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A Safety Study of LY2951742 in Participants With Migraine, With or Without Aura

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ClinicalTrials.gov Identifier: NCT02614287
Recruitment Status : Active, not recruiting
First Posted : November 25, 2015
Last Update Posted : May 19, 2017
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The main purpose of this study is to evaluate the longer term safety of the study drug known as LY2951742 in participants with episodic or chronic migraine.

Condition or disease Intervention/treatment Phase
Migraine Drug: LY2951742 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Long-Term, Open-Label Safety Study of LY2951742 in Patients With Migraine
Study Start Date : November 2015
Primary Completion Date : May 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Dose Level 1 LY2951742
Dose Level 1 LY2951742 given by subcutaneous (SC) injection once a month for up to 12 months.
Drug: LY2951742
Administered SC
Experimental: Dose Level 2 LY2951742
Dose Level 2 LY2951742 given by SC injection once a month for up to 12 months.
Drug: LY2951742
Administered SC

Primary Outcome Measures :
  1. Percentage of Participants who Discontinue [ Time Frame: Baseline through Month 12 ]

Secondary Outcome Measures :
  1. Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY2951742 [ Time Frame: Baseline through Month 12 ]
  2. Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP) [ Time Frame: Baseline through Month 12 ]
  3. Percentage of Participants Developing Anti-Drug Antibodies to LY2951742 [ Time Frame: Baseline through Month 12 ]
  4. Mean Change from Baseline in the Number of Migraine Headache Days [ Time Frame: Baseline, Month 12 ]
  5. Mean Change from Baseline in the Number of Headache Days [ Time Frame: Baseline, Month 12 ]
  6. Proportion of Participants with Reduction from Baseline ≥50% in Monthly Migraine Headache Days [ Time Frame: Month 12 ]
  7. Mean Change from Baseline in the Frequency of Medication Use for the Acute Treatment of Migraines or Headaches [ Time Frame: Baseline, Month 12 ]
  8. Mean Patient Global Impression-Improvement (PGI-I) Score [ Time Frame: Month 12 ]
  9. Mean Change from Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score [ Time Frame: Baseline, Month 12 ]
  10. Mean Change from Baseline on the Migraine-Specific Quality of Life Questionnaire [ Time Frame: Baseline, Month 12 ]
  11. Participant Satisfaction with Medication Questionnaire-Modified (PSMQ-M) Score [ Time Frame: Month 12 ]
  12. Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score [ Time Frame: Month 12 ]

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

Inclusion Criteria:

  • Have a diagnosis of episodic or chronic migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.1, 1.2 or 1.3) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, and migraine onset prior to age 50.
  • Prior to baseline, a history of 4 or more migraine headache days per month on average for the past 3 months.

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.

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): NCT02614287

  Show 28 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
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

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02614287     History of Changes
Other Study ID Numbers: 15770
I5Q-MC-CGAJ ( Other Identifier: Eli Lilly and Company )
2015-001884-38 ( EudraCT Number )
First Posted: November 25, 2015    Key Record Dates
Last Update Posted: May 19, 2017
Last Verified: May 2017

Keywords provided by Eli Lilly and Company:

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