NCT00384774

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2006

Shorter than P25 for phase_2

Geographic Reach
3 countries

3 active sites

Status
completed

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

October 4, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2006

Completed
26 days until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
12.5 years until next milestone

Results Posted

Study results publicly available

December 2, 2019

Completed
Last Updated

December 2, 2019

Status Verified

January 1, 2018

Enrollment Period

7 months

First QC Date

October 4, 2006

Results QC Date

November 8, 2019

Last Update Submit

November 8, 2019

Conditions

Migraine

Keywords

Migraine

Outcome Measures

Primary Outcomes (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.

    2 hours post dose

Secondary Outcomes (8)

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

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

  • Percentage of Participants Headache Free

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

  • Number of Participants With Sustained Headache Response

    2 to 24 hours post dose

  • Number of Participants With Sustained Pain Free

    2 to 24 hours post dose

  • Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia

    2 hours post dose

  • +3 more secondary outcomes

Study Arms (2)

Lasmiditan

EXPERIMENTAL

Participants received escalating doses of 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 45 mg of lasmiditan as intravenous injection.

Drug: Lasmiditan

Placebo

PLACEBO COMPARATOR

Participants received intravenous infusion of placebo solution.

Drug: Placebo

Interventions

LasmiditanDRUG

Administered as intravenous infusion

Also known as: LY573144, COL-144
Lasmiditan
PlaceboDRUG

Administered as intravenous infusion

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Helsinki, Finland

Location

Unknown Facility

Essen, Germany

Location

Unknown Facility

Leiden, Netherlands

Location

Related Publications (3)

  • 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.

    RESULT

  • 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: 37965170DERIVED

  • 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.

    PMID: 20855362DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

lasmiditan

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
ClinicalTrials.gov@lilly.com
800-545-5979

Study Officials

  • 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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2006

First Posted

October 6, 2006

Study Start

November 1, 2006

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

December 2, 2019

Results First Posted

December 2, 2019

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will share

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.

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.
More information

Locations

NL(1)FI(1)DE(1)