Status:
COMPLETED
Dose-ranging Study of Oral COL-144 in Acute Migraine Treatment
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
CoLucid Pharmaceuticals
Conditions:
Migraine Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 pha...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
512 Patients enrolled
Trial Details
Trial ID
NCT00883051
Start Date
July 1 2009
End Date
February 1 2010
Last Update
December 23 2019
Active Locations (39)
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1
Montegnée, Liege, Belgium, 4420
2
Hasselt, Limburg, Belgium, 3500
3
Leuven, Vlaams-Brabant, Belgium, 3000
4
Bruges, West-Vlaanderen, Belgium, 8000