Clinical trial NCT00883051: Dose-ranging Study of Oral COL-144 in Acute Migraine Treatment
Official title: A Double Blind Randomized Placebo-Controlled Parallel Group Dose-Ranging Study of Oral COL-144 in the Acute Treatment of Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Migraine Disorders
Keywords: COL-144
acute treatment
migraine
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: CoLucid Pharmaceuticals
First posted: 2009-04-17
Enrollment: 512
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Percentage of Participants With Headache Response
timeFrame: 2 hours postdose
Secondary outcomes:
measure: Percentage of Participants Who Are Headache Free (Absence of Headache) After First Dose
timeFrame: 2 hours post dose
measure: Percentage of Participants With Headache Recurrence
timeFrame: up to 24 hours postdose
measure: Percentage of Participants With Headache Severity (4 Point Rating Scale)
timeFrame: 2 hours postdose
measure: Percentage of Participants Who Have Symptoms of Nausea
timeFrame: 2 hours postdose
measure: Percentage of Participants Who Have Symptoms Phonophobia
timeFrame: 2 hours postdose
measure: Percentage of Participants Who Have Photophobia
timeFrame: 2 hours postdose
measure: Percentage of Participants With Vomiting
timeFrame: 2 hours postdose
measure: Disability (4 Point Scale: Not at All, Mild Interference, Marked Interference, Completely - Needs Bed Rest)
timeFrame: 2 hours postdose
measure: Percentage of Participants Who Used Rescue Medication
timeFrame: Postdose 2 through 24 hours
measure: Number of Participants Reporting a Score on the Patient Global Impression of Improvement (PGI-I)
timeFrame: 2 hours postdose
measure: Actual Time to Headache Relief and Time to Pain Free
timeFrame: up to 24 hours postdose
measure: Change From Baseline in Heart Rate
timeFrame: Baseline through Day 14
measure: Change From Baseline in Systolic Blood Pressure
timeFrame: Baseline through Day 14
measure: Change From Baseline in Diastolic Blood Pressure
timeFrame: Baseline through Day 14
measure: Percentage of Participants With Change From Baseline in Physical Examination Parameters
timeFrame: Baseline through Day 14
measure: Change From Baseline in Hematology Tests
timeFrame: Baseline through Day 14
measure: Number of Serious Adverse Events
timeFrame: up to 8 weeks
Other outcomes:
Locations:
city: Montegnee
country: Belgium
state: Liege
city: Hasselt
country: Belgium
state: Limburg
city: Leuven
country: Belgium
state: Vlaams-Brabant
city: Brugge
country: Belgium
state: West-Vlaanderen
city: Bruxelles
country: Belgium
city: Liege
country: Belgium
city: Helsinki
country: Finland
state: Etelä-Suomi
city: Hyvinkää
country: Finland
state: Etelä-Suomi
city: Mikkeli
country: Finland
state: Itä-Suomen Lääni
city: Pori
country: Finland
state: Länsi-Suomen
city: Jyväskylä
country: Finland
state: Länsi-Suomi
city: Tampere
country: Finland
state: Länsi-Suomi
city: Turku
country: Finland
state: Länsi-Suomi
city: Nice
country: France
state: Alpes-Maritimes
city: Bordeaux
country: France
state: Gironde
city: Toulouse
country: France
state: Haute-Garonne
city: Lille
country: France
state: Nord
city: Rouen
country: France
state: Seine-Maritime
city: Paris
country: France
city: Freiburg/Breisgau
country: Germany
state: Baden-Württemberg
city: Göppingen
country: Germany
state: Baden-Württemberg
city: München
country: Germany
state: Bayern
city: München
country: Germany
state: Bayern
city: Wiesbaden
country: Germany
state: Hessen
city: Erkelenz
country: Germany
state: Nordrhein-Westfalen
city: Essen
country: Germany
state: Nordrhein-Westfalen
city: Münster
country: Germany
state: Nordrhein-Westfalen
city: Itzehoe
country: Germany
state: Schleswig-Holstein
city: Berlin
country: Germany
city: Bremen
country: Germany
city: Hamburg
country: Germany
city: Sevilla
country: Spain
state: Andalucía
city: Barcelona
country: Spain
state: Catalunya
city: Gandia
country: Spain
state: Comunidad Valenciana
city: Valencia
country: Spain
state: Comunidad Valenciana
city: Santiago de Compostela
country: Spain
state: Comunidade Autónoma De Galicia
city: Alcorcon
country: Spain
state: Madrid
city: Pamplona
country: Spain
state: Nafarroako Foru Komunitatea
city: Oviedo
country: Spain
state: Principado De Asturias
Study officials:
affiliation: Eli Lilly and Company
name: 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
References:
citation: 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.