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MigrainePhase 2NCT00384774

A Placebo-Controlled Adaptive Treatment Assignment Study of Intravenous COL-144 in the Acute Treatment of Migraine

A Phase 2 study testing Lasmiditan in people with Migraine, run by Eli Lilly and Company at 3 sites in 3 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

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Migraine
What is being tested?
Lasmiditan
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
130 participants
Where
3 sitesin 3 countries
Study dates
Nov 2006to Jun 2007
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 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

Who cannot join

  • 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)
Show all 15Show fewer
  • 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

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

Finland1 site

  • Study site

    Helsinki

Other trials in Finland

Germany1 site

  • Study site

    Essen

Other trials in Germany

Netherlands1 site

  • Study site

    Leiden

Other trials in Netherlands

About this study

Official title: 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.

Read the 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
Conditions
Migraine
Being tested
Lasmiditan, Placebo
Keywords
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, COL-144

    Administered as intravenous infusion

  • PlaceboDrug

    Administered as intravenous infusion

Study groups in NCT00384774
Study groupRoleWhat they receive
LasmiditanExperimentalParticipants received escalating doses of 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 45 mg of lasmiditan as intravenous injection.
Receives: Drug: Lasmiditan
PlaceboPlacebo comparatorParticipants received intravenous infusion of placebo solution.
Receives: Drug: Placebo

What is being measured

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

  1. Number of Participants With Headache Response at Two Hours After Initiation of Infusion of Study Drug

    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.

    Measured: 2 hours post dose

Secondary outcomes (8)

  1. Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose

    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.

    Measured: 10, 20, 40, 60 90, 120, 180 and 240 minutes post dose

  2. Percentage of Participants Headache Free

    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.

    Measured: 10, 20, 40, 60 90, 120, 180 and 240 minutes post dose

  3. Number of Participants With Sustained Headache Response

    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.

    Measured: 2 to 24 hours post dose

  4. Number of Participants With Sustained Pain Free

    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.

    Measured: 2 to 24 hours post dose

  5. Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia

    Number of participants with absence of nausea, vomiting, photophobia and phonophobia.

    Measured: 2 hours post dose

  6. Number of Participants With Clinical Disability

    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.

    Measured: 2 hours post dose

  7. Percentage of Participants Using Rescue Medication

    Use of rescue medication up to 24 hours after initiation of study drug.

    Measured: 24 hours post dose

  8. Percentage of Participants Reporting a Score on the Patient Global Impression (PGI)

    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.

    Measured: 2 hours post dose

Timeline

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

  1. First posted6 Oct 2006 (estimated)
  2. Study startNov 2006
  3. Primary completionJun 2007
  4. Study completionJun 2007

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
Double blind
Who is masked
Participant, Investigator
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00384774
Sponsor's protocol ID
16891
Other IDs
2006-003903-38, COL MIG-201, H8H-CD-LAHM
Status last verified
Jan 2018
First submitted
4 Oct 2006
Last updated
2 Dec 2019
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

  • 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.

  • 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

  • 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.

    PubMed 20855362

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lasmiditan in people with Migraine, run by Eli Lilly and Company at 3 sites in 3 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 15 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 2 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 3 sites in Finland, Germany, Netherlands. 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 2 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?

Number of Participants With Headache Response at Two Hours After Initiation of Infusion of Study Drug (time frame: 2 hours post dose). 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 NCT00384774, which also lists 3 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 2 Dec 2019.

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