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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-003903-38 | EudraCT Number | ||
| COL MIG-201 | Other Identifier | Colucid | |
| H8H-CD-LAHM | Other Identifier | Eli Lilly and Company |
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| Name | Class |
|---|---|
| CoLucid Pharmaceuticals | INDUSTRY |
This study evaluates the efficacy of a range of intravenous doses of COL-144 in the treatment of migraine headache in order to select a dose range for further studies.
This study is set up:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lasmiditan | Experimental | Participants received escalating doses of 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 45 mg of lasmiditan as intravenous injection. |
|
| Placebo | Placebo Comparator | Participants received intravenous infusion of placebo solution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lasmiditan | Drug | Administered as intravenous infusion |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Headache Response at Two Hours After Initiation of Infusion of Study Drug | 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. | 2 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 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. | 10, 20, 40, 60 90, 120, 180 and 240 minutes post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| 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) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki | Finland | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. | ||
| 37965170 | Derived | 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. | |
| 20855362 |
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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.
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.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received intravenous infusion of placebo solution. |
| FG001 | Lasmiditan 2.5 mg | Participants received 2.5 mg of lasmiditan administered as intravenous infusion. |
| FG002 | Lasmiditan 5.0 mg | Participants received 5 mg of lasmiditan administered as intravenous infusion. |
| FG003 | Lasmiditan 10 mg | Participants received 10 mg of lasmiditan administered as intravenous infusion. |
| FG004 | Lasmiditan 20 mg | Participants received 20 mg of lasmiditan administered as intravenous infusion. |
| FG005 | Lasmiditan 30 mg | Participants received 30 mg of lasmiditan administered as intravenous infusion. |
| FG006 | Lasmiditan 45 mg | Participants received 45 mg of lasmiditan administered as intravenous infusion. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All randomized participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received intravenous infusion of placebo solution. |
| BG001 | Lasmiditan 2.5 mg | Participants received 2.5 mg of lasmiditan administered as intravenous infusion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Headache Response at Two Hours After Initiation of Infusion of Study Drug | 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. | All randomized participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | 2 hours post dose |
|
Up To 7 Days
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received intravenous injection of placebo solution. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C554777 | lasmiditan |
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| Placebo | Drug | Administered as intravenous infusion |
|
| Percentage of Participants Headache Free |
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. |
| 10, 20, 40, 60 90, 120, 180 and 240 minutes post dose |
| Number of Participants With Sustained Headache Response | 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. | 2 to 24 hours post dose |
| Number of Participants With Sustained Pain Free | 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. | 2 to 24 hours post dose |
| Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia | Number of participants with absence of nausea, vomiting, photophobia and phonophobia. | 2 hours post dose |
| Number of Participants With Clinical Disability | 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. | 2 hours post dose |
| Percentage of Participants Using Rescue Medication | Use of rescue medication up to 24 hours after initiation of study drug. | 24 hours post dose |
| Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | 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. | 2 hours post dose |
| Essen |
| Germany |
| Leiden | Netherlands |
| Derived |
| Ferrari MD, Farkkila M, Reuter U, Pilgrim A, Davis C, Krauss M, Diener HC; European COL-144 Investigators. Acute treatment of migraine with the selective 5-HT1F receptor agonist lasmiditan--a randomised proof-of-concept trial. Cephalalgia. 2010 Oct;30(10):1170-8. doi: 10.1177/0333102410375512. Epub 2010 Jun 15. |
| BG002 | Lasmiditan 5.0 mg | Participants received 5 mg of lasmiditan administered as intravenous infusion. |
| BG003 | Lasmiditan 10 mg | Participants received 10 mg of lasmiditan administered as intravenous infusion. |
| BG004 | Lasmiditan 20 mg | Participants received 20 mg of lasmiditan administered as intravenous infusion. |
| BG005 | Lasmiditan 30 mg | Participants received 30 mg of lasmiditan administered as intravenous infusion. |
| BG006 | Lasmiditan 45 mg | Participants received 45 mg of lasmiditan administered as intravenous infusion. |
| BG007 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
Participants received 2.5 mg of lasmiditan administered as intravenous infusion.
| OG002 | Lasmiditan 5.0 mg | Participants received 5 mg of lasmiditan administered as intravenous infusion. |
| OG003 | Lasmiditan 10 mg | Participants received 10 mg of lasmiditan administered as intravenous infusion. |
| OG004 | Lasmiditan 20 mg | Participants received 20 mg of lasmiditan administered as intravenous infusion. |
| OG005 | Lasmiditan 30 mg | Participants received 30 mg of lasmiditan administered as intravenous infusion. |
| OG006 | Lasmiditan 45 mg | Participants received 45 mg of lasmiditan administered as intravenous infusion. |
|
|
|
| Secondary | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 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. | All randomized participants who received at least one dose of study drug. | Posted | Number | Percentage of participants | 10, 20, 40, 60 90, 120, 180 and 240 minutes post dose |
|
|
|
| Secondary | Percentage of Participants Headache Free | 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. | All randomized participants who received at least one dose of study drug. | Posted | Number | Percentage of participants | 10, 20, 40, 60 90, 120, 180 and 240 minutes post dose |
|
|
|
| Secondary | Number of Participants With Sustained Headache Response | 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. | All randomized participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | 2 to 24 hours post dose |
|
|
|
| Secondary | Number of Participants With Sustained Pain Free | 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. | All randomized participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | 2 to 24 hours post dose |
|
|
|
| Secondary | Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia | Number of participants with absence of nausea, vomiting, photophobia and phonophobia. | All randomized participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | 2 hours post dose |
|
|
|
| Secondary | Number of Participants With Clinical Disability | 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. | All randomized participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | 2 hours post dose |
|
|
|
| Secondary | Percentage of Participants Using Rescue Medication | Use of rescue medication up to 24 hours after initiation of study drug. | All randomized participants who received at least one dose of study drug. | Posted | Number | Percentage of participants | 24 hours post dose |
|
|
|
| Secondary | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | 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. | All randomized participants who received at least one dose of study drug. | Posted | Number | Percentage of Participants | 2 hours post dose |
|
|
|
| 42 |
| 0 |
| 42 |
| 18 |
| 42 |
| EG001 | Lasmiditan 2.5 mg | Participants received 2.5 mg of lasmiditan administered as intravenous infusion. | 0 | 4 | 0 | 4 | 2 | 4 |
| EG002 | Lasmiditan 5.0 mg | Participants received 5 mg of lasmiditan administered as intravenous infusion. | 0 | 12 | 0 | 12 | 3 | 12 |
| EG003 | Lasmiditan 10 mg | Participants received 10 mg of lasmiditan administered as intravenous infusion. | 0 | 24 | 0 | 24 | 17 | 24 |
| EG004 | Lasmiditan 20 mg | Participants received 20 mg of lasmiditan administered as intravenous infusion. | 0 | 28 | 0 | 28 | 19 | 28 |
| EG005 | Lasmiditan 30 mg | Participants received 30 mg of lasmiditan administered as intravenous infusion. | 0 | 16 | 0 | 16 | 13 | 16 |
| EG006 | Lasmiditan 45 mg | Participants received 45 mg of lasmiditan administered as intravenous infusion. | 0 | 4 | 0 | 4 | 3 | 4 |
| Palpitations | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 22.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 22.0 | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 22.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Paraesthesia oral | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Discomfort | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Feeling cold | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Feeling of relaxation | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Infusion site paraesthesia | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Sensation of blood flow | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Swelling | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Formication | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Head discomfort | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Restless legs syndrome | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Serotonin syndrome | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
|
| Phonophobia | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
|
| Tension | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
|
| Menstruation delayed | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
|
| Vasoconstriction | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
|
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.
| D009422 | Nervous System Diseases |
| 20 min |
|
| 40 min |
|
| 60 min |
|
| 90 min |
|
| 120 min |
|
| 180 min |
|
| 240 min |
|
| 20 min |
|
| 40 min |
|
| 60 min |
|
| 90 min |
|
| 120 min |
|
| 180 min |
|
| 240 min |
|
| Yes |
|
| Yes |
|
| Vomiting |
|
| Photophobia |
|
| Phonophobia |
|
| Mild disability |
|
| Moderate disability |
|
| Severe disability |
|
| Much better |
|
| A little better |
|
| No change |
|
| A little worse |
|
| Much worse |
|
| Very much worse |
|