A Phase 4, Open-label Study to Evaluate the Safety and Tolerability of Daily Dosing of Rimegepant in Episodic Migraine Prevention
Overview
- Phase
- Phase 4
- Intervention
- Rimegepant
- Conditions
- Migraine
- Sponsor
- Pfizer
- Enrollment
- 441
- Locations
- 19
- Primary Endpoint
- Number of Participants With On-Treatment Adverse Events (AEs) (Frequency >=5%) According to Intensity
- Status
- Completed
- Last Updated
- 8 months ago
Overview
Brief Summary
The purpose of this study is to further evaluate the long-term safety and tolerability of daily dosing of rimegepant for the prevention of episodic migraine.
Detailed Description
This is a post marketing required study being conducted to further evaluate the long-term safety and tolerability of a more frequent daily dosing regimen of rimegepant for the prevention of episodic migraine.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject has at least 1 year history of episodic migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following:
- •Age of onset of migraines prior to 50 years of age
- •Migraine attacks, on average, lasting 4 -72 hours if untreated
- •Per subject report, 4-14 migraine attacks per month within the last 3 months prior to the Screening Visit (month is defined as 4 weeks for the purpose of this protocol)
- •Subjects ≥ 18 years
Exclusion Criteria
- •Subject history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Subjects with myocardial infarction (MI), acute coronary syndrome (ACS), percutaneous coronary intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months (24 weeks) prior to the Screening Visit.
- •Uncontrolled hypertension (high blood pressure) or uncontrolled diabetes.
- •The subject has a history or current evidence of any unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known or suspected infection, hepatitis B or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the study
- •History of use of opioid- or barbiturate- (e.g. butalbital) containing medication for 4 or more days per month during the 3 months (12 weeks) prior to the Screening Visit
- •WOCBP who are unwilling or unable to use an acceptable contraceptive method or abstinence to avoid pregnancy for the entire study and for 28 days after the last dose of study drug
- •Women who are pregnant or breastfeeding
- •Women with a positive pregnancy test at screening or prior to study drug administration
Arms & Interventions
Rimegepant
rimegepant 75 mg ODT daily
Intervention: Rimegepant
Outcomes
Primary Outcomes
Number of Participants With On-Treatment Adverse Events (AEs) (Frequency >=5%) According to Intensity
Time Frame: From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks)
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and did not necessarily have causal relationship with treatment. On-treatment AEs were those AEs which occurred after the study treatment start date until 7 days after last dose of study treatment. AEs were classified according to intensity as: mild: transient and required minimal treatment or therapeutic intervention, event did not interfere with usual activities of daily living; moderate: alleviated with additional specific therapeutic intervention, event interfered with activities of daily living, causing discomfort; severe: interrupted activities of daily living, affected clinical status, or required intensive treatment. AEs occurring in \>=5% participants are reported in this OM.
Number of Participants With On-Treatment Serious Adverse Events (SAEs)
Time Frame: From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks)
An SAE was any event that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; was persistent or caused significant disability/incapacity or congenital anomaly/birth defect in the offspring of a participant who received Rimegepant, or other important medical events. On-treatment AEs were those AEs which occurred after the study treatment start date until 7 days after last dose of study treatment.
Number of Participants With AEs Leading to Study Drug Discontinuation
Time Frame: From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks)
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and did not necessarily have causal relationship with treatment. Number of participants with AEs leading to study drug discontinuations are reported in this outcome measure.
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale
Time Frame: From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks)
The following laboratory parameters were assessed: eosinophils, hemoglobin low and high, leukocytes low, lymphocytes low and high, neutrophils, platelets, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium low and high, cholesterol, creatine kinase, creatinine, glomerular filtration rate estimated, glucose low and high, lactate dehydrogenase, low-density lipoprotein (LDL) cholesterol, LDL cholesterol fasting and not fasting, potassium low and high, sodium low and high, triglycerides, triglycerides fasting and not fasting, uric acid, urine glucose and urine protein. Laboratory abnormalities were graded according to NCI CTCAE v5.0; where grade 3=severe and grade 4=life-threatening except for glucose, LDL cholesterol, and urinalysis where DAIDS v2.1 was used. (grade 3= severe and grade 4= life-threatening).
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale
Time Frame: From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks)
The following laboratory parameters were assessed: eosinophils, hemoglobin, leukocytes low, lymphocytes low and high, neutrophils, platelets, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, blood urine nitrogen, calcium low and high, cholesterol, creatine, glucose low and high, potassium low and high, protein, sodium low and high, urine glucose and urine protein. Laboratory abnormality events were graded according to FDA toxicity grading scale (grade 3= severe and grade 4= life-threatening).