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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 2580

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.
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: 0
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. Participation in any clinical trial of an experimental drug or device
since completing EoS/Visit 2 of COL MIG-301 or COL MIG-302.
6. 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 non compliant
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

Secondary Outcome Measures

Name	Time	Method

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