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

NCT ID: NCT00384774

Last Updated: 2019-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2007-06-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Lasmiditan

Intervention Type: DRUG

Administered as intravenous infusion

Placebo

Participants received intravenous infusion of placebo solution.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered as intravenous infusion

Interventions

Lasmiditan

Administered as intravenous infusion

Intervention Type: DRUG

Placebo

Administered as intravenous infusion

Intervention Type: DRUG

Other Intervention Names

LY573144, COL-144

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CoLucid Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Helsinki, , Finland

Essen, , Germany

Leiden, , Netherlands

Countries

Finland; Germany; Netherlands

References

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.

Reference Type: 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.

Reference Type: DERIVED

PMID: 37965170 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20855362 (View on PubMed)

Other Identifiers

2006-003903-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

COL MIG-201

Identifier Type: OTHER

Identifier Source: secondary_id

H8H-CD-LAHM

Identifier Type: OTHER

Identifier Source: secondary_id

16891

Identifier Type: -

Identifier Source: org_study_id