- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00821483
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:
- 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
- To assess recurrence rate between two group
- To assess the safety and tolerability
Study Overview
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:
- Adults aged 18 to 65 years
- 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
- Onset of migraine disease must have occurred before the patients was 50 years of age
- Able and willing to sign informed consent, and able and willing to comply with study procedures, including the completion of diary cards.
Exclusion Criteria:
- 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
- Clinically significant renal dysfunction(creatinine≥2.0mg/dl) or hepatic dysfunction(ALT,AST≥2 ULN)
- Patients with clinically significant abnormal ECGs or with resting diastolic blood pressure above 95mmHg
- Patients with clinically significant cardiovascular or cerebrovascular disease
- Patients with a history of clinically relevant allergy, including allergy to triptan
- Previous treatment with Frovatriptan at any time or treatment with an investigational drug within 30 days before screening visit
- Patients with a diagnosis of vertebrobasilar or hemiplegic(prolonged atypical aura) migraine(IHS criteria)
- Potentially unco-operative patients, those unable to provide informed consent, and those unable to complete the diary
- 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
- Patients who are not able to tell that they are having a migraine headache
- 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
- Treatment with a monoamine-oxidase inhibitor(MAOI) within two weeks of the screening visit
- 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.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FRESH
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.
Clinical Trials on Migraine
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Austrian Migraine Registry CollaborationMedical University of Vienna; Medical University Innsbruck; Austrian Headache...RecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With Aura | Episodic MigraineAustria
-
Tonix Pharmaceuticals, Inc.PremierCompletedChronic Migraine | Chronic Migraine, Headache | Chronic Migraine Without Aura | Aura MigraineUnited States
-
Harvard University Faculty of MedicineBrigham and Women's Hospital; Palmer Center for Chiropractic Research (PCCR)CompletedMigraine | Migraine Disorders | Migraine Without Aura | Migraine With Aura | Migraine, ClassicUnited States
-
University of FlorenceAzienda Ospedaliera Città della Salute e della Scienza di Torino; University... and other collaboratorsRecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With AuraItaly
-
CoolTech LLCTerminatedMigraine | Migraine Without Aura | Migraine With Aura | Episodic MigraineUnited States
-
University of FlorenceAzienda Ospedaliera Città della Salute e della Scienza di Torino; University... and other collaboratorsRecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With AuraItaly
-
Notre-Dame Hospital, Montreal, Quebec, CanadaAllerganCompletedChronic Migraine | Migraine Without Aura | Migraine With AuraCanada
-
Glostrup University Hospital, CopenhagenUnknownChronic Migraine | Migraine Without Aura | Migraine With AuraDenmark
-
Fondazione I.R.C.C.S. Istituto Neurologico Carlo...CompletedMigraine With Aura | Migraine in ChildrenItaly
-
The Cleveland ClinicWithdrawnMigraine | Migraine Disorders | Headache Disorders, Primary | Migraine Headache | Migraine Without Aura | Migraine With Aura | Headache, MigraineUnited States
Clinical Trials on Frovatriptan
-
Endo PharmaceuticalsCompleted
-
Endo PharmaceuticalsVernalis (R&D) LtdCompletedMigrainePoland, United Kingdom, South Africa, Hungary, Germany
-
ClinvestEndo PharmaceuticalsCompletedMigraineUnited States
-
Scott and White Hospital & ClinicEndo PharmaceuticalsCompletedPrevention of Menstrual Migraines: Using Frovatriptan or Placebo During Hormone Free Intervals (MAM)Bleeding | Migraines | SpottingUnited States
-
Endo PharmaceuticalsVernalis (R&D) LtdCompletedMenstrually Associated MigraineUnited States
-
Thomas Jefferson UniversityCompleted
-
University of CalgaryAlberta Health servicesCompletedMedication Overuse Headache | Analgesic Overuse HeadacheCanada
-
Endo PharmaceuticalsCompletedMenstrual Migraine (MM) HeadachesUnited States
-
Assiut UniversityNot yet recruitingCorneal Higher-order AberrationsEgypt
-
Seattle Nuclear MedicineCompletedCancer | Bone MetastasesUnited States