You are here

Eletriptan for the Treatment of Migraine in Patients With Previous Poor Response or Tolerance to Oral Sumatriptan

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Arhus Kommunehospital
Arhus C, , 8000 Denmark
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Migraine With or Without Aura
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-68 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male and female subjects age ≥ 18 years who met the International Headache Society
(IHS) diagnostic criteria for migraine, with or without aura, and could reasonably
expect to suffer at least one acute attack of migraine every 6 weeks.

- Subjects required to have discontinued therapy with oral sumatriptan at least 2 weeks,
but not longer than 2 years, prior to the screening visit.

- Female subjects required to be adequately protected against pregnancy.

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

- pregnancy or breastfeeding, known coronary artery disease, significant arrhythmias,
heart failure, significant ECG abnormalities, and uncontrolled hypertension.

- Any significant systemic, organ, neurological, endocrine, metabolic, and psychological
disorders reported by the patient or discovered during the physical examination

- Subjects considered to have atypical migraine such as frequent attacks, prolonged aura
or any migraine that was considered atypical.

- Subjects who, during the course of the trial, required treatment with sumatriptan or
any other 5-HT1B/1D agonist in addition to study medication.

NCT01989936
Pfizer
Completed
Eletriptan for the Treatment of Migraine in Patients With Previous Poor Response or Tolerance to Oral Sumatriptan

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Locally Advanced or Metastatic Solid Tumors, BRCA 1 Genes
NCT03565991
All Genders
Rheumatoid Arthritis, Psoriasis Arthritis
NCT01623752
All Genders
Non Small Cell Lung Cancer ALK Positive or ROS1 Positive
NCT03178071
All Genders
18+
Years
Multiple Sites
Healthy, Chronic Rhinosinusitis With Nasal Polyps, Atopic Dermatitis
NCT02743871
All Genders
18+
Years
Multiple Sites
Eletriptan for the Treatment of Migraine in Patients With Previous Poor Response or Tolerance to Oral Sumatriptan
A Multicenter, Double - Blind, Randomized, Placebo - Controlled Parallel Group Study of the Efficacy and Safety of Oral Eletriptan (40 and 80mg) Given for the Treatment of Acute Migraine in Subjects Discontinued From Oral Sumatriptan
To determine the tolerability and efficacy of eletriptan in patients who had discontinued oral sumatriptan due to lack of efficacy or intolerable adverse events (AEs) during previous clinical treatment (not a controlled trial).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Migraine With or Without Aura
  • Drug: Placebo
    Subjects were randomized to one of the 3 treatment groups (eletriptan 40 mg, eletriptan 80 mg, or placebo) in a 2:2:1 ratio and were given sufficient medication to treat 3 migraine attacks (including a second dose for each attack for recurrence) within 18 weeks of the initial visit. Subjects were instructed to treat a moderate to severe migraine within 6 hours of the onset of pain provided the headache was not decreasing in severity, the aura phase had ended and they had taken no analgesic or antiemetic within 6 hours. Efficacy data was collected in a diary. Subjects were allowed to take rescue medication if they had no response to the study medication within 4 hours of onset.
  • Drug: Eletriptan 40 mg
    Subjects were randomized to one of the 3 treatment groups (eletriptan 40 mg, eletriptan 80 mg, or placebo) in a 2:2:1 ratio and were given sufficient medication to treat 3 migraine attacks (including a second dose for each attack for recurrence) within 18 weeks of the initial visit. Subjects were instructed to treat a moderate to severe migraine within 6 hours of the onset of pain provided the headache was not decreasing in severity, the aura phase had ended and they had taken no analgesic or antiemetic within 6 hours. Efficacy data was collected in a diary. Subjects were allowed to take rescue medication if they had no response to the study medication within 4 hours of onset.
  • Drug: Eletriptan 80 mg
    Subjects were randomized to one of the 3 treatment groups (eletriptan 40 mg, eletriptan 80 mg, or placebo) in a 2:2:1 ratio and were given sufficient medication to treat 3 migraine attacks (including a second dose for each attack for recurrence) within 18 weeks of the initial visit. Subjects were instructed to treat a moderate to severe migraine within 6 hours of the onset of pain provided the headache was not decreasing in severity, the aura phase had ended and they had taken no analgesic or antiemetic within 6 hours. Efficacy data was collected in a diary. Subjects were allowed to take rescue medication if they had no response to the study medication within 4 hours of onset.
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Eletriptan 40 mg
    Intervention: Drug: Eletriptan 40 mg
  • Experimental: Eletriptan 80 mg
    Intervention: Drug: Eletriptan 80 mg
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
446
September 2000
September 2000   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and female subjects age ? 18 years who met the International Headache Society (IHS) diagnostic criteria for migraine, with or without aura, and could reasonably expect to suffer at least one acute attack of migraine every 6 weeks.
  • Subjects required to have discontinued therapy with oral sumatriptan at least 2 weeks, but not longer than 2 years, prior to the screening visit.
  • Female subjects required to be adequately protected against pregnancy.

Exclusion Criteria:

  • pregnancy or breastfeeding, known coronary artery disease, significant arrhythmias, heart failure, significant ECG abnormalities, and uncontrolled hypertension.
  • Any significant systemic, organ, neurological, endocrine, metabolic, and psychological disorders reported by the patient or discovered during the physical examination
  • Subjects considered to have atypical migraine such as frequent attacks, prolonged aura or any migraine that was considered atypical.
  • Subjects who, during the course of the trial, required treatment with sumatriptan or any other 5-HT1B/1D agonist in addition to study medication.
Sexes Eligible for Study: All
18 Years to 68 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Finland,   Netherlands,   Norway,   Sweden
 
 
NCT01989936
A1601006
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2013

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now