Clinical trial NCT05371652: A Study to Learn About the Long-term Safety of Rimegepant for the Acute Treatment of Migraine in Chinese Participants
Official title: A Multicenter, Open Label, Long-term Safety Study of BHV3000 for the Acute Treatment of Migraine in Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Migraine
Keywords: Migraine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-05-12
Enrollment: 241
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is to evaluate the long-term safety and tolerability of Rimegepant 75mg ODT in Chinese subjects with migraine


Eligibility criteria: Inclusion Criteria:

At least a one-year history of migraines (with or without aura), consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd edition beta version, including the following:

* Age of onset of migraines prior to 50 years of age
* Migraine attacks, on average, lasting 4 - 72 hours if untreated
* 6-18 migraine attacks of moderate or severe intensity per month within the last 3 months prior to the Screening Visit
* 6 or more migraine days requiring treatment during Observation Phase
* Ability to distinguish migraine attacks from tension/cluster headaches
* Subjects on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable dose for at least 2 months prior to the Baseline Visit, and the dose is not expected to change during the course of the study. subjects who previously discontinued prophylactic migraine medication must have done so at least 5 half-lives of the prophylactic medication prior to the Screening Visit
* Subjects with contraindications for use of triptans may be included provided they meet all other study entry criteria

Age and Reproductive Status:

* Male or female subjects ≥ 18 years
* Women of childbearing potential (WOCBP) must voluntarily use 1 acceptable methods of contraception to avoid pregnancy and to minimize the risk of pregnancy from signing of informed consent through 28 days after study drug administration. WOCBP is defined in Section 12.3. No contraception methods are required for male subjects in this study.

Exclusion Criteria:

Target Disease Exclusion:

\* Subjects has a history of basilar migraine with brain stem aura or hemiplegic migraine

Medical History and Comorbidities:

* History of HIV disease
* Current evidence of poorly controlled, unstable, or recently diagnosed cardiovascular or cerebrovascular disease such as ischemic heart disease, coronary vasospasm, and cerebral ischemia. Myocardial infarction (MI), acute coronary syndrome (ACS), percutaneous coronary intervention (PCI), cardiac surgery, stroke, or transient ischemic attack (TIA) during 6 months prior to screening
* Poorly controlled hypertension (high blood pressure) or poorly controlled diabetes (but subjects with stable hypertension and/or diabetes for at least 3 months prior to screening may be included in the study). Blood pressure greater than 150 mmHg systolic or 100 mmHg diastolic after 10 minutes of rest is exclusionary
* Subjects with a current diagnosis of major depression or a major depressive episode within the last 12 months, other pain syndromes, psychiatric disorders, dementia, or significant neurological disorders (other than migraine) that, in the opinion of the investigator, might interfere with study assessments
* History of gastric or small intestinal surgery (including gastric bypass, gastric banding, gastric sleeve, gastric water ball, etc.) or diseases resulting in malabsorption
* Subject has a history or diagnosis of Gilibert's Syndrome or any other active hepatic or biliary disorder
* History or presence of significant and/or unstable medical conditions (e.g., history of congenital heart disease or cardiac arrhythmia, known suspected infection, hepatitis B or C or neoplasm) that, in the opinion of the investigator, would expose the subjects to undue risk of a significant adverse events (AE) or interfere with the assessment of safety or effectiveness during the trial
* History or evidence of alcohol or drug abuse within the past 12 months, or treatment for alcohol or drug abuse, or meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria for any significant substance abuse disorder within the past 12 months prior to the Screening Visit
* Subjects should be excluded if they have a positive drug screen for drugs of abuse and are considered medically significant by the investigator, would compromise subject safety, or interfere with the interpretation of study results. In addition:
* Subjects with detectable levels of cocaine, amphetamines, and phencyclidine in drug abuse screening need to be excluded.

Subjects who are positive for amphetamines on the urine drug screen may have their urine samples evaluated for further analysis at the investigator's discretion to rule out a false positive result

* Subjects with detectable levels of marijuana during substance abuse screening may not be excluded if they do not meet DSMV criteria for substance abuse or dependence in the subject's opinion as documented by the investigator, and a positive result does not signal a clinical condition that would impact the subject safety or interpretation of the study results
* Diagnosis of hematologic or solid malignancy within 5 years prior to screening. Subjects with a history of localized basal cell or squamous cell skin cancer may be included in the study if they are cancer-free prior to the screening visit for this study
* Subjects with a current diagnosis of schizophrenia, major depression requiring treatment with atypical antipsychotics, bipolar disorder or borderline personality disorder
* Body mass index (BMI) ≥ 35 kg/ m2
* Subjects with a history of gallstones or cholecystectomy
* Use of St. John's Wort, products containing St. John's Wort, Coltsfoot root, or extracts within 14 days prior to the baseline visit
* Use of narcotic drugs such as opioids (e.g., morphine, codeine, oxycodone, and hydrocodone) within 2 days prior to the baseline visit.

Allergy and Adverse Reactions:

\*. History of drug or other allergy that, in the opinion of the investigator, would make the subject unsuitable for participation in the study

Primary outcomes:
measure: Treatment Safety Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: From Day 1 of study treatment up to Week 52 of the treatment safety period
measure: Follow-up Safety Period: Number of Participants With TEAEs
timeFrame: From Week 52 to Week 54 of the follow-up safety period
measure: Treatment Safety Period: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: From Day 1 of study treatment up to Week 52 of the treatment safety period
measure: Follow-up Safety Period: Number of Participants With SAEs
timeFrame: From Week 52 to Week 54 of the follow-up safety period
measure: Treatment Safety Period: Number of Participants With AEs Leading to Study Drug Discontinuation
timeFrame: From Day 1 of study treatment up to Week 52 of the treatment safety period
measure: Follow-up Safety Period: Number of Participants With AEs Leading to Study Drug Discontinuation
timeFrame: From Week 52 to Week 54 of the follow-up safety period
measure: Treatment Safety Period: Number of Participants With Electrocardiogram (ECG) Abnormalities
timeFrame: From Day 1 of study treatment up to Week 52 of the treatment safety period
measure: Follow-up Safety Period: Number of Participants With ECG Abnormalities
timeFrame: From Week 52 to Week 54 of the follow-up safety period
measure: Treatment Safety Period: Number of Participants With Vital Signs Abnormalities
timeFrame: From Day 1 of study treatment up to Week 52 of the treatment safety period
measure: Follow-up Safety Period: Number of Participants With Vital Signs Abnormalities.
timeFrame: From Week 52 to Week 54 of the follow-up safety period
measure: Treatment Safety Period: Number of Participants With Hematology Test Abnormalities
timeFrame: From Day 1 of study treatment up to Week 52 of the treatment safety period
measure: Follow-up Safety Period: Number of Participants With Hematology Test Abnormalities
timeFrame: From Week 52 to Week 54 of the follow-up safety period
measure: Treatment Safety Period: Number of Participants With Chemistry Test Abnormalities
timeFrame: From Day 1 of study treatment up to Week 52 of the treatment safety period
measure: Follow-up Safety Period: Number of Participants With Chemistry Test Abnormalities
timeFrame: From Week 52 to Week 54 of the follow-up safety period
Secondary outcomes:
measure: Change From Observation Period in the Number of Migraine Days by Pain Intensity at Every 4 Week Interval and Overall Period
timeFrame: Baseline (observation period); Week 1 to 4, 5 to 8, 9 to 12, 13 to 16, 17 to 20, 21 to 24, 25 to 28, 29 to 32, 33 to 36, 37 to 40, 41 to 44, 45 to 48, 49 to 52 and Overall (Week 1 to 52)
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Second Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Xiamen
country: China
facility: The First Affiliated hospital of Xiamen University
state: Fujian
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Shijiazhuang
country: China
facility: Hebei General Hospital
state: Hebei
city: Wuhan
country: China
facility: Renmin Hospital Of Wuhan University
state: Hubei
city: Wuhan
country: China
facility: Wuhan Third Hospital
state: Hubei
city: Changsha
country: China
facility: Changsha Central Hospital
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: General Hospital of Northern Theater Command
state: Liaoning
city: Xi'an
country: China
facility: Shaanxi Provincial People' Hospital
state: Shaanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Medical University
state: Shaanxi
city: Xianyang
country: China
facility: Yan'an University Xianyang Hospital Co., Ltd
state: Shaanxi
city: Liaocheng
country: China
facility: LiaoCheng People's Hospital
state: Shandong
city: Shanghai
country: China
facility: Tongji Hospital of Tongji University
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Wulumuqi
country: China
facility: The Second Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Kunming
country: China
facility: The Second Affiliated hospital of Kunming Medical University
state: Yunnan
city: Beijing
country: China
facility: Peking University People's Hospital
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: