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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
This study has been completed.
Sponsored by: SK Chemicals Co.,Ltd.
Information provided by: SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier: NCT00821483
  Purpose

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 Intervention Phase
Migraine
 Drug: Frovatriptan
 Phase III

Genetics Home Reference related topics: familial hemiplegic migraine
MedlinePlus related topics: Headache Migraine
Drug Information available for: Frovatriptan Frovatriptan succinate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Phase 3 Study to Assess the Efficacy and Safety of Frovatriptan

Further study details as provided by SK Chemicals Co.,Ltd.:

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 [ Time Frame: at 2 hours ] [ Designated as safety issue: No ]

Enrollment: 298
Study Start Date: November 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: placebo: Placebo Comparator Drug: Frovatriptan
2.5mg, qd
2 Frovatriptan: Active Comparator Drug: Frovatriptan
2.5mg, qd

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00821483

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: Licensing & Development, SKChemical ( Clinical Research Team )
Study ID Numbers: FRESH
Study First Received: January 12, 2009
Last Updated: January 13, 2009
ClinicalTrials.gov Identifier: NCT00821483  
Health Authority: Korea: Food and Drug Administration

Study placed in the following topic categories:
Frovatriptan
Migraine Disorders
Headache
Central Nervous System Diseases
 Headache Disorders, Primary
Brain Diseases
Serotonin
Headache Disorders

Additional relevant MeSH terms:
Serotonin Agonists
Neurotransmitter Agents
Serotonin Agents
Molecular Mechanisms of Pharmacological Action
 Physiological Effects of Drugs
Nervous System Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009



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