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

Sponsor:	Duramed Research
Information provided by (Responsible Party):	Duramed Research
ClinicalTrials.gov Identifier:	NCT00781456

Purpose

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.

Condition	Intervention	Phase
Migraine	Drug: DR-105 Drug: Placebo	Phase II

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

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

U.S. FDA Resources

Further study details as provided by Duramed Research:

Primary Outcome Measures:

Portion of subjects with ≥ 50% reduction in migraine frequency during the treatment period compared to baseline [ Time Frame: Duration of Study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Portion of subjects with ≥ 50% reduction in migraine frequency during the first, second and third month of the study compared to baseline [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
Change in migraine severity during the first, second and thrid month of the study, and the whole 91-day treatment period. [ Time Frame: Duration of Study ] [ Designated as safety issue: No ]
Incidence and use of rescue medications during the study period. [ Time Frame: Baseline to end of treatment period ] [ Designated as safety issue: No ]
Incidence of adverse events [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
Incidence of bleeding and spotting [ Time Frame: Duration of the study ] [ Designated as safety issue: Yes ]

Enrollment:	109
Study Start Date:	November 2008
Study Completion Date:	August 2011
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: DR-105 Levonorgestrel [LNG]/ethinyl estradiol [EE] 0.15/0.03 mg for 84 days and EE 0.01 mg tablets for 7 days 1 tablet daily Other Name: Seasonique [LNG/EE and EE]
Placebo Comparator: 2	Drug: Placebo 1 tablet daily to match experimental arm

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.

Eligibility

Ages Eligible for Study:	18 Years to 34 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00781456

Show 22 Study Locations

Sponsors and Collaborators

Duramed Research

Investigators

Study Chair:

Duramed Research Protocol Chair

Duramed Research, Inc.

More Information

No publications provided

Responsible Party:	Duramed Research
ClinicalTrials.gov Identifier:	NCT00781456 History of Changes
Other Study ID Numbers:	DR-105-201
Study First Received:	October 28, 2008
Last Updated:	October 20, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Duramed Research:

Migraine headache
menstrual
oral contraceptive
Menstrually-Related Migraine Headache

Additional relevant MeSH terms:

Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases

Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on February 09, 2012