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

Lilly

Status and phase

Completed

Phase 2

Conditions

Migraine

Treatments

Drug: Placebo

Drug: Lasmiditan

Study type

Interventional

Funder types

Industry

Identifiers

NCT00384774

COL MIG-201 (Other Identifier)

16891

H8H-CD-LAHM (Other Identifier)

2006-003903-38 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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 participants 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

Enrollment

130 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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