A clinical trial to study the safety of long term use of lasmiditan 100 mg and 200 mg in the treatment of migraine

Phase 1

• Conditions: acute migraine; MedDRA version: 20.0Level: LLTClassification code 10066635Term: Acute migraineSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0Level: PTClassification code 10052787Term: Migraine without auraSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0Level: HLTClassification code 10027603Term: Migraine headachesSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0Level: PTClassification code 10027599Term: MigraineSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0Level: PTClassification code 10027607Term: Migraine with auraSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-005674-37-DE
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-27
• Study Completion: 2019-08-20
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2171

Inclusion Criteria

All subjects entered into this trial must meet the following criteria:
1. Able and willing to give written informed consent
2. Completed COL MIG-301 or COL MIG-302 within the last 12 weeks.
3. Females of child-bearing potential must be using or willing to use a highly effective form of contraception (e.g. combined oral contraceptive, IUD, abstinence, or vasectomized partner).
4. Able and willing to complete an electronic diary to record details of all migraine attacks treated with study drug.

Inclusion criteria for sub-study:
use this subsection in addition to the corresponding subsection (with the
exception of inclusion criterion #2) in the main protocol:
[12] Have completed either COL MIG-301 or COL MIG-302.
[13] Have a Migraine Disability Assessment score (MIDAS) score =11
(see Appendix 2 of the main protocol)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2451
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 129

Exclusion Criteria

Subjects will be excluded from this trial if they meet any of the following criteria:
1. Any medical condition or clinical laboratory test which in the judgment of the Investigator makes the subject unsuitable for the study.
2. Pregnant or breast-feeding women.
3. Women of child-bearing potential not using or not willing to use highly effective contraception.
4. Subject is at imminent risk of suicide (positive response to question 4 or 5 on the C-SSRS).
5. Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes since completing COL MIG-301 or COL MIG-302.
6. Participation in any clinical trial of an experimental drug or device since completing EoS/Visit 2 of COL MIG-301 or COL MIG-302.
7. Subject did not dose a migraine during the allotted time while enrolled in COL MIG-301 or COL MIG-302 or was evaluated to be noncompliant with the e-diary requirements (particularly recording their migraine and post-dose assessments).

Exclusion criteria sub-study
Use this subsection in addition to the corresponding subsection in the
main protocol:
[5] Exclusion criterion #5 from the main protocol (Initiation of or a
change in concomitant medication to reduce the frequency of migraine
episodes since completing COL MIG-301 or COL MIG-302) is not
exclusionary for those subjects participating in this protocol addendum
and has been deleted.
[14] Subject did not dose a migraine during the allotted time while
enrolled in COL MIG-302 or was evaluated to be noncompliant with the
e-diary
requirements (particularly recording their migraine and post-dose
assessments). In exceptional circumstances, and with the prior approval
of the Sponsor, patients previously considered ineligible due to this
criterion may be reconsidered.
Refer to the main protocol for the remainder of Section 6.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary objective<br>To evaluate the safety and tolerability of long-term intermittent use of lasmiditan 100 mg and of lasmiditan 200 mg, as the first and as a second dose, in the acute treatment of migraine.;Secondary Objective: Secondary Objectives<br>To explore the long-term efficacy of lasmiditan 100 mg and lasmiditan 200 mg in terms of headache response over time.<br><br>Additional Objectives<br>To compare patient reported resource utilization during the study to patient reported information from COL MIG-301 or COL MIG-302 in terms of cardiovascular events and in terms of migraine episodes.;Primary end point(s): The proportion of patients and the proportion of attacks associated with any adverse event and with specific adverse events.;Timepoint(s) of evaluation of this end point: Calculated for each 3 months period

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The proportion of migraine attacks treated with lasmiditan 100 mg and with lasmiditan 200 mg which respond at 2 hours, calculated for each 3 month period.;Timepoint(s) of evaluation of this end point: 2 hours post-dose, calculated for each 3 months period