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

NCT ID: NCT00821483

Last Updated: 2013-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 298 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2008-02-29

Brief Summary

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

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1: placebo

Group Type: PLACEBO_COMPARATOR

Frovatriptan

Intervention Type: DRUG

2.5mg, qd

2 Frovatriptan

Group Type: ACTIVE_COMPARATOR

Frovatriptan

Intervention Type: DRUG

2.5mg, qd

Interventions

Frovatriptan

2.5mg, qd

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SK Chemicals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sun U Kwon, professor

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, Asan Medical Center, University of Ulsan

Other Identifiers

FRESH

Identifier Type: -

Identifier Source: org_study_id