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Trial record 7 of 42 for:    FROVATRIPTAN

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00821483
Recruitment Status : Completed
First Posted : January 13, 2009
Last Update Posted : April 18, 2013
Information provided by (Responsible Party):
SK Chemicals Co., Ltd.

Tracking Information
First Submitted Date  ICMJE January 12, 2009
First Posted Date  ICMJE January 13, 2009
Last Update Posted Date April 18, 2013
Study Start Date  ICMJE November 2006
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00821483 on Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE A Double Blind Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of Frovatriptan in the Acute Treatment of Migraine
Official Title  ICMJE Phase 3 Study to Assess the Efficacy and Safety of Frovatriptan
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Migraine
Intervention  ICMJE Drug: Frovatriptan
2.5mg, qd
Study Arms  ICMJE
  • Placebo Comparator: 1: placebo
    Intervention: Drug: Frovatriptan
  • Active Comparator: 2 Frovatriptan
    Intervention: Drug: Frovatriptan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 12, 2009)
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00821483
Other Study ID Numbers  ICMJE FRESH
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party SK Chemicals Co., Ltd.
Study Sponsor  ICMJE SK Chemicals Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sun U Kwon, professor Department of Neurology, Asan Medical Center, University of Ulsan
PRS Account SK Chemicals Co., Ltd.
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP