Back to resultsDose-ranging Study of Oral COL-144 in Acute Migraine Treatment
Primary Purpose
Migraine Disorders
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Lasmiditan
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Migraine Disorders focused on measuring COL-144, acute treatment, migraine
Eligibility Criteria
Inclusion Criteria:
- Patients with migraine with or without aura fulfilling the IHS diagnostic criteria 1.1 and 1.2.1 (2004)
- History of migraine of at least 1 year
- Migraine onset before the age of 50 years
- History of 1 - 8 migraine attacks per month
- Male or female patients aged 18 to 65 years
- Female patients of child-bearing potential must be using a highly effective form of contraception (e.g., combined oral contraceptive, IUD, abstinence, vasectomized partner)
- Able and willing to give written informed consent
- Able and willing to complete a migraine diary card to record details of the attack treated with study medication
Exclusion Criteria:
- History of life threatening or intolerable adverse reaction to any triptan
- Use of prescription migraine prophylactic drugs within 15 days (30 days for flunarizine) prior to Screening Visit and during study participation
- Using herbal preparations (e.g., feverfew, butterbur) for migraine prophylaxis
- Using 5-HT reuptake inhibitors
- Using drugs known to inhibit CYP450 enzymes (see Appendix 2 for details)
- Pregnant or breast-feeding women
- Women of child-bearing potential not using highly effective contraception
- History or evidence of coronary artery disease, ischemic or hemorrhagic stroke, epilepsy or any other condition placing the patient at increased risk of seizures
- History of hypertension (controlled or uncontrolled)
- History of orthostatic hypotension
- Current use of hemodynamically active cardiovascular drugs
- History within the previous 3 years or current evidence of abuse of any drug, prescription or illicit, or alcohol
- Significant renal or hepatic impairment
- Previous participation in this clinical trial
- Participation in any clinical trial of an experimental drug or device in the previous 30 days
- Any medical condition or laboratory test which in the judgment of the investigator makes the patient unsuitable for the study
- Known Hepatitis B or C or HIV infection
- Patients who are employees of the sponsor
- Relatives of, or staff directly reporting to, the investigator
- Patients with known hypersensitivity to COL-144, other 5HT1F receptor agonists or to any excipient of COL-144 drug product
- Patients who were treated with study medication in the COL MIG-201 study (Patients screened but not treated under that protocol are not excluded)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
50 mg Lasmiditan
100 mg Lasmiditan
200 mg Lasmiditan
400 mg Lasmiditan
Placebo
Arm 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)
Outcomes
Primary Outcome Measures
Percentage of Participants With Headache Response
Headache response is a binary response variable derived from the headache intensities recorded in the participant diary. Headache response is defined as a reduction in headache severity from moderate or severe at baseline to mild or no headache, at two hours after administration of study drug.
Secondary Outcome Measures
Percentage of Participants Who Are Headache Free (Absence of Headache) After First Dose
The percentage of participants defined as mild, moderate, or severe headache pain becoming none.
Percentage of Participants With Headache Recurrence
Participants who received study drug and which became pain free at 2 hours postdose and worsened again upto 24 hours post-dose.
Percentage of Participants With Headache Severity (4 Point Rating Scale)
Headache severity was evaluated by the participant using the International Headache Society (IHS) four point headache severity rating scale (0=no pain, 1=mild pain, 2=moderate pain, and 3=severe pain) with a lower score being less severe and a higher score being more severe.
Percentage of Participants Who Have Symptoms of Nausea
Percentage of participants who have symptoms of nausea two hours post treatment.
Percentage of Participants Who Have Symptoms Phonophobia
Percentage of participants who have symptoms of phonophobia two hours post treatment.
Percentage of Participants Who Have Photophobia
Percentage of participants who have symptoms of photophobia two hours post treatment.
Percentage of Participants With Vomiting
Percentage of participants with vomiting 2 hours post treatment.
Disability (4 Point Scale: Not at All, Mild Interference, Marked Interference, Completely - Needs Bed Rest)
The participant is asked "How much is the migraine interfering with normal activities?" on a 4 point scale 0-Not at all, 1-Mild interference, 2-Marked interference ,3-Completely needs bed rest, with a lower score having lower interference and higher score worse interference.
Percentage of Participants Who Used Rescue Medication
Rescue medication was permitted after completion of the 2 hour assessment if migraine did not respond (participant was not pain free).
Number of Participants Reporting a Score on the Patient Global Impression of Improvement (PGI-I)
PGI-I requests participants to mark the box that best describes their cluster headache condition since they started taking the medicine. The options in the displayed boxes are represented on a 7-point scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse, a lower number indicates much better and a higher number indicates worse.
Actual Time to Headache Relief and Time to Pain Free
The participant answered "Did your migraine pain go away completely (pain free) within 24 hours of dosing" and record the time.
Actual time to meaningful pain relief and actual time to pain free will be censored at 24 hours if meaningful pain relief or pain free is documented to be greater than 24 hours after dosing and "Did you experience meaningful relief (headache relief) from your migraine within 24 hours after dosing?".
Change From Baseline in Heart Rate
Change from baseline in assessment of vital signs (heart rate).
Change From Baseline in Systolic Blood Pressure
Change from baseline in vital signs (systolic blood pressure).
Change From Baseline in Diastolic Blood Pressure
Change from baseline in vital signs (diastolic blood pressure).
Percentage of Participants With Change From Baseline in Physical Examination Parameters
Participants were evaluated for skin, head, ear, nose and throat, cardiovascular and musculoskeletal changes from a normal screening to an abnormal screening. Changes in the physical examination noted as non-serious AEs or SAEs, regardless of causality, are located in the Reported Adverse Events section.
Change From Baseline in Hematology Tests
Hematology tests, including a complete blood count (CBC) measured red blood cells, white blood cells, hemoglobin, neutrophils and platelets.
Number of Serious Adverse Events
A summary of non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Full Information
NCT ID
NCT00883051
First Posted
April 16, 2009
Last Updated
December 20, 2019
Sponsor
Eli Lilly and Company
Collaborators
CoLucid Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00883051
Brief Title
Dose-ranging Study of Oral COL-144 in Acute Migraine Treatment
Official Title
A Double Blind Randomized Placebo-Controlled Parallel Group Dose-Ranging Study of Oral COL-144 in the Acute Treatment of Migraine
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
Collaborators
CoLucid Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of a range of oral doses of COL-144 in treating migraine headache, in order to select a dose or doses for further evaluation.
Detailed Description
Migraine is a common chronic neurological disorder characterized by recurrent disabling episodes of moderate to severe headache accompanied by nausea, vomiting, photophobia, and phonophobia. Acute pharmacologic therapy for migraine aims to terminate the attack or reduce its severity. Analgesics are commonly used or, if these are ineffective, triptans. Since triptans are contraindicated in patients with coronary artery disease, uncontrolled hypertension, and cerebrovascular disease alternative medications are required for patients where simple analgesics do not work. COL-144 has no vasoconstrictor activity at clinically relevant concentrations and might meet this need. COL-144 was effective when given intravenously in a placebo-controlled dose-ranging study. This study investigates which dose of oral COL-144 is effective in the in acute treatment of migraine headache.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders
Keywords
COL-144, acute treatment, migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
512 (Actual)
8. Arms, Groups, and Interventions
Arm Title
50 mg Lasmiditan
Arm Type
Experimental
Arm Description
50 mg lasmiditan administered orally (PO)
Arm Title
100 mg Lasmiditan
Arm Type
Experimental
Arm Description
100 mg lasmiditan administered orally (PO)
Arm Title
200 mg Lasmiditan
Arm Type
Experimental
Arm Description
200 mg lasmiditan administered orally (PO)
Arm Title
400 mg Lasmiditan
Arm Type
Experimental
Arm Description
400 mg lasmiditan administered orally (PO)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered orally (PO)
Intervention Type
Drug
Intervention Name(s)
Lasmiditan
Other Intervention Name(s)
LY573144
Intervention Description
Oral application of one dose of either 50 mg lasmiditan,100 mg lasmiditan, 200 mg lasmiditan, 400 mg lasmiditan or placebo as the first treatment for a new migraine attack providing that any aura symptoms have resolved and the headache is either moderate or severe and has been so for less than 4 hours.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Percentage of Participants With Headache Response
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
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Are Headache Free (Absence of Headache) After First Dose
Description
The percentage of participants defined as mild, moderate, or severe headache pain becoming none.
Time Frame
2 hours post dose
Title
Percentage of Participants With Headache Recurrence
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
Title
Percentage of Participants With Headache Severity (4 Point Rating Scale)
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
Title
Percentage of Participants Who Have Symptoms of Nausea
Description
Percentage of participants who have symptoms of nausea two hours post treatment.
Time Frame
2 hours postdose
Title
Percentage of Participants Who Have Symptoms Phonophobia
Description
Percentage of participants who have symptoms of phonophobia two hours post treatment.
Time Frame
2 hours postdose
Title
Percentage of Participants Who Have Photophobia
Description
Percentage of participants who have symptoms of photophobia two hours post treatment.
Time Frame
2 hours postdose
Title
Percentage of Participants With Vomiting
Description
Percentage of participants with vomiting 2 hours post treatment.
Time Frame
2 hours postdose
Title
Disability (4 Point Scale: Not at All, Mild Interference, Marked Interference, Completely - Needs Bed Rest)
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
Title
Percentage of Participants Who Used Rescue Medication
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
Title
Number of Participants Reporting a Score on the Patient Global Impression of Improvement (PGI-I)
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
Title
Actual Time to Headache Relief and Time to Pain Free
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
Title
Change From Baseline in Heart Rate
Description
Change from baseline in assessment of vital signs (heart rate).
Time Frame
Baseline through Day 14
Title
Change From Baseline in Systolic Blood Pressure
Description
Change from baseline in vital signs (systolic blood pressure).
Time Frame
Baseline through Day 14
Title
Change From Baseline in Diastolic Blood Pressure
Description
Change from baseline in vital signs (diastolic blood pressure).
Time Frame
Baseline through Day 14
Title
Percentage of Participants With Change From Baseline in Physical Examination Parameters
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
Title
Change From Baseline in Hematology Tests
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
Title
Number of Serious Adverse Events
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with migraine with or without aura fulfilling the IHS diagnostic criteria 1.1 and 1.2.1 (2004)
History of migraine of at least 1 year
Migraine onset before the age of 50 years
History of 1 - 8 migraine attacks per month
Male or female patients aged 18 to 65 years
Female patients of child-bearing potential must be using a highly effective form of contraception (e.g., combined oral contraceptive, IUD, abstinence, vasectomized partner)
Able and willing to give written informed consent
Able and willing to complete a migraine diary card to record details of the attack treated with study medication
Exclusion Criteria:
History of life threatening or intolerable adverse reaction to any triptan
Use of prescription migraine prophylactic drugs within 15 days (30 days for flunarizine) prior to Screening Visit and during study participation
Using herbal preparations (e.g., feverfew, butterbur) for migraine prophylaxis
Using 5-HT reuptake inhibitors
Using drugs known to inhibit CYP450 enzymes (see Appendix 2 for details)
Pregnant or breast-feeding women
Women of child-bearing potential not using highly effective contraception
History or evidence of coronary artery disease, ischemic or hemorrhagic stroke, epilepsy or any other condition placing the patient at increased risk of seizures
History of hypertension (controlled or uncontrolled)
History of orthostatic hypotension
Current use of hemodynamically active cardiovascular drugs
History within the previous 3 years or current evidence of abuse of any drug, prescription or illicit, or alcohol
Significant renal or hepatic impairment
Previous participation in this clinical trial
Participation in any clinical trial of an experimental drug or device in the previous 30 days
Any medical condition or laboratory test which in the judgment of the investigator makes the patient unsuitable for the study
Known Hepatitis B or C or HIV infection
Patients who are employees of the sponsor
Relatives of, or staff directly reporting to, the investigator
Patients with known hypersensitivity to COL-144, other 5HT1F receptor agonists or to any excipient of COL-144 drug product
Patients who were treated with study medication in the COL MIG-201 study (Patients screened but not treated under that protocol are not excluded)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
City
Montegnee
State/Province
Liege
ZIP/Postal Code
4420
Country
Belgium
City
Hasselt
State/Province
Limburg
ZIP/Postal Code
3500
Country
Belgium
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
City
Brugge
State/Province
West-Vlaanderen
ZIP/Postal Code
8000
Country
Belgium
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
City
Liege
ZIP/Postal Code
4000
Country
Belgium
City
Helsinki
State/Province
Etelä-Suomi
ZIP/Postal Code
00029 HUS
Country
Finland
City
Hyvinkää
State/Province
Etelä-Suomi
ZIP/Postal Code
05850
Country
Finland
City
Mikkeli
State/Province
Itä-Suomen Lääni
ZIP/Postal Code
50100
Country
Finland
City
Pori
State/Province
Länsi-Suomen
ZIP/Postal Code
28100
Country
Finland
City
Jyväskylä
State/Province
Länsi-Suomi
ZIP/Postal Code
40100
Country
Finland
City
Tampere
State/Province
Länsi-Suomi
ZIP/Postal Code
33200
Country
Finland
City
Turku
State/Province
Länsi-Suomi
ZIP/Postal Code
20100
Country
Finland
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06002
Country
France
City
Bordeaux
State/Province
Gironde
ZIP/Postal Code
33076
Country
France
City
Toulouse
State/Province
Haute-Garonne
ZIP/Postal Code
31059
Country
France
City
Lille
State/Province
Nord
ZIP/Postal Code
59 037
Country
France
City
Rouen
State/Province
Seine-Maritime
ZIP/Postal Code
76031
Country
France
City
Paris
ZIP/Postal Code
75010
Country
France
City
Freiburg/Breisgau
State/Province
Baden-Württemberg
ZIP/Postal Code
79106
Country
Germany
City
Göppingen
State/Province
Baden-Württemberg
ZIP/Postal Code
73033
Country
Germany
City
München
State/Province
Bayern
ZIP/Postal Code
80802
Country
Germany
City
München
State/Province
Bayern
ZIP/Postal Code
81377
Country
Germany
City
Wiesbaden
State/Province
Hessen
ZIP/Postal Code
65189
Country
Germany
City
Erkelenz
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
41812
Country
Germany
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45122
Country
Germany
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48129
Country
Germany
City
Itzehoe
State/Province
Schleswig-Holstein
ZIP/Postal Code
25524
Country
Germany
City
Berlin
ZIP/Postal Code
10117
Country
Germany
City
Bremen
ZIP/Postal Code
28329
Country
Germany
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
City
Sevilla
State/Province
Andalucía
ZIP/Postal Code
41013
Country
Spain
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08036
Country
Spain
City
Gandia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46701
Country
Spain
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46021
Country
Spain
City
Santiago de Compostela
State/Province
Comunidade Autónoma De Galicia
ZIP/Postal Code
15706
Country
Spain
City
Alcorcon
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
City
Pamplona
State/Province
Nafarroako Foru Komunitatea
ZIP/Postal Code
31008
Country
Spain
City
Oviedo
State/Province
Principado De Asturias
ZIP/Postal Code
33007
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
https://vivli.org/
Citations:
PubMed Identifier
22459549
Citation
Farkkila M, Diener HC, Geraud G, Lainez M, Schoenen J, Harner N, Pilgrim A, Reuter U; COL MIG-202 study group. Efficacy and tolerability of lasmiditan, an oral 5-HT(1F) receptor agonist, for the acute treatment of migraine: a phase 2 randomised, placebo-controlled, parallel-group, dose-ranging study. Lancet Neurol. 2012 May;11(5):405-13. doi: 10.1016/S1474-4422(12)70047-9. Epub 2012 Mar 28.
Results Reference
derived
Learn more about this trial
Dose-ranging Study of Oral COL-144 in Acute Migraine Treatment
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