A Multicenter Study to Evaluate the Efficacy of a 91-Day Extended Cycle Oral Contraceptive for Menstrually-Related Migraine Headaches

Migraine Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00781456
• Other study ID #: DR-105-201
• Status: Completed
• Phase: Phase 2
• First received: October 28, 2008
• Last updated: August 19, 2014
• Start date: January 2009
• Est. completion date: August 2011

Study information

• Verified date: August 2014
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is being conducted to evaluate the efficacy of a 91-day extended cycle oral contraceptive compared to placebo for decreasing the frequency and severity of menstrually-related migraine headaches.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 34 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Headache
• Migraine
• Migraine Disorders

Intervention

Drug:
• 91-day Levonorgestrel Oral Contraceptive
91-day treatment consisting of 84 blue combination tablets containing 150 µg LNG/30 µg EE and 7 yellow tablets containing 10 µg EE.
• Placebo
1 tablet daily to match experimental arm

Locations

Country	Name	City	State
United States	Teva Investigational Site	Columbia	South Carolina
United States	Duramed Investigational Site	Dallas	Texas
United States	Duramed Investigational Site	Edison	New Jersey
United States	Teva Investigational Site	Hilton Head	South Carolina
United States	Teva Investigational Site	Houston	Texas
United States	Teva Investigational Site	La Mesa	California
United States	Teva Investigational Site	Medford	Oregon
United States	Teva Investigational Site	Memphis	Tennessee
United States	Duramed Investigational Site	New York	New York
United States	Duramed Investigational Site	Philadelphia	Pennsylvania
United States	Duramed Investigational Site	San Antonio	Texas
United States	Duramed Investigational Site	San Diego	California
United States	Teva Investigational Site	San Diego	California
United States	Duramed Investigational Site	San Francisco	California
United States	Teva Investigational Site	Savannah	Georgia
United States	Duramed Investigational Site	Seattle	Washington
United States	Teva Investigational Site	Tulsa	Oklahoma
United States	Teva Investigational Site	Uniontown	Pennsylvania
United States	Duramed Investigational Site	Virginia Beach	Virginia
United States	Duramed Investigational Site	Washington	District of Columbia
United States	Duramed Investigational Site	West Palm Beach	Florida
United States	Teva Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duramed Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With = 50% Reduction in Migraine Frequency During the Treatment Period	The number of participants with at least 50% reduction in migraine frequency (average weekly number of migraine episodes) through the end of the 91-day treatment period compared with Baseline (the 25- to 35-day baseline qualification period). Participants recorded the incidence, timing and intensity of migraines in a migraine diary during the prequalification period and throughout the 91-day treatment period.	Baseline (25-35 days before Day 1) and Days 1-91	No
Secondary	Percentage of Participants With = 50% Reduction in Migraine Frequency During the First, Second and Third Months	The percentage of participants with at least 50% reduction in migraine frequency (average weekly number of migraine episodes) compared to Baseline at each month of the treatment period.	Baseline, Month1, Month 2 and Month 3	No
Secondary	Change From Baseline in Average Migraine Severity	Migraine severity was recorded by participants in the Baseline qualification diary and study migraine diary during the treatment period. Participants could report a severity of none (score = 0), mild (1), moderate (2), or severe (3). In general, if a headache was mild, daily activities could be resumed and little to no medication was taken. Moderate headaches required medication and effected daily activities. Severe headaches were debilitating and required medication.; Average migraine severity is defined as the sum of the severity ratings divided by the total number of migraine episodes reported during the observation period (for example, Baseline, First Month, Second Month, Third Month, and 91-Day Treatment Period). A negative change from Baseline score indicates improvement in severity.	Baseline and Month 1, Month 2 and Month 3	No
Secondary	Percentage of Participants Who Required Rescue Medications During the Study Period	Participants recorded use of rescue medications for migraines in the migraine diary during the course of study treatment.	Baseline, Month 1, Month 2 and Month 3	No
Secondary	Change From Baseline in Migraine Disability Assessment	The migraine disability assessment (MIDAS) test is used to determine how severely migraines affect a patient's life. Participants were asked five questions about how often their headaches limited their ability to go to work or school, to do household work or to do family or leisure activities in the past 3 months.; The MIDAS score equals the sum of the days answered for each question and ranges from 0 (no disability) to approximately 270 (severe disability; the upper bound is dependent on the number of days a participant would plan to work or participate in other activities).; The MIDAS score is classified into four grades of severity: 0 to 5: MIDAS Grade I, Little or no disability; 6 to 10: MIDAS Grade II, Mild disability; 11 to 20: MIDAS Grade III, Moderate disability; 21+: MIDAS Grade IV, Severe disability	Baseline and Week 15	No
Secondary	Change From Baseline in Headache Impact Test	The Headache Impact Test (HIT) is a tool used to measure the impact headaches have on patients' ability to function on the job, at school, at home and in social situations.; HIT-6 consists of 6 questions each scored on a scale from Never (6 points) to Always (13 points). The total score ranges from 36 to 78 with higher scores indicating greater impact on life.; There was an error in administration of the HIT-6 in this study. Question 6 was not administered, and question 3 from the MIDAS was included instead. Therefore, the total score of the HIT-6 could not be calculated.	Baseline and Week 15	No
Secondary	Number of Participants With Adverse Events (AEs)	An AE is any untoward medical occurrence in a clinical investigation participant and which does not necessarily have to have a causal relationship with this treatment or clinical study.; The following definitions were used to assess AE severity: Mild: Awareness of signs or symptoms, but they are easily tolerated; Moderate: Enough discomfort to cause interference with usual activity; Severe: Incapacitating, with inability to perform usual activity.; Relationship to study drug was assessed as either: None: Causal relationship can be ruled out; Possibly: Causal relationship at least reasonably possible, i.e. relationship cannot be ruled out; Definitely: Causal relationship is certain.; A serious adverse event (SAE) is one that met any one of the following criteria: Fatal or life threatening; Requires or prolongs in patient hospitalization; Results in persistent or significant disability/incapacity; Congenital anomaly / birth defect; Important medical event.	Up to 15 weeks	Yes
Secondary	Mean Number of Days of Bleeding or Spotting	Bleeding and spotting were recorded by participants in the migraine diary during the 91-day treatment period.	91-day treatment period	Yes