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

Purpose

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.

Condition	Intervention	Phase
Migraine	Drug: COL-144	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Placebo-Controlled, Group Sequential, Adaptive Treatment Assignment Study of Intravenous COL-144 (LY573144) in the Acute Treatment of Migraine

Resource links provided by NLM:

MedlinePlus related topics: Headache Migraine

U.S. FDA Resources

Further study details as provided by CoLucid Pharmaceuticals:

Primary Outcome Measures:

- Headache response at two hours after initiation of infusion of study drug

Secondary Outcome Measures:

Rates of headache response; Proportion of pts headache free; Rates of sustained response; Rates of sustained pain free; Relief of nausea, vomiting, etc.; Degree of clinical disability; Proportion of pts using rescue medication; Pt global impression


Estimated Enrollment:	160
Study Start Date:	October 2006
Study Completion Date:	June 2007

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 patients 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

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
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 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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00384774

Locations


Finland

Helsinki, Finland
Germany

Essen, Germany
Netherlands

Leiden, Netherlands

Sponsors and Collaborators

CoLucid Pharmaceuticals

Investigators


Study Director:	Alison J. Pilgrim, BM BCh DPhil	CoLucid Pharmaceuticals Inc.

More Information

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ferrari MD, Färkkilä 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.


ClinicalTrials.gov Identifier:	NCT00384774 History of Changes
Other Study ID Numbers:	COL MIG-201 EudraCT No: 2006-003903-38
Study First Received:	October 4, 2006
Last Updated:	December 4, 2008

Keywords provided by CoLucid Pharmaceuticals:


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 July 18, 2017