A Double Blind Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of Frovatriptan in the Acute Treatment of Migraine

April 16, 2013 updated by: SK Chemicals Co., Ltd.

Phase 3 Study to Assess the Efficacy and Safety of Frovatriptan

The purpose of this study is:

  1. To compare the efficacy of a single dose of Frovatriptan 2.5 mg with that of placebo in acute treatment of up to one migraine attract
  2. To assess recurrence rate between two group
  3. To assess the safety and tolerability

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

298

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adults aged 18 to 65 years
  2. The patients must have a history of migraine according to the criteria of the Headache Classification Committee of the International Headache Society(IHS), over the previous 1 year. The patient must have experienced one to eight moderate or severe migraine attacks(with or without aura) each month over at least the previous two months
  3. Onset of migraine disease must have occurred before the patients was 50 years of age
  4. Able and willing to sign informed consent, and able and willing to comply with study procedures, including the completion of diary cards.

Exclusion Criteria:

  1. Pregnant or lactating females, or women intend to become pregnant or breast feed during the study period, or women of childbearing potential not using adequate contraception. Females of reproductive potential must have a negative pregnancy test at screening
  2. Clinically significant renal dysfunction(creatinine≥2.0mg/dl) or hepatic dysfunction(ALT,AST≥2 ULN)
  3. Patients with clinically significant abnormal ECGs or with resting diastolic blood pressure above 95mmHg
  4. Patients with clinically significant cardiovascular or cerebrovascular disease
  5. Patients with a history of clinically relevant allergy, including allergy to triptan
  6. Previous treatment with Frovatriptan at any time or treatment with an investigational drug within 30 days before screening visit
  7. Patients with a diagnosis of vertebrobasilar or hemiplegic(prolonged atypical aura) migraine(IHS criteria)
  8. Potentially unco-operative patients, those unable to provide informed consent, and those unable to complete the diary
  9. patients who habitually abuse headache medication including ergotamine-containing compounds, and patients with a history of alcohol and/or medicine abuse, in the Investigator's opinion
  10. Patients who are not able to tell that they are having a migraine headache
  11. Patients who have 15 or more headache days per month, on average, or those taking symptomatic medication for headaches on more than two days per week, on average
  12. Treatment with a monoamine-oxidase inhibitor(MAOI) within two weeks of the screening visit
  13. Patients who are taking prophylactic migraine medication, unless dose has been stabilized for 30 days and it expected to continue for the duration of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 1: placebo
2.5mg, qd
ACTIVE_COMPARATOR: 2 Frovatriptan
2.5mg, qd

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
A comparison between Frovatriptan and placebo for the proportion of patients who have complete(grade 0) or almost complete(grade 1) relief of headache at 2 hours after taking Frovatriptan
Time Frame: at 2 hours
at 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sun U Kwon, professor, Department of Neurology, Asan Medical Center, University of Ulsan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (ACTUAL)

February 1, 2008

Study Completion (ACTUAL)

February 1, 2008

Study Registration Dates

First Submitted

January 12, 2009

First Submitted That Met QC Criteria

January 12, 2009

First Posted (ESTIMATE)

January 13, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 18, 2013

Last Update Submitted That Met QC Criteria

April 16, 2013

Last Verified

April 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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