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Trial record 1 of 1 for:    Evaluation of LY2951742 in the Prevention of Episodic Migraine (EVOLVE-1)
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Evaluation of LY2951742 in the Prevention of Episodic Migraine- the EVOLVE-1 Study (EVOLVE-1)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02614183
First Posted: November 25, 2015
Last Update Posted: April 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eli Lilly and Company
  Purpose
The main purpose of this study is to evaluate the efficacy of the study drug known as LY2951742 in participants with episodic migraine.

Condition Intervention Phase
Migraine Drug: LY2951742 Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Episodic Migraine - the EVOLVE-1 Study

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Mean Change from Baseline in the Number of Monthly Migraine Headache Days [ Time Frame: Baseline, Month 6 ]

Secondary Outcome Measures:
  • Proportion of Participants with Reduction from Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days [ Time Frame: Month 6 ]
  • Mean Change from Baseline on the Migraine-Specific Quality of Life Questionnaire [ Time Frame: Baseline, Month 6 ]
  • Mean Change from Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache [ Time Frame: Baseline, Month 6 ]
  • Mean Change from Baseline in the Patient Global Impression of Severity (PGI-S) Score [ Time Frame: Baseline, Month 6 ]
  • Mean Change from Baseline in Headache Hours [ Time Frame: Baseline, Month 6 ]
  • Mean Change from Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score [ Time Frame: Baseline, Month 6 ]
  • Percentage of Participants Developing Anti-drug Antibodies to LY2951742 [ Time Frame: Baseline through Month 6 ]
  • Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY2951742 [ Time Frame: Baseline through Month 6 ]
  • Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP) [ Time Frame: Baseline through Month 6 ]

Estimated Enrollment: 825
Study Start Date: November 2015
Estimated Study Completion Date: October 2018
Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose Level 1 LY2951742
Dose level 1 LY2951742 given by subcutaneous (SC) injection once a month for 6 months.
Drug: LY2951742
Administered SC
Experimental: Dose Level 2 LY2951742
Dose level 2 LY2951742 given by SC injection once a month for 6 months.
Drug: LY2951742
Administered SC
Placebo Comparator: Placebo
Placebo given by SC injection once a month for 6 months.
Drug: Placebo
Administered SC

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a diagnosis of episodic migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.1 or 1.2) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, and migraine onset prior to age 50.

Exclusion Criteria:

  • Are currently enrolled in or have participated within the last 30 days or within 5 half-lives (whichever is longer) in a clinical trial involving an investigational product.
  • Current use or prior exposure to LY2951742 or another CGRP antibody.
  • Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to LY2951742.
  • History of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine) defined by IHS ICHD-3 beta.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02614183


  Show 95 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02614183     History of Changes
Other Study ID Numbers: 15767
I5Q-MC-CGAG ( Other Identifier: Eli Lilly and Company )
First Submitted: November 23, 2015
First Posted: November 25, 2015
Last Update Posted: April 20, 2017
Last Verified: April 2017

Keywords provided by Eli Lilly and Company:
prevention
prophylaxis
headache

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases