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

Primary Purpose

Migraine

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Frovatriptan

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

1: placebo

2 Frovatriptan

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00821483

First Posted

January 12, 2009

Last Updated

April 16, 2013

Sponsor

SK Chemicals Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT00821483

Brief Title

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

Official Title

Phase 3 Study to Assess the Efficacy and Safety of Frovatriptan

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

November 2006 (undefined)

Primary Completion Date

February 2008 (Actual)

Study Completion Date

February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SK Chemicals Co., Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Migraine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

298 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1: placebo

Arm Type

Placebo Comparator

Arm Title

2 Frovatriptan

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Frovatriptan

Intervention Description

2.5mg, qd

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sun U Kwon, professor

Organizational Affiliation

Department of Neurology, Asan Medical Center, University of Ulsan

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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