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

Migraine Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01662492
• Other study ID #: 191622-103
• Status: Completed
• Phase: Phase 3
• First received: August 8, 2012
• Last updated: October 5, 2016
• Start date: October 2012
• Est. completion date: August 2016

Study information

• Verified date: October 2016
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headache
• Migraine Disorders

Intervention

Biological:
• Botulinum toxin type A Dose 1
Botulinum toxin type A Dose 1 intramuscular injections into specified muscles.
• Botulinum toxin type A Dose 2
Botulinum toxin type A Dose 2 intramuscular injections into specified muscles.

Drug:
• Placebo (Normal Saline)
Placebo (Normal Saline) intramuscular injections into specified muscles.

Locations

Country	Name	City	State
United States	Michigan Head Pain & Neurological Institute	Ann Arbor	Michigan
United States	Associated Neurologists of Southern CT, P.C.	Fairfield	Connecticut
United States	Fullerton Neurology and Headache Center	Fullerton	California
United States	NW FL Clinical Research Group, LLC	Gulf Breeze	Florida
United States	Josephson Wallack Munshower Neurology, P.C.	Indianapolis	Indiana
United States	Advanced Clinical Research	Meridian	Idaho
United States	Nashville Neuroscience Group	Nashville	Tennessee
United States	The Research Center of Southern California	Oceanside	California
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Pediatric Neurology, PA	Orlando	Florida
United States	CPFCC Neurology Research Department	Overland Park	Kansas
United States	Phoenix Children's Hospital	Phoenix	Arizona
United States	Jill Waldo, CCRC	Pittsburgh	Pennsylvania
United States	Renown Institution for Neurosciences	Reno	Nevada
United States	Rochester Clinical Research, Inc	Rochester	New York
United States	Wasatch Clinical Research	Salt Lake City	Utah
United States	Texas Association of Pediatric Neurology/Road Runner Research	San Antonio	Texas
United States	San Francisco Clinical Research Center	San Francisco	California
United States	CORE (Center for Outpatient Research)	Springfield	Missouri
United States	New England Institute for Clinical Research	Stamford	Connecticut
United States	Stanford Hospital and Clinics	Stanford	California
United States	The Premiere Research Institute at Palm Beach Neurology	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the frequency of headache days		Baseline, 12 Weeks	No
Secondary	Change from baseline in the frequency of severe headache days		Baseline, 12 Weeks	No
Secondary	Change from baseline in the total cumulative hours of headache on headache days		Baseline, 12 Weeks	No
Secondary	Percentage of patients with = 50% decrease from baseline in the frequency of headache days		Baseline, 12 Weeks	No
Secondary	Percentage of patients who are prescribed oral rescue migraine prophylactic treatment		12 Weeks	No

External Links

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