Clinical trial NCT00384774: A Placebo-Controlled Adaptive Treatment Assignment Study of Intravenous COL-144 in the Acute Treatment of Migraine
Official title: A Placebo-Controlled, Group Sequential, Adaptive Treatment Assignment Study of Intravenous COL-144 (LY573144) in the Acute Treatment of Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Migraine
Keywords: Migraine
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: CoLucid Pharmaceuticals
First posted: 2006-10-06
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Eligibility 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

Primary outcomes:
measure: Number of Participants With Headache Response at Two Hours After Initiation of Infusion of Study Drug
timeFrame: 2 hours post dose
Secondary outcomes:
measure: Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose
timeFrame: 10, 20, 40, 60 90, 120, 180 and 240 minutes post dose
measure: Percentage of Participants Headache Free
timeFrame: 10, 20, 40, 60 90, 120, 180 and 240 minutes post dose
measure: Number of Participants With Sustained Headache Response
timeFrame: 2 to 24 hours post dose
measure: Number of Participants With Sustained Pain Free
timeFrame: 2 to 24 hours post dose
measure: Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia
timeFrame: 2 hours post dose
measure: Number of Participants With Clinical Disability
timeFrame: 2 hours post dose
measure: Percentage of Participants Using Rescue Medication
timeFrame: 24 hours post dose
measure: Percentage of Participants Reporting a Score on the Patient Global Impression (PGI)
timeFrame: 2 hours post dose
Other outcomes:
Locations:
city: Helsinki
country: Finland
city: Essen
country: Germany
city: Leiden
country: Netherlands
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Ferrari MD, Farkkila 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.