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

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NCT01859481

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Eeuwfeestkliniek
Antwerpen, , 2018 Belgium
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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.

NCT01859481
Pfizer
Completed
Eletriptan Provides Consistent Migraine Relief: Results Of A Within-Patient Multiple-Dose Study

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Eletriptan Provides Consistent Migraine Relief: Results Of A Within-Patient Multiple-Dose Study
A Multicentre, Dose Optimisation Study to Assess the Consistency of Efficacy of Eletriptan for the Treatment of Migraine (With and Without Aura)
Evaluation of headache response at 2 hours for active treated attacks for increasing dose.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Migraine Without Aura
  • Migraine With Aura
  • 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.
  • 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
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.
 
Completed
971
March 2002
March 2002   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Hungary,   Italy,   Netherlands,   Norway,   Portugal,   Spain,   Sweden,   Turkey
 
 
NCT01859481
A1601015
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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