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Migraine DisordersPhase 3NCT00168428

A Study Using Botulinum Toxin Type A as Headache Prophylaxis for Migraine Patients With Frequent Headaches

A Phase 3 study testing Botulinum Toxin Type A in people with Migraine Disorders, run by Allergan at 6 sites in 6 countries.

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

This is a 60 week study including a double-blind phase followed by an open-label phase. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Migraine Disorders
What is being tested?
Botulinum Toxin Type A
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
705 participants
Where
6 sitesin 6 countries
Study dates
Mar 2006to Aug 2008
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Frequent migraine (>=15 headache days per month)
  • >=4 distinct headache episodes lasting >=4 hours
  • >=50% of baseline headache days migraine/probable migraine days

Who cannot join

  • Previous use of botulinum toxin of any serotype or immunization to any botulinum toxin serotype
  • Any medical condition that puts the patient at increased risk with exposure to BOTOX
  • Diagnosis of complicated migraine, chronic tension-type headache, hypnic headache, hemicrania continua, new daily persistent headache
  • Use of prophylactic headache medication within 28 days prior to week -4
  • Unremitting headache lasting continuously throughout the 4-week baseline period
  • Known or suspected TMD
Show all 9Show fewer
  • Diagnosis of fibromyalgia
  • Beck depression inventory score >24 at week-4
  • Psychiatric problems that may have interfered with study participation

Trial locations and contacts

6 sites in 6 countries.

6 sites in 6 countries

United States1 site

  • Study site

    Walnut Creek, California

Other trials in United States

Canada1 site

  • Study site

    Calgary, Alberta

Other trials in Canada

Croatia1 site

  • Study site

    Zagreb

Other trials in Croatia

Germany1 site

  • Study site

    Essen

Other trials in Germany

Switzerland1 site

  • Study site

    Zurich

Other trials in Switzerland

United Kingdom1 site

  • Study site

    London

Other trials in United Kingdom

About this study

This is a 60 week study including a double-blind phase followed by an open-label phase.

Being tested
Botulinum Toxin Type A, placebo (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 ABiological

    Also called BOTOX®

    Two treatment sessions in the double-blind phase and three treatment sessions in the open-label phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.

  • placebo (saline)Other

    Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.

Study groups in NCT00168428
Study groupRoleWhat they receive
botulinum toxin Type AExperimentalTwo treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
Receives: Biological: Botulinum Toxin Type A
Placebo (saline)Placebo comparatorTwo treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
Receives: Other: placebo (saline)

What is being measured

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

  1. Change in Frequency of Headache Days

    Mean change from baseline in frequency (number) of headache days during the 28 day period ending with Week 24. Headache day defined as a calendar day [00:00 to 23:59] for which the patient reported >= 4 continuous hours of headache.

    Measured: Baseline, Week 24

Secondary outcomes (5)

  1. Change in Total Cumulative Hours of Headache Occurring on Headache Days

    Mean change from baseline in total cumulative hours of headache occurring on headache days during the 28 day period ending with Week 24. Headache day defined as a calendar day [00:00 to 23:59] when the patient reported >= 4 continuous hours of headache.

    Measured: Baseline, Week 24

  2. Change in Frequency of Moderate/Severe Headache Days

    Mean change from baseline in frequency (number) of moderate/severe headache days during the 28 day period ending with Week 24. Those calendar days with >= 4 continuous hours of headache were selected. As per the patient diary, all headache episodes occurring during those days with a maximum severity of moderate or severe were counted.

    Measured: Baseline, Week 24

  3. Change in Frequency of Migraine/Probable Migraine Headache Days

    Mean change from baseline in frequency (number) of migraine/probable migraine headache days during the 28 day period ending with Week 24. Headache day defined as a calendar day with >= 4 continuous hours of headache meeting the ICHD-II criteria for migraine or probable migraine.

    Measured: Baseline, Week 24

  4. Change in Frequency of Headache Episodes

    Mean change from baseline in frequency (number) of headache episodes during the 28 day period ending with Week 24. Headache episode defined as patient-reported headache with a start and stop time indicating that the pain lasted >= 4 continuous hours.

    Measured: Baseline, Week 24

  5. Percentage of Patients With Severe HIT-6 Impact Category Scores

    Percentage of patients with a severe (60-78) score on the Headache Impact Test (HIT-6) Questionnaire during the 28 day period, ending with Week 24. The HIT-6 consisted of 6 questions about headache and impact on the patient's health and well-being. Answers for each question ranged from 6=Never, 8=Rarely, 10=Sometimes, 11=Very Often, and 13=Always. The total scores ranged from 36-49 (Little or No Impact), 50-55 (Some Impact), 56-59 (Substantial Impact) and 60-78 (Severe Impact).

    Measured: Week 24

Timeline

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

  1. First posted15 Sep 2005 (estimated)
  2. Study startMar 2006
  3. Primary completionDec 2007
  4. Study completionAug 2008

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
705 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00168428
Sponsor's protocol ID
191622-080
Status last verified
Oct 2013
First submitted
12 Sep 2005
Last updated
18 Nov 2013

Publications

  • Diener HC, Dodick DW, Lipton RB, Manack Adams A, DeGryse RE, Silberstein SD. Benefits Beyond Headache Days With OnabotulinumtoxinA Treatment: A Pooled PREEMPT Analysis. Pain Ther. 2020 Dec;9(2):683-694. doi: 10.1007/s40122-020-00198-w. Epub 2020 Oct 7.

    PubMed 33026631

  • Silberstein SD, Diener HC, Dodick DW, Manack Adams A, DeGryse RE, Lipton RB. The Impact of OnabotulinumtoxinA vs. Placebo on Efficacy Outcomes in Headache Day Responder and Nonresponder Patients with Chronic Migraine. Pain Ther. 2020 Dec;9(2):695-707. doi: 10.1007/s40122-020-00199-9. Epub 2020 Oct 7.

    PubMed 33026630

  • Dodick DW, Silberstein SD, Lipton RB, DeGryse RE, Adams AM, Diener HC. Early onset of effect of onabotulinumtoxinA for chronic migraine treatment: Analysis of PREEMPT data. Cephalalgia. 2019 Jul;39(8):945-956. doi: 10.1177/0333102418825382. Epub 2019 May 21.

    PubMed 31112399

  • Silberstein SD, Dodick DW, Aurora SK, Diener HC, DeGryse RE, Lipton RB, Turkel CC. Per cent of patients with chronic migraine who responded per onabotulinumtoxinA treatment cycle: PREEMPT. J Neurol Neurosurg Psychiatry. 2015 Sep;86(9):996-1001. doi: 10.1136/jnnp-2013-307149. Epub 2014 Dec 12.

    PubMed 25500317

  • Rendas-Baum R, Yang M, Varon SF, Bloudek LM, DeGryse RE, Kosinski M. Validation of the Headache Impact Test (HIT-6) in patients with chronic migraine. Health Qual Life Outcomes. 2014 Aug 1;12:117. doi: 10.1186/s12955-014-0117-0.

    PubMed 25080874

  • Aurora SK, Winner P, Freeman MC, Spierings EL, Heiring JO, DeGryse RE, VanDenburgh AM, Nolan ME, Turkel CC. OnabotulinumtoxinA for treatment of chronic migraine: pooled analyses of the 56-week PREEMPT clinical program. Headache. 2011 Oct;51(9):1358-73. doi: 10.1111/j.1526-4610.2011.01990.x. Epub 2011 Aug 29.

    PubMed 21883197

  • Dodick DW, Turkel CC, DeGryse RE, Aurora SK, Silberstein SD, Lipton RB, Diener HC, Brin MF; PREEMPT Chronic Migraine Study Group. OnabotulinumtoxinA for treatment of chronic migraine: pooled results from the double-blind, randomized, placebo-controlled phases of the PREEMPT clinical program. Headache. 2010 Jun;50(6):921-36. doi: 10.1111/j.1526-4610.2010.01678.x. Epub 2010 May 7.

    PubMed 20487038

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Botulinum Toxin Type A in people with Migraine Disorders, run by Allergan at 6 sites in 6 countries.

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 3 inclusion and 9 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 18 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, Canada, Croatia, Germany, Switzerland and 1 more country. 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 7 Dec 2010). 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 in Frequency of Headache Days (time frame: Baseline, Week 24). 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 NCT00168428, which also lists 7 linked publications.

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 18 Nov 2013.

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