- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00384774
A Placebo-Controlled Adaptive Treatment Assignment Study of Intravenous COL-144 in the Acute Treatment of Migraine
November 8, 2019 updated by: Eli Lilly and Company
A Placebo-Controlled, Group Sequential, Adaptive Treatment Assignment Study of Intravenous COL-144 (LY573144) in the Acute Treatment of Migraine
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.
Study Overview
Detailed Description
This study is set up:
- to evaluate the efficacy (headache response at two hours) of a range of intravenous doses of COL-144 in order to select a dose range for further evaluation,
- to explore the time course and effect of a range of dose levels of COL-144 on features of the migraine including: headache response, proportion of participants pain-free, headache recurrence, nausea, photophobia, phonophobia, disability, use of rescue medication, patient global impression and vomiting
- to explore the safety and tolerability of a range of doses of COL-144 in terms of adverse events, physical exam, vital signs, laboratory evaluations, and ECGs
- to determine key PK parameters for COL-144 and to explore the relationship between the PK of COL-144 and the time course and extent of clinical response
Study Type
Interventional
Enrollment (Actual)
130
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Helsinki, Finland
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Essen, Germany
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Leiden, Netherlands
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 subjects aged 18 to 65 years
- Female patients of child-bearing potential must be using a highly effective form of contraception (eg combined oral contraceptive, IUD, abstinence, vasectomized partner)
- Able and willing to return to the clinic for treatment within 4 hours of the onset of a migraine headache
- Able and willing to give written informed consent
Exclusion Criteria:
- History of life threatening or intolerable adverse reaction to any triptan
- Use of prescription migraine prophylactic drugs
- 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)
- Sitting BP >160mmHg systolic or >90mmHg diastolic on 2 repeated measurements at screening
- 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 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Lasmiditan
Participants received escalating doses of 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 45 mg of lasmiditan as intravenous injection.
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Administered as intravenous infusion
Other Names:
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PLACEBO_COMPARATOR: Placebo
Participants received intravenous infusion of placebo solution.
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Administered as intravenous infusion
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants With Headache Response at Two Hours After Initiation of Infusion of Study Drug
Time Frame: 2 hours post dose
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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.
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2 hours post dose
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose
Time Frame: 10, 20, 40, 60 90, 120, 180 and 240 minutes post dose
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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.
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10, 20, 40, 60 90, 120, 180 and 240 minutes post dose
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Percentage of Participants Headache Free
Time Frame: 10, 20, 40, 60 90, 120, 180 and 240 minutes post dose
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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.
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10, 20, 40, 60 90, 120, 180 and 240 minutes post dose
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Number of Participants With Sustained Headache Response
Time Frame: 2 to 24 hours post dose
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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.
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2 to 24 hours post dose
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Number of Participants With Sustained Pain Free
Time Frame: 2 to 24 hours post dose
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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.
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2 to 24 hours post dose
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Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia
Time Frame: 2 hours post dose
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Number of participants with absence of nausea, vomiting, photophobia and phonophobia.
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2 hours post dose
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Number of Participants With Clinical Disability
Time Frame: 2 hours post dose
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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.
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2 hours post dose
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Percentage of Participants Using Rescue Medication
Time Frame: 24 hours post dose
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Use of rescue medication up to 24 hours after initiation of study drug.
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24 hours post dose
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Percentage of Participants Reporting a Score on the Patient Global Impression (PGI)
Time Frame: 2 hours post dose
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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.
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2 hours post dose
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 1, 2006
Primary Completion (ACTUAL)
June 1, 2007
Study Completion (ACTUAL)
June 1, 2007
Study Registration Dates
First Submitted
October 4, 2006
First Submitted That Met QC Criteria
October 5, 2006
First Posted (ESTIMATE)
October 6, 2006
Study Record Updates
Last Update Posted (ACTUAL)
December 2, 2019
Last Update Submitted That Met QC Criteria
November 8, 2019
Last Verified
January 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16891
- 2006-003903-38 (EUDRACT_NUMBER)
- COL MIG-201 (OTHER: Colucid)
- H8H-CD-LAHM (OTHER: Eli Lilly and Company)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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 Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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