Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
120

Summary

Conditions
Migraine Disorders
Type
Interventional
Phase
Phase 4
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: After a run-in phase of 4 weeks, patients will be randomized, according to a 1:1 ratio, to a 24 weeks of treatment, as follow: Sequence 1: A/B Sequence 2: B/A where: A=monthly subcutaneous erenumab 140 mg for 12 weeks; B=monthly subcutaneous masked placebo for 12 weeks. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Study treatments will be all identical in packaging, labeling, schedule of administration, appearance, taste and odorPrimary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

Description

This is a randomized, double blind, placebo-controlled trial with a 2-sequence, 2-period, 2-treatment crossover design. The study population will consist of adult male and female subjects with a documented history of episodic migraine (4 to 14 baseline migraine days), who have failed at least 2 prev...

This is a randomized, double blind, placebo-controlled trial with a 2-sequence, 2-period, 2-treatment crossover design. The study population will consist of adult male and female subjects with a documented history of episodic migraine (4 to 14 baseline migraine days), who have failed at least 2 previous migraine prophylactic treatment for lack of efficacy or tolerability. After a run-in phase of 4 weeks, patients will be randomized, according to a 1:1 ratio, to a 24 weeks of treatment, as follow: Sequence 1: A/B Sequence 2: B/A where: A=monthly subcutaneous erenumab 140 mg for 12 weeks; B=monthly subcutaneous masked placebo for 12 weeks

Tracking Information

NCT #
NCT03977649
Collaborators
Not Provided
Investigators
Not Provided
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