Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
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 : Completed
First Posted : October 1, 2015
Results First Posted : August 25, 2020
Last Update Posted : August 25, 2020
Sponsor:
Collaborator:
CoLucid Pharmaceuticals
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE September 29, 2015
First Posted Date  ICMJE October 1, 2015
Results First Submitted Date  ICMJE August 7, 2020
Results First Posted Date  ICMJE August 25, 2020
Last Update Posted Date August 25, 2020
Actual Study Start Date  ICMJE October 7, 2015
Actual Primary Completion Date August 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2020)
Number of Participants With at Least 1 Treatment Emergent Adverse Event [ Time Frame: Up to 12 months ]
An AE with an onset on or within 48 hours after a dose of study drug, or an event that worsened in intensity within 48 hours of a dose of study drug was considered a treatment-emergent adverse event (TEAE). A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.
Original Primary Outcome Measures  ICMJE
 (submitted: September 30, 2015)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2020)
  • Percentage of Migraine Attacks With Pain Freedom (PF) at 2 Hours After Dose [ Time Frame: Up to 12 months ]
    Pain freedom is defined as a reduction in headache severity from mild (1), moderate (2), or severe (3) at baseline to none (0).
  • Percentage of Migraine Attacks With Most Bothersome Symptom-Free (MBS) at 2 Hours After Dose [ Time Frame: Up to 12 months ]
    MBS-free, defined as the absence of the associated symptom of migraine (nausea, phonophobia, and/or photophobia) at 2 hours postdose that was identified predose as the most bothersome symptom.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2015)
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
Current Other Pre-specified Outcome Measures
 (submitted: August 7, 2020)
Percentage of Participants With Medical Resource Utilization [ Time Frame: Up to 12 months ]
Medical Resource utilization for any cardiovascular (CV) events and/or related resource utilization, such as visits to cardiologists, procedures, hospitalizations, new treatments or treatment adjustments for CV disease and any visits to an emergency room (ER) or physician's office for treatment of migraine was reported.
Original Other Pre-specified Outcome Measures
 (submitted: September 30, 2015)
Medical resource utilization [ Time Frame: Up to 12 months ]
Use of health care professionals or services beyond the scope of the clinical trial
 
Descriptive Information
Brief Title  ICMJE An Open-label, Long-term, Safety Study of Lasmiditan for the Acute Treatment of Migraine
Official Title  ICMJE An Open-label, LonG-term, Safety Study of LAsmiDItan (100 mg and 200 mg) in the Acute Treatment Of MigRaine (GLADIATOR)
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) or for a subset of lasmiditan-naïve subjects with migraine. 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Migraine Disorders
Intervention  ICMJE Drug: Lasmiditan
oral tablet
Other Name: LY573144
Study Arms  ICMJE
  • Experimental: Lasmiditan 100mg
    Participants received oral dose of 100 milligrams (mg) Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond within 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
    Intervention: Drug: Lasmiditan
  • Experimental: Lasmiditan 200mg
    Participants received oral dose of 200mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond with in 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
    Intervention: Drug: Lasmiditan
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 7, 2020)
2171
Original Estimated Enrollment  ICMJE
 (submitted: September 30, 2015)
2580
Actual Study Completion Date  ICMJE August 20, 2019
Actual Primary Completion Date August 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Able and willing to give written informed consent and authorize Health Insurance Portability and Accountability Act (HIPAA).
  • Completed COL MIG-301 or COL MIG-302 within the last 12 weeks. Subjects that completed COL MIG-301 prior to COL MIG-305 being available will be allowed to enroll as long as enrollment occurs within 4 weeks of COL MIG-305 activation at their site. (NOTE: Additional subjects may qualify if they completed COL MIG-301 or COL MIG-302 >12 weeks prior or if they have not participated in either prior study, but meet eligibility criteria outlined for COL MIG-302.)
  • 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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02565186
Other Study ID Numbers  ICMJE 16890
H8H-CD-LAHL ( Other Identifier: Eli Lilly and Company )
2015-005674-37 ( EudraCT Number )
COL MIG-305 ( Other Identifier: Colucid )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE CoLucid Pharmaceuticals
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP