NCT00156910

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
679

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2006

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

December 7, 2010

Completed
Last Updated

November 18, 2013

Status Verified

October 1, 2013

Enrollment Period

1.7 years

First QC Date

September 7, 2005

Results QC Date

November 5, 2010

Last Update Submit

October 24, 2013

Conditions

Migraine Disorders

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, Week 24

Secondary Outcomes (4)

  • Change in Frequency of Headache Days

    Baseline, Week 24

  • Change in Frequency of Acute Headache Pain Medication Intakes

    Baseline, Week 24

  • Change in Frequency of Migraine/Probable Migraine Headache Days

    Baseline, Week 24

  • Change in Frequency of Migraine/Probable Migraine Headache Episodes

    Baseline, Week 24

Study Arms (2)

botulinum toxin Type A

EXPERIMENTAL

Two 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.

Biological: Botulinum Toxin Type A

Placebo (saline)

PLACEBO COMPARATOR

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.

Other: Placebo (saline)

Interventions

Botulinum Toxin Type ABIOLOGICAL

Two 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.

Also known as: BOTOX®
botulinum toxin Type A
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.

Placebo (saline)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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 Temporomandibular Disorders (TMD)
  • Diagnosis of fibromyalgia
  • Beck depression inventory score \>24 at week-4
  • Psychiatric problems that may have interfered with study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Seattle, Washington, United States

Location

Unknown Facility

Markham, Ontario, Canada

Location

Related Publications (7)

  • 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.

    PMID: 33026631DERIVED

  • 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.

    PMID: 33026630DERIVED

  • 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.

    PMID: 31112399DERIVED

  • 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.

    PMID: 25500317DERIVED

  • 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.

    PMID: 25080874DERIVED

  • 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.

    PMID: 21883197DERIVED

  • 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.

    PMID: 20487038DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

Botulinum Toxins, Type ASodium Chloride

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological FactorsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Results Point of Contact

Title
Therapeutic Area Head
Organization
Allergan, Inc.
clinicaltrials@allergan.com
(714) 246-4500

Study Officials

  • Medical Director

    Allergan

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

February 1, 2006

Primary Completion

November 1, 2007

Study Completion

July 1, 2008

Last Updated

November 18, 2013

Results First Posted

December 7, 2010

Record last verified: 2013-10

Locations

CA(1)US(1)