ClinicalTrials.gov
ClinicalTrials.gov Menu

An Open-label, Long-term, Safety Study of Lasmiditan for the Acute Treatment of Migraine (GLADIATOR)

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.
ClinicalTrials.gov Identifier: NCT02565186
Recruitment Status : Enrolling by invitation
First Posted : October 1, 2015
Last Update Posted : November 5, 2018
Sponsor:
Collaborator:
CoLucid Pharmaceuticals
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
This is a prospective, randomized, open-label study in subjects with migraine who have completed the Phase 3 studies, COL MIG 301/LAHJ (NCT02439320) or COL MIG-302/LAHK (NCT02605174). The study is designed to evaluate the safety and tolerability of long-term intermittent use of lasmiditan 100 mg and of lasmiditan 200 mg, as the first dose and as a second dose, for the acute treatment of migraine. Long term efficacy will also be evaluated.

Condition or disease Intervention/treatment Phase
Migraine Disorders Drug: lasmiditan Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2580 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, LonG-term, Safety Study of LAsmiDItan (100 mg and 200 mg) in the Acute Treatment Of MigRaine (GLADIATOR)
Actual Study Start Date : October 7, 2015
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: lasmiditan 100 mg
single tablet with second dose for rescue/recurrence
Drug: lasmiditan
oral tablet
Other Name: LY573144

Experimental: lasmiditan 200 mg
single tablet with second dose for rescue/recurrence
Drug: lasmiditan
oral tablet
Other Name: LY573144




Primary Outcome Measures :
  1. Safety (Adverse events) [ Time Frame: up to 12 months ]
    Adverse events will be summarized in terms of the proportion of patients and the proportion of attacks associated with any adverse event and with specific adverse events


Secondary Outcome Measures :
  1. Efficacy (proportion of attacks treated with study medication which respond at 2 hours) [ Time Frame: up to 12 months ]
    The proportion of attacks treated with study medication which respond at 2 hours will be calculated for each 3 month period


Other Outcome Measures:
  1. Medical resource utilization [ Time Frame: up to 12 months ]
    Use of health care professionals or services beyond the scope of the clinical trial



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able and willing to give written informed consent and authorize Health Insurance Portability and Accountability Act (HIPAA).
  • Completed COL MIG-301/LAHJ (NCT02439320) or COL MIG-302/LAHK (NCT02605174) within the last 4 weeks.
  • Females of child-bearing potential must be using or willing to use a highly effective form of contraception (e.g. combined oral contraceptive, intrauterine device (IUD), abstinence or vasectomized partner).
  • Able and willing to complete an electronic diary to record details of all migraine attacks treated with study drug.

Exclusion Criteria:

  • Any medical condition or clinical laboratory test which in the judgment of the Investigator makes the subject unsuitable for the study.
  • Pregnant or breast-feeding women.
  • Women of child-bearing potential not using or not willing to use highly effective contraception.
  • Participant is at imminent risk of suicide (positive response to question 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
  • Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes since completing COL MIG-301/LAHJ (NCT02439320) or COL MIG-302/LAHK (NCT02605174).
  • Participation in any clinical trial of an experimental drug or device since completing EoS/Visit 2 of COL MIG 301/LAHJ (NCT02439320) or COL MIG-302/LAHK (NCT02605174).

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): NCT02565186


  Show 202 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
CoLucid Pharmaceuticals
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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02565186     History of Changes
Other Study ID Numbers: 16890
H8H-CD-LAHL ( Other Identifier: Eli Lilly and Company )
2015-005674-37 ( EudraCT Number )
COL MIG-305 ( Other Identifier: Colucid )
First Posted: October 1, 2015    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: November 1, 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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