Clinical Trials List
2016-02-01 - 2020-04-02
Phase III
Terminated5
A Phase 3, randomized, double-blind, placebo-controlled study to evaluate LY2951742 in patients with chronic migraine — the REGAIN trial.
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Trial Applicant
ELI LILLY AND COMPANY(TAIWAN), INC.
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Sponsor
Eli Lilly and Company (Taiwan), Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/10/29
Investigators and Locations
Co-Principal Investigator
- 陳韋達 Division of Neurology
- 陳世彬 Division of Neurology
- YEN-FENG WANG Division of Neurology
- Jong-Ling Fuh Division of Neurology
- 陳世彬 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 林慧娟 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 郭蔭庭 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
The Statistical Analysis Plan (SAP) will detail the specific methods for testing the following key secondary endpoints (including testing hierarchy, correlations, and allocation/transfer of Type I error):
Proportion of patients with a ≥50% reduction from baseline in MMD over the 3-month double-blind period.
Proportion of patients with a ≥75% reduction from baseline in MMD over the 3-month double-blind period.
Proportion of patients with a 100% reduction from baseline in MMD over the 3-month double-blind period.
Mean change from baseline to Month 3 in the Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) Role Function–Restrictive domain score.
Mean change in monthly migraine days requiring acute migraine/headache medications over the 3-month double-blind period.
Mean change from baseline to Month 3 in the Patient Global Impression of Severity (PGI-S) score.
Inclution Criteria
You are able and willing to use an electronic diary to record information about headaches, including occurrence, duration, symptoms, severity, and any treatments used for your headaches.
You agree not to post any personal medical information or trial-related content on websites or social media platforms (such as Facebook, Twitter, LinkedIn, Google+, etc.) until the entire study is completed.
Exclusion Criteria
You are currently receiving or are expected to receive prohibited medications or treatments during the study (your study doctor will review this with you).
You have a history of specific types of migraine or headache types other than migraine or tension-type headaches (your study doctor will review this with you).
You have sustained a head or neck injury within 6 months prior to the start of the study.
You currently have, or have had, heart, liver, respiratory, autoimmune, hematologic, endocrine, psychiatric, or neurologic disorders, or any other significant medical condition that may pose safety concerns during the study.
You have known allergies to certain medications (to be reviewed by your study doctor).
You currently have suicidal thoughts or intent.
You are pregnant or breastfeeding.
You have a history of drug or alcohol abuse within 1 year prior to study entry, or you have a positive urine drug screen at the first visit.
You have used opioid or barbiturate analgesics more than 3 times per month for over 2 months within the past 6 months.
You are currently participating in another clinical trial that may interfere with this study’s results.
You are allergic to LY2951742 or any other similar class of medications.
You are a study investigator, a member of the study team, or an immediate family member (spouse, parent, sibling, or child—biological or legally adopted) of either.
You are an employee of Eli Lilly and Company.
The Estimated Number of Participants
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Taiwan
40 participants
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Global
825 participants
