Eletriptan Provides Consistent Migraine Relief: Results Of A Within-Patient Multiple-Dose Study

NCT01859481

Last updated date
Study Location
Eeuwfeestkliniek
Antwerpen, , 2018, Belgium
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Migraine Without Aura, Migraine With Aura
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male and Female subjects in good general health, aged 18 to 65 years.

- Subjects should meet IHS diagnostic criteria for migraine with or without aura.

- Based on past history, subjects should expect to suffer at least one acute attack of migraine with or without aura, each 6 weeks

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Known coronary-artery disease, clinically significant arrhythmia, heart failure, or
uncontrolled hypertension.


- Pregnant or lactating women.


- Clinically significant electrocardiogram abnormalities at screening.

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ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Eletriptan Provides Consistent Migraine Relief: Results Of A Within-Patient Multiple-Dose Study
Official Title  ICMJE A Multicentre, Dose Optimisation Study to Assess the Consistency of Efficacy of Eletriptan for the Treatment of Migraine (With and Without Aura)
Brief Summary Evaluation of headache response at 2 hours for active treated attacks for increasing dose.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Migraine Without Aura
  • Migraine With Aura
Intervention  ICMJE
  • Drug: Placebo
    All subjects will receive open label eletriptan 40 mg per attack for the first three attacks in the phase 1 of the study. For the next 4 attacks subjects will be assigned to either eletriptan 40 mg or 80 mg group based on the response in the phase 1 portion of the study. In phase II, in each group subjects will receive eletriptan 40 mg or 80 mg for 3 attacks and placebo for 1 attack. In each group double-blind placebo will be inserted at random.
  • Drug: Eletriptan HBr 40 mg
    All subjects will receive open label eletriptan 40 mg per attack for the first three attacks in the phase 1 of the study. For the next 4 attacks subjects will be assigned to either eletriptan 40 mg or 80 mg group based on the response in the phase 1 portion of the study. In phase II, in each group subjects will receive eletriptan 40 mg or 80 mg for 3 attacks and placebo for 1 attack. In each group double-blind placebo will be inserted at random.
  • Drug: Eletriptan HBr 80 mg
    All subjects will receive open label eletriptan 40 mg per attack for the first three attacks in the phase 1 of the study. For the next 4 attacks subjects will be assigned to either eletriptan 40 mg or 80 mg group based on the response in the phase 1 portion of the study. In phase II, in each group subjects will receive eletriptan 40 mg or 80 mg for 3 attacks and placebo for 1 attack. In each group double-blind placebo will be inserted at random.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Eletriptan HBr 40 mg
    Intervention: Drug: Eletriptan HBr 40 mg
  • Experimental: Eletriptan HBr 80 mg
    Intervention: Drug: Eletriptan HBr 80 mg
Publications * Almas M, Tepper SJ, Landy S, Schweizer E, Ramos E. Consistency of eletriptan in treating migraine: Results of a randomized, within-patient multiple-dose study. Cephalalgia. 2014 Feb;34(2):126-35. doi: 10.1177/0333102413500726. Epub 2013 Aug 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 17, 2013)
971
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2002
Actual Primary Completion Date March 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and Female subjects in good general health, aged 18 to 65 years.
  • Subjects should meet IHS diagnostic criteria for migraine with or without aura.
  • Based on past history, subjects should expect to suffer at least one acute attack of migraine with or without aura, each 6 weeks

Exclusion Criteria:

  • Known coronary-artery disease, clinically significant arrhythmia, heart failure, or uncontrolled hypertension.
  • Pregnant or lactating women.
  • Clinically significant electrocardiogram abnormalities at screening.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Hungary,   Italy,   Netherlands,   Norway,   Portugal,   Spain,   Sweden,   Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01859481
Other Study ID Numbers  ICMJE A1601015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP