Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00384774
Recruitment Status : Completed
First Posted : October 6, 2006
Last Update Posted : January 4, 2018
Sponsor:
Collaborator:
CoLucid Pharmaceuticals
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE October 4, 2006
First Posted Date  ICMJE October 6, 2006
Last Update Posted Date January 4, 2018
Study Start Date  ICMJE October 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2006)
- Headache response at two hours after initiation of infusion of study drug
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00384774 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2006)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE A Placebo-Controlled Adaptive Treatment Assignment Study of Intravenous COL-144 in the Acute Treatment of Migraine
Official Title  ICMJE A Placebo-Controlled, Group Sequential, Adaptive Treatment Assignment Study of Intravenous COL-144 (LY573144) in the Acute Treatment of Migraine
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 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
Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Migraine
Intervention  ICMJE Drug: COL-144
Other Name: LY573144
Study Arms Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: October 5, 2006)
160
Original Enrollment  ICMJE Same as current
Actual Study Completion Date June 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland,   Germany,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00384774
Other Study ID Numbers  ICMJE 16891
2006-003903-38 ( EudraCT Number )
COL MIG-201 ( Other Identifier: Colucid )
H8H-CD-LAHM ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE CoLucid Pharmaceuticals
Investigators  ICMJE
Study Director: 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) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP