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Migraine DisordersPhase 2NCT00883051

Dose-ranging Study of Oral COL-144 in Acute Migraine Treatment

A Phase 2 study testing Lasmiditan in people with Migraine Disorders, run by Eli Lilly and Company at 39 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Migraine Disorders
What is being tested?
Lasmiditan
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
512 participants
Where
39 sitesin 5 countries
Study dates
Jul 2009to Feb 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 21Show fewer
  • 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)

Trial locations and contacts

39 sites in 5 countries.

39 sites in 5 countries

Germany12 sites

  • Study site

    Berlin, 10117

  • Study site

    Bremen, 28329

  • Study site

    Erkelenz, North Rhine-Westphalia, 41812

  • Study site

    Essen, North Rhine-Westphalia, 45122

  • Study site

    Freiburg/Breisgau, Baden-Wurttemberg, 79106

  • Study site

    Göppingen, Baden-Wurttemberg, 73033

  • Study site

    Hamburg, 20246

  • Study site

    Itzehoe, Schleswig-Holstein, 25524

  • Study site

    München, Bavaria, 80802

  • Study site

    München, Bavaria, 81377

  • Study site

    Münster, North Rhine-Westphalia, 48129

  • Study site

    Wiesbaden, Hesse, 65189

Other trials in Germany

Spain8 sites

  • Study site

    Alcorcón, Madrid, 28922

  • Study site

    Barcelona, Catalonia, 08036

  • Study site

    Gandia, Valencia, 46701

  • Study site

    Oviedo, Principality of Asturias, 33007

  • Study site

    Pamplona, Navarre, 31008

  • Study site

    Santiago de Compostela, Galicia, 15706

  • Study site

    Seville, Andalusia, 41013

  • Study site

    Valencia, Valencia, 46021

Other trials in Spain

Finland7 sites

  • Study site

    Helsinki, Etelä-Suomi, 00029 HUS

  • Study site

    Hyvinkää, Etelä-Suomi, 05850

  • Study site

    Jyväskylä, Länsi-Suomi, 40100

  • Study site

    Mikkeli, Itä-Suomen Lääni, 50100

  • Study site

    Pori, Länsi-Suomen, 28100

  • Study site

    Tampere, Länsi-Suomi, 33200

  • Study site

    Turku, Länsi-Suomi, 20100

Other trials in Finland

Belgium6 sites

  • Study site

    Bruges, West-Vlaanderen, 8000

  • Study site

    Brussels, 1070

  • Study site

    Hasselt, Limburg, 3500

  • Study site

    Leuven, Vlaams-Brabant, 3000

  • Study site

    Liège, 4000

  • Study site

    Montegnée, Liege, 4420

Other trials in Belgium

France6 sites

  • Study site

    Bordeaux, Gironde, 33076

  • Study site

    Lille, Nord, 59 037

  • Study site

    Nice, Alpes-Maritimes, 06002

  • Study site

    Paris, 75010

  • Study site

    Rouen, Seine-Maritime, 76031

  • Study site

    Toulouse, Haute-Garonne, 31059

Other trials in France

About this study

Official title: A Double Blind Randomized Placebo-Controlled Parallel Group Dose-Ranging Study of Oral COL-144 in the Acute Treatment of Migraine

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.

Read the 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.

Being tested
Lasmiditan, Placebo
Keywords
COL-144, acute treatment, migraine
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LasmiditanDrug

    Also called LY573144

    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.

  • PlaceboDrug

    Placebo

Study groups in NCT00883051
Study groupRoleWhat they receive
50 mg LasmiditanExperimental50 mg lasmiditan administered orally (PO)
Receives: Drug: Lasmiditan
100 mg LasmiditanExperimental100 mg lasmiditan administered orally (PO)
Receives: Drug: Lasmiditan
200 mg LasmiditanExperimental200 mg lasmiditan administered orally (PO)
Receives: Drug: Lasmiditan
400 mg LasmiditanExperimental400 mg lasmiditan administered orally (PO)
Receives: Drug: Lasmiditan
PlaceboPlacebo comparatorPlacebo administered orally (PO)
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 hours postdose

Secondary outcomes (17)

  1. 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.

    Measured: 2 hours post dose

  2. 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.

    Measured: up to 24 hours postdose

  3. 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.

    Measured: 2 hours postdose

  4. Percentage of Participants Who Have Symptoms of Nausea

    Percentage of participants who have symptoms of nausea two hours post treatment.

    Measured: 2 hours postdose

  5. Percentage of Participants Who Have Symptoms Phonophobia

    Percentage of participants who have symptoms of phonophobia two hours post treatment.

    Measured: 2 hours postdose

  6. Percentage of Participants Who Have Photophobia

    Percentage of participants who have symptoms of photophobia two hours post treatment.

    Measured: 2 hours postdose

  7. Percentage of Participants With Vomiting

    Percentage of participants with vomiting 2 hours post treatment.

    Measured: 2 hours postdose

  8. 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.

    Measured: 2 hours postdose

  9. 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).

    Measured: Postdose 2 through 24 hours

  10. 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.

    Measured: 2 hours postdose

  11. 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?".

    Measured: up to 24 hours postdose

  12. Change From Baseline in Heart Rate

    Change from baseline in assessment of vital signs (heart rate).

    Measured: Baseline through Day 14

  13. Change From Baseline in Systolic Blood Pressure

    Change from baseline in vital signs (systolic blood pressure).

    Measured: Baseline through Day 14

  14. Change From Baseline in Diastolic Blood Pressure

    Change from baseline in vital signs (diastolic blood pressure).

    Measured: Baseline through Day 14

  15. 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.

    Measured: Baseline through Day 14

  16. 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.

    Measured: Baseline through Day 14

  17. 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.

    Measured: up to 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionFeb 2010
  4. Study completionFeb 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
512 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00883051
Sponsor's protocol ID
16892
Other IDs
H8H-CD-LAHO, 2008-005010-43, COL MIG-202, 2008
Status last verified
Jan 2018
First submitted
16 Apr 2009
Last updated
23 Dec 2019
Data monitoring committee
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 37965170

  • 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.

    PubMed 22459549

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lasmiditan in people with Migraine Disorders, run by Eli Lilly and Company at 39 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in Germany, Spain, Finland, Belgium, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Headache Response (time frame: 2 hours postdose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00883051, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2019.

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