CompletedPhase 3

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

298 participantsStarted 2006-11

Plain-language 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

Who can participate

Age range18 Years – 65 Years

SexALL

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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

What they're measuring

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

Timeframe: at 2 hours

Trial details

NCT IDNCT00821483

SponsorSK Chemicals Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-02

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