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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT02614287
First received: November 23, 2015
Last updated: April 8, 2016
Last verified: April 2016
  Purpose
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 Intervention Phase
Migraine
Drug: LY2951742
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Long-Term, Open-Label Safety Study of LY2951742 in Patients With Migraine

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Percentage of Participants who Discontinue [ Time Frame: Baseline through Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY2951742 [ Time Frame: Baseline through Month 12 ] [ Designated as safety issue: No ]
  • Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP) [ Time Frame: Baseline through Month 12 ] [ Designated as safety issue: No ]
  • Percentage of Participants Developing Anti-Drug Antibodies to LY2951742 [ Time Frame: Baseline through Month 12 ] [ Designated as safety issue: No ]
  • Mean Change from Baseline in the Number of Migraine Headache Days [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
  • Mean Change from Baseline in the Number of Headache Days [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
  • Proportion of Participants with Reduction from Baseline ≥50% in Monthly Migraine Headache Days [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Mean Change from Baseline in the Frequency of Medication Use for the Acute Treatment of Migraines or Headaches [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
  • Mean Patient Global Impression-Improvement (PGI-I) Score [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Mean Change from Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
  • Mean Change from Baseline on the Migraine-Specific Quality of Life Questionnaire [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
  • Participant Satisfaction with Medication Questionnaire-Modified (PSMQ-M) Score [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score [ Time Frame: Month 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: November 2015
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 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 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

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02614287

  Show 28 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: NCT02614287     History of Changes
Other Study ID Numbers: 15770  I5Q-MC-CGAJ  2015-001884-38 
Study First Received: November 23, 2015
Last Updated: April 8, 2016
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Hungary: National Institute of Pharmacy
Belgium: Federal Agency for Medicines and Health Products, FAMHP

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

ClinicalTrials.gov processed this record on December 05, 2016