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A Placebo-Controlled Adaptive Treatment Assignment Study of Intravenous COL-144 in the Acute Treatment of Migraine

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: NCT00384774
Recruitment Status : Completed
First Posted : October 6, 2006
Results First Posted : December 2, 2019
Last Update Posted : December 2, 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: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Migraine
Interventions Drug: Lasmiditan
Drug: Placebo
Enrollment 130
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Lasmiditan 2.5 mg Lasmiditan 5.0 mg Lasmiditan 10 mg Lasmiditan 20 mg Lasmiditan 30 mg Lasmiditan 45 mg
Hide Arm/Group Description Participants received intravenous infusion of placebo solution. Participants received 2.5 mg of lasmiditan administered as intravenous infusion. Participants received 5 mg of lasmiditan administered as intravenous infusion. Participants received 10 mg of lasmiditan administered as intravenous infusion. Participants received 20 mg of lasmiditan administered as intravenous infusion. Participants received 30 mg of lasmiditan administered as intravenous infusion. Participants received 45 mg of lasmiditan administered as intravenous infusion.
Period Title: Overall Study
Started 42 4 12 24 28 16 4
Received at Least 1 Dose of Study Drug 42 4 12 24 28 16 4
Completed 42 4 12 24 28 16 4
Not Completed 0 0 0 0 0 0 0
Arm/Group Title Placebo Lasmiditan 2.5 mg Lasmiditan 5.0 mg Lasmiditan 10 mg Lasmiditan 20 mg Lasmiditan 30 mg Lasmiditan 45 mg Total
Hide Arm/Group Description Participants received intravenous infusion of placebo solution. Participants received 2.5 mg of lasmiditan administered as intravenous infusion. Participants received 5 mg of lasmiditan administered as intravenous infusion. Participants received 10 mg of lasmiditan administered as intravenous infusion. Participants received 20 mg of lasmiditan administered as intravenous infusion. Participants received 30 mg of lasmiditan administered as intravenous infusion. Participants received 45 mg of lasmiditan administered as intravenous infusion. Total of all reporting groups
Overall Number of Baseline Participants 42 4 12 24 28 16 4 130
Hide Baseline Analysis Population Description
All randomized participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 4 participants 12 participants 24 participants 28 participants 16 participants 4 participants 130 participants
40.3  (13.1) 46.8  (14.0) 39.2  (8.8) 34.5  (10.3) 38.9  (10.1) 40.3  (11.2) 40.8  (11.0) 39.0  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 4 participants 12 participants 24 participants 28 participants 16 participants 4 participants 130 participants
Female 38 3 10 21 24 14 3 113
Male 4 1 2 3 4 2 1 17
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 42 participants 4 participants 12 participants 24 participants 28 participants 16 participants 4 participants 130 participants
Caucasian 42 4 11 20 28 16 4 125
Black 0 0 0 1 0 0 0 1
Latin 0 0 1 0 0 0 0 1
South-American 0 0 0 1 0 0 0 1
Romanian 0 0 0 1 0 0 0 1
Unknown or Not Reported 0 0 0 1 0 0 0 1
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 42 participants 4 participants 12 participants 24 participants 28 participants 16 participants 4 participants 130 participants
Netherlands 3 0 1 3 1 0 1 9
Finland 10 0 6 4 2 1 1 24
Germany 29 4 5 17 25 15 2 97
1.Primary Outcome
Title Number of Participants With Headache Response at Two Hours After Initiation of Infusion of Study Drug
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 initiation of infusion of study drug.
Time Frame 2 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug.
Arm/Group Title Placebo Lasmiditan 2.5 mg Lasmiditan 5.0 mg Lasmiditan 10 mg Lasmiditan 20 mg Lasmiditan 30 mg Lasmiditan 45 mg
Hide Arm/Group Description:
Participants received intravenous infusion of placebo solution.
Participants received 2.5 mg of lasmiditan administered as intravenous infusion.
Participants received 5 mg of lasmiditan administered as intravenous infusion.
Participants received 10 mg of lasmiditan administered as intravenous infusion.
Participants received 20 mg of lasmiditan administered as intravenous infusion.
Participants received 30 mg of lasmiditan administered as intravenous infusion.
Participants received 45 mg of lasmiditan administered as intravenous infusion.
Overall Number of Participants Analyzed 42 4 12 24 28 16 4
Measure Type: Count of Participants
Unit of Measure: Participants
No 23 2 10 11 10 5 1
Yes 19 2 2 13 18 11 3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lasmiditan 2.5 mg
Comments Headache Response
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lasmiditan 5.0 mg
Comments Headache Response
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0991
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Lasmiditan 10 mg
Comments Headache Response
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4851
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Lasmiditan 20 mg
Comments Headache Response
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1178
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Lasmiditan 30 mg
Comments Headache Response
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1093
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Lasmiditan 45 mg
Comments Headache Response
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3364
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose
Hide Description 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 initiation of infusion of study drug.
Time Frame 10, 20, 40, 60 90, 120, 180 and 240 minutes post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug.
Arm/Group Title Placebo Lasmiditan 2.5 mg Lasmiditan 5.0 mg Lasmiditan 10 mg Lasmiditan 20 mg Lasmiditan 30 mg Lasmiditan 45 mg
Hide Arm/Group Description:
Participants received intravenous infusion of placebo solution.
Participants received 2.5 mg of lasmiditan administered as intravenous infusion.
Participants received 5 mg of lasmiditan administered as intravenous infusion.
Participants received 10 mg of lasmiditan administered as intravenous infusion.
Participants received 20 mg of lasmiditan administered as intravenous infusion.
Participants received 30 mg of lasmiditan administered as intravenous infusion.
Participants received 45 mg of lasmiditan administered as intravenous infusion.
Overall Number of Participants Analyzed 42 4 12 24 28 16 4
Measure Type: Number
Unit of Measure: Percentage of participants
10 min 11.9 0 8.3 8.3 14.3 12.5 75.0
20 min 26.2 0 16.7 25.0 39.3 50.0 75.0
40 min 35.7 0 25.0 37.5 50.0 75.0 75.0
60 min 33.3 50.0 25.0 50.0 53.6 75.0 50.0
90 min 47.6 50.0 25.0 45.8 53.6 68.8 75.0
120 min 45.2 50.0 16.7 54.2 64.3 68.8 75.0
180 min 33.3 50.0 25.0 54.2 60.7 68.8 75.0
240 min 31.0 75.0 33.3 54.2 57.1 68.8 25.0
3.Secondary Outcome
Title Percentage of Participants Headache Free
Hide Description Headache free is defined as a reduction in headache severity from moderate or severe at baseline to no headache pain at 10 min, 20 min, 40 min, 60 min, 90 min, 120 min, 180 min, and 240 min after initiation of study drug.
Time Frame 10, 20, 40, 60 90, 120, 180 and 240 minutes post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug.
Arm/Group Title Placebo Lasmiditan 2.5 mg Lasmiditan 5.0 mg Lasmiditan 10 mg Lasmiditan 20 mg Lasmiditan 30 mg Lasmiditan 45 mg
Hide Arm/Group Description:
Participants received intravenous infusion of placebo solution.
Participants received 2.5 mg of lasmiditan administered as intravenous infusion.
Participants received 5 mg of lasmiditan administered as intravenous infusion.
Participants received 10 mg of lasmiditan administered as intravenous infusion.
Participants received 20 mg of lasmiditan administered as intravenous infusion.
Participants received 30 mg of lasmiditan administered as intravenous infusion.
Participants received 45 mg of lasmiditan administered as intravenous infusion.
Overall Number of Participants Analyzed 42 4 12 24 27 16 3
Measure Type: Number
Unit of Measure: Percentage of participants
10 min 0 0 0 0 3.6 0 25.0
20 min 2.4 0 0 8.3 3.6 0 25.0
40 min 2.4 0 0 8.3 14.3 18.8 25.0
60 min 7.1 0 0 20.8 21.4 25.0 25.0
90 min 14.3 0 0 20.8 25.0 37.5 25.0
120 min 19.0 0 0 20.8 28.6 37.5 25.0
180 min 21.4 0 0 20.8 32.1 37.5 25.0
240 min 21.4 25.0 0 20.8 28.6 31.3 25.0
4.Secondary Outcome
Title Number of Participants With Sustained Headache Response
Hide Description Sustained headache response at 2 hours is a binary response variable derived from the headache intensities recorded in the participant diary. Sustained headache response was defined as moderate or severe headache pain at baseline which became mild or absent (pain free) at 2 hours after initiation of study drug and which did not recur (became moderate or severe) within 24 hours of initiation of study drug. If rescue medication was taken within 24 hours, this was considered a headache recurrence, even if no headache was reported.
Time Frame 2 to 24 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug.
Arm/Group Title Placebo Lasmiditan 2.5 mg Lasmiditan 5.0 mg Lasmiditan 10 mg Lasmiditan 20 mg Lasmiditan 30 mg Lasmiditan 45 mg
Hide Arm/Group Description:
Participants received intravenous infusion of placebo solution.
Participants received 2.5 mg of lasmiditan administered as intravenous infusion.
Participants received 5 mg of lasmiditan administered as intravenous infusion.
Participants received 10 mg of lasmiditan administered as intravenous infusion.
Participants received 20 mg of lasmiditan administered as intravenous infusion.
Participants received 30 mg of lasmiditan administered as intravenous infusion.
Participants received 45 mg of lasmiditan administered as intravenous infusion.
Overall Number of Participants Analyzed 42 4 12 24 28 16 4
Measure Type: Count of Participants
Unit of Measure: Participants
No 29 2 11 16 18 7 3
Yes 13 2 1 8 10 9 1
5.Secondary Outcome
Title Number of Participants With Sustained Pain Free
Hide Description Sustained pain free was defined as moderate or severe headache pain at baseline which became mild or absent (pain free) at 2 hours after initiation of study drug and which did not recur (became moderate or severe) within 24 hours of initiation of study drug. If rescue medication was taken within 24 hours, this was considered a headache recurrence, even if no headache was reported.
Time Frame 2 to 24 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug.
Arm/Group Title Placebo Lasmiditan 2.5 mg Lasmiditan 5.0 mg Lasmiditan 10 mg Lasmiditan 20 mg Lasmiditan 30 mg Lasmiditan 45 mg
Hide Arm/Group Description:
Participants received intravenous infusion of placebo solution.
Participants received 2.5 mg of lasmiditan administered as intravenous infusion.
Participants received 5 mg of lasmiditan administered as intravenous infusion.
Participants received 10 mg of lasmiditan administered as intravenous infusion.
Participants received 20 mg of lasmiditan administered as intravenous infusion.
Participants received 30 mg of lasmiditan administered as intravenous infusion.
Participants received 45 mg of lasmiditan administered as intravenous infusion.
Overall Number of Participants Analyzed 42 4 12 24 28 16 4
Measure Type: Count of Participants
Unit of Measure: Participants
No 35 4 12 21 23 13 3
Yes 7 0 0 3 5 3 1
6.Secondary Outcome
Title Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia
Hide Description Number of participants with absence of nausea, vomiting, photophobia and phonophobia.
Time Frame 2 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug.
Arm/Group Title Placebo Lasmiditan 2.5 mg Lasmiditan 5.0 mg Lasmiditan 10 mg Lasmiditan 20 mg Lasmiditan 30 mg Lasmiditan 45 mg
Hide Arm/Group Description:
Participants received intravenous infusion of placebo solution.
Participants received 2.5 mg of lasmiditan administered as intravenous infusion.
Participants received 5 mg of lasmiditan administered as intravenous infusion.
Participants received 10 mg of lasmiditan administered as intravenous infusion.
Participants received 20 mg of lasmiditan administered as intravenous infusion.
Participants received 30 mg of lasmiditan administered as intravenous infusion.
Participants received 45 mg of lasmiditan administered as intravenous infusion.
Overall Number of Participants Analyzed 42 4 12 24 28 16 4
Measure Type: Count of Participants
Unit of Measure: Participants
Nausea 7 1 5 3 6 1 1
Vomiting 1 0 0 1 0 0 0
Photophobia 21 1 9 11 12 4 1
Phonophobia 18 1 5 6 7 4 1
7.Secondary Outcome
Title Number of Participants With Clinical Disability
Hide Description Clinical disability for each participant was assessed using the Clinical Disability Questionnaire (CDQ). Participants graded their disability on the following scale: 0, no disability, able to function normally; 1, performance of daily activities mildly impaired, can still do everything but with difficulty; 2, performance of daily activities moderately impaired, unable to do some things; 3, performance of daily activities severely impaired, cannot do all or most things, bed rest may be necessary.
Time Frame 2 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug.
Arm/Group Title Placebo Lasmiditan 2.5 mg Lasmiditan 5.0 mg Lasmiditan 10 mg Lasmiditan 20 mg Lasmiditan 30 mg Lasmiditan 45 mg
Hide Arm/Group Description:
Participants received intravenous infusion of placebo solution.
Participants received 2.5 mg of lasmiditan administered as intravenous infusion.
Participants received 5 mg of lasmiditan administered as intravenous infusion.
Participants received 10 mg of lasmiditan administered as intravenous infusion.
Participants received 20 mg of lasmiditan administered as intravenous infusion.
Participants received 30 mg of lasmiditan administered as intravenous infusion.
Participants received 45 mg of lasmiditan administered as intravenous infusion.
Overall Number of Participants Analyzed 42 4 12 24 28 16 4
Measure Type: Count of Participants
Unit of Measure: Participants
No disability 11 2 1 6 9 7 3
Mild disability 10 1 1 7 7 5 0
Moderate disability 14 0 6 7 11 3 0
Severe disability 7 1 4 4 1 1 1
8.Secondary Outcome
Title Percentage of Participants Using Rescue Medication
Hide Description Use of rescue medication up to 24 hours after initiation of study drug.
Time Frame 24 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug.
Arm/Group Title Placebo Lasmiditan 2.5 mg Lasmiditan 5.0 mg Lasmiditan 10 mg Lasmiditan 20 mg Lasmiditan 30 mg Lasmiditan 45 mg
Hide Arm/Group Description:
Participants received intravenous infusion of placebo solution.
Participants received 2.5 mg of lasmiditan administered as intravenous infusion.
Participants received 5 mg of lasmiditan administered as intravenous infusion.
Participants received 10 mg of lasmiditan administered as intravenous infusion.
Participants received 20 mg of lasmiditan administered as intravenous infusion.
Participants received 30 mg of lasmiditan administered as intravenous infusion.
Participants received 45 mg of lasmiditan administered as intravenous infusion.
Overall Number of Participants Analyzed 42 4 12 24 28 16 4
Measure Type: Number
Unit of Measure: Percentage of participants
69.0 25.0 91.7 58.3 53.6 37.5 25.0
9.Secondary Outcome
Title Percentage of Participants Reporting a Score on the Patient Global Impression (PGI)
Hide Description PGI scale is a participant-rated instrument that measures participants own global impression of their illness severity. Participants were asked to mark the box that best describes their 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.
Time Frame 2 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug.
Arm/Group Title Placebo Lasmiditan 2.5 mg Lasmiditan 5.0 mg Lasmiditan 10 mg Lasmiditan 20 mg Lasmiditan 30 mg Lasmiditan 45 mg
Hide Arm/Group Description:
Participants received intravenous infusion of placebo solution.
Participants received 2.5 mg of lasmiditan administered as intravenous infusion.
Participants received 5 mg of lasmiditan administered as intravenous infusion.
Participants received 10 mg of lasmiditan administered as intravenous infusion.
Participants received 20 mg of lasmiditan administered as intravenous infusion.
Participants received 30 mg of lasmiditan administered as intravenous infusion.
Participants received 45 mg of lasmiditan administered as intravenous infusion.
Overall Number of Participants Analyzed 42 4 12 24 28 16 4
Measure Type: Number
Unit of Measure: Percentage of Participants
Very much better 9.5 0 0 8.3 25.0 37.5 0
Much better 19.0 75.0 8.3 29.2 17.9 31.3 50.0
A little better 23.8 0 41.7 29.2 42.9 18.8 25.0
No change 19.0 0 25.0 29.2 7.1 12.5 25.0
A little worse 14.3 0 8.3 4.2 7.1 0 0
Much worse 11.9 0 0 0 0 0 0
Very much worse 2.4 25.0 16.7 0 0 0 0
Time Frame Up To 7 Days
Adverse Event Reporting Description All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
 
Arm/Group Title Placebo Lasmiditan 2.5 mg Lasmiditan 5.0 mg Lasmiditan 10 mg Lasmiditan 20 mg Lasmiditan 30 mg Lasmiditan 45 mg
Hide Arm/Group Description Participants received intravenous injection of placebo solution. Participants received 2.5 mg of lasmiditan administered as intravenous infusion. Participants received 5 mg of lasmiditan administered as intravenous infusion. Participants received 10 mg of lasmiditan administered as intravenous infusion. Participants received 20 mg of lasmiditan administered as intravenous infusion. Participants received 30 mg of lasmiditan administered as intravenous infusion. Participants received 45 mg of lasmiditan administered as intravenous infusion.
All-Cause Mortality
Placebo Lasmiditan 2.5 mg Lasmiditan 5.0 mg Lasmiditan 10 mg Lasmiditan 20 mg Lasmiditan 30 mg Lasmiditan 45 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/42 (0.00%)      0/4 (0.00%)      0/12 (0.00%)      0/24 (0.00%)      0/28 (0.00%)      0/16 (0.00%)      0/4 (0.00%)    
Hide Serious Adverse Events
Placebo Lasmiditan 2.5 mg Lasmiditan 5.0 mg Lasmiditan 10 mg Lasmiditan 20 mg Lasmiditan 30 mg Lasmiditan 45 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/42 (0.00%)      0/4 (0.00%)      0/12 (0.00%)      0/24 (0.00%)      0/28 (0.00%)      0/16 (0.00%)      0/4 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Lasmiditan 2.5 mg Lasmiditan 5.0 mg Lasmiditan 10 mg Lasmiditan 20 mg Lasmiditan 30 mg Lasmiditan 45 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/42 (42.86%)      2/4 (50.00%)      3/12 (25.00%)      17/24 (70.83%)      19/28 (67.86%)      13/16 (81.25%)      3/4 (75.00%)    
Blood and lymphatic system disorders               
Leukopenia † 1  1/42 (2.38%)  1 0/4 (0.00%)  0 0/12 (0.00%)  0 0/24 (0.00%)  0 0/28 (0.00%)  0 0/16 (0.00%)  0 0/4 (0.00%)  0
Cardiac disorders               
Palpitations † 1  2/42 (4.76%)  3 0/4 (0.00%)  0 0/12 (0.00%)  0 0/24 (0.00%)  0 0/28 (0.00%)  0 0/16 (0.00%)  0 0/4 (0.00%)  0
Ear and labyrinth disorders               
Vertigo † 1  0/42 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 1/24 (4.17%)  1 1/28 (3.57%)  1 2/16 (12.50%)  2 0/4 (0.00%)  0
Eye disorders               
Vision blurred † 1  0/42 (0.00%)  0 1/4 (25.00%)  1 0/12 (0.00%)  0 0/24 (0.00%)  0 0/28 (0.00%)  0 0/16 (0.00%)  0 0/4 (0.00%)  0
Visual impairment † 1  0/42 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/24 (0.00%)  0 1/28 (3.57%)  1 0/16 (0.00%)  0 0/4 (0.00%)  0
Gastrointestinal disorders               
Abdominal pain † 1  1/42 (2.38%)  3 0/4 (0.00%)  0 0/12 (0.00%)  0 0/24 (0.00%)  0 0/28 (0.00%)  0 0/16 (0.00%)  0 0/4 (0.00%)  0
Diarrhoea † 1  1/42 (2.38%)  1 0/4 (0.00%)  0 0/12 (0.00%)  0 0/24 (0.00%)  0 1/28 (3.57%)  1 0/16 (0.00%)  0 0/4 (0.00%)  0
Dry mouth † 1  2/42 (4.76%)  2 0/4 (0.00%)  0 0/12 (0.00%)  0 0/24 (0.00%)  0 0/28 (0.00%)  0 0/16 (0.00%)  0 0/4 (0.00%)  0
Nausea † 1  2/42 (4.76%)  2 0/4 (0.00%)  0 0/12 (0.00%)  0 0/24 (0.00%)  0 3/28 (10.71%)  3 1/16 (6.25%)  1 0/4 (0.00%)  0
Paraesthesia oral † 1  0/42 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/24 (0.00%)  0 0/28 (0.00%)  0 1/16 (6.25%)  1 0/4 (0.00%)  0
Vomiting † 1  0/42 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/24 (0.00%)  0 2/28 (7.14%)  2 0/16 (0.00%)  0 0/4 (0.00%)  0
General disorders               
Chest pain † 1  2/42 (4.76%)  2 0/4 (0.00%)  0 0/12 (0.00%)  0 0/24 (0.00%)  0 0/28 (0.00%)  0 1/16 (6.25%)  1 0/4 (0.00%)  0
Chills † 1  0/42 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/24 (0.00%)  0 1/28 (3.57%)  1 0/16 (0.00%)  0 0/4 (0.00%)  0
Discomfort † 1  1/42 (2.38%)  1 0/4 (0.00%)  0 0/12 (0.00%)  0 2/24 (8.33%)  2 3/28 (10.71%)  4 3/16 (18.75%)  3 0/4 (0.00%)  0
Fatigue † 1  4/42 (9.52%)  4 0/4 (0.00%)  0 1/12 (8.33%)  1 1/24 (4.17%)  1 5/28 (17.86%)  6 3/16 (18.75%)  3 0/4 (0.00%)  0
Feeling abnormal † 1  0/42 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 1/24 (4.17%)  1 0/28 (0.00%)  0 1/16 (6.25%)  1 0/4 (0.00%)  0
Feeling cold † 1  1/42 (2.38%)  1 0/4 (0.00%)  0 0/12 (0.00%)  0 1/24 (4.17%)  1 0/28 (0.00%)  0 0/16 (0.00%)  0 0/4 (0.00%)  0
Feeling hot † 1  2/42 (4.76%)  2 0/4 (0.00%)  0 0/12 (0.00%)  0 0/24 (0.00%)  0 0/28 (0.00%)  0 1/16 (6.25%)  1 0/4 (0.00%)  0
Feeling of relaxation † 1  0/42 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/24 (0.00%)  0 2/28 (7.14%)  2 3/16 (18.75%)  3 0/4 (0.00%)  0
Infusion site paraesthesia † 1  0/42 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/24 (0.00%)  0 0/28 (0.00%)  0 2/16 (12.50%)  2 0/4 (0.00%)  0
Injection site pain † 1  0/42 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 1/24 (4.17%)  1 0/28 (0.00%)  0 0/16 (0.00%)  0 0/4 (0.00%)  0
Sensation of blood flow † 1  0/42 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 1/24 (4.17%)  2 0/28 (0.00%)  0 0/16 (0.00%)  0 0/4 (0.00%)  0
Swelling † 1  1/42 (2.38%)  1 0/4 (0.00%)  0 0/12 (0.00%)  0 1/24 (4.17%)  1 0/28 (0.00%)  0 0/16 (0.00%)  0 0/4 (0.00%)  0
Infections and infestations               
Nasopharyngitis † 1  2/42 (4.76%)  2 0/4 (0.00%)  0 0/12 (0.00%)  0 0/24 (0.00%)  0 0/28 (0.00%)  0 0/16 (0.00%)  0 0/4 (0.00%)  0
Upper respiratory tract infection † 1  0/42 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 1/24 (4.17%)  1 0/28 (0.00%)  0 0/16 (0.00%)  0 0/4 (0.00%)  0
Musculoskeletal and connective tissue disorders               
Limb discomfort † 1  0/42 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/24 (0.00%)  0 1/28 (3.57%)  2 1/16 (6.25%)  1 0/4 (0.00%)  0
Musculoskeletal pain † 1  1/42 (2.38%)  1 0/4 (0.00%)  0 0/12 (0.00%)  0 0/24 (0.00%)  0 0/28 (0.00%)  0 0/16 (0.00%)  0 0/4 (0.00%)  0
Neck pain † 1  0/42 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 1/24 (4.17%)  1 0/28 (0.00%)  0 0/16 (0.00%)  0 0/4 (0.00%)  0
Pain in extremity † 1  0/42 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/24 (0.00%)  0 0/28 (0.00%)  0 1/16 (6.25%)  1 0/4 (0.00%)  0
Nervous system disorders               
Dizziness † 1  6/42 (14.29%)  6 2/4 (50.00%)  2 1/12 (8.33%)  1 8/24 (33.33%)  9 7/28 (25.00%)  7 3/16 (18.75%)  4 1/4 (25.00%)  1
Formication † 1  0/42 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/24 (0.00%)  0 0/28 (0.00%)  0 3/16 (18.75%)  3 0/4 (0.00%)  0
Head discomfort † 1  0/42 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/24 (0.00%)  0 1/28 (3.57%)  1 0/16 (0.00%)  0 0/4 (0.00%)  0
Headache † 1  1/42 (2.38%)  1 0/4 (0.00%)  0 0/12 (0.00%)  0 0/24 (0.00%)  0 0/28 (0.00%)  0 0/16 (0.00%)  0 0/4 (0.00%)  0
Hypoaesthesia † 1  0/42 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 1/24 (4.17%)  1 2/28 (7.14%)  2 0/16 (0.00%)  0 1/4 (25.00%)  1
Migraine † 1  1/42 (2.38%)  1 0/4 (0.00%)  0 0/12 (0.00%)  0 0/24 (0.00%)  0 0/28 (0.00%)  0 0/16 (0.00%)  0 0/4 (0.00%)  0
Paraesthesia † 1  0/42 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 5/24 (20.83%)  5 8/28 (28.57%)  11 3/16 (18.75%)  4 1/4 (25.00%)  1
Restless legs syndrome † 1  0/42 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 1/24 (4.17%)  1 0/28 (0.00%)  0 0/16 (0.00%)  0 0/4 (0.00%)  0
Serotonin syndrome † 1  0/42 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/24 (0.00%)  0 0/28 (0.00%)  0 0/16 (0.00%)  0 1/4 (25.00%)  1
Somnolence † 1  1/42 (2.38%)  1 0/4 (0.00%)  0 0/12 (0.00%)  0 1/24 (4.17%)  1 1/28 (3.57%)  1 0/16 (0.00%)  0 0/4 (0.00%)  0
Tension headache † 1  1/42 (2.38%)  1 0/4 (0.00%)  0 0/12 (0.00%)  0 0/24 (0.00%)  0 0/28 (0.00%)  0 0/16 (0.00%)  0 0/4 (0.00%)  0
Tremor † 1  0/42 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/24 (0.00%)  0 0/28 (0.00%)  0 1/16 (6.25%)  1 0/4 (0.00%)  0
Psychiatric disorders               
Confusional state † 1  0/42 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/24 (0.00%)  0 1/28 (3.57%)  1 0/16 (0.00%)  0 0/4 (0.00%)  0
Insomnia † 1  0/42 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 1/24 (4.17%)  1 0/28 (0.00%)  0 0/16 (0.00%)  0 0/4 (0.00%)  0
Phonophobia † 1  1/42 (2.38%)  1 0/4 (0.00%)  0 0/12 (0.00%)  0 0/24 (0.00%)  0 0/28 (0.00%)  0 0/16 (0.00%)  0 0/4 (0.00%)  0
Tension † 1  0/42 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/24 (0.00%)  0 1/28 (3.57%)  1 0/16 (0.00%)  0 0/4 (0.00%)  0
Reproductive system and breast disorders               
Menstruation delayed † 1  1/38 (2.63%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0 0/21 (0.00%)  0 0/24 (0.00%)  0 0/14 (0.00%)  0 0/3 (0.00%)  0
Respiratory, thoracic and mediastinal disorders               
Dyspnoea † 1  0/42 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/24 (0.00%)  0 1/28 (3.57%)  1 1/16 (6.25%)  1 0/4 (0.00%)  0
Skin and subcutaneous tissue disorders               
Cold sweat † 1  1/42 (2.38%)  1 0/4 (0.00%)  0 0/12 (0.00%)  0 0/24 (0.00%)  0 0/28 (0.00%)  0 0/16 (0.00%)  0 0/4 (0.00%)  0
Photosensitivity reaction † 1  1/42 (2.38%)  1 0/4 (0.00%)  0 0/12 (0.00%)  0 0/24 (0.00%)  0 0/28 (0.00%)  0 0/16 (0.00%)  0 0/4 (0.00%)  0
Rash † 1  1/42 (2.38%)  1 0/4 (0.00%)  0 0/12 (0.00%)  0 0/24 (0.00%)  0 0/28 (0.00%)  0 0/16 (0.00%)  0 0/4 (0.00%)  0
Skin reaction † 1  1/42 (2.38%)  1 0/4 (0.00%)  0 0/12 (0.00%)  0 0/24 (0.00%)  0 0/28 (0.00%)  0 0/16 (0.00%)  0 0/4 (0.00%)  0
Vascular disorders               
Flushing † 1  0/42 (0.00%)  0 0/4 (0.00%)  0 1/12 (8.33%)  1 0/24 (0.00%)  0 0/28 (0.00%)  0 0/16 (0.00%)  0 1/4 (25.00%)  1
Vasoconstriction † 1  1/42 (2.38%)  1 0/4 (0.00%)  0 0/12 (0.00%)  0 0/24 (0.00%)  0 0/28 (0.00%)  0 0/16 (0.00%)  0 0/4 (0.00%)  0
1
Term from vocabulary, MedDRA 22.0
†
Indicates events were collected by systematic assessment
[Not Specified]
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.
Details of the Study and its results shall not be publicized in any form without prior consent of the Sponsor. Such approval is necessary to prevent premature disclosure of trade secrets and other confidential information.
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
Publications of Results:
Reuter U, Pilgrim A, Diener HC, Färkkilä M, Ferrari M for the European COL-144 investigators. COL-144: A Selective 5-HT1F Agonist For the Treatment of Migraine Attacks. European Headache & Migraine Trust International Congress 2008, London, England, Poster #PC.11, September 5, 2008.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00384774    
Other Study ID Numbers: 16891
2006-003903-38 ( EudraCT Number )
COL MIG-201 ( Other Identifier: Colucid )
H8H-CD-LAHM ( Other Identifier: Eli Lilly and Company )
First Submitted: October 4, 2006
First Posted: October 6, 2006
Results First Submitted: November 8, 2019
Results First Posted: December 2, 2019
Last Update Posted: December 2, 2019