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Dose-ranging Study of Oral COL-144 in Acute Migraine Treatment

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: NCT00883051
Recruitment Status : Completed
First Posted : April 17, 2009
Results First Posted : December 23, 2019
Last Update Posted : December 23, 2019
Sponsor:
Collaborator:
CoLucid Pharmaceuticals
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Migraine Disorders
Interventions Drug: Lasmiditan
Drug: Placebo
Enrollment 512
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Lasmiditan 400 mg Lasmiditan Placebo
Hide Arm/Group Description 50 mg lasmiditan administered PO within 4 hours of a migraine attack 100 mg lasmiditan administered PO within 4 hours of a migraine attack 200 mg lasmiditan administered PO within 4 hours of a migraine attack 400 mg lasmiditan administered PO within 4 hours of a migraine attack Placebo administered PO within 4 hours of a migraine attack
Period Title: Overall Study
Started 106 104 100 99 103
No Study Medication Used 24 22 29 29 17
Received at Least 1 Dose of Study Drug 82 82 71 70 86
Completed 82 82 71 70 85 [1]
Not Completed 24 22 29 29 18
Reason Not Completed
Lost to Follow-up             0             0             0             0             1
Did not use study medication             24             22             29             29             17
[1]
One participant was lost to follow up and did not provide adverse event data.
Arm/Group Title 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Lasmiditan 400 mg Lasmiditan Placebo Total
Hide Arm/Group Description 50 mg lasmiditan administered PO within 4 hours of a migraine attack 100 mg lasmiditan administered PO within 4 hours of a migraine attack 200 mg lasmiditan administered PO within 4 hours of a migraine attack 400 mg lasmiditan administered PO within 4 hours of a migraine attack Placebo administered PO within 4 hours of a migraine attack Total of all reporting groups
Overall Number of Baseline Participants 82 82 71 70 86 391
Hide Baseline Analysis Population Description
All randomized participants who received at least 1 dose of study drug.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 82 participants 82 participants 71 participants 70 participants 86 participants 391 participants
41
(18 to 65)
45
(20 to 65)
41
(18 to 57)
40
(20 to 60)
41
(19 to 66)
41.0
(18.0 to 66.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 82 participants 71 participants 70 participants 86 participants 391 participants
Female 69 68 65 65 75 342
Male 13 14 6 5 11 49
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 82 participants 71 participants 70 participants 86 participants 391 participants
Hispanic or Latino 0 0 0 1 0 1
Not Hispanic or Latino 82 82 71 69 86 390
Unknown or Not Reported 0 0 0 0 0 0
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 82 participants 71 participants 70 participants 86 participants 391 participants
American Indian or Alaska Native 0 0 0 0 0 0
Asian 0 0 0 0 0 0
Native Hawaiian or Other Pacific Islander 0 0 0 0 0 0
Black or African American 1 0 0 0 0 1
White 81 81 70 69 86 387
More than one race 0 0 0 0 0 0
Unknown or Not Reported 0 1 1 1 0 3
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 82 participants 82 participants 71 participants 70 participants 86 participants 391 participants
Belgium 5 5 6 4 7 27
Finland 26 26 23 19 30 124
France 9 8 5 5 9 36
Germany 36 34 34 37 32 173
Spain 6 9 3 5 8 31
1.Primary Outcome
Title Percentage of Participants With Headache Response
Hide Description 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.
Time Frame 2 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had a post-baseline evaluation.
Arm/Group Title 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Lasmiditan 400 mg Lasmiditan Placebo
Hide Arm/Group Description:
50 mg lasmiditan administered orally (PO)
100 mg lasmiditan administered orally (PO)
200 mg lasmiditan administered orally (PO)
400 mg lasmiditan administered orally (PO)
Placebo administered orally (PO)
Overall Number of Participants Analyzed 79 81 69 68 81
Measure Type: Number
Unit of Measure: percentage of participants
No 57.0 35.8 49.3 35.3 74.1
Yes 43.0 64.2 50.7 64.7 25.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 50 mg Lasmiditan, 100 mg Lasmiditan, 200 mg Lasmiditan, 400 mg Lasmiditan, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments A hierarchical test procedure was applied only for analysis of the primary efficacy endpoint.
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Armitage test for trend
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Who Are Headache Free (Absence of Headache) After First Dose
Hide Description The percentage of participants defined as mild, moderate, or severe headache pain becoming none.
Time Frame 2 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug, a 2 hour postdose evaluation and evaluable headache relief data.
Arm/Group Title 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Lasmiditan 400 mg Lasmiditan Placebo
Hide Arm/Group Description:
50 mg lasmiditan administered orally (PO)
100 mg lasmiditan administered orally (PO)
200 mg lasmiditan administered orally (PO)
400 mg lasmiditan administered orally (PO)
Placebo administered orally (PO)
Overall Number of Participants Analyzed 79 81 69 68 81
Measure Type: Number
Unit of Measure: percentage of participants
13.9 13.6 18.8 27.9 7.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 50 mg Lasmiditan, 100 mg Lasmiditan, 200 mg Lasmiditan, 400 mg Lasmiditan
Comments [Not Specified]
Type of Statistical Test Other
Comments A hierarchical test procedure was applied only for analysis of the primary efficacy endpoint.
Statistical Test of Hypothesis P-Value =0.0006
Comments [Not Specified]
Method Cochran-Armitage test for trend]
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With Headache Recurrence
Hide Description Participants who received study drug and which became pain free at 2 hours postdose and worsened again upto 24 hours post-dose.
Time Frame up to 24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received a dose of study drug, were pain free at 2 hours postdose and had postdose headache severity or symptom assessments.
Arm/Group Title 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Lasmiditan 400 mg Lasmiditan Placebo
Hide Arm/Group Description:
50 mg lasmiditan administered orally (PO)
100 mg lasmiditan administered orally (PO)
200 mg lasmiditan administered orally (PO)
400 mg lasmiditan administered orally (PO)
Placebo administered orally (PO)
Overall Number of Participants Analyzed 34 52 35 44 21
Measure Type: Number
Unit of Measure: percentage of participants
55.9 57.7 62.9 50.0 57.1
4.Secondary Outcome
Title Percentage of Participants With Headache Severity (4 Point Rating Scale)
Hide Description 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.
Time Frame 2 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received a dose of study drug and had postdose headache severity or symptom assessments.
Arm/Group Title 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Lasmiditan 400 mg Lasmiditan Placebo
Hide Arm/Group Description:
50 mg lasmiditan administered orally (PO)
100 mg lasmiditan administered orally (PO)
200 mg lasmiditan administered orally (PO)
400 mg lasmiditan administered orally (PO)
Placebo administered orally (PO)
Overall Number of Participants Analyzed 79 80 68 67 81
Measure Type: Number
Unit of Measure: percentage of participants
None (0) 13.9 13.6 18.8 27.9 7.4
Mild(1) 29.1 50.6 31.9 36.8 18.5
Moderate(2) 27.8 23.5 26.1 20.6 27.2
Severe(3) 29.1 11.1 21.7 13.2 46.9
5.Secondary Outcome
Title Percentage of Participants Who Have Symptoms of Nausea
Hide Description Percentage of participants who have symptoms of nausea two hours post treatment.
Time Frame 2 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received a dose of study drug and had postdose symptom assessments.
Arm/Group Title 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Lasmiditan 400 mg Lasmiditan Placebo
Hide Arm/Group Description:
50 mg lasmiditan administered orally (PO)
100 mg lasmiditan administered orally (PO)
200 mg lasmiditan administered orally (PO)
400 mg lasmiditan administered orally (PO)
Placebo administered orally (PO)
Overall Number of Participants Analyzed 79 80 68 67 81
Measure Type: Number
Unit of Measure: percentage of participants
31.65 25.00 35.29 26.87 40.74
6.Secondary Outcome
Title Percentage of Participants Who Have Symptoms Phonophobia
Hide Description Percentage of participants who have symptoms of phonophobia two hours post treatment.
Time Frame 2 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received a dose of study drug and had postdose symptom assessments.
Arm/Group Title 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Lasmiditan 400 mg Lasmiditan Placebo
Hide Arm/Group Description:
50 mg lasmiditan administered orally (PO)
100 mg lasmiditan administered orally (PO)
200 mg lasmiditan administered orally (PO)
400 mg lasmiditan administered orally (PO)
Placebo administered orally (PO)
Overall Number of Participants Analyzed 79 80 68 67 81
Measure Type: Number
Unit of Measure: percentage of participants
41.77 23.75 39.71 31.34 48.15
7.Secondary Outcome
Title Percentage of Participants Who Have Photophobia
Hide Description Percentage of participants who have symptoms of photophobia two hours post treatment.
Time Frame 2 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received a dose of study drug and had postdose symptom assessments.
Arm/Group Title 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Lasmiditan 400 mg Lasmiditan Placebo
Hide Arm/Group Description:
50 mg lasmiditan administered orally (PO)
100 mg lasmiditan administered orally (PO)
200 mg lasmiditan administered orally (PO)
400 mg lasmiditan administered orally (PO)
Placebo administered orally (PO)
Overall Number of Participants Analyzed 79 80 68 67 81
Measure Type: Number
Unit of Measure: percentage of participants
46.84 31.25 41.18 37.31 65.43
8.Secondary Outcome
Title Percentage of Participants With Vomiting
Hide Description Percentage of participants with vomiting 2 hours post treatment.
Time Frame 2 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received a dose of study drug and had postdose symptom assessments.
Arm/Group Title 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Lasmiditan 400 mg Lasmiditan Placebo
Hide Arm/Group Description:
50 mg lasmiditan administered orally (PO)
100 mg lasmiditan administered orally (PO)
200 mg lasmiditan administered orally (PO)
400 mg lasmiditan administered orally (PO)
Placebo administered orally (PO)
Overall Number of Participants Analyzed 79 80 68 67 81
Measure Type: Number
Unit of Measure: percentage of participants
5.06 0.00 7.35 4.80 11.11
9.Secondary Outcome
Title Disability (4 Point Scale: Not at All, Mild Interference, Marked Interference, Completely - Needs Bed Rest)
Hide Description 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.
Time Frame 2 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had evaluable data.
Arm/Group Title 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Lasmiditan 400 mg Lasmiditan Placebo
Hide Arm/Group Description:
50 mg lasmiditan administered orally (PO)
100 mg lasmiditan administered orally (PO)
200 mg lasmiditan administered orally (PO)
400 mg lasmiditan administered orally (PO)
Placebo administered orally (PO)
Overall Number of Participants Analyzed 79 78 66 63 81
Measure Type: Count of Participants
Unit of Measure: Participants
Not at all (0) 13 14 12 10 6
Mild interference (1) 26 33 23 26 23
Marked interference (2) 24 20 17 15 21
Completely needs bed rest (3) 16 11 14 12 31
10.Secondary Outcome
Title Percentage of Participants Who Used Rescue Medication
Hide Description Rescue medication was permitted after completion of the 2 hour assessment if migraine did not respond (participant was not pain free).
Time Frame Postdose 2 through 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received a dose of study drug and had postdose headache severity or symptom assessments.
Arm/Group Title 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Lasmiditan 400 mg Lasmiditan Placebo
Hide Arm/Group Description:
50 mg lasmiditan administered orally (PO)
100 mg lasmiditan administered orally (PO)
200 mg lasmiditan administered orally (PO)
400 mg lasmiditan administered orally (PO)
Placebo administered orally (PO)
Overall Number of Participants Analyzed 79 81 69 69 81
Measure Type: Number
Unit of Measure: percentage of participants
54.5 51.9 61.2 41.8 68.8
11.Secondary Outcome
Title Number of Participants Reporting a Score on the Patient Global Impression of Improvement (PGI-I)
Hide Description 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.
Time Frame 2 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had a PGI-I measurement post dose.
Arm/Group Title 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Lasmiditan 400 mg Lasmiditan Placebo
Hide Arm/Group Description:
50 mg lasmiditan administered orally (PO)
100 mg lasmiditan administered orally (PO)
200 mg lasmiditan administered orally (PO)
400 mg lasmiditan administered orally (PO)
Placebo administered orally (PO)
Overall Number of Participants Analyzed 79 81 69 67 81
Measure Type: Count of Participants
Unit of Measure: Participants
Very much better 3 2 3 4 3
Much better 15 27 16 19 10
A little better 28 30 21 22 18
No change 18 11 12 7 27
A little worse 7 6 6 9 8
Much worse 5 4 3 4 9
Very much worse 3 1 8 2 6
12.Secondary Outcome
Title Actual Time to Headache Relief and Time to Pain Free
Hide Description

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?".

Time Frame up to 24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug.
Arm/Group Title 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Lasmiditan 400 mg Lasmiditan Placebo
Hide Arm/Group Description:
50 mg lasmiditan administered orally (PO)
100 mg lasmiditan administered orally (PO)
200 mg lasmiditan administered orally (PO)
400 mg lasmiditan administered orally (PO)
Placebo administered orally (PO)
Overall Number of Participants Analyzed 79 81 69 68 81
Mean (Standard Error)
Unit of Measure: minutes
Pain relief 650.87  (77.53) 291.05  (32.24) 407.16  (52.48) 218.93  (23.87) 760.15  (71.19)
Pain free 871.27  (72.74) 767.33  (74.36) 690.89  (59.67) 437.12  (36.05) 1046.47  (77.90)
13.Secondary Outcome
Title Change From Baseline in Heart Rate
Hide Description Change from baseline in assessment of vital signs (heart rate).
Time Frame Baseline through Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least 1 dose of study drug and had evaluable ECG parameters.
Arm/Group Title 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Lasmiditan 400 mg Lasmiditan Placebo
Hide Arm/Group Description:
50 mg lasmiditan administered orally (PO)
100 mg lasmiditan administered orally (PO)
200 mg lasmiditan administered orally (PO)
400 mg lasmiditan administered orally (PO)
Placebo administered orally (PO)
Overall Number of Participants Analyzed 81 82 71 70 83
Median (Full Range)
Unit of Measure: beats per minute
2.0
(-27.0 to 28.0)
3.0
(-16.0 to 24.0)
1.0
(-18.0 to 28.0)
2.0
(-21.0 to 28.0)
1.0
(-66.0 to 18.0)
14.Secondary Outcome
Title Change From Baseline in Systolic Blood Pressure
Hide Description Change from baseline in vital signs (systolic blood pressure).
Time Frame Baseline through Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had evaluable blood pressure.
Arm/Group Title 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Lasmiditan 400 mg Lasmiditan Placebo
Hide Arm/Group Description:
50 mg lasmiditan administered orally (PO)
100 mg lasmiditan administered orally (PO)
200 mg lasmiditan administered orally (PO)
400 mg lasmiditan administered orally (PO)
Placebo administered orally (PO)
Overall Number of Participants Analyzed 82 82 70 70 83
Median (Full Range)
Unit of Measure: millimeters of mercury
1.0
(-30.0 to 29.0)
0.0
(-25.0 to 42.0)
-1.5
(-23.0 to 35.0)
-0.5
(-35.0 to 36.0)
-0.0
(-30.0 to 35.0)
15.Secondary Outcome
Title Change From Baseline in Diastolic Blood Pressure
Hide Description Change from baseline in vital signs (diastolic blood pressure).
Time Frame Baseline through Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least 1 dose of study drug and had evaluable blood pressure.
Arm/Group Title 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Lasmiditan 400 mg Lasmiditan Placebo
Hide Arm/Group Description:
50 mg lasmiditan administered orally (PO)
100 mg lasmiditan administered orally (PO)
200 mg lasmiditan administered orally (PO)
400 mg lasmiditan administered orally (PO)
Placebo administered orally (PO)
Overall Number of Participants Analyzed 82 82 70 70 83
Median (Full Range)
Unit of Measure: millimeters of mercury
0.0
(-14.0 to 21.0)
0.0
(-20.0 to 25.0)
0.0
(-22.0 to 15.0)
0.0
(-20.0 to 20.0)
0.0
(-20.0 to 21.0)
16.Secondary Outcome
Title Percentage of Participants With Change From Baseline in Physical Examination Parameters
Hide Description 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.
Time Frame Baseline through Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at last 1 dose of study drug and had a physical examination.
Arm/Group Title 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Lasmiditan 400 mg Lasmiditan Placebo
Hide Arm/Group Description:
50 mg lasmiditan administered orally (PO)
100 mg lasmiditan administered orally (PO)
200 mg lasmiditan administered orally (PO)
400 mg lasmiditan administered orally (PO)
Placebo administered orally (PO)
Overall Number of Participants Analyzed 82 82 71 70 86
Measure Type: Number
Unit of Measure: percentage of participants
Skin 1.2 2.4 1.4 0 0
Head, ears, nose, throat 0 0 0 1.4 0
Musculoskeletal 0 1.2 0 0 3.5
17.Secondary Outcome
Title Change From Baseline in Hematology Tests
Hide Description Hematology tests, including a complete blood count (CBC) measured red blood cells, white blood cells, hemoglobin, neutrophils and platelets.
Time Frame Baseline through Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had evaluable blood parameters.
Arm/Group Title 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Lasmiditan 400 mg Lasmiditan Placebo
Hide Arm/Group Description:
50 mg lasmiditan administered orally (PO)
100 mg lasmiditan administered orally (PO)
200 mg lasmiditan administered orally (PO)
400 mg lasmiditan administered orally (PO)
Placebo administered orally (PO)
Overall Number of Participants Analyzed 82 82 71 70 84
Mean (Standard Error)
Unit of Measure: million cells per liter
Hemoglobin 0.0  (0.4) 0.0  (0.4) 0.1  (0.4) 0.0  (0.4) 0.0  (0.4)
Red blood cells 0.0  (0.2) 0.0  (0.2) 0.0  (0.2) 0.0  (0.2) 0.0  (0.2)
White blood cells -0.1  (1.3) 0.3  (1.4) -0.3  (1.6) -0.4  (1.7) -0.2  (1.6)
Neutrophils -3.2  (9.3) -0.3  (7.9) -2.8  (14.7) -3.2  (14.7) -3.9  (9.9)
Platelets -2.3  (35.2) -0.5  (25.9) 4.6  (48.4) 2.9  (34.7) 1.7  (34.7)
18.Secondary Outcome
Title Number of Serious Adverse Events
Hide Description A summary of non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Time Frame up to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Lasmiditan 400 mg Lasmiditan Placebo
Hide Arm/Group Description:
50 mg lasmiditan administered orally (PO)
100 mg lasmiditan administered orally (PO)
200 mg lasmiditan administered orally (PO)
400 mg lasmiditan administered orally (PO)
Placebo administered orally (PO)
Overall Number of Participants Analyzed 82 82 71 70 85
Measure Type: Number
Unit of Measure: adverse events
0 0 1 0 0
Time Frame up to 8 weeks
Adverse Event Reporting 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.
 
Arm/Group Title 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Lasmiditan 400 mg Lasmiditan Placebo
Hide Arm/Group Description 50 mg lasmiditan administered orally (PO) 100 mg lasmiditan administered orally (PO) 200 mg lasmiditan administered orally (PO) 400 mg lasmiditan administered orally (PO) Placebo administered orally (PO)
All-Cause Mortality
50 mg Lasmiditan 100 mg Lasmiditan 200 mg Lasmiditan 400 mg Lasmiditan Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/82 (0.00%)      0/82 (0.00%)      0/71 (0.00%)      0/70 (0.00%)      0/85 (0.00%)    
Hide Serious Adverse Events
50 mg Lasmiditan 100 mg Lasmiditan 200 mg Lasmiditan 400 mg Lasmiditan Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/82 (0.00%)      0/82 (0.00%)      1/71 (1.41%)      0/70 (0.00%)      0/85 (0.00%)    
Nervous system disorders           
Dizziness  1  0/82 (0.00%)  0 0/82 (0.00%)  0 1/71 (1.41%)  1 0/70 (0.00%)  0 0/85 (0.00%)  0
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
50 mg Lasmiditan 100 mg Lasmiditan 200 mg Lasmiditan 400 mg Lasmiditan Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   53/82 (64.63%)      59/82 (71.95%)      60/71 (84.51%)      59/70 (84.29%)      19/85 (22.35%)    
Blood and lymphatic system disorders           
Lymphadenopathy  1  1/82 (1.22%)  1 0/82 (0.00%)  0 0/71 (0.00%)  0 0/70 (0.00%)  0 0/85 (0.00%)  0
Neutropenia  1  0/82 (0.00%)  0 0/82 (0.00%)  0 0/71 (0.00%)  0 1/70 (1.43%)  1 2/85 (2.35%)  2
Cardiac disorders           
Cardiovascular disorder  1  1/82 (1.22%)  1 0/82 (0.00%)  0 1/71 (1.41%)  1 0/70 (0.00%)  0 0/85 (0.00%)  0
Extrasystoles  1  1/82 (1.22%)  1 0/82 (0.00%)  0 0/71 (0.00%)  0 0/70 (0.00%)  0 0/85 (0.00%)  0
Palpitations  1  1/82 (1.22%)  1 2/82 (2.44%)  2 0/71 (0.00%)  0 0/70 (0.00%)  0 1/85 (1.18%)  1
Tachycardia  1  0/82 (0.00%)  0 0/82 (0.00%)  0 1/71 (1.41%)  1 3/70 (4.29%)  3 0/85 (0.00%)  0
Ear and labyrinth disorders           
Ear pain  1  0/82 (0.00%)  0 0/82 (0.00%)  0 0/71 (0.00%)  0 0/70 (0.00%)  0 1/85 (1.18%)  1
Tinnitus  1  0/82 (0.00%)  0 2/82 (2.44%)  2 1/71 (1.41%)  1 1/70 (1.43%)  1 1/85 (1.18%)  1
Vertigo  1  8/82 (9.76%)  8 12/82 (14.63%)  12 12/71 (16.90%)  12 16/70 (22.86%)  16 1/85 (1.18%)  1
Eye disorders           
Diplopia  1  0/82 (0.00%)  0 0/82 (0.00%)  0 0/71 (0.00%)  0 1/70 (1.43%)  1 0/85 (0.00%)  0
Halo vision  1  0/82 (0.00%)  0 1/82 (1.22%)  1 0/71 (0.00%)  0 0/70 (0.00%)  0 0/85 (0.00%)  0
Vision blurred  1  1/82 (1.22%)  1 0/82 (0.00%)  0 3/71 (4.23%)  3 2/70 (2.86%)  2 0/85 (0.00%)  0
Visual impairment  1  0/82 (0.00%)  0 2/82 (2.44%)  2 1/71 (1.41%)  1 2/70 (2.86%)  2 0/85 (0.00%)  0
Gastrointestinal disorders           
Abdominal discomfort  1  0/82 (0.00%)  0 0/82 (0.00%)  0 1/71 (1.41%)  1 0/70 (0.00%)  0 0/85 (0.00%)  0
Abdominal pain upper  1  0/82 (0.00%)  0 1/82 (1.22%)  1 2/71 (2.82%)  2 0/70 (0.00%)  0 1/85 (1.18%)  1
Diarrhoea  1  0/82 (0.00%)  0 1/82 (1.22%)  2 0/71 (0.00%)  0 1/70 (1.43%)  1 0/85 (0.00%)  0
Dry mouth  1  0/82 (0.00%)  0 0/82 (0.00%)  0 1/71 (1.41%)  1 3/70 (4.29%)  3 1/85 (1.18%)  1
Dyspepsia  1  1/82 (1.22%)  1 0/82 (0.00%)  0 0/71 (0.00%)  0 2/70 (2.86%)  2 0/85 (0.00%)  0
Epigastric discomfort  1  0/82 (0.00%)  0 0/82 (0.00%)  0 0/71 (0.00%)  0 1/70 (1.43%)  1 0/85 (0.00%)  0
Hypoaesthesia oral  1  1/82 (1.22%)  3 1/82 (1.22%)  1 0/71 (0.00%)  0 1/70 (1.43%)  1 0/85 (0.00%)  0
Nausea  1  4/82 (4.88%)  4 8/82 (9.76%)  8 2/71 (2.82%)  2 5/70 (7.14%)  6 0/85 (0.00%)  0
Paraesthesia oral  1  0/82 (0.00%)  0 0/82 (0.00%)  0 1/71 (1.41%)  1 1/70 (1.43%)  1 0/85 (0.00%)  0
Salivary hypersecretion  1  0/82 (0.00%)  0 0/82 (0.00%)  0 0/71 (0.00%)  0 0/70 (0.00%)  0 1/85 (1.18%)  1
Vomiting  1  3/82 (3.66%)  3 2/82 (2.44%)  2 1/71 (1.41%)  1 1/70 (1.43%)  1 0/85 (0.00%)  0
General disorders           
Asthenia  1  3/82 (3.66%)  3 7/82 (8.54%)  7 2/71 (2.82%)  2 4/70 (5.71%)  4 0/85 (0.00%)  0
Chest discomfort  1  2/82 (2.44%)  2 2/82 (2.44%)  2 1/71 (1.41%)  1 1/70 (1.43%)  1 1/85 (1.18%)  1
Chills  1  0/82 (0.00%)  0 0/82 (0.00%)  0 1/71 (1.41%)  1 0/70 (0.00%)  0 0/85 (0.00%)  0
Discomfort  1  2/82 (2.44%)  2 2/82 (2.44%)  2 4/71 (5.63%)  4 4/70 (5.71%)  4 2/85 (2.35%)  2
Fatigue  1  10/82 (12.20%)  11 17/82 (20.73%)  17 15/71 (21.13%)  15 16/70 (22.86%)  16 2/85 (2.35%)  2
Feeling abnormal  1  0/82 (0.00%)  0 1/82 (1.22%)  1 1/71 (1.41%)  1 1/70 (1.43%)  1 0/85 (0.00%)  0
Feeling cold  1  3/82 (3.66%)  3 4/82 (4.88%)  4 2/71 (2.82%)  2 1/70 (1.43%)  1 1/85 (1.18%)  1
Feeling hot  1  1/82 (1.22%)  1 1/82 (1.22%)  1 2/71 (2.82%)  2 0/70 (0.00%)  0 0/85 (0.00%)  0
Feeling of body temperature change  1  0/82 (0.00%)  0 1/82 (1.22%)  1 0/71 (0.00%)  0 0/70 (0.00%)  0 0/85 (0.00%)  0
Feeling of relaxation  1  1/82 (1.22%)  1 1/82 (1.22%)  1 0/71 (0.00%)  0 0/70 (0.00%)  0 0/85 (0.00%)  0
Gait disturbance  1  0/82 (0.00%)  0 1/82 (1.22%)  1 2/71 (2.82%)  2 2/70 (2.86%)  2 0/85 (0.00%)  0
Malaise  1  2/82 (2.44%)  2 1/82 (1.22%)  1 1/71 (1.41%)  1 2/70 (2.86%)  2 0/85 (0.00%)  0
Pyrexia  1  1/82 (1.22%)  1 1/82 (1.22%)  1 0/71 (0.00%)  0 0/70 (0.00%)  0 0/85 (0.00%)  0
Sensation of blood flow  1  0/82 (0.00%)  0 1/82 (1.22%)  1 0/71 (0.00%)  0 0/70 (0.00%)  0 0/85 (0.00%)  0
Thirst  1  1/82 (1.22%)  1 1/82 (1.22%)  1 0/71 (0.00%)  0 1/70 (1.43%)  1 0/85 (0.00%)  0
Infections and infestations           
Gastroenteritis  1  0/82 (0.00%)  0 1/82 (1.22%)  1 0/71 (0.00%)  0 0/70 (0.00%)  0 0/85 (0.00%)  0
Herpes zoster  1  0/82 (0.00%)  0 1/82 (1.22%)  1 0/71 (0.00%)  0 0/70 (0.00%)  0 0/85 (0.00%)  0
Investigations           
Blood pressure increased  1  0/82 (0.00%)  0 0/82 (0.00%)  0 1/71 (1.41%)  1 0/70 (0.00%)  0 0/85 (0.00%)  0
Cardiac murmur  1  0/82 (0.00%)  0 0/82 (0.00%)  0 1/71 (1.41%)  1 0/70 (0.00%)  0 0/85 (0.00%)  0
Hepatic enzyme increased  1  0/82 (0.00%)  0 0/82 (0.00%)  0 0/71 (0.00%)  0 1/70 (1.43%)  1 0/85 (0.00%)  0
Transaminases increased  1  0/82 (0.00%)  0 0/82 (0.00%)  0 1/71 (1.41%)  1 0/70 (0.00%)  0 0/85 (0.00%)  0
Metabolism and nutrition disorders           
Decreased appetite  1  0/82 (0.00%)  0 0/82 (0.00%)  0 0/71 (0.00%)  0 1/70 (1.43%)  1 0/85 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Arthralgia  1  1/82 (1.22%)  1 0/82 (0.00%)  0 0/71 (0.00%)  0 0/70 (0.00%)  0 0/85 (0.00%)  0
Limb discomfort  1  2/82 (2.44%)  2 2/82 (2.44%)  2 3/71 (4.23%)  3 2/70 (2.86%)  2 0/85 (0.00%)  0
Muscle twitching  1  0/82 (0.00%)  0 0/82 (0.00%)  0 1/71 (1.41%)  2 0/70 (0.00%)  0 0/85 (0.00%)  0
Muscular weakness  1  3/82 (3.66%)  3 5/82 (6.10%)  5 4/71 (5.63%)  4 3/70 (4.29%)  3 0/85 (0.00%)  0
Musculoskeletal stiffness  1  1/82 (1.22%)  2 0/82 (0.00%)  0 0/71 (0.00%)  0 1/70 (1.43%)  1 0/85 (0.00%)  0
Nervous system disorders           
Ataxia  1  1/82 (1.22%)  1 1/82 (1.22%)  1 0/71 (0.00%)  0 2/70 (2.86%)  2 0/85 (0.00%)  0
Balance disorder  1  1/82 (1.22%)  1 1/82 (1.22%)  1 3/71 (4.23%)  3 2/70 (2.86%)  2 0/85 (0.00%)  0
Coordination abnormal  1  0/82 (0.00%)  0 1/82 (1.22%)  1 0/71 (0.00%)  0 0/70 (0.00%)  0 0/85 (0.00%)  0
Depressed level of consciousness  1  0/82 (0.00%)  0 0/82 (0.00%)  0 0/71 (0.00%)  0 1/70 (1.43%)  1 1/85 (1.18%)  1
Disturbance in attention  1  1/82 (1.22%)  1 3/82 (3.66%)  4 1/71 (1.41%)  1 2/70 (2.86%)  2 0/85 (0.00%)  0
Dizziness  1  19/82 (23.17%)  21 21/82 (25.61%)  22 26/71 (36.62%)  26 26/70 (37.14%)  27 0/85 (0.00%)  0
Dizziness postural  1  0/82 (0.00%)  0 0/82 (0.00%)  0 1/71 (1.41%)  1 0/70 (0.00%)  0 0/85 (0.00%)  0
Dysaesthesia  1  1/82 (1.22%)  1 0/82 (0.00%)  0 1/71 (1.41%)  1 2/70 (2.86%)  2 0/85 (0.00%)  0
Dysarthria  1  0/82 (0.00%)  0 0/82 (0.00%)  0 0/71 (0.00%)  0 1/70 (1.43%)  1 0/85 (0.00%)  0
Dysgeusia  1  0/82 (0.00%)  0 1/82 (1.22%)  1 0/71 (0.00%)  0 0/70 (0.00%)  0 0/85 (0.00%)  0
Facial paresis  1  0/82 (0.00%)  0 0/82 (0.00%)  0 0/71 (0.00%)  0 2/70 (2.86%)  2 0/85 (0.00%)  0
Fine motor delay  1  1/82 (1.22%)  1 0/82 (0.00%)  0 0/71 (0.00%)  0 0/70 (0.00%)  0 0/85 (0.00%)  0
Head discomfort  1  0/82 (0.00%)  0 1/82 (1.22%)  1 0/71 (0.00%)  0 0/70 (0.00%)  0 0/85 (0.00%)  0
Headache  1  0/82 (0.00%)  0 1/82 (1.22%)  1 0/71 (0.00%)  0 0/70 (0.00%)  0 0/85 (0.00%)  0
Hyperkinesia  1  0/82 (0.00%)  0 0/82 (0.00%)  0 0/71 (0.00%)  0 1/70 (1.43%)  1 0/85 (0.00%)  0
Hypertonia  1  0/82 (0.00%)  0 1/82 (1.22%)  1 0/71 (0.00%)  0 0/70 (0.00%)  0 0/85 (0.00%)  0
Hypoaesthesia  1  1/82 (1.22%)  1 3/82 (3.66%)  4 5/71 (7.04%)  5 4/70 (5.71%)  5 1/85 (1.18%)  1
Hypotonia  1  2/82 (2.44%)  2 0/82 (0.00%)  0 0/71 (0.00%)  0 0/70 (0.00%)  0 0/85 (0.00%)  0
Lethargy  1  0/82 (0.00%)  0 0/82 (0.00%)  0 2/71 (2.82%)  2 0/70 (0.00%)  0 0/85 (0.00%)  0
Migraine  1  2/82 (2.44%)  2 0/82 (0.00%)  0 0/71 (0.00%)  0 1/70 (1.43%)  1 0/85 (0.00%)  0
Paraesthesia  1  2/82 (2.44%)  2 9/82 (10.98%)  9 12/71 (16.90%)  16 14/70 (20.00%)  14 2/85 (2.35%)  2
Presyncope  1  0/82 (0.00%)  0 0/82 (0.00%)  0 1/71 (1.41%)  1 0/70 (0.00%)  0 0/85 (0.00%)  0
Sedation  1  2/82 (2.44%)  2 0/82 (0.00%)  0 0/71 (0.00%)  0 0/70 (0.00%)  0 0/85 (0.00%)  0
Slow response to stimuli  1  0/82 (0.00%)  0 1/82 (1.22%)  1 0/71 (0.00%)  0 0/70 (0.00%)  0 0/85 (0.00%)  0
Somnolence  1  8/82 (9.76%)  8 10/82 (12.20%)  11 8/71 (11.27%)  9 8/70 (11.43%)  8 2/85 (2.35%)  3
Speech disorder  1  0/82 (0.00%)  0 0/82 (0.00%)  0 1/71 (1.41%)  1 3/70 (4.29%)  3 0/85 (0.00%)  0
Taste disorder  1  0/82 (0.00%)  0 0/82 (0.00%)  0 0/71 (0.00%)  0 0/70 (0.00%)  0 1/85 (1.18%)  1
Tremor  1  3/82 (3.66%)  3 2/82 (2.44%)  2 0/71 (0.00%)  0 3/70 (4.29%)  3 1/85 (1.18%)  1
Psychiatric disorders           
Agitation  1  0/82 (0.00%)  0 0/82 (0.00%)  0 1/71 (1.41%)  1 2/70 (2.86%)  2 0/85 (0.00%)  0
Anxiety  1  0/82 (0.00%)  0 0/82 (0.00%)  0 1/71 (1.41%)  1 0/70 (0.00%)  0 0/85 (0.00%)  0
Confusional state  1  0/82 (0.00%)  0 0/82 (0.00%)  0 1/71 (1.41%)  1 0/70 (0.00%)  0 1/85 (1.18%)  1
Depressed mood  1  0/82 (0.00%)  0 2/82 (2.44%)  2 0/71 (0.00%)  0 1/70 (1.43%)  1 0/85 (0.00%)  0
Derealisation  1  0/82 (0.00%)  0 1/82 (1.22%)  1 0/71 (0.00%)  0 1/70 (1.43%)  1 0/85 (0.00%)  0
Disorientation  1  0/82 (0.00%)  0 0/82 (0.00%)  0 0/71 (0.00%)  0 1/70 (1.43%)  1 0/85 (0.00%)  0
Euphoric mood  1  1/82 (1.22%)  1 0/82 (0.00%)  0 0/71 (0.00%)  0 0/70 (0.00%)  0 0/85 (0.00%)  0
Fear  1  0/82 (0.00%)  0 0/82 (0.00%)  0 0/71 (0.00%)  0 2/70 (2.86%)  2 0/85 (0.00%)  0
Hallucination, visual  1  0/82 (0.00%)  0 0/82 (0.00%)  0 1/71 (1.41%)  1 0/70 (0.00%)  0 0/85 (0.00%)  0
Illusion  1  0/82 (0.00%)  0 0/82 (0.00%)  0 0/71 (0.00%)  0 1/70 (1.43%)  1 0/85 (0.00%)  0
Insomnia  1  0/82 (0.00%)  0 1/82 (1.22%)  1 1/71 (1.41%)  1 1/70 (1.43%)  1 0/85 (0.00%)  0
Nervousness  1  0/82 (0.00%)  0 1/82 (1.22%)  1 1/71 (1.41%)  1 0/70 (0.00%)  0 0/85 (0.00%)  0
Nightmare  1  1/82 (1.22%)  1 0/82 (0.00%)  0 1/71 (1.41%)  1 1/70 (1.43%)  1 1/85 (1.18%)  1
Restlessness  1  1/82 (1.22%)  1 0/82 (0.00%)  0 1/71 (1.41%)  1 2/70 (2.86%)  2 0/85 (0.00%)  0
Renal and urinary disorders           
Micturition urgency  1  0/82 (0.00%)  0 0/82 (0.00%)  0 0/71 (0.00%)  0 1/70 (1.43%)  1 0/85 (0.00%)  0
Polyuria  1  1/82 (1.22%)  1 0/82 (0.00%)  0 0/71 (0.00%)  0 0/70 (0.00%)  0 0/85 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Dyspnoea  1  0/82 (0.00%)  0 0/82 (0.00%)  0 1/71 (1.41%)  1 0/70 (0.00%)  0 0/85 (0.00%)  0
Skin and subcutaneous tissue disorders           
Hyperhidrosis  1  0/82 (0.00%)  0 1/82 (1.22%)  1 0/71 (0.00%)  0 2/70 (2.86%)  2 0/85 (0.00%)  0
Pruritus  1  0/82 (0.00%)  0 1/82 (1.22%)  1 0/71 (0.00%)  0 0/70 (0.00%)  0 0/85 (0.00%)  0
Rash pruritic  1  1/82 (1.22%)  1 0/82 (0.00%)  0 0/71 (0.00%)  0 0/70 (0.00%)  0 0/85 (0.00%)  0
Vascular disorders           
Flushing  1  0/82 (0.00%)  0 2/82 (2.44%)  2 1/71 (1.41%)  1 0/70 (0.00%)  0 0/85 (0.00%)  0
Hypertension  1  0/82 (0.00%)  0 0/82 (0.00%)  0 1/71 (1.41%)  1 0/70 (0.00%)  0 0/85 (0.00%)  0
Peripheral coldness  1  0/82 (0.00%)  0 1/82 (1.22%)  2 0/71 (0.00%)  0 0/70 (0.00%)  0 0/85 (0.00%)  0
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
One participant from the placebo group did not report adverse events and was lost to follow up.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
EMail: ClinicalTrials.gov@lilly.com
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00883051    
Other Study ID Numbers: 16892
H8H-CD-LAHO ( Other Identifier: Eli Lilly and Company )
2008-005010-43 ( EudraCT Number )
COL MIG-202 ( Other Identifier: Colucid )
First Submitted: April 16, 2009
First Posted: April 17, 2009
Results First Submitted: November 8, 2019
Results First Posted: December 23, 2019
Last Update Posted: December 23, 2019