A Multicenter Study to Evaluate the Efficacy of DR-105 for Menstrually-Related Migraine Headaches

Condition(s) targeted: Migraine

Intervention: DR-105 (Drug); Placebo (Other)

Phase: Phase 2

Status: Recruiting

Sponsored by: Duramed Research

Official(s) and/or principal investigator(s):
Duramed Research Protocol Chair, Study Chair, Affiliation: Duramed Research, Inc.

Overall contact:
Sally M Fedon, Pharm.D., Phone: 215-293-7279, Email: medicalaffairs@barrlabs.com

This study is being conducted to evaluate the efficacy of DR-105 compared to placebo for decreasing the frequency and severity of menstrually-related migraine headaches.

Official title: A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy of DR-105 Compared to Placebo For the Management of Menstrually-Related Migraine Headaches.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome: Portion of subjects with ≥ 50% reduction in migraine frequency during the treatment period compared to baseline

Secondary outcome:

Portion of subjects with ≥ 50% reduction in migraine frequency during the first, second and third month of the study compared to baseline

Change in migraine severity during the first, second and thrid month of the study, and the whole 91-day treatment period.

Incidence and use of rescue medications during the study period.

Incidence of adverse events

Incidence of bleeding and spotting

Detailed description: This is a multicenter, randomized, study to evaluate and compare the frequency and severity of menstrually-related migraine headaches before and during the 7-day ethinyl estradiol monotherapy interval in women treated with DR-105 compared to placebo during the 91-day treatment period.

Minimum age: 18 Years. Maximum age: 34 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Premenopausal, non-pregnant, non-lactating

- History of migraine headaches without aura for at least 6 months

- History of migraine headaches associated with menstruation

- Others as directed by FDA-approved protocol

Exclusion Criteria:

- History of migraine headaches with aura or focal neurological symptoms

- Any contraindication to the use of oral contraceptives

- Others as dictated by FDA-approved protocol

Sally M Fedon, Pharm.D., Phone: 215-293-7279, Email: medicalaffairs@barrlabs.com

Teva Investigational Site, La Mesa, California 91942, United States; Recruiting

Duramed Investigational Site, San Diego, California 92108, United States; Recruiting

Teva Investigational Site, San Diego, California 92123, United States; Recruiting

Duramed Investigational Site, San Francisco, California 94109-4841, United States; Recruiting

Duramed Investigational Site, San Francisco, California 94102, United States; Recruiting

Duramed Investigational Site, Washington, District of Columbia 20036, United States; Recruiting

Duramed Investigational Site, West Palm Beach, Florida 33409, United States; Recruiting

Teva Investigational Site, Savannah, Georgia 31406, United States; Recruiting

Duramed Investigational Site, Edison, New Jersey 08817, United States; Recruiting

Duramed Investigational Site, New York, New York 10022, United States; Recruiting

Duramed Investigational Site, Rochester, New York 14609, United States; Recruiting

Duramed Investigational Site, Greensboro, North Carolina 27405, United States; Recruiting

Teva Investigational Site, Winston-Salem, North Carolina 27103, United States; Recruiting

Duramed Investigational Site, West Chester, Ohio 45069, United States; Recruiting

Teva Investigational Site, Medford, Oregon 97504, United States; Recruiting

Duramed Investigational Site, Philadelphia, Pennsylvania 19114, United States; Recruiting

Teva Investigational Site, Hilton Head, South Carolina 29926, United States; Recruiting

Duramed Investigational Site, Dallas, Texas 75234, United States; Recruiting

Teva Investigational Site, Houston, Texas 77054, United States; Recruiting

Duramed Investigational Site, San Antonio, Texas 78229, United States; Recruiting

Duramed Investigational Site, Virginia Beach, Virginia 23454, United States; Recruiting

Duramed Investigational Site, Seattle, Washington 98105, United States; Recruiting

Starting date: November 2008
Last updated: August 9, 2010