Dose-ranging Study of Oral COL-144 in Acute Migraine Treatment
A Double Blind Randomized Placebo-Controlled Parallel Group Dose-Ranging Study of Oral COL-144 in the Acute Treatment of Migraine
4 other identifiers
interventional
512
5 countries
39
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2009
Shorter than P25 for phase_2
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2009
CompletedFirst Posted
Study publicly available on registry
April 17, 2009
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedResults Posted
Study results publicly available
December 23, 2019
CompletedDecember 23, 2019
January 1, 2018
7 months
April 16, 2009
November 8, 2019
December 20, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
2 hours postdose
Secondary Outcomes (17)
Percentage of Participants Who Are Headache Free (Absence of Headache) After First Dose
2 hours post dose
Percentage of Participants With Headache Recurrence
up to 24 hours postdose
Percentage of Participants With Headache Severity (4 Point Rating Scale)
2 hours postdose
Percentage of Participants Who Have Symptoms of Nausea
2 hours postdose
Percentage of Participants Who Have Symptoms Phonophobia
2 hours postdose
- +12 more secondary outcomes
Study Arms (5)
50 mg Lasmiditan
EXPERIMENTAL50 mg lasmiditan administered orally (PO)
100 mg Lasmiditan
EXPERIMENTAL100 mg lasmiditan administered orally (PO)
200 mg Lasmiditan
EXPERIMENTAL200 mg lasmiditan administered orally (PO)
400 mg Lasmiditan
EXPERIMENTAL400 mg lasmiditan administered orally (PO)
Placebo
PLACEBO COMPARATORPlacebo administered orally (PO)
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eli Lilly and Companylead
- CoLucid Pharmaceuticalscollaborator
Study Sites (39)
Unknown Facility
Montegnée, Liege, 4420, Belgium
Unknown Facility
Hasselt, Limburg, 3500, Belgium
Unknown Facility
Leuven, Vlaams-Brabant, 3000, Belgium
Unknown Facility
Bruges, West-Vlaanderen, 8000, Belgium
Unknown Facility
Brussels, 1070, Belgium
Unknown Facility
Liège, 4000, Belgium
Unknown Facility
Helsinki, Etelä-Suomi, 00029 HUS, Finland
Unknown Facility
Hyvinkää, Etelä-Suomi, 05850, Finland
Unknown Facility
Mikkeli, Itä-Suomen Lääni, 50100, Finland
Unknown Facility
Pori, Länsi-Suomen, 28100, Finland
Unknown Facility
Jyväskylä, Länsi-Suomi, 40100, Finland
Unknown Facility
Tampere, Länsi-Suomi, 33200, Finland
Unknown Facility
Turku, Länsi-Suomi, 20100, Finland
Unknown Facility
Nice, Alpes-Maritimes, 06002, France
Unknown Facility
Bordeaux, Gironde, 33076, France
Unknown Facility
Toulouse, Haute-Garonne, 31059, France
Unknown Facility
Lille, Nord, 59 037, France
Unknown Facility
Rouen, Seine-Maritime, 76031, France
Unknown Facility
Paris, 75010, France
Unknown Facility
Freiburg/Breisgau, Baden-Wurttemberg, 79106, Germany
Unknown Facility
Göppingen, Baden-Wurttemberg, 73033, Germany
Unknown Facility
München, Bavaria, 80802, Germany
Unknown Facility
München, Bavaria, 81377, Germany
Unknown Facility
Wiesbaden, Hesse, 65189, Germany
Unknown Facility
Erkelenz, North Rhine-Westphalia, 41812, Germany
Unknown Facility
Essen, North Rhine-Westphalia, 45122, Germany
Unknown Facility
Münster, North Rhine-Westphalia, 48129, Germany
Unknown Facility
Itzehoe, Schleswig-Holstein, 25524, Germany
Unknown Facility
Berlin, 10117, Germany
Unknown Facility
Bremen, 28329, Germany
Unknown Facility
Hamburg, 20246, Germany
Unknown Facility
Seville, Andalusia, 41013, Spain
Unknown Facility
Barcelona, Catalonia, 08036, Spain
Unknown Facility
Santiago de Compostela, Galicia, 15706, Spain
Unknown Facility
Alcorcón, Madrid, 28922, Spain
Unknown Facility
Pamplona, Navarre, 31008, Spain
Unknown Facility
Oviedo, Principality of Asturias, 33007, Spain
Unknown Facility
Gandia, Valencia, 46701, Spain
Unknown Facility
Valencia, Valencia, 46021, Spain
Related Publications (2)
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.
PMID: 37965170DERIVEDFarkkila 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.
PMID: 22459549DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
One participant from the placebo group did not report adverse events and was lost to follow up.
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2009
First Posted
April 17, 2009
Study Start
July 1, 2009
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
December 23, 2019
Results First Posted
December 23, 2019
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.