Clinical Trials Logo
  1. Home
  2. Migraine
  3. NCT00632385
  4. Details
NCT00632385 Clinical Trial

Efficacy and Safety of Eletriptan for the Treatment of Migraine in Patients Not Satisfied With Rizatriptan Therapy

Migraine Clinical Trial

Official title:
An Open-label Study of Eletriptan for the Acute Treatment of Migraine in Migraine Sufferers Who Are Dissatisfied With Rizatriptan Therapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00632385
Other study ID # A1601092
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 2003
Est. completion date August 2003

Study information
Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To assess the efficacy and safety of eletriptan for migraine headaches in subjects who were not satisfied with rizatriptan therapy

Recruitment information / eligibility
Status Completed
Enrollment 127
Est. completion date August 2003
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Diagnosis of migraine headache according to International Headache Society criteria and migraine headaches for at least 1 year - Eletriptan naive - Previously treated with rizatriptan and failed to achieve a satisfactory response within the past 12 months Exclusion Criteria: - Non-migraine headaches on average more than 6 days per month or have less than 24 hours of freedom from headache between migraine attacks - Migraine attacks that are atypical or chronic daily headaches - A history of migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, migrainous infarction, migraine aura without headache, migraine with acute onset aura

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Eletriptan
40 mg oral tablet for migraine attack, followed by 40 mg oral tablet if migraine reoccurred >2 hours from first dose and within 24 hours of first dose

Locations
Country Name City State
United States Pfizer Investigational Site Alexandria Virginia
United States Pfizer Investigational Site Chesterfield Missouri
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Eugene Oregon
United States Pfizer Investigational Site Greensboro North Carolina
United States Pfizer Investigational Site Irvine California
United States Pfizer Investigational Site Marietta Georgia
United States Pfizer Investigational Site Milford Massachusetts
United States Pfizer Investigational Site Newport Beach California
United States Pfizer Investigational Site Plantation Florida
United States Pfizer Investigational Site Saint Petersburg Florida
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Francisco California
United States Pfizer Investigational Site South Bend Indiana
United States Pfizer Investigational Site Springfield Missouri
United States Pfizer Investigational Site Tampa Florida

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in headache pain severity 1, 2, 4, and 24 hours
Secondary Functional impairment 1, 2, 4, and 24 hours
Secondary Work Productivity Questionnaire Week 10
Secondary Time Loss Week 10
Secondary Subject Preference Questionnaire Week 10
Secondary Global Evaluation Week 10
Secondary Subject Satisfaction Scale Week 10
Secondary Associated Symptoms 1, 2, 4, and 24 hours
Secondary Use of Rescue Medication Week 10
Secondary Adverse events Week 10
Secondary Vital signs Week 10
Secondary Physical examination Week 10
See also
  Status Clinical Trial Phase
Completed NCT06192173 - Patent Foramen Ovale Closure in Migraine
Completed NCT05525611 - Cabergoline as a Preventive Treatment for Chronic Migraine N/A
Recruiting NCT03832998 - Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine Phase 3
Enrolling by invitation NCT04196933 - Analysis of Vestibular Compensation Following Clinical Intervention for Vestibular Schwannoma N/A
Not yet recruiting NCT06428838 - Eptinezumab as an Adjunct to Standard of Care for Migraine in an Acute Emergency Context Phase 3
Completed NCT06304675 - Manageable Environmental Factors in Migraine
Completed NCT04084314 - Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study Phase 4
Recruiting NCT05517200 - Pilot Study for a Machine Learning Test for Migraine
Completed NCT04179474 - Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With Migraine Phase 1
Recruiting NCT04603976 - Registry for Migraine - Clinical Core Phase 4
Completed NCT03597529 - CHOCOlate MeLatonin for AdolescenT MigrainE Phase 2
Completed NCT04197349 - Safety, Tolerability and Pharmacokinetics of ALD1910 in Healthy Men and Woman Phase 1
Recruiting NCT05891808 - miR-155 Expression in Episodic and Chronic Migraine
Active, not recruiting NCT05064371 - Long-Term Extension Study With Eptinezumab as Preventive Treatment in Participants With Migraine in Japan Phase 3
Suspended NCT04069572 - Vibratory Stimulation for the Treatment of Chronic Pain N/A
Not yet recruiting NCT04859374 - Chronic Pain and Conditioned Pain Modulation After on Line-behavioral Approach N/A
Not yet recruiting NCT03083860 - Evaluation of Migraine Management Mobile App Combined With Electrophysiological Measurements for Identification of Migraine Attack Risk and Beneficial Preventive Actions. N/A
Completed NCT02905227 - A Study of the Pulmonary Safety and Pharmacokinetics of Zolmitriptan Inhalation Powder Phase 1
Enrolling by invitation NCT02532023 - The Combined Effects of omega3 Fatty Acids and Curcumin Supplementation on Inflammatory and Endothelial Factors in Migraine Patients Phase 4
Completed NCT02108678 - One-Day Intervention for Depression and Impairment in Migraine Patients N/A

External Links