A Phase 1/2 interventional study of Entacapone and Bevacizumab in Glioblastoma, sponsored by First Affiliated Hospital of Wenzhou Medical University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by First Affiliated Hospital of Wenzhou Medical University · Phase 1/2, Interventional, and Treatment
This investigator-initiated, multicenter clinical trial will evaluate the safety and preliminary effectiveness of adding entacapone to bevacizumab in adults with isocitrate dehydrogenase (IDH)-wildtype glioblastoma at first recurrence after standard first-line treatment. Participants must not have previously received bevacizumab. A multidisciplinary neuro-oncology team must determine that repeat tumor resection is not appropriate, or the patient must decline repeat surgery after being informed of its potential benefits and risks.
The study has two stages. In the first stage, 6 participants who can be evaluated for dose-limiting toxicity will receive open-label entacapone 400 mg by mouth three times daily plus bevacizumab. Enrollment will occur in two cohorts of 3, with safety review by an independent data and safety monitoring board. Up to 3 participants who cannot complete the 28-day toxicity evaluation for reasons unrelated to toxicity may be replaced.
If the combination has acceptable safety and the required approvals are obtained, 90 new participants will enter the second stage and be randomly assigned in a 1:1 ratio to entacapone or matching placebo. Both groups will receive bevacizumab. The primary endpoint of the randomized stage is progression-free survival assessed by blinded independent central review. The study plans to obtain data from 96 evaluable participants, with no more than 99 participants receiving study treatment.
Glioblastoma commonly recurs after surgery and standard chemoradiotherapy, and treatment options at recurrence remain limited. Preclinical research by the study team indicates that myoferlin (MYOF) facilitates the nuclear translocation of phosphorylated STAT3 and that entacapone can target MYOF and inhibit glioma growth in experimental models. This study evaluates a drug-repurposing strategy combining inhibition of the MYOF/p-STAT3 signaling pathway with bevacizumab-based antiangiogenic treatment.
Stage 1 is an open-label, single-target-dose safety lead-in. Participants will receive entacapone 400 mg orally three times daily together with bevacizumab 10 mg/kg intravenously every 2 weeks. Six participants evaluable for dose-limiting toxicity will be enrolled in two sequential cohorts of 3. If 0 or 1 participant in the first cohort experiences a dose-limiting toxicity during the initial 28-day evaluation period, enrollment of the second cohort may proceed after review by the independent data and safety monitoring board. If 2 or more participants experience dose-limiting toxicity at any time, enrollment and study treatment will be paused for safety review. Transition to Stage 2 requires no more than 1 dose-limiting toxicity among 6 evaluable participants, acceptable overall safety, written support from the data and safety monitoring board, ethics committee stage review, and institutional authorization. Up to 3 participants who are not evaluable for non-toxicity reasons may be replaced.
Stage 2 will enroll 90 new participants. Participants will be randomly assigned in a 1:1 ratio to entacapone 400 mg orally three times daily or matching placebo. Both groups will receive bevacizumab 10 mg/kg intravenously every 2 weeks. If treatment-related adverse reactions occur, entacapone or matching placebo may be reduced to 200 mg three times daily and may not subsequently be increased. Oral study treatment may continue for up to 13 cycles or 364 days, subject to protocol-defined discontinuation criteria.
Tumor imaging will be performed every 8 weeks. The primary efficacy endpoint is progression-free survival, defined as the time from randomization to disease progression according to Response Assessment in Neuro-Oncology 2.0 criteria, as determined by blinded independent central review, or death from any cause, whichever occurs first. Participants in the safety lead-in will not enter the randomized stage, and their data will not be included in the primary efficacy analysis of Stage 2.
2,132 studies on the registry are indexed under Glioblastoma; 464 are open to participants now.
This study's planned enrollment of 96 is above the median of 36 across 1,753 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →First Affiliated Hospital of Wenzhou Medical University is the lead sponsor of 83 studies on the registry; 57 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The same medical eligibility criteria apply to both study stages. For Stage 1, references to randomization correspond to the first study treatment date; for Stage 2, they correspond to the randomization date.
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in Stage 1 receive open-label entacapone 400 mg orally three times daily plus bevacizumab 10 mg/kg intravenously every 2 weeks. Six participants evaluable for dose-limiting toxicity are enrolled in two sequential cohorts of three. Up to three participants who cannot complete the 28-day dose-limiting toxicity evaluation for reasons unrelated to toxicity may be replaced.
Drug: Entacapone · Drug: Bevacizumab
Participants randomized to this arm in Stage 2 receive entacapone 400 mg orally three times daily plus bevacizumab 10 mg/kg intravenously every 2 weeks. If a treatment-related adverse reaction occurs, entacapone may be reduced to 200 mg three times daily without subsequent dose re-escalation. Oral study treatment may continue for up to 13 cycles (364 days), subject to protocol-defined discontinuation criteria.
Drug: Entacapone · Drug: Bevacizumab
Participants randomized to this arm in Stage 2 receive matching placebo orally three times daily plus bevacizumab 10 mg/kg intravenously every 2 weeks. If a treatment-related adverse reaction occurs, matching placebo may be reduced to the equivalent of 200 mg three times daily without subsequent dose re-escalation. Oral study treatment may continue for up to 13 cycles (364 days), subject to protocol-defined discontinuation criteria.
Drug: Bevacizumab · Drug: Placebo
Entacapone is administered orally at a starting dose of 400 mg three times daily in the open-label safety lead-in and the experimental arm of the randomized stage. If a treatment-related adverse reaction occurs, the dose may be reduced to 200 mg three times daily and may not subsequently be increased. Treatment may continue for up to 13 cycles (364 days), subject to protocol-defined discontinuation criteria.
Bevacizumab is administered intravenously at a dose of 10 mg/kg every 2 weeks as background treatment in all three study arms. Treatment is continued or discontinued according to disease status, safety, participant preference, and the protocol-defined treatment discontinuation criteria.
A matching placebo is administered orally three times daily in the control arm of Stage 2. If a treatment-related adverse reaction occurs, the blinded study treatment may be reduced using the same dose-reduction procedure corresponding to entacapone 200 mg three times daily, without subsequent dose re-escalation. Treatment may continue for up to 13 cycles (364 days), subject to protocol-defined discontinuation criteria.
Also known as: Matching Placebo for Entacapone
Number of Participants With Dose-Limiting Toxicities
The number of dose-limiting toxicity-evaluable participants who experience at least one protocol-defined dose-limiting toxicity during the initial 28-day safety evaluation period will be reported. Each participant will be counted once, regardless of the number of dose-limiting toxicities experienced. A lower number indicates better tolerability.
Time frame: From the first dose through Day 28
Progression-Free Survival Assessed by Blinded Independent Central Review
Progression-free survival is defined as the time from randomization to the first documented disease progression according to Response Assessment in Neuro-Oncology 2.0 criteria, as determined by blinded independent central review, or death from any cause, whichever occurs first. Participants without an event will be censored at the date of their last adequate blinded independent central review assessment.
Time frame: From randomization until disease progression or death from any cause, assessed up to 30 months
Overall Survival
Overall survival is defined as the time from randomization to death from any cause. Participants who are alive at the time of analysis will be censored at the date on which they were last known to be alive.
Time frame: From randomization until death from any cause, assessed up to 30 months
Progression-Free Survival Rate at 6 Months Assessed by Blinded Independent Central Review
The proportion of participants who are alive and free from disease progression at 6 months after randomization will be estimated using the Kaplan-Meier method. Disease progression will be determined by blinded independent central review according to Response Assessment in Neuro-Oncology 2.0 criteria.
Time frame: At 6 months after randomization
Objective Response Rate Assessed by Blinded Independent Central Review
Objective response rate is defined as the proportion of randomized participants whose best overall response is complete response or partial response, as determined by blinded independent central review according to Response Assessment in Neuro-Oncology 2.0 criteria.
Time frame: From randomization until disease progression or initiation of subsequent anticancer therapy, assessed up to 30 months
Duration of Response Assessed by Blinded Independent Central Review
Among participants who achieve a complete or partial response, duration of response is defined as the time from the first documented objective response to disease progression, as determined by blinded independent central review according to Response Assessment in Neuro-Oncology 2.0 criteria, or death from any cause, whichever occurs first.
Time frame: From the first documented objective response until disease progression or death, assessed up to 30 months
Investigator-Assessed Progression-Free Survival
Investigator-assessed progression-free survival is defined as the time from randomization to the first documented disease progression according to Response Assessment in Neuro-Oncology 2.0 criteria, as assessed by the site investigator, or death from any cause, whichever occurs first. Participants without an event will be censored at the date of their last adequate investigator-assessed disease evaluation.
Time frame: From randomization until disease progression or death from any cause, assessed up to 30 months
Change From Baseline in Karnofsky Performance Status
Karnofsky Performance Status is assessed on a scale from 0 to 100, with higher scores indicating better functional status. Change from baseline will be calculated as the post-baseline score minus the baseline score. A positive change indicates improvement and a negative change indicates deterioration.
Time frame: Baseline and every 8 weeks during disease follow-up, assessed up to 30 months
Change From Baseline in Neurologic Assessment in Neuro-Oncology Scale Score
The Neurologic Assessment in Neuro-Oncology scale evaluates nine neurologic domains and yields a total score ranging from 0 to 23. Higher scores indicate greater neurologic impairment. Change from baseline will be calculated as the post-baseline score minus the baseline score. A positive change indicates neurologic deterioration and a negative change indicates improvement.
Time frame: Baseline and every 8 weeks during disease follow-up, assessed up to 30 months
Change From Baseline in EORTC QLQ-C30 Scores
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 assesses global health status and quality of life, functioning, and cancer-related symptoms. Scores are linearly transformed to a scale from 0 to 100. Higher scores on the global health status and functioning scales indicate better status, whereas higher symptom scores indicate greater symptom burden. Changes from baseline will be summarized by treatment group and assessment time.
Time frame: Baseline, every 8 weeks, and at the end-of-treatment visit, assessed up to 30 months
Change From Baseline in Dexamethasone-Equivalent Daily Corticosteroid Dose
Systemic corticosteroid use will be converted to the dexamethasone-equivalent daily dose in milligrams per day. Change from baseline will be calculated as the post-baseline daily dose minus the baseline daily dose. A negative change indicates a reduction in corticosteroid requirement.
Time frame: Baseline, every 8 weeks, and at the end-of-treatment visit, assessed up to 30 months
Adherence to Oral Study Treatment
Adherence to entacapone or matching placebo will be calculated as the number of doses actually taken divided by the number of doses planned, multiplied by 100%. Adherence will be assessed using participant medication diaries, tablet counts, drug dispensing and return records, and participant interviews. Higher percentages indicate greater adherence.
Time frame: From the first dose through the end of oral study treatment, up to 364 days
Duration of Exposure to Oral Study Treatment
The duration of exposure to entacapone or matching placebo will be calculated from the date of the first dose to the date of the last dose. Treatment duration, dose level, dose reductions, treatment interruptions, and reasons for treatment discontinuation will be summarized by treatment group.
Time frame: From the first dose through the last dose of oral study treatment, up to 364 days
Number of Participants With Treatment-Emergent Adverse Events
The number and proportion of participants who experience one or more treatment-emergent adverse events will be reported. Adverse events will be summarized according to severity, seriousness, relationship to study treatment, and whether they result in dose reduction, treatment interruption, or permanent treatment discontinuation.
Time frame: From the first dose through 30 days after the last dose of any study treatment, assessed up to 36 months
Number of Participants With Serious Adverse Events
The number and proportion of participants who experience one or more serious adverse events will be reported. Serious adverse events will be summarized by event type, severity, relationship to study treatment, outcome, and action taken with the study treatment.
Time frame: From informed consent through 30 days after the last dose of any study treatment, assessed up to 36 months
Number of Participants With Adverse Events of Special Interest
The number and proportion of participants who experience one or more protocol-defined adverse events of special interest will be reported. Events will be summarized by category, severity, relationship to study treatment, clinical outcome, and any resulting dose modification, treatment interruption, or permanent discontinuation.
Time frame: From the first dose through 30 days after the last dose of any study treatment, assessed up to 36 months
Number of Participants With Clinically Significant Liver Test Abnormalities
The number and proportion of participants with protocol-defined clinically significant abnormalities in alanine aminotransferase, aspartate aminotransferase, total or direct bilirubin, or alkaline phosphatase will be reported. Changes from baseline, severity, clinical interpretation, relationship to study treatment, and any resulting treatment modification will be summarized.
Time frame: From the first dose through 30 days after the last dose of any study treatment, assessed up to 36 months
Plan to share: No — Individual participant data will not be made publicly available. Aggregate study results will be reported. Any secondary use of multicenter data beyond the scope of the approved protocol would require additional ethics review and, where applicable, additional informed consent.
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Studies of the drug tested here: Entacapone
First Affiliated Hospital of Wenzhou Medical University