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Dose-ranging Study of Oral COL-144 in Acute Migraine Treatment

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: NCT00883051
Recruitment Status : Completed
First Posted : April 17, 2009
Results First Posted : December 23, 2019
Last Update Posted : December 23, 2019
Sponsor:
Collaborator:
CoLucid Pharmaceuticals
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Migraine Disorders Drug: Lasmiditan Drug: Placebo Phase 2

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 pharmacologic therapy for migraine aims to terminate the attack or reduce its severity. Analgesics are commonly used or, if these are ineffective, triptans. Since triptans are contraindicated in patients with coronary artery disease, uncontrolled hypertension, and cerebrovascular disease alternative medications are required for patients where simple analgesics do not work. COL-144 has no vasoconstrictor activity at clinically relevant concentrations and might meet this need. COL-144 was effective when given intravenously in a placebo-controlled dose-ranging study. This study investigates which dose of oral COL-144 is effective in the in acute treatment of migraine headache.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 512 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind Randomized Placebo-Controlled Parallel Group Dose-Ranging Study of Oral COL-144 in the Acute Treatment of Migraine
Study Start Date : July 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Experimental: 50 mg Lasmiditan
50 mg lasmiditan administered orally (PO)
Drug: Lasmiditan
Oral application of one dose of either 50 mg lasmiditan,100 mg lasmiditan, 200 mg lasmiditan, 400 mg lasmiditan or placebo as the first treatment for a new migraine attack providing that any aura symptoms have resolved and the headache is either moderate or severe and has been so for less than 4 hours.
Other Name: LY573144

Experimental: 100 mg Lasmiditan
100 mg lasmiditan administered orally (PO)
Drug: Lasmiditan
Oral application of one dose of either 50 mg lasmiditan,100 mg lasmiditan, 200 mg lasmiditan, 400 mg lasmiditan or placebo as the first treatment for a new migraine attack providing that any aura symptoms have resolved and the headache is either moderate or severe and has been so for less than 4 hours.
Other Name: LY573144

Experimental: 200 mg Lasmiditan
200 mg lasmiditan administered orally (PO)
Drug: Lasmiditan
Oral application of one dose of either 50 mg lasmiditan,100 mg lasmiditan, 200 mg lasmiditan, 400 mg lasmiditan or placebo as the first treatment for a new migraine attack providing that any aura symptoms have resolved and the headache is either moderate or severe and has been so for less than 4 hours.
Other Name: LY573144

Experimental: 400 mg Lasmiditan
400 mg lasmiditan administered orally (PO)
Drug: Lasmiditan
Oral application of one dose of either 50 mg lasmiditan,100 mg lasmiditan, 200 mg lasmiditan, 400 mg lasmiditan or placebo as the first treatment for a new migraine attack providing that any aura symptoms have resolved and the headache is either moderate or severe and has been so for less than 4 hours.
Other Name: LY573144

Placebo Comparator: Placebo
Placebo administered orally (PO)
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Percentage of Participants With Headache Response [ Time Frame: 2 hours postdose ]
    Headache response is a binary response variable derived from the headache intensities recorded in the participant diary. Headache response is defined as a reduction in headache severity from moderate or severe at baseline to mild or no headache, at two hours after administration of study drug.


Secondary Outcome Measures :
  1. Percentage of Participants Who Are Headache Free (Absence of Headache) After First Dose [ Time Frame: 2 hours post dose ]
    The percentage of participants defined as mild, moderate, or severe headache pain becoming none.

  2. Percentage of Participants With Headache Recurrence [ Time Frame: up to 24 hours postdose ]
    Participants who received study drug and which became pain free at 2 hours postdose and worsened again upto 24 hours post-dose.

  3. Percentage of Participants With Headache Severity (4 Point Rating Scale) [ Time Frame: 2 hours postdose ]
    Headache severity was evaluated by the participant using the International Headache Society (IHS) four point headache severity rating scale (0=no pain, 1=mild pain, 2=moderate pain, and 3=severe pain) with a lower score being less severe and a higher score being more severe.

  4. Percentage of Participants Who Have Symptoms of Nausea [ Time Frame: 2 hours postdose ]
    Percentage of participants who have symptoms of nausea two hours post treatment.

  5. Percentage of Participants Who Have Symptoms Phonophobia [ Time Frame: 2 hours postdose ]
    Percentage of participants who have symptoms of phonophobia two hours post treatment.

  6. Percentage of Participants Who Have Photophobia [ Time Frame: 2 hours postdose ]
    Percentage of participants who have symptoms of photophobia two hours post treatment.

  7. Percentage of Participants With Vomiting [ Time Frame: 2 hours postdose ]
    Percentage of participants with vomiting 2 hours post treatment.

  8. Disability (4 Point Scale: Not at All, Mild Interference, Marked Interference, Completely - Needs Bed Rest) [ Time Frame: 2 hours postdose ]
    The participant is asked "How much is the migraine interfering with normal activities?" on a 4 point scale 0-Not at all, 1-Mild interference, 2-Marked interference ,3-Completely needs bed rest, with a lower score having lower interference and higher score worse interference.

  9. Percentage of Participants Who Used Rescue Medication [ Time Frame: Postdose 2 through 24 hours ]
    Rescue medication was permitted after completion of the 2 hour assessment if migraine did not respond (participant was not pain free).

  10. Number of Participants Reporting a Score on the Patient Global Impression of Improvement (PGI-I) [ Time Frame: 2 hours postdose ]
    PGI-I requests participants to mark the box that best describes their cluster headache condition since they started taking the medicine. The options in the displayed boxes are represented on a 7-point scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse, a lower number indicates much better and a higher number indicates worse.

  11. Actual Time to Headache Relief and Time to Pain Free [ Time Frame: up to 24 hours postdose ]

    The participant answered "Did your migraine pain go away completely (pain free) within 24 hours of dosing" and record the time.

    Actual time to meaningful pain relief and actual time to pain free will be censored at 24 hours if meaningful pain relief or pain free is documented to be greater than 24 hours after dosing and "Did you experience meaningful relief (headache relief) from your migraine within 24 hours after dosing?".


  12. Change From Baseline in Heart Rate [ Time Frame: Baseline through Day 14 ]
    Change from baseline in assessment of vital signs (heart rate).

  13. Change From Baseline in Systolic Blood Pressure [ Time Frame: Baseline through Day 14 ]
    Change from baseline in vital signs (systolic blood pressure).

  14. Change From Baseline in Diastolic Blood Pressure [ Time Frame: Baseline through Day 14 ]
    Change from baseline in vital signs (diastolic blood pressure).

  15. Percentage of Participants With Change From Baseline in Physical Examination Parameters [ Time Frame: Baseline through Day 14 ]
    Participants were evaluated for skin, head, ear, nose and throat, cardiovascular and musculoskeletal changes from a normal screening to an abnormal screening. Changes in the physical examination noted as non-serious AEs or SAEs, regardless of causality, are located in the Reported Adverse Events section.

  16. Change From Baseline in Hematology Tests [ Time Frame: Baseline through Day 14 ]
    Hematology tests, including a complete blood count (CBC) measured red blood cells, white blood cells, hemoglobin, neutrophils and platelets.

  17. Number of Serious Adverse Events [ Time Frame: up to 8 weeks ]
    A summary of non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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 Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00883051


Locations
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Belgium
Montegnee, Liege, Belgium, 4420
Hasselt, Limburg, Belgium, 3500
Leuven, Vlaams-Brabant, Belgium, 3000
Brugge, West-Vlaanderen, Belgium, 8000
Bruxelles, Belgium, 1070
Liege, Belgium, 4000
Finland
Helsinki, Etelä-Suomi, Finland, 00029 HUS
Hyvinkää, Etelä-Suomi, Finland, 05850
Mikkeli, Itä-Suomen Lääni, Finland, 50100
Pori, Länsi-Suomen, Finland, 28100
Jyväskylä, Länsi-Suomi, Finland, 40100
Tampere, Länsi-Suomi, Finland, 33200
Turku, Länsi-Suomi, Finland, 20100
France
Nice, Alpes-Maritimes, France, 06002
Bordeaux, Gironde, France, 33076
Toulouse, Haute-Garonne, France, 31059
Lille, Nord, France, 59 037
Rouen, Seine-Maritime, France, 76031
Paris, France, 75010
Germany
Freiburg/Breisgau, Baden-Württemberg, Germany, 79106
Göppingen, Baden-Württemberg, Germany, 73033
München, Bayern, Germany, 80802
München, Bayern, Germany, 81377
Wiesbaden, Hessen, Germany, 65189
Erkelenz, Nordrhein-Westfalen, Germany, 41812
Essen, Nordrhein-Westfalen, Germany, 45122
Münster, Nordrhein-Westfalen, Germany, 48129
Itzehoe, Schleswig-Holstein, Germany, 25524
Berlin, Germany, 10117
Bremen, Germany, 28329
Hamburg, Germany, 20246
Spain
Sevilla, Andalucía, Spain, 41013
Barcelona, Catalunya, Spain, 08036
Gandia, Comunidad Valenciana, Spain, 46701
Valencia, Comunidad Valenciana, Spain, 46021
Santiago de Compostela, Comunidade Autónoma De Galicia, Spain, 15706
Alcorcon, Madrid, Spain, 28922
Pamplona, Nafarroako Foru Komunitatea, Spain, 31008
Oviedo, Principado De Asturias, Spain, 33007
Sponsors and Collaborators
Eli Lilly and Company
CoLucid Pharmaceuticals
Investigators
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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00883051    
Other Study ID Numbers: 16892
H8H-CD-LAHO ( Other Identifier: Eli Lilly and Company )
2008-005010-43 ( EudraCT Number )
COL MIG-202 ( Other Identifier: Colucid )
First Posted: April 17, 2009    Key Record Dates
Results First Posted: December 23, 2019
Last Update Posted: December 23, 2019
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/
Keywords provided by Eli Lilly and Company:
COL-144
acute treatment
migraine
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases