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

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ClinicalTrials.gov Identifier: NCT01859481
Recruitment Status : Completed
First Posted : May 22, 2013
Last Update Posted : May 22, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
Evaluation of headache response at 2 hours for active treated attacks for increasing dose.

Condition or disease Intervention/treatment Phase
Migraine Without Aura Migraine With Aura Drug: Placebo Drug: Eletriptan HBr 40 mg Drug: Eletriptan HBr 80 mg Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 971 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicentre, Dose Optimisation Study to Assess the Consistency of Efficacy of Eletriptan for the Treatment of Migraine (With and Without Aura)
Study Start Date : March 2000
Actual Primary Completion Date : March 2002
Actual Study Completion Date : March 2002


Arm Intervention/treatment
Placebo Comparator: Placebo 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.

Experimental: Eletriptan HBr 40 mg 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.

Experimental: Eletriptan HBr 80 mg 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.




Primary Outcome Measures :
  1. Consistency of headache response (3 responses out of 3 active treated attacks) . Headache response was defined as migraine headache pain of moderate or severe intensity pre dose becoming basent or mild within 2 hours post dose. [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Consistency of headache response (2 responses out of 3 active treated attacks). Headache response was defined as migraine headache pain of moderate or severe intensity pre dose becoming basent or mild within 2 hours post dose. [ Time Frame: 24 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01859481


  Show 140 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01859481     History of Changes
Other Study ID Numbers: A1601015
First Posted: May 22, 2013    Key Record Dates
Last Update Posted: May 22, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
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Migraine Disorders
Migraine with Aura
Migraine without Aura
Epilepsy
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Eletriptan
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs