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| ID | Type | Description | Link |
|---|---|---|---|
| H8H-MC-LAHC | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to measure how much of the drug gets into the blood stream and how long it takes the body to get rid of it during an acute migraine attack and also during the time between acute migraine attacks.
Information about any side effects that may occur will also be collected.
This study includes two study periods. Each study period requires an overnight stay in the Clinical Research Unit (CRU) for at least one night (and up to three nights), followed by up to two outpatient appointments. This study will last approximately 5-6 weeks (not including screening).
Follow-up is required four to seven days after last dose of investigational drug. Screening is required within 28 days prior to the start of the study.
This study is for research purposes only and is not intended to treat any medical condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lasmiditan (Period 1) | Experimental | 200 mg Lasmiditan tablet given once orally during migraine attack. |
|
| Lasmiditan (Period 2) | Experimental | 200 mg Lasmiditan tablet given once orally during inter-ictal period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lasmiditan | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan in Each Period | PK: Cmax of Lasmiditan in Each Period. | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8,12, 18, 24, 48, and 72h post-dose |
| PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Lasmiditan in Each Period | PK: AUC(0-∞) of Lasmiditan in Each Period. | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8,12, 18, 24, 48, and 72h post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| PK: Maximum Observed Drug Concentration (Cmax) of Major Lasmiditan Metabolites [M3, M8, M7, (S,R)-M18and (S,S)-M18] in Each Period | PK: Cmax of Major Lasmiditan Metabolites [M3, M8, M7, (S,R)-M18and (S,S)-M18] in Each Period. | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 48, and 72h 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 |
|---|---|---|---|---|---|---|
| eStudySite | San Diego | California | 92120 | United States | ||
| AGA Clinical Trials |
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| Label | URL |
|---|---|
| A Study of Lasmiditan in Participants With Migraine | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lasmiditan | Participants were administered a single oral dose of 200 mg lasmiditan tablet on 2 occasions (Day 1 of each period) during a migraine attack (Period 1) and during their inter-ictal period (Period 2). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: Migraine Attack |
| ||||||||||||||||
| Period 2: Inter-ictal Period |
|
All enrolled participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lasmiditan | Participants were administered a single oral dose of 200 mg lasmiditan tablet on 2 occasions (Day 1 of each period) during a migraine attack (Period 1) and during their inter-ictal period (Period 2). |
| 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 | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan in Each Period | PK: Cmax of Lasmiditan in Each Period. | All enrolled participants who received at least one dose of study drug and have evaluable pharmacokinetic data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8,12, 18, 24, 48, and 72h post-dose |
|
Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk 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 | Lasmiditan (Period 1) | Participants were administered a single oral dose of 200 mg Lasmiditan tablet on day 1 during migraine attack. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Photophobia | Eye disorders | MedDRA 20.0 | 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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 13, 2017 | Jan 24, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 11, 2017 | Jan 24, 2019 | SAP_001.pdf |
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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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Multi-center, open-label study with 2 study periods.
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| PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Major Lasmiditan Metabolites [M3, M8, M7, (S,R)-M18and (S,S)-M18] in Each Period |
PK: AUC(0-∞) of Major Lasmiditan Metabolites [M3, M8, M7, (S,R)-M18and (S,S)-M18] in Each Period. |
| Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 48, and 72h post-dose |
| Hialeah |
| Florida |
| 33012 |
| United States |
| Meridien Research Inc. | Tampa | Florida | 33634 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
|
|
| Primary | PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Lasmiditan in Each Period | PK: AUC(0-∞) of Lasmiditan in Each Period. | All enrolled participants who received at least one dose of study drug and have evaluable pharmacokinetic data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*h/mL) | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8,12, 18, 24, 48, and 72h post-dose |
|
|
|
| Secondary | PK: Maximum Observed Drug Concentration (Cmax) of Major Lasmiditan Metabolites [M3, M8, M7, (S,R)-M18and (S,S)-M18] in Each Period | PK: Cmax of Major Lasmiditan Metabolites [M3, M8, M7, (S,R)-M18and (S,S)-M18] in Each Period. | All enrolled participants who received at least one dose of study drug and have evaluable pharmacokinetic data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 48, and 72h post-dose |
|
|
|
| Secondary | PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Major Lasmiditan Metabolites [M3, M8, M7, (S,R)-M18and (S,S)-M18] in Each Period | PK: AUC(0-∞) of Major Lasmiditan Metabolites [M3, M8, M7, (S,R)-M18and (S,S)-M18] in Each Period. | All enrolled participants who received at least one dose of study drug and have evaluable pharmacokinetic data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 48, and 72h post-dose |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 16 |
| 16 |
| EG001 | Lasmiditan (Period 2) | Participants were administered a single oral dose of 200 mg Lasmiditan tablet on day 1 during inter-ictal period. | 0 | 16 | 0 | 16 | 12 | 16 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Vulvovaginitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 20.0 | Systematic Assessment |
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| Blood urea increased | Investigations | MedDRA 20.0 | Systematic Assessment |
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| Electrocardiogram QT prolonged | Investigations | MedDRA 20.0 | Systematic Assessment |
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| Electrocardiogram T wave abnormal | Investigations | MedDRA 20.0 | Systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Phonophobia | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Flushing | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | MedDRA 20.0 | 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 |
| Metabolite: M7 |
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| Metabolite: (S,R)-M18 |
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| Metabolite: (S,S)-M18 |
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| Metabolite: M8 |
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| Metabolite: M7 |
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| Metabolite: (S,R)-M18 |
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| Metabolite: (S,S)-M18 |
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