Migraine DisordersPhase 3NCT01662492

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

A Phase 3 study testing Botulinum toxin type A Dose 1 and Botulinum toxin type A Dose 2 in people with Migraine Disorders, run by Allergan at 22 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 12 to 17 years
Conditions the study is for: Migraine Disorders
What is being tested?: Botulinum toxin type A Dose 1 and Botulinum toxin type A Dose 2
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 125 participants
Where: 22 sitesUnited States
Study dates: Oct 2012to Aug 2016
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

22 sites in 1 country.

City, postcode or hospital

22 sites in 1 country

United States22 sites

Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, 48104
Associated Neurologists of Southern CT, P.C.
Fairfield, Connecticut, 06824
Fullerton Neurology and Headache Center
Fullerton, California, 92835
NW FL Clinical Research Group, LLC
Gulf Breeze, Florida, 32561
Josephson Wallack Munshower Neurology, P.C.
Indianapolis, Indiana, 46237
Advanced Clinical Research
Meridian, Idaho, 83642
Nashville Neuroscience Group
Nashville, Tennessee, 37203
The Research Center of Southern California
Oceanside, California, 92056
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
Pediatric Neurology, PA
Orlando, Florida, 32819
CPFCC Neurology Research Department
Overland Park, Kansas, 66212
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Jill Waldo, CCRC
Pittsburgh, Pennsylvania, 15236
Renown Institution for Neurosciences
Reno, Nevada, 89502
Rochester Clinical Research, Inc
Rochester, New York, 14609
Wasatch Clinical Research
Salt Lake City, Utah, 84107
Texas Association of Pediatric Neurology/Road Runner Research
San Antonio, Texas, 78258
San Francisco Clinical Research Center
San Francisco, California, 94109
CORE (Center for Outpatient Research)
Springfield, Missouri, 65804
New England Institute for Clinical Research
Stamford, Connecticut, 06905
Stanford Hospital and Clinics
Stanford, California, 94305
The Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, 33407

Other trials in United States

About this study

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

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.

Conditions: Migraine Disorders
Being tested: Botulinum toxin type A Dose 1, Botulinum toxin type A Dose 2, Placebo (Normal Saline)
Medical subject headings: Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Botulinum toxin type A Dose 1Biological
Also called onabotulinumtoxinA, BOTOX®
Botulinum toxin type A Dose 1 intramuscular injections into specified muscles.
Botulinum toxin type A Dose 2Biological
Also called onabotulinumtoxinA, BOTOX®
Botulinum toxin type A Dose 2 intramuscular injections into specified muscles.
Placebo (Normal Saline)Drug
Placebo (Normal Saline) intramuscular injections into specified muscles.

Study groups in NCT01662492
Study group	Role	What they receive
Botulinum toxin type A Dose 1	Experimental	Botulinum toxin type A Dose 1 intramuscular injections into specified muscles. Receives: Biological: Botulinum toxin type A Dose 1
Botulinum toxin type A Dose 2	Experimental	Botulinum toxin type A Dose 2 intramuscular injections into specified muscles. Receives: Biological: Botulinum toxin type A Dose 2
Placebo (Normal Saline)	Placebo comparator	Placebo (Normal Saline) intramuscular injections into specified muscles. Receives: Drug: Placebo (Normal Saline)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, 12 Weeks

Secondary outcomes (4)

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.
Measured: Baseline, 12 Weeks
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.
Measured: Baseline, 12 Weeks
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.
Measured: Baseline, 12 Weeks
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.
Measured: 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2012Aug 2016

First posted10 Aug 2012 (estimated)
Study startOct 2012
Primary completionAug 2016
Study completionAug 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Migraine DisordersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 125 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01662492
Sponsor's protocol ID: 191622-103
Status last verified: Jul 2017
First submitted: 8 Aug 2012
Last updated: 5 Sep 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 29877131

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Migraine Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01662492
Acronym / sponsor ID: 191622-103
Conditions: Migraine Disorders
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 125 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Oct 2012
Primary completion: Aug 2016 (actual)
Study completion: Aug 2016 (actual)
First posted: 10 Aug 2012 (estimated)
Results: Posted 5 Sep 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Botulinum toxin type A Dose 1	Experimental	Biological: Botulinum toxin type A Dose 1Botulinum toxin type A Dose 1 intramuscular injections into specified muscles.
Botulinum toxin type A Dose 2	Experimental	Biological: Botulinum toxin type A Dose 2Botulinum toxin type A Dose 2 intramuscular injections into specified muscles.
Placebo (Normal Saline)	Placebo comparator	Drug: Placebo (Normal Saline)Placebo (Normal Saline) intramuscular injections into specified muscles.

Who may qualify

Ages: 12 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Botulinum toxin type A Dose 1Also: onabotulinumtoxinA, BOTOX®Botulinum toxin type A Dose 1 intramuscular injections into specified muscles.	Biological	Botulinum toxin type A Dose 1
Botulinum toxin type A Dose 2Also: onabotulinumtoxinA, BOTOX®Botulinum toxin type A Dose 2 intramuscular injections into specified muscles.	Biological	Botulinum toxin type A Dose 2
Placebo (Normal Saline)Placebo (Normal Saline) intramuscular injections into specified muscles.	Drug	Placebo (Normal Saline)

Primary outcome

Change From Baseline in the Frequency of Headache Days
Time frame: 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.

4 secondary outcomes

Change From Baseline in the Frequency of Severe Headache Days
Time frame: Baseline, 12 Weeks
Change From Baseline in the Total Cumulative Hours of Headache on Headache Days
Time frame: Baseline, 12 Weeks
Percentage of Patients With ≥ 50% Decrease From Baseline in the Frequency of Headache Days
Time frame: Baseline, 12 Weeks
Percentage of Patients Who Are Prescribed Oral Rescue Migraine Prophylactic Treatment
Time frame: 12 Weeks

Results and safety

Results posted to the registry on 5 Sep 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Botulinum Toxin Type A 155 U	45	42
Botulinum Toxin Type A 74 U	43	42
Placebo (Normal Saline)	37	31

Primary outcome: Change From Baseline in the Frequency of Headache Days

Time frame: Baseline, 12 Weeks. Mean (Standard Deviation). Unit: Headache days

Measure	Botulinum Toxin Type A 155 U n = 45	Botulinum Toxin Type A 74 U n = 43	Placebo (Normal Saline) n = 37
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)

Population analysed: Intent-to-Treat (ITT) Population: All randomized subjects.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Week 12. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Botulinum Toxin Type A 155 U	1 of 43 (2.3%)	8 of 43 (18.6%)	Not reported
Botulinum Toxin Type A 74 U	2 of 43 (4.7%)	14 of 43 (32.6%)	Not reported
Placebo (Normal Saline)	0 of 37 (0%)	8 of 37 (21.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29877131Shah 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.

Related trials for Migraine Disorders

Active, not recruiting
Intra-Nasal Mechanical Stimulation (INMEST) as a Potential Preventative Treatment for Migraine
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Enrolling by invitationObservational study
Studio TIARA: Alessitimia ed Emicrania Cronica
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Allergan

22 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Botulinum toxin type A Dose 1 and Botulinum toxin type A Dose 2 in people with Migraine Disorders, run by Allergan at 22 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the Frequency of Headache Days (time frame: Baseline, 12 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01662492, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2017.