Brief Summary
The primary purpose of this study is to evaluate the efficacy of rimegepant (BMS-927711) compared with placebo in the acute treatment of migraine as measured by Pain Freedom (headache pain intensity level reported as "no pain") at 2 hours post dose using a four point numeric rating scale (no pain, mild pain, moderate pain, severe pain) while identifying an optimal dose to support the Phase 3 clinical trials.
Brief Title
Dose Ranging Study of Rimegepant (BMS-927711) for the Acute Treatment of Migraine
Detailed Description
Intervention Model: Parallel Versus Comparator + Placebo
Categories
Completion Date
Completion Date Type
Actual
Conditions
Migraine
Acute Treatment of Migraine
Eligibility Criteria
Key Inclusion Criteria:
* Patient with at least 1-year history of migraines (with or without aura) including the following:
* Migraine attacks more than 1 year with age of onset prior to 50 years of age
* Migraine attacks, on average, last about 4 - 72 hours if untreated
* No more than 8 attacks of moderate to severe intensity per month within last 3 months
* Patient must be able to distinguish migraine attacks from tension/cluster attacks and must have consistent migraine headaches of at least 2 migraine headaches attacks of moderate to severe intensity in each of the last 3 months
* Less than 15 days of headache (migraine or non-migraine) per month in each of 3 months prior to screening
* Male and female ≥ 18 years and ≤ age 65
* No clinically significant abnormality identified on the medical or laboratory evaluation
Key Exclusion Criteria:
* Patient has a history of basilar migraine or hemiplegic migraine
* Patient does not receive migraine relief from triptan migraine treatment
* Medications that may alter the pH of the stomach (acid reducing agents), such as H-2 antagonists, Proton Pump inhibitors (PPI), antacids
* History of ergotamine or triptan intake greater than/equal 10 days per month on a regular basis for greater than 3 months
* History of non-narcotic analgesic intake on greater then/equal 15 days per month for greater than/equal 3 months
* Patient with at least 1-year history of migraines (with or without aura) including the following:
* Migraine attacks more than 1 year with age of onset prior to 50 years of age
* Migraine attacks, on average, last about 4 - 72 hours if untreated
* No more than 8 attacks of moderate to severe intensity per month within last 3 months
* Patient must be able to distinguish migraine attacks from tension/cluster attacks and must have consistent migraine headaches of at least 2 migraine headaches attacks of moderate to severe intensity in each of the last 3 months
* Less than 15 days of headache (migraine or non-migraine) per month in each of 3 months prior to screening
* Male and female ≥ 18 years and ≤ age 65
* No clinically significant abnormality identified on the medical or laboratory evaluation
Key Exclusion Criteria:
* Patient has a history of basilar migraine or hemiplegic migraine
* Patient does not receive migraine relief from triptan migraine treatment
* Medications that may alter the pH of the stomach (acid reducing agents), such as H-2 antagonists, Proton Pump inhibitors (PPI), antacids
* History of ergotamine or triptan intake greater than/equal 10 days per month on a regular basis for greater than 3 months
* History of non-narcotic analgesic intake on greater then/equal 15 days per month for greater than/equal 3 months
Inclusion Criteria
Inclusion Criteria:
* Patient with at least 1-year history of migraines (with or without aura) including the following:
* Migraine attacks more than 1 year with age of onset prior to 50 years of age
* Migraine attacks, on average, last about 4 - 72 hours if untreated
* No more than 8 attacks of moderate to severe intensity per month within last 3 months
* Patient must be able to distinguish migraine attacks from tension/cluster attacks and must have consistent migraine headaches of at least 2 migraine headaches attacks of moderate to severe intensity in each of the last 3 months
* Less than 15 days of headache (migraine or non-migraine) per month in each of 3 months prior to screening
* Male and female ≥ 18 years and ≤ age 65
* No clinically significant abnormality identified on the medical or laboratory evaluation
* Patient with at least 1-year history of migraines (with or without aura) including the following:
* Migraine attacks more than 1 year with age of onset prior to 50 years of age
* Migraine attacks, on average, last about 4 - 72 hours if untreated
* No more than 8 attacks of moderate to severe intensity per month within last 3 months
* Patient must be able to distinguish migraine attacks from tension/cluster attacks and must have consistent migraine headaches of at least 2 migraine headaches attacks of moderate to severe intensity in each of the last 3 months
* Less than 15 days of headache (migraine or non-migraine) per month in each of 3 months prior to screening
* Male and female ≥ 18 years and ≤ age 65
* No clinically significant abnormality identified on the medical or laboratory evaluation
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
65 Years
Minimum Age
18 Years
NCT Id
NCT01430442
Org Class
Industry
Org Full Name
Pfizer
Org Study Id
CN170-003
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Phase IIb: Double-Blind, Randomized, Placebo Controlled, Dose-ranging Trial of BMS-927711 for the Acute Treatment of Migraine
Primary Outcomes
Outcome Description
Pain freedom was defined as participants reporting a value of "none" on the four-point numeric rating scale (none=0, mild =1, moderate =2, severe =3) from baseline. Participants with baseline moderate pain or severe pain were included in the analysis.
Outcome Measure
Number of Pain Free Participants (Pain Freedom) at 2 Hours Post-dose
Outcome Time Frame
Baseline, 2 hours post-dose
Secondary Outcomes
Outcome Description
Total migraine freedom is defined as complete absence of migraine symptoms. A participant was positive for total migraine freedom at a particular time point if he/she reports the absence of: pain, nausea, photophobia, and phonophobia. This corresponds to reporting "none" on each of the four-point numeric rating scale (none =0, mild =1, moderate =2, severe =3) from baseline associated with these symptoms. Participants with baseline moderate pain or severe pain were included in the analysis.
Outcome Time Frame
Baseline, 2 hours post dose
Outcome Measure
Number of Participants With Total Migraine Freedom at 2 Hours Post Dose
Outcome Description
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition, unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or suspected transmission of an infectious agent, or encompassed any other clinically significant event that could jeopardize the subject or require medical or surgical intervention to prevent one of the aforementioned outcomes.
Outcome Time Frame
AEs: from first dose to end of treatment visit (up to 7 weeks); SAE: from signing of informed consent to 30 days after the last dose (up to 11 weeks).
Outcome Measure
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuation Due to Adverse Events
Outcome Description
Participants were considered to have sustained pain freedom if all of their reported pain readings in the interval are "none" on the four point numeric rating scale (no pain=0, mild pain=1, moderate pain=2, severe pain=3). The intervals are inclusive of the endpoints. Sustained pain freedom was analyzed with a Cochran Mantel Haenszel (CMH) test for general association that compares the ED90 to placebo, and controls for baseline pain severity.
Outcome Time Frame
2 hours to 24 hours post dose
Outcome Measure
Number of Participants Achieving Sustained Pain Freedom From 2 to 24 Hours Post Dose
Outcome Description
Participants were considered to have sustained pain freedom if all of their reported pain readings in the interval are "none" on the four point numeric rating scale (no pain=0, mild pain=1, moderate pain=2, severe pain=3). The intervals are inclusive of the endpoints. Sustained pain freedom was analyzed with a CMH test for general association that compares the ED90 to placebo, and controls for baseline pain severity.
Outcome Time Frame
2 hours to 48 hours post dose
Outcome Measure
Number of Participants Achieving Sustained Pain Freedom From 2 to 48 Hours Post Dose
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
65
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Brian Grosberg
Investigator Email
bgrosber@montefiore.org
Investigator Phone
Categories Mesh Debug
Brain, Spinal Cord & Nervous System --- MIGRAINE DISORDERS
Headaches & Migraine --- MIGRAINE DISORDERS
Brain, Spinal Cord & Nervous System --- HEADACHE DISORDERS, PRIMARY
Headaches & Migraine --- HEADACHE DISORDERS, PRIMARY
Brain, Spinal Cord & Nervous System --- HEADACHE DISORDERS
Headaches & Migraine --- HEADACHE DISORDERS
Alzheimer's --- BRAIN DISEASES
Brain, Spinal Cord & Nervous System --- BRAIN DISEASES
Brain, Spine & Nerve Cancers --- BRAIN DISEASES
Alzheimer's --- CENTRAL NERVOUS SYSTEM DISEASES
Brain, Spinal Cord & Nervous System --- CENTRAL NERVOUS SYSTEM DISEASES
Brain, Spine & Nerve Cancers --- CENTRAL NERVOUS SYSTEM DISEASES
Brain, Spinal Cord & Nervous System --- NERVOUS SYSTEM DISEASES
Brain, Spine & Nerve Cancers --- NERVOUS SYSTEM DISEASES
MeSH Terms
MIGRAINE DISORDERS
HEADACHE DISORDERS, PRIMARY
HEADACHE DISORDERS
BRAIN DISEASES
CENTRAL NERVOUS SYSTEM DISEASES
NERVOUS SYSTEM DISEASES
RIMEGEPANT SULFATE
COUNTERFEIT DRUGS
SUMATRIPTAN
SUBSTANDARD DRUGS
PHARMACEUTICAL PREPARATIONS
SULFONAMIDES
AMIDES
ORGANIC CHEMICALS
SULFONES
SULFUR COMPOUNDS
TRYPTAMINES
INDOLES
HETEROCYCLIC COMPOUNDS, 2-RING
HETEROCYCLIC COMPOUNDS, FUSED-RING
HETEROCYCLIC COMPOUNDS