Dose-ranging Study of Oral COL-144 in Acute Migraine Trea... | NCT00883051 | Trialant
NCT00883051
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Dec 23, 2019Actual
Enrollment
512Actual
Phase
Phase 2
Conditions
Migraine Disorders
Interventions
Lasmiditan
Placebo
Countries
Belgium
Finland
France
Germany
Spain
Protocol Section
Identification Module
NCT ID
NCT00883051
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
16892
Secondary IDs
ID
Type
Description
Link
H8H-CD-LAHO
Other Identifier
Eli Lilly and Company
2008-005010-43
EudraCT Number
COL MIG-202
Other Identifier
Colucid
Brief Title
Dose-ranging Study of Oral COL-144 in Acute Migraine Treatment
Official Title
A Double Blind Randomized Placebo-Controlled Parallel Group Dose-Ranging Study of Oral COL-144 in the Acute Treatment of Migraine
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Jan 2018
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 2009
Primary Completion Date
Feb 2010Actual
Completion Date
Feb 2010Actual
First Submitted Date
Apr 16, 2009
First Submission Date that Met QC Criteria
Apr 16, 2009
First Posted Date
Apr 17, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 8, 2019
Results First Submitted that Met QC Criteria
Dec 20, 2019
Results First Posted Date
Dec 23, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 20, 2019
Last Update Posted Date
Dec 23, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Name
Class
CoLucid Pharmaceuticals
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of a range of oral doses of COL-144 in treating migraine headache, in order to select a dose or doses for further evaluation.
Detailed Description
Migraine is a common chronic neurological disorder characterized by recurrent disabling episodes of moderate to severe headache accompanied by nausea, vomiting, photophobia, and phonophobia. Acute pharmacologic therapy for migraine aims to terminate the attack or reduce its severity. Analgesics are commonly used or, if these are ineffective, triptans. Since triptans are contraindicated in patients with coronary artery disease, uncontrolled hypertension, and cerebrovascular disease alternative medications are required for patients where simple analgesics do not work. COL-144 has no vasoconstrictor activity at clinically relevant concentrations and might meet this need. COL-144 was effective when given intravenously in a placebo-controlled dose-ranging study. This study investigates which dose of oral COL-144 is effective in the in acute treatment of migraine headache.
Conditions Module
Conditions
Migraine Disorders
Keywords
COL-144
acute treatment
migraine
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
512Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
50 mg Lasmiditan
Experimental
50 mg lasmiditan administered orally (PO)
Drug: Lasmiditan
100 mg Lasmiditan
Experimental
100 mg lasmiditan administered orally (PO)
Drug: Lasmiditan
200 mg Lasmiditan
Experimental
200 mg lasmiditan administered orally (PO)
Drug: Lasmiditan
400 mg Lasmiditan
Experimental
400 mg lasmiditan administered orally (PO)
Drug: Lasmiditan
Placebo
Placebo Comparator
Placebo administered orally (PO)
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Lasmiditan
Drug
Oral application of one dose of either 50 mg lasmiditan,100 mg lasmiditan, 200 mg lasmiditan, 400 mg lasmiditan or placebo as the first treatment for a new migraine attack providing that any aura symptoms have resolved and the headache is either moderate or severe and has been so for less than 4 hours.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Headache Response
Headache response is a binary response variable derived from the headache intensities recorded in the participant diary. Headache response is defined as a reduction in headache severity from moderate or severe at baseline to mild or no headache, at two hours after administration of study drug.
2 hours postdose
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Who Are Headache Free (Absence of Headache) After First Dose
The percentage of participants defined as mild, moderate, or severe headache pain becoming none.
2 hours post dose
Percentage of Participants With Headache Recurrence
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Patients with migraine with or without aura fulfilling the IHS diagnostic criteria 1.1 and 1.2.1 (2004)
History of migraine of at least 1 year
Migraine onset before the age of 50 years
History of 1 - 8 migraine attacks per month
Male or female patients aged 18 to 65 years
Female patients of child-bearing potential must be using a highly effective form of contraception (e.g., combined oral contraceptive, IUD, abstinence, vasectomized partner)
Able and willing to give written informed consent
Able and willing to complete a migraine diary card to record details of the attack treated with study medication
Exclusion Criteria:
History of life threatening or intolerable adverse reaction to any triptan
Use of prescription migraine prophylactic drugs within 15 days (30 days for flunarizine) prior to Screening Visit and during study participation
Using herbal preparations (e.g., feverfew, butterbur) for migraine prophylaxis
Using 5-HT reuptake inhibitors
Using drugs known to inhibit CYP450 enzymes (see Appendix 2 for details)
Pregnant or breast-feeding women
Women of child-bearing potential not using highly effective contraception
History or evidence of coronary artery disease, ischemic or hemorrhagic stroke, epilepsy or any other condition placing the patient at increased risk of seizures
History of hypertension (controlled or uncontrolled)
History of orthostatic hypotension
Current use of hemodynamically active cardiovascular drugs
History within the previous 3 years or current evidence of abuse of any drug, prescription or illicit, or alcohol
Significant renal or hepatic impairment
Previous participation in this clinical trial
Participation in any clinical trial of an experimental drug or device in the previous 30 days
Any medical condition or laboratory test which in the judgment of the investigator makes the patient unsuitable for the study
Known Hepatitis B or C or HIV infection
Patients who are employees of the sponsor
Relatives of, or staff directly reporting to, the investigator
Patients with known hypersensitivity to COL-144, other 5HT1F receptor agonists or to any excipient of COL-144 drug product
Patients who were treated with study medication in the COL MIG-201 study (Patients screened but not treated under that protocol are not excluded)
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
65 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
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)
Blumenfeld A, Tepper SJ, Khanna R, Doty E, Vincent M, Miller SI. Serotonin syndrome in the acute treatment landscape of migraine: the lasmiditan experience. Front Neurol. 2023 Oct 27;14:1291102. doi: 10.3389/fneur.2023.1291102. eCollection 2023.
Farkkila M, Diener HC, Geraud G, Lainez M, Schoenen J, Harner N, Pilgrim A, Reuter U; COL MIG-202 study group. Efficacy and tolerability of lasmiditan, an oral 5-HT(1F) receptor agonist, for the acute treatment of migraine: a phase 2 randomised, placebo-controlled, parallel-group, dose-ranging study. Lancet Neurol. 2012 May;11(5):405-13. doi: 10.1016/S1474-4422(12)70047-9. Epub 2012 Mar 28.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
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.
Types
Study Protocol
Statistical Analysis Plan (SAP)
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.
Participants who received study drug and which became pain free at 2 hours postdose and worsened again upto 24 hours post-dose.
up to 24 hours postdose
Percentage of Participants With Headache Severity (4 Point Rating Scale)
Headache severity was evaluated by the participant using the International Headache Society (IHS) four point headache severity rating scale (0=no pain, 1=mild pain, 2=moderate pain, and 3=severe pain) with a lower score being less severe and a higher score being more severe.
2 hours postdose
Percentage of Participants Who Have Symptoms of Nausea
Percentage of participants who have symptoms of nausea two hours post treatment.
2 hours postdose
Percentage of Participants Who Have Symptoms Phonophobia
Percentage of participants who have symptoms of phonophobia two hours post treatment.
2 hours postdose
Percentage of Participants Who Have Photophobia
Percentage of participants who have symptoms of photophobia two hours post treatment.
2 hours postdose
Percentage of Participants With Vomiting
Percentage of participants with vomiting 2 hours post treatment.
2 hours postdose
Disability (4 Point Scale: Not at All, Mild Interference, Marked Interference, Completely - Needs Bed Rest)
The participant is asked "How much is the migraine interfering with normal activities?" on a 4 point scale 0-Not at all, 1-Mild interference, 2-Marked interference ,3-Completely needs bed rest, with a lower score having lower interference and higher score worse interference.
2 hours postdose
Percentage of Participants Who Used Rescue Medication
Rescue medication was permitted after completion of the 2 hour assessment if migraine did not respond (participant was not pain free).
Postdose 2 through 24 hours
Number of Participants Reporting a Score on the Patient Global Impression of Improvement (PGI-I)
PGI-I requests participants to mark the box that best describes their cluster headache condition since they started taking the medicine. The options in the displayed boxes are represented on a 7-point scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse, a lower number indicates much better and a higher number indicates worse.
2 hours postdose
Actual Time to Headache Relief and Time to Pain Free
The participant answered "Did your migraine pain go away completely (pain free) within 24 hours of dosing" and record the time.
Actual time to meaningful pain relief and actual time to pain free will be censored at 24 hours if meaningful pain relief or pain free is documented to be greater than 24 hours after dosing and "Did you experience meaningful relief (headache relief) from your migraine within 24 hours after dosing?".
up to 24 hours postdose
Change From Baseline in Heart Rate
Change from baseline in assessment of vital signs (heart rate).
Baseline through Day 14
Change From Baseline in Systolic Blood Pressure
Change from baseline in vital signs (systolic blood pressure).
Baseline through Day 14
Change From Baseline in Diastolic Blood Pressure
Change from baseline in vital signs (diastolic blood pressure).
Baseline through Day 14
Percentage of Participants With Change From Baseline in Physical Examination Parameters
Participants were evaluated for skin, head, ear, nose and throat, cardiovascular and musculoskeletal changes from a normal screening to an abnormal screening. Changes in the physical examination noted as non-serious AEs or SAEs, regardless of causality, are located in the Reported Adverse Events section.
Baseline through Day 14
Change From Baseline in Hematology Tests
Hematology tests, including a complete blood count (CBC) measured red blood cells, white blood cells, hemoglobin, neutrophils and platelets.
Baseline through Day 14
Number of Serious Adverse Events
A summary of non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
up to 8 weeks
Hasselt
Limburg
3500
Belgium
Leuven
Vlaams-Brabant
3000
Belgium
Bruges
West-Vlaanderen
8000
Belgium
Brussels
1070
Belgium
Liège
4000
Belgium
Helsinki
Etelä-Suomi
00029 HUS
Finland
Hyvinkää
Etelä-Suomi
05850
Finland
Mikkeli
Itä-Suomen Lääni
50100
Finland
Pori
Länsi-Suomen
28100
Finland
Jyväskylä
Länsi-Suomi
40100
Finland
Tampere
Länsi-Suomi
33200
Finland
Turku
Länsi-Suomi
20100
Finland
Nice
Alpes-Maritimes
06002
France
Bordeaux
Gironde
33076
France
Toulouse
Haute-Garonne
31059
France
Lille
Nord
59 037
France
Rouen
Seine-Maritime
76031
France
Paris
75010
France
Freiburg/Breisgau
Baden-Wurttemberg
79106
Germany
Göppingen
Baden-Wurttemberg
73033
Germany
München
Bavaria
80802
Germany
München
Bavaria
81377
Germany
Wiesbaden
Hesse
65189
Germany
Erkelenz
North Rhine-Westphalia
41812
Germany
Essen
North Rhine-Westphalia
45122
Germany
Münster
North Rhine-Westphalia
48129
Germany
Itzehoe
Schleswig-Holstein
25524
Germany
Berlin
10117
Germany
Bremen
28329
Germany
Hamburg
20246
Germany
Seville
Andalusia
41013
Spain
Barcelona
Catalonia
08036
Spain
Santiago de Compostela
Galicia
15706
Spain
Alcorcón
Madrid
28922
Spain
Pamplona
Navarre
31008
Spain
Oviedo
Principality of Asturias
33007
Spain
Gandia
Valencia
46701
Spain
Valencia
Valencia
46021
Spain
FG002
200 mg Lasmiditan
200 mg lasmiditan administered PO within 4 hours of a migraine attack
FG003
400 mg Lasmiditan
400 mg lasmiditan administered PO within 4 hours of a migraine attack
FG004
Placebo
Placebo administered PO within 4 hours of a migraine attack
FG000106 subjects
FG001104 subjects
FG002100 subjects
FG00399 subjects
FG004103 subjects
No Study Medication Used
FG00024 subjects
FG00122 subjects
FG00229 subjects
FG00329 subjects
FG00417 subjects
Received at Least 1 Dose of Study Drug
FG00082 subjects
FG00182 subjects
FG00271 subjects
FG00370 subjects
FG00486 subjects
COMPLETED
FG00082 subjects
FG00182 subjects
FG00271 subjects
FG00370 subjects
FG00485 subjectsOne participant was lost to follow up and did not provide adverse event data.
NOT COMPLETED
FG00024 subjects
FG00122 subjects
FG00229 subjects
FG00329 subjects
FG00418 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
Did not use study medication
FG00024 subjects
FG00122 subjects
FG00229 subjects
FG00329 subjects
FG004
All randomized participants who received at least 1 dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
50 mg Lasmiditan
50 mg lasmiditan administered PO within 4 hours of a migraine attack
BG001
100 mg Lasmiditan
100 mg lasmiditan administered PO within 4 hours of a migraine attack
BG002
200 mg Lasmiditan
200 mg lasmiditan administered PO within 4 hours of a migraine attack
BG003
400 mg Lasmiditan
400 mg lasmiditan administered PO within 4 hours of a migraine attack
BG004
Placebo
Placebo administered PO within 4 hours of a migraine attack
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00082
BG00182
BG00271
BG00370
BG00486
BG005391
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Median
Full Range
years
Title
Denominators
Categories
Title
Measurements
BG00041(18 to 65)
BG00145(20 to 65)
BG00241(18 to 57)
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00069
BG00168
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
Belgium
Title
Measurements
BG0005
BG0015
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With Headache Response
Headache response is a binary response variable derived from the headache intensities recorded in the participant diary. Headache response is defined as a reduction in headache severity from moderate or severe at baseline to mild or no headache, at two hours after administration of study drug.
All randomized participants who received at least 1 dose of study drug and had a post-baseline evaluation.
Posted
Number
percentage of participants
2 hours postdose
ID
Title
Description
OG000
50 mg Lasmiditan
50 mg lasmiditan administered orally (PO)
OG001
100 mg Lasmiditan
100 mg lasmiditan administered orally (PO)
OG002
200 mg Lasmiditan
200 mg lasmiditan administered orally (PO)
OG003
400 mg Lasmiditan
400 mg lasmiditan administered orally (PO)
OG004
Placebo
Placebo administered orally (PO)
Units
Counts
Participants
OG00079
OG00181
OG00269
OG003
Title
Denominators
Categories
No
Title
Measurements
OG00057.0
OG00135.8
OG00249.3
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
OG004
Cochran-Armitage test for trend
<0.0001
Other
A hierarchical test procedure was applied only for analysis of the primary efficacy endpoint.
Secondary
Percentage of Participants Who Are Headache Free (Absence of Headache) After First Dose
The percentage of participants defined as mild, moderate, or severe headache pain becoming none.
All randomized participants who received at least 1 dose of study drug, a 2 hour postdose evaluation and evaluable headache relief data.
Posted
Number
percentage of participants
2 hours post dose
ID
Title
Description
OG000
50 mg Lasmiditan
50 mg lasmiditan administered orally (PO)
OG001
100 mg Lasmiditan
100 mg lasmiditan administered orally (PO)
OG002
200 mg Lasmiditan
200 mg lasmiditan administered orally (PO)
OG003
400 mg Lasmiditan
400 mg lasmiditan administered orally (PO)
OG004
Placebo
Secondary
Percentage of Participants With Headache Recurrence
Participants who received study drug and which became pain free at 2 hours postdose and worsened again upto 24 hours post-dose.
Randomized participants who received a dose of study drug, were pain free at 2 hours postdose and had postdose headache severity or symptom assessments.
Posted
Number
percentage of participants
up to 24 hours postdose
ID
Title
Description
OG000
50 mg Lasmiditan
50 mg lasmiditan administered orally (PO)
OG001
100 mg Lasmiditan
100 mg lasmiditan administered orally (PO)
OG002
200 mg Lasmiditan
200 mg lasmiditan administered orally (PO)
OG003
400 mg Lasmiditan
400 mg lasmiditan administered orally (PO)
OG004
Placebo
Secondary
Percentage of Participants With Headache Severity (4 Point Rating Scale)
Headache severity was evaluated by the participant using the International Headache Society (IHS) four point headache severity rating scale (0=no pain, 1=mild pain, 2=moderate pain, and 3=severe pain) with a lower score being less severe and a higher score being more severe.
Randomized participants who received a dose of study drug and had postdose headache severity or symptom assessments.
Posted
Number
percentage of participants
2 hours postdose
ID
Title
Description
OG000
50 mg Lasmiditan
50 mg lasmiditan administered orally (PO)
OG001
100 mg Lasmiditan
100 mg lasmiditan administered orally (PO)
OG002
200 mg Lasmiditan
200 mg lasmiditan administered orally (PO)
OG003
400 mg Lasmiditan
400 mg lasmiditan administered orally (PO)
OG004
Secondary
Percentage of Participants Who Have Symptoms of Nausea
Percentage of participants who have symptoms of nausea two hours post treatment.
Randomized participants who received a dose of study drug and had postdose symptom assessments.
Posted
Number
percentage of participants
2 hours postdose
ID
Title
Description
OG000
50 mg Lasmiditan
50 mg lasmiditan administered orally (PO)
OG001
100 mg Lasmiditan
100 mg lasmiditan administered orally (PO)
OG002
200 mg Lasmiditan
200 mg lasmiditan administered orally (PO)
OG003
400 mg Lasmiditan
400 mg lasmiditan administered orally (PO)
OG004
Placebo
Placebo administered orally (PO)
Secondary
Percentage of Participants Who Have Symptoms Phonophobia
Percentage of participants who have symptoms of phonophobia two hours post treatment.
Randomized participants who received a dose of study drug and had postdose symptom assessments.
Posted
Number
percentage of participants
2 hours postdose
ID
Title
Description
OG000
50 mg Lasmiditan
50 mg lasmiditan administered orally (PO)
OG001
100 mg Lasmiditan
100 mg lasmiditan administered orally (PO)
OG002
200 mg Lasmiditan
200 mg lasmiditan administered orally (PO)
OG003
400 mg Lasmiditan
400 mg lasmiditan administered orally (PO)
OG004
Placebo
Placebo administered orally (PO)
Secondary
Percentage of Participants Who Have Photophobia
Percentage of participants who have symptoms of photophobia two hours post treatment.
Randomized participants who received a dose of study drug and had postdose symptom assessments.
Posted
Number
percentage of participants
2 hours postdose
ID
Title
Description
OG000
50 mg Lasmiditan
50 mg lasmiditan administered orally (PO)
OG001
100 mg Lasmiditan
100 mg lasmiditan administered orally (PO)
OG002
200 mg Lasmiditan
200 mg lasmiditan administered orally (PO)
OG003
400 mg Lasmiditan
400 mg lasmiditan administered orally (PO)
OG004
Placebo
Placebo administered orally (PO)
Secondary
Percentage of Participants With Vomiting
Percentage of participants with vomiting 2 hours post treatment.
Randomized participants who received a dose of study drug and had postdose symptom assessments.
Posted
Number
percentage of participants
2 hours postdose
ID
Title
Description
OG000
50 mg Lasmiditan
50 mg lasmiditan administered orally (PO)
OG001
100 mg Lasmiditan
100 mg lasmiditan administered orally (PO)
OG002
200 mg Lasmiditan
200 mg lasmiditan administered orally (PO)
OG003
400 mg Lasmiditan
400 mg lasmiditan administered orally (PO)
OG004
Placebo
Placebo administered orally (PO)
Secondary
Disability (4 Point Scale: Not at All, Mild Interference, Marked Interference, Completely - Needs Bed Rest)
The participant is asked "How much is the migraine interfering with normal activities?" on a 4 point scale 0-Not at all, 1-Mild interference, 2-Marked interference ,3-Completely needs bed rest, with a lower score having lower interference and higher score worse interference.
All randomized participants who received at least 1 dose of study drug and had evaluable data.
Posted
Count of Participants
Participants
No
2 hours postdose
ID
Title
Description
OG000
50 mg Lasmiditan
50 mg lasmiditan administered orally (PO)
OG001
100 mg Lasmiditan
100 mg lasmiditan administered orally (PO)
OG002
200 mg Lasmiditan
200 mg lasmiditan administered orally (PO)
OG003
400 mg Lasmiditan
400 mg lasmiditan administered orally (PO)
Secondary
Percentage of Participants Who Used Rescue Medication
Rescue medication was permitted after completion of the 2 hour assessment if migraine did not respond (participant was not pain free).
Randomized participants who received a dose of study drug and had postdose headache severity or symptom assessments.
Posted
Number
percentage of participants
Postdose 2 through 24 hours
ID
Title
Description
OG000
50 mg Lasmiditan
50 mg lasmiditan administered orally (PO)
OG001
100 mg Lasmiditan
100 mg lasmiditan administered orally (PO)
OG002
200 mg Lasmiditan
200 mg lasmiditan administered orally (PO)
OG003
400 mg Lasmiditan
400 mg lasmiditan administered orally (PO)
OG004
Placebo
Secondary
Number of Participants Reporting a Score on the Patient Global Impression of Improvement (PGI-I)
PGI-I requests participants to mark the box that best describes their cluster headache condition since they started taking the medicine. The options in the displayed boxes are represented on a 7-point scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse, a lower number indicates much better and a higher number indicates worse.
All randomized participants who received at least 1 dose of study drug and had a PGI-I measurement post dose.
Posted
Count of Participants
Participants
No
2 hours postdose
ID
Title
Description
OG000
50 mg Lasmiditan
50 mg lasmiditan administered orally (PO)
OG001
100 mg Lasmiditan
100 mg lasmiditan administered orally (PO)
OG002
200 mg Lasmiditan
200 mg lasmiditan administered orally (PO)
OG003
400 mg Lasmiditan
Secondary
Actual Time to Headache Relief and Time to Pain Free
The participant answered "Did your migraine pain go away completely (pain free) within 24 hours of dosing" and record the time.
Actual time to meaningful pain relief and actual time to pain free will be censored at 24 hours if meaningful pain relief or pain free is documented to be greater than 24 hours after dosing and "Did you experience meaningful relief (headache relief) from your migraine within 24 hours after dosing?".
All randomized participants who received at least 1 dose of study drug.
Posted
Mean
Standard Error
minutes
up to 24 hours postdose
ID
Title
Description
OG000
50 mg Lasmiditan
50 mg lasmiditan administered orally (PO)
OG001
100 mg Lasmiditan
100 mg lasmiditan administered orally (PO)
OG002
200 mg Lasmiditan
200 mg lasmiditan administered orally (PO)
OG003
400 mg Lasmiditan
400 mg lasmiditan administered orally (PO)
Secondary
Change From Baseline in Heart Rate
Change from baseline in assessment of vital signs (heart rate).
Randomized participants who received at least 1 dose of study drug and had evaluable ECG parameters.
Posted
Median
Full Range
beats per minute
Baseline through Day 14
ID
Title
Description
OG000
50 mg Lasmiditan
50 mg lasmiditan administered orally (PO)
OG001
100 mg Lasmiditan
100 mg lasmiditan administered orally (PO)
OG002
200 mg Lasmiditan
200 mg lasmiditan administered orally (PO)
OG003
400 mg Lasmiditan
400 mg lasmiditan administered orally (PO)
OG004
Placebo
Placebo administered orally (PO)
Secondary
Change From Baseline in Systolic Blood Pressure
Change from baseline in vital signs (systolic blood pressure).
All randomized participants who received at least 1 dose of study drug and had evaluable blood pressure.
Posted
Median
Full Range
millimeters of mercury
Baseline through Day 14
ID
Title
Description
OG000
50 mg Lasmiditan
50 mg lasmiditan administered orally (PO)
OG001
100 mg Lasmiditan
100 mg lasmiditan administered orally (PO)
OG002
200 mg Lasmiditan
200 mg lasmiditan administered orally (PO)
OG003
400 mg Lasmiditan
400 mg lasmiditan administered orally (PO)
OG004
Placebo
Placebo administered orally (PO)
Secondary
Change From Baseline in Diastolic Blood Pressure
Change from baseline in vital signs (diastolic blood pressure).
Randomized participants who received at least 1 dose of study drug and had evaluable blood pressure.
Posted
Median
Full Range
millimeters of mercury
Baseline through Day 14
ID
Title
Description
OG000
50 mg Lasmiditan
50 mg lasmiditan administered orally (PO)
OG001
100 mg Lasmiditan
100 mg lasmiditan administered orally (PO)
OG002
200 mg Lasmiditan
200 mg lasmiditan administered orally (PO)
OG003
400 mg Lasmiditan
400 mg lasmiditan administered orally (PO)
OG004
Placebo
Placebo administered orally (PO)
Secondary
Percentage of Participants With Change From Baseline in Physical Examination Parameters
Participants were evaluated for skin, head, ear, nose and throat, cardiovascular and musculoskeletal changes from a normal screening to an abnormal screening. Changes in the physical examination noted as non-serious AEs or SAEs, regardless of causality, are located in the Reported Adverse Events section.
All randomized participants who received at last 1 dose of study drug and had a physical examination.
Posted
Number
percentage of participants
Baseline through Day 14
ID
Title
Description
OG000
50 mg Lasmiditan
50 mg lasmiditan administered orally (PO)
OG001
100 mg Lasmiditan
100 mg lasmiditan administered orally (PO)
OG002
200 mg Lasmiditan
200 mg lasmiditan administered orally (PO)
OG003
400 mg Lasmiditan
400 mg lasmiditan administered orally (PO)
Secondary
Change From Baseline in Hematology Tests
Hematology tests, including a complete blood count (CBC) measured red blood cells, white blood cells, hemoglobin, neutrophils and platelets.
All randomized participants who received at least 1 dose of study drug and had evaluable blood parameters.
Posted
Mean
Standard Error
million cells per liter
Baseline through Day 14
ID
Title
Description
OG000
50 mg Lasmiditan
50 mg lasmiditan administered orally (PO)
OG001
100 mg Lasmiditan
100 mg lasmiditan administered orally (PO)
OG002
200 mg Lasmiditan
200 mg lasmiditan administered orally (PO)
OG003
400 mg Lasmiditan
400 mg lasmiditan administered orally (PO)
OG004
Placebo
Secondary
Number of Serious Adverse Events
A summary of non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
All randomized participants who received at least 1 dose of study drug excluding one participant who was lost to follow-up and did not report adverse events.
Posted
Number
adverse events
up to 8 weeks
ID
Title
Description
OG000
50 mg Lasmiditan
50 mg lasmiditan administered orally (PO)
OG001
100 mg Lasmiditan
100 mg lasmiditan administered orally (PO)
OG002
200 mg Lasmiditan
200 mg lasmiditan administered orally (PO)
OG003
400 mg Lasmiditan
400 mg lasmiditan administered orally (PO)
OG004
Placebo
Placebo administered orally (PO)
Time Frame
up to 8 weeks
Description
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
50 mg Lasmiditan
50 mg lasmiditan administered orally (PO)
0
82
0
82
53
82
EG001
100 mg Lasmiditan
100 mg lasmiditan administered orally (PO)
0
82
0
82
59
82
EG002
200 mg Lasmiditan
200 mg lasmiditan administered orally (PO)
0
71
1
71
60
71
EG003
400 mg Lasmiditan
400 mg lasmiditan administered orally (PO)
0
70
0
70
59
70
EG004
Placebo
Placebo administered orally (PO)
0
85
0
85
19
85
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Dizziness
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected71 at risk
EG0030 events0 affected70 at risk
EG0040 events0 affected85 at risk
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected82 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected71 at risk
EG0030 events0 affected70 at risk
EG0040 events0 affected85 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Cardiovascular disorder
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected82 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected71 at risk
EG003
Extrasystoles
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected82 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected82 at risk
EG0012 events2 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected71 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0012 events2 affected82 at risk
EG0021 events1 affected71 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0008 events8 affected82 at risk
EG00112 events12 affected82 at risk
EG00212 events12 affected71 at risk
EG003
Diplopia
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Halo vision
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Vision blurred
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected82 at risk
EG0010 events0 affected82 at risk
EG0023 events3 affected71 at risk
EG003
Visual impairment
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0012 events2 affected82 at risk
EG0021 events1 affected71 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected71 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0011 events1 affected82 at risk
EG0022 events2 affected71 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0012 events1 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected71 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected82 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Epigastric discomfort
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Hypoaesthesia oral
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0003 events1 affected82 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0004 events4 affected82 at risk
EG0018 events8 affected82 at risk
EG0022 events2 affected71 at risk
EG003
Paraesthesia oral
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected71 at risk
EG003
Salivary hypersecretion
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0003 events3 affected82 at risk
EG0012 events2 affected82 at risk
EG0021 events1 affected71 at risk
EG003
Asthenia
General disorders
MedDRA 22.0
Systematic Assessment
EG0003 events3 affected82 at risk
EG0017 events7 affected82 at risk
EG0022 events2 affected71 at risk
EG003
Chest discomfort
General disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected82 at risk
EG0012 events2 affected82 at risk
EG0021 events1 affected71 at risk
EG003
Chills
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected71 at risk
EG003
Discomfort
General disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected82 at risk
EG0012 events2 affected82 at risk
EG0024 events4 affected71 at risk
EG003
Fatigue
General disorders
MedDRA 22.0
Systematic Assessment
EG00011 events10 affected82 at risk
EG00117 events17 affected82 at risk
EG00215 events15 affected71 at risk
EG003
Feeling abnormal
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0011 events1 affected82 at risk
EG0021 events1 affected71 at risk
EG003
Feeling cold
General disorders
MedDRA 22.0
Systematic Assessment
EG0003 events3 affected82 at risk
EG0014 events4 affected82 at risk
EG0022 events2 affected71 at risk
EG003
Feeling hot
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected82 at risk
EG0011 events1 affected82 at risk
EG0022 events2 affected71 at risk
EG003
Feeling of body temperature change
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Feeling of relaxation
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected82 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Gait disturbance
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0011 events1 affected82 at risk
EG0022 events2 affected71 at risk
EG003
Malaise
General disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected82 at risk
EG0011 events1 affected82 at risk
EG0021 events1 affected71 at risk
EG003
Pyrexia
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected82 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Sensation of blood flow
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Thirst
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected82 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Blood pressure increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected71 at risk
EG003
Cardiac murmur
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected71 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Transaminases increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected71 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected82 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected82 at risk
EG0012 events2 affected82 at risk
EG0023 events3 affected71 at risk
EG003
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0010 events0 affected82 at risk
EG0022 events1 affected71 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0003 events3 affected82 at risk
EG0015 events5 affected82 at risk
EG0024 events4 affected71 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0002 events1 affected82 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Ataxia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected82 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected82 at risk
EG0011 events1 affected82 at risk
EG0023 events3 affected71 at risk
EG003
Coordination abnormal
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Depressed level of consciousness
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected82 at risk
EG0014 events3 affected82 at risk
EG0021 events1 affected71 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG00021 events19 affected82 at risk
EG00122 events21 affected82 at risk
EG00226 events26 affected71 at risk
EG003
Dizziness postural
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected71 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected82 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected71 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Facial paresis
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Fine motor delay
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected82 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Head discomfort
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Headache
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Hyperkinesia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Hypertonia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected82 at risk
EG0014 events3 affected82 at risk
EG0025 events5 affected71 at risk
EG003
Hypotonia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected82 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0010 events0 affected82 at risk
EG0022 events2 affected71 at risk
EG003
Migraine
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected82 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected82 at risk
EG0019 events9 affected82 at risk
EG00216 events12 affected71 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected71 at risk
EG003
Sedation
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected82 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Slow response to stimuli
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0008 events8 affected82 at risk
EG00111 events10 affected82 at risk
EG0029 events8 affected71 at risk
EG003
Speech disorder
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected71 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Tremor
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0003 events3 affected82 at risk
EG0012 events2 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected71 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected71 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected71 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0012 events2 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Derealisation
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Disorientation
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Euphoric mood
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected82 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Fear
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Hallucination, visual
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected71 at risk
EG003
Illusion
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0011 events1 affected82 at risk
EG0021 events1 affected71 at risk
EG003
Nervousness
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0011 events1 affected82 at risk
EG0021 events1 affected71 at risk
EG003
Nightmare
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected82 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected71 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected82 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected71 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Polyuria
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected82 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected71 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected82 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected71 at risk
EG003
Flushing
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0012 events2 affected82 at risk
EG0021 events1 affected71 at risk
EG003
Hypertension
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected71 at risk
EG003
Peripheral coldness
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected82 at risk
EG0012 events1 affected82 at risk
EG0020 events0 affected71 at risk
EG003
One participant from the placebo group did not report adverse events and was lost to follow up.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
GT60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Chief Medical Officer
Eli Lilly and Company
800-545-5979
ClinicalTrials.gov@lilly.com
ID
Term
D008881
Migraine Disorders
Ancestor Terms
ID
Term
D051270
Headache Disorders, Primary
D020773
Headache Disorders
D001927
Brain Diseases
D002493
Central Nervous System Diseases
D009422
Nervous System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C554777
lasmiditan
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
17 subjects
40
(20 to 60)
BG00441(19 to 66)
BG00541.0(18.0 to 66.0)
65
BG00365
BG00475
BG005342
Male
BG00013
BG00114
BG0026
BG0035
BG00411
BG00549
0
BG0031
BG0040
BG0051
Not Hispanic or Latino
BG00082
BG00182
BG00271
BG00369
BG00486
BG005390
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
0
BG0030
BG0040
BG0050
Asian
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
Black or African American
BG0001
BG0010
BG0020
BG0030
BG0040
BG0051
White
BG00081
BG00181
BG00270
BG00369
BG00486
BG005387
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
Unknown or Not Reported
BG0000
BG0011
BG0021
BG0031
BG0040
BG0053
6
BG0034
BG0047
BG00527
Finland
Title
Measurements
BG00026
BG00126
BG00223
BG00319
BG00430
BG005124
France
Title
Measurements
BG0009
BG0018
BG0025
BG0035
BG0049
BG00536
Germany
Title
Measurements
BG00036
BG00134
BG00234
BG00337
BG00432
BG005173
Spain
Title
Measurements
BG0006
BG0019
BG0023
BG0035
BG0048
BG00531
68
OG00481
35.3
OG00474.1
Yes
Title
Measurements
OG00043.0
OG00164.2
OG00250.7
OG00364.7
OG00425.9
Placebo administered orally (PO)
Units
Counts
Participants
OG00079
OG00181
OG00269
OG00368
OG00481
Title
Denominators
Categories
Title
Measurements
OG00013.9
OG00113.6
OG00218.8
OG00327.9
OG0047.4
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
Cochran-Armitage test for trend]
=0.0006
Other
A hierarchical test procedure was applied only for analysis of the primary efficacy endpoint.