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

This study has been completed.
Sponsor:
Collaborator:
FGK Clinical Research GmbH
Information provided by:
CoLucid Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00883051
First received: April 16, 2009
Last updated: April 22, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Migraine Disorders
Drug: COL-144
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind Randomized Placebo-Controlled Parallel Group Dose-Ranging Study of Oral COL-144 in the Acute Treatment of Migraine

Resource links provided by NLM:


Further study details as provided by CoLucid Pharmaceuticals:

Primary Outcome Measures:
  • Headache response, defined as a reduction in headache severity from moderate or severe at baseline to mild or no headache two hours after intake of study drug. [ Time Frame: Two hours after intake of study drug ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Headache free (absence of headache) [ Time Frame: Two hours after intake of study drug ] [ Designated as safety issue: No ]
  • Headache severity (4 point scale: none, mild, moderate, severe) [ Time Frame: From time immediately before intake of study drug until 2 hours after after intake of study drug ] [ Designated as safety issue: No ]
  • Headache recurrence [ Time Frame: Within 24 hours hours after after intake of study drug ] [ Designated as safety issue: No ]
  • Presence or absence of nausea, phonophobia, photophobia, vomiting [ Time Frame: From time immediately before intake of study drug until 2 hours after intake of study drug ] [ Designated as safety issue: No ]
  • Disability (4 point scale: not at all, mild interference, marked interference, completely - needs bed rest) [ Time Frame: From time immediately before intake of study drug until 2 hours after intake of study drug ] [ Designated as safety issue: No ]
  • Requirement for rescue medication (yes or no) [ Time Frame: Between 2 and 24 hours after intake of study drug ] [ Designated as safety issue: No ]
  • Patient global impression (7 point scale) [ Time Frame: Between 2 hours after intake of study drug ] [ Designated as safety issue: No ]
  • Time to headache relief and time to pain free [ Time Frame: Within 24 hours after intake of study drug ] [ Designated as safety issue: No ]
  • Adverse events (spontaneously reported) [ Time Frame: Throughout the whole study duration ] [ Designated as safety issue: Yes ]
  • 12-Lead electrocardiograms (ECGs) [ Time Frame: Baseline and within 14 days after treatment ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: Baseline and within 14 days after treatment ] [ Designated as safety issue: Yes ]
  • Clinical laboratory parameters [ Time Frame: Baseline and within 14 days after treatment ] [ Designated as safety issue: Yes ]
  • Physical examination [ Time Frame: Baseline and within 14 days after treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 450
Study Start Date: July 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
COL-144 50 mg
Drug: COL-144
Oral application of one dose of either COL-144 50 mg, COL-144 100 mg, COL-144 200 mg, COL-144 400 mg 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.
Other Name: Former Eli Lilly & Company name of COL-144 was LY573144
Experimental: 2
COL-144 100 mg
Drug: COL-144
Oral application of one dose of either COL-144 50 mg, COL-144 100 mg, COL-144 200 mg, COL-144 400 mg 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.
Other Name: Former Eli Lilly & Company name of COL-144 was LY573144
Experimental: 3
COL-144 200 mg
Drug: COL-144
Oral application of one dose of either COL-144 50 mg, COL-144 100 mg, COL-144 200 mg, COL-144 400 mg 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.
Other Name: Former Eli Lilly & Company name of COL-144 was LY573144
Experimental: 4
COL-144 400 mg
Drug: COL-144
Oral application of one dose of either COL-144 50 mg, COL-144 100 mg, COL-144 200 mg, COL-144 400 mg 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.
Other Name: Former Eli Lilly & Company name of COL-144 was LY573144
Placebo Comparator: 5
Placebo
Drug: Placebo
Placebo
Other Name: Placebo

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00883051

Locations
Belgium
Montegnee, Liege, Belgium, 4420
Hasselt, Limburg, Belgium, 3500
Leuven, Vlaams-Brabant, Belgium, 3000
Brugge, West-Vlaanderen, Belgium, 8000
Bruxelles, Belgium, 1070
Liege, Belgium, 4000
Finland
Helsinki, Etelä-Suomi, Finland, 00029 HUS
Hyvinkää, Etelä-Suomi, Finland, 05850
Mikkeli, Itä-Suomen lääni, Finland, 50100
Pori, Länsi-Suomen, Finland, 28100
Jyväskylä, Länsi-Suomi, Finland, 40100
Tampere, Länsi-Suomi, Finland, 33200
Turku, Länsi-Suomi, Finland, 20100
France
Nice, Alpes-Maritimes, France, 06002
Bordeaux, Gironde, France, 33076
Toulouse, Haute-Garonne, France, 31059
Lille, Nord, France, 59 037
Rouen, Seine-Maritime, France, 76031
Paris, France, 75010
Germany
Freiburg/Breisgau, Baden-Württemberg, Germany, 79106
Göppingen, Baden-Württemberg, Germany, 73033
München, Bayern, Germany, 81377
München, Bayern, Germany, 80802
Wiesbaden, Hessen, Germany, 65189
Erkelenz, Nordrhein-Westfalen, Germany, 41812
Essen, Nordrhein-Westfalen, Germany, 45122
Münster, Nordrhein-Westfalen, Germany, 48129
Itzehoe, Schleswig-Holstein, Germany, 25524
Berlin, Germany, 10117
Bremen, Germany, 28329
Hamburg, Germany, 20246
Spain
Sevilla, Andalucía, Spain, 41013
Barcelona, Catalunya, Spain, 08036
Gandia, Comunidad Valenciana, Spain, 46701
Valencia, Comunidad Valenciana, Spain, 46021
Santiago de Compostela, Comunidade Autónoma de Galicia, Spain, 15706
Alcorcon, Madrid, Spain, 28922
Pamplona, Nafarroako Foru Komunitatea, Spain, 31008
Oviedo, Principado de Asturias, Spain, 33007
Sponsors and Collaborators
CoLucid Pharmaceuticals
FGK Clinical Research GmbH
Investigators
Study Director: Alison J. Pilgrim, BM,BCh,DPhil CoLucid Pharmaceuticals Inc, USA
  More Information

No publications provided by CoLucid Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nadia Rupniak, Ph.D., Vice President of Research & Development, CoLucid Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00883051     History of Changes
Other Study ID Numbers: COL MIG-202, EudraCT No.: 2008-005010-43
Study First Received: April 16, 2009
Last Updated: April 22, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Finland: Finnish Medicines Agency
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Spain: Spanish Agency of Medicines

Keywords provided by CoLucid Pharmaceuticals:
COL-144
acute treatment
migraine

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 22, 2014