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

NCT ID: NCT00883051

Last Updated: 2019-12-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 512 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-02-28

Brief 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.

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.

Conditions

Migraine Disorders

Keywords

COL-144; acute treatment; migraine

Study Design

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

Study Groups

50 mg Lasmiditan

50 mg lasmiditan administered orally (PO)

Group Type: EXPERIMENTAL

Lasmiditan

Intervention Type: DRUG

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.

100 mg Lasmiditan

100 mg lasmiditan administered orally (PO)

Group Type: EXPERIMENTAL

Lasmiditan

Intervention Type: DRUG

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.

200 mg Lasmiditan

200 mg lasmiditan administered orally (PO)

Group Type: EXPERIMENTAL

Lasmiditan

Intervention Type: DRUG

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.

400 mg Lasmiditan

400 mg lasmiditan administered orally (PO)

Group Type: EXPERIMENTAL

Lasmiditan

Intervention Type: DRUG

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.

Placebo

Placebo administered orally (PO)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

Lasmiditan

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.

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Other Intervention Names

LY573144

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 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

Exclusion Criteria

• 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
• 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)

• 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

Montegnée, Liege, Belgium

Hasselt, Limburg, Belgium

Leuven, Vlaams-Brabant, Belgium

Bruges, West-Vlaanderen, Belgium

Brussels, , Belgium

Liège, , Belgium

Helsinki, Etelä-Suomi, Finland

Hyvinkää, Etelä-Suomi, Finland

Mikkeli, Itä-Suomen Lääni, Finland

Pori, Länsi-Suomen, Finland

Jyväskylä, Länsi-Suomi, Finland

Tampere, Länsi-Suomi, Finland

Turku, Länsi-Suomi, Finland

Nice, Alpes-Maritimes, France

Bordeaux, Gironde, France

Toulouse, Haute-Garonne, France

Lille, Nord, France

Rouen, Seine-Maritime, France

Paris, , France

Freiburg/Breisgau, Baden-Wurttemberg, Germany

Göppingen, Baden-Wurttemberg, Germany

München, Bavaria, Germany

München, Bavaria, Germany

Wiesbaden, Hesse, Germany

Erkelenz, North Rhine-Westphalia, Germany

Essen, North Rhine-Westphalia, Germany

Münster, North Rhine-Westphalia, Germany

Itzehoe, Schleswig-Holstein, Germany

Berlin, , Germany

Bremen, , Germany

Hamburg, , Germany

Seville, Andalusia, Spain

Barcelona, Catalonia, Spain

Santiago de Compostela, Galicia, Spain

Alcorcón, Madrid, Spain

Pamplona, Navarre, Spain

Oviedo, Principality of Asturias, Spain

Gandia, Valencia, Spain

Valencia, Valencia, Spain

Countries

Belgium; Finland; France; Germany; Spain

References

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)

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.

Reference Type: DERIVED

PMID: 22459549 (View on PubMed)

Other Identifiers

H8H-CD-LAHO

Identifier Type: OTHER

Identifier Source: secondary_id

2008-005010-43

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

COL MIG-202

Identifier Type: OTHER

Identifier Source: secondary_id

16892

Identifier Type: -

Identifier Source: org_study_id