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Trial record 7 of 41 for:    FROVATRIPTAN

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

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

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

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

Active Comparator: 2 Frovatriptan Drug: Frovatriptan
2.5mg, qd




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 ]


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00821483


Sponsors and Collaborators
SK Chemicals Co., Ltd.
Investigators
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Principal Investigator: Sun U Kwon, professor Department of Neurology, Asan Medical Center, University of Ulsan

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Responsible Party: SK Chemicals Co., Ltd.
ClinicalTrials.gov Identifier: NCT00821483     History of Changes
Other Study ID Numbers: FRESH
First Posted: January 13, 2009    Key Record Dates
Last Update Posted: April 18, 2013
Last Verified: April 2013
Additional relevant MeSH terms:
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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