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

• ClinicalTrials.gov Identifier: NCT00821483
• Recruitment Status: Completed
• First Posted: January 13, 2009
• Last Update Posted: April 18, 2013
• Sponsor: SK Chemicals Co., Ltd.
• Information provided by (Responsible Party): SK Chemicals Co., Ltd.

Study Description

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

Condition or disease	Intervention/treatment	Phase
Migraine	Drug: Frovatriptan	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 298 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Phase 3 Study to Assess the Efficacy and Safety of Frovatriptan
• Study Start Date: November 2006
• Actual Primary Completion Date: February 2008
• Actual Study Completion Date: February 2008

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: 1: placebo	Drug: Frovatriptan; 2.5mg, qd
Active Comparator: 2 Frovatriptan	Drug: Frovatriptan; 2.5mg, qd

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Sponsors and Collaborators

SK Chemicals Co., Ltd.

Investigators

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

More Information

• Responsible Party: SK Chemicals Co., Ltd.
• ClinicalTrials.gov Identifier: NCT00821483
• Other Study ID Numbers: FRESH
• First Posted: January 13, 2009
• Last Update Posted: April 18, 2013
• Last Verified: April 2013

Additional relevant MeSH terms:

Frovatriptan; Migraine Disorders; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Serotonin Receptor Agonists; Serotonin Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs