Status:
COMPLETED
A Placebo-Controlled Adaptive Treatment Assignment Study of Intravenous COL-144 in the Acute Treatment of Migraine
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
CoLucid Pharmaceuticals
Conditions:
Migraine
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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.
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 t...
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 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
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00384774
Start Date
November 1 2006
End Date
June 1 2007
Last Update
December 2 2019
Active Locations (3)
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1
Helsinki, Finland
2
Essen, Germany
3
Leiden, Netherlands