervention Name(s)
Botulinum toxin type A Dose 2
Other Intervention Name(s)
onabotulinumtoxinA, BOTOX®
Intervention Description
Botulinum toxin type A Dose 2 intramuscular injections into specified muscles.
Intervention Type
Drug
Intervention Name(s)
Placebo (Normal Saline)
Intervention Description
Placebo (Normal Saline) intramuscular injections into specified muscles.
Primary Outcome Measure Information:
Title
Change From Baseline in the Frequency of Headache Days
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
Secondary Outcome Measure Information:
Title
Change From Baseline in the Frequency of Severe Headache Days
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
Title
Change From Baseline in the Total Cumulative Hours of Headache on Headache Days
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
Title
Percentage of Patients With ≥ 50% Decrease From Baseline in the Frequency of Headache Days
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
Title
Percentage of Patients Who Are Prescribed Oral Rescue Migraine Prophylactic Treatment
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Fullerton Neurology and Headache Center
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
The Research Center of Southern California
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
San Francisco Clinical Research Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Stanford Hospital and Clinics
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Associated Neurologists of Southern CT, P.C.
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06824
Country
United States
Facility Name
New England Institute for Clinical Research
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
NW FL Clinical Research Group, LLC
City
Gulf Breeze
State/Province
Florida
ZIP/Postal Code
32561
Country
United States
Facility Name
Pediatric Neurology, PA
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Facility Name
The Premiere Research Institute at Palm Beach Neurology
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Advanced Clinical Research
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Josephson Wallack Munshower Neurology, P.C.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
CPFCC Neurology Research Department
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
Michigan Head Pain & Neurological Institute
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
CORE (Center for Outpatient Research)
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Renown Institution for Neurosciences
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Rochester Clinical Research, Inc
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Jill Waldo, CCRC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Facility Name
Nashville Neuroscience Group
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Association of Pediatric Neurology/Road Runner Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Wasatch Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29877131
Citation
Shah S, Calderon MD, Wu W, Grant J, Rinehart J. Onabotulinumtoxin A (BOTOX(R)) for ProphylaCTIC Treatment of Pediatric Migraine: A Retrospective Longitudinal Analysis. J Child Neurol. 2018 Aug;33(9):580-586. doi: 10.1177/0883073818776142. Epub 2018 Jun 7.
Results Reference
derived
Links:
URL
http://www.allerganclinicaltrials.com
Description
More Information

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

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