- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00883051
Dose-ranging Study of Oral COL-144 in Acute Migraine Treatment
A Double Blind Randomized Placebo-Controlled Parallel Group Dose-Ranging Study of Oral COL-144 in the Acute Treatment of Migraine
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Bruxelles, Belgium, 1070
-
Liege, Belgium, 4000
-
-
Liege
-
Montegnee, Liege, Belgium, 4420
-
-
Limburg
-
Hasselt, Limburg, Belgium, 3500
-
-
Vlaams-Brabant
-
Leuven, Vlaams-Brabant, Belgium, 3000
-
-
West-Vlaanderen
-
Brugge, West-Vlaanderen, Belgium, 8000
-
-
-
-
Etelä-Suomi
-
Helsinki, Etelä-Suomi, Finland, 00029 HUS
-
Hyvinkää, Etelä-Suomi, Finland, 05850
-
-
Itä-Suomen Lääni
-
Mikkeli, Itä-Suomen Lääni, Finland, 50100
-
-
Länsi-Suomen
-
Pori, Länsi-Suomen, Finland, 28100
-
-
Länsi-Suomi
-
Jyväskylä, Länsi-Suomi, Finland, 40100
-
Tampere, Länsi-Suomi, Finland, 33200
-
Turku, Länsi-Suomi, Finland, 20100
-
-
-
-
-
Paris, France, 75010
-
-
Alpes-Maritimes
-
Nice, Alpes-Maritimes, France, 06002
-
-
Gironde
-
Bordeaux, Gironde, France, 33076
-
-
Haute-Garonne
-
Toulouse, Haute-Garonne, France, 31059
-
-
Nord
-
Lille, Nord, France, 59 037
-
-
Seine-Maritime
-
Rouen, Seine-Maritime, France, 76031
-
-
-
-
-
Berlin, Germany, 10117
-
Bremen, Germany, 28329
-
Hamburg, Germany, 20246
-
-
Baden-Württemberg
-
Freiburg/Breisgau, Baden-Württemberg, Germany, 79106
-
Göppingen, Baden-Württemberg, Germany, 73033
-
-
Bayern
-
München, Bayern, Germany, 81377
-
München, Bayern, Germany, 80802
-
-
Hessen
-
Wiesbaden, Hessen, Germany, 65189
-
-
Nordrhein-Westfalen
-
Erkelenz, Nordrhein-Westfalen, Germany, 41812
-
Essen, Nordrhein-Westfalen, Germany, 45122
-
Münster, Nordrhein-Westfalen, Germany, 48129
-
-
Schleswig-Holstein
-
Itzehoe, Schleswig-Holstein, Germany, 25524
-
-
-
-
Andalucía
-
Sevilla, Andalucía, Spain, 41013
-
-
Catalunya
-
Barcelona, Catalunya, Spain, 08036
-
-
Comunidad Valenciana
-
Gandia, Comunidad Valenciana, Spain, 46701
-
Valencia, Comunidad Valenciana, Spain, 46021
-
-
Comunidade Autónoma De Galicia
-
Santiago de Compostela, Comunidade Autónoma De Galicia, Spain, 15706
-
-
Madrid
-
Alcorcon, Madrid, Spain, 28922
-
-
Nafarroako Foru Komunitatea
-
Pamplona, Nafarroako Foru Komunitatea, Spain, 31008
-
-
Principado De Asturias
-
Oviedo, Principado De Asturias, Spain, 33007
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 50 mg Lasmiditan
50 mg lasmiditan administered orally (PO)
|
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 Names:
|
Experimental: 100 mg Lasmiditan
100 mg lasmiditan administered orally (PO)
|
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 Names:
|
Experimental: 200 mg Lasmiditan
200 mg lasmiditan administered orally (PO)
|
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 Names:
|
Experimental: 400 mg Lasmiditan
400 mg lasmiditan administered orally (PO)
|
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 Names:
|
Placebo Comparator: Placebo
Placebo administered orally (PO)
|
Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 hours postdose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 hours post dose
|
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.
|
up to 24 hours postdose
|
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.
|
2 hours postdose
|
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.
|
2 hours postdose
|
Percentage of Participants Who Have Symptoms Phonophobia
Time Frame: 2 hours postdose
|
Percentage of participants who have symptoms of phonophobia two hours post treatment.
|
2 hours postdose
|
Percentage of Participants Who Have Photophobia
Time Frame: 2 hours postdose
|
Percentage of participants who have symptoms of photophobia two hours post treatment.
|
2 hours postdose
|
Percentage of Participants With Vomiting
Time Frame: 2 hours postdose
|
Percentage of participants with vomiting 2 hours post treatment.
|
2 hours postdose
|
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.
|
2 hours postdose
|
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).
|
Postdose 2 through 24 hours
|
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.
|
2 hours postdose
|
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?". |
up to 24 hours postdose
|
Change From Baseline in Heart Rate
Time Frame: Baseline through Day 14
|
Change from baseline in assessment of vital signs (heart rate).
|
Baseline through Day 14
|
Change From Baseline in Systolic Blood Pressure
Time Frame: Baseline through Day 14
|
Change from baseline in vital signs (systolic blood pressure).
|
Baseline through Day 14
|
Change From Baseline in Diastolic Blood Pressure
Time Frame: Baseline through Day 14
|
Change from baseline in vital signs (diastolic blood pressure).
|
Baseline through Day 14
|
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.
|
Baseline through Day 14
|
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.
|
Baseline through Day 14
|
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.
|
up to 8 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Clinical Study Report (CSR)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Migraine Disorders
-
Austrian Migraine Registry CollaborationMedical University of Vienna; Medical University Innsbruck; Austrian Headache...RecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With Aura | Episodic MigraineAustria
-
Harvard University Faculty of MedicineBrigham and Women's Hospital; Palmer Center for Chiropractic Research (PCCR)CompletedMigraine | Migraine Disorders | Migraine Without Aura | Migraine With Aura | Migraine, ClassicUnited States
-
University of FlorenceAzienda Ospedaliera Città della Salute e della Scienza di Torino; University... and other collaboratorsRecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With AuraItaly
-
Notre-Dame Hospital, Montreal, Quebec, CanadaAllerganCompletedChronic Migraine | Migraine Without Aura | Migraine With AuraCanada
-
Glostrup University Hospital, CopenhagenUnknownChronic Migraine | Migraine Without Aura | Migraine With AuraDenmark
-
University of FlorenceAzienda Ospedaliera Città della Salute e della Scienza di Torino; University... and other collaboratorsRecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With AuraItaly
-
CoolTech LLCTerminatedMigraine | Migraine Without Aura | Migraine With Aura | Episodic MigraineUnited States
-
Tonix Pharmaceuticals, Inc.PremierCompletedChronic Migraine | Chronic Migraine, Headache | Chronic Migraine Without Aura | Aura MigraineUnited States
-
Fondazione I.R.C.C.S. Istituto Neurologico Carlo...CompletedMigraine With Aura | Migraine in ChildrenItaly
-
Second Affiliated Hospital, School of Medicine,...SICHUAN CREDIT PHARMACEUTICAL CO., LTD.Not yet recruitingMigraine Without Aura | Migraine With AuraChina
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States