Clinical trials

The primary purpose of this study is to assess potential drug-drug interactions of E2086 when coadministered orally with Itraconazole, Carbamazepine, Midazolam, Dextromethorphan, Bupropion, or Combined Oral Contraceptives in Healthy Participants

The primary purpose of this study is to evaluate the efficacy of LEQEMBI in participants with early Alzheimer's disease (AD) indicated per Canada Product Monograph (APOE4 non-carriers and heterozygotes; indicated population) compared with placebo (PBO)-treated participants from BAN2401-G000-301 (Study 301) Core study on change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months of treatment.

The primary purpose of this study is to evaluate the safety of lecanemab-irmb in the real-world clinical setting as reported by events of amyloid-related imaging abnormalities (ARIA)-edema (ARIA-E), ARIA-hemosiderin deposition (ARIA-H), symptomatic ARIA-E, symptomatic ARIA-H, and intracerebral hemorrhage (ICH) greater-than 1 cm in participants treated with lecanemab-irmb. The secondary purpose of this study is to: Evaluate the safety of lecanemab-irmb in the real-world clinical setting as reported by events of seizures, anaphylaxis, central nervous system (CNS) ischemic event, and death. Assess the safety of lecanemab-irmb when stratified by baseline characteristics including apolipoprotein E (APOE) genotype, baseline magnetic resonance imaging (MRI) findings consistent with a high risk for cerebral amyloid angiopathy (CAA), prior Alzheimer's Disease (AD) treatments, and antithrombotic therapy. Assess the risk of safety outcomes (ARIA-E, ARIA-H, ICH greater than 1 cm, seizures, anaphylaxis, CNS ischemic event, and death) associated with APOE genotype, baseline MRI findings consistent with high risk for CAA, prior AD treatment, and antithrombotic therapy within participants exposed to lecanemab-irmb in ALZ-NET. Assess the risk of safety outcomes (ARIA-E, ARIA-H, ICH greater than 1 cm, seizures, anaphylaxis, CNS ischemic event, and death) between participants exposed to lecanemab-irmb in ALZ-NET and subjects exposed to lecanemab irmb in Study 301. Assess the risk of safety outcomes (ARIA-E, ARIA-H, ICH greater than 1 cm, seizures, anaphylaxis, CNS ischemic event,and death) between participants exposed to lecanemabirmb in ALZ-NET and subjects exposed to placebo (PBO) in Study 301. Assess the risk of safety outcomes (ARIA-E, ARIA-H, ICH greater than 1 cm, seizures, anaphylaxis, CNS ischemic event, and death) between participants exposed to lecanemab-irmb in ALZ-NET and participants not exposed to anti-amyloid therapies in ALZ-NET. Assess whether the risk of safety outcomes associated with APOE genotype, baseline MRI findings consistent with high risk for CAA, prior Alzheimer's Disease treatments, and antithrombotic therapy differs between participants exposed to lecanemab-irmb in ALZ-NET versus those not exposed to anti-amyloid therapies in ALZ-NET.

The primary purpose of this study is to evaluate proof of mechanism (POM) and long-term safety and tolerability of E2511 in participants with Early AD. The study consists of 2 parts. In Part A, participants will be randomly assigned to receive either E2511 or donepezil. In Part B, participants will receive E2511 only. Once Part A and Part B participants complete the Core Trial (which includes Pretreatment and Treatment phases) they will have the option to enter the Extension Phase where they will receive E2511 for 18 months.

This is an extended access study for participants who have completed Rufinamide Study E2080-G000-303 to continue to have access to rufinamide until it becomes commercially available in Poland or until no participants remain in the EAP.

The primary objectives of the study are: (1) in the dose-escalation part: to evaluate safety and tolerability and to determine the recommended Phase 2 dose (RP2D) of farletuzumab ecteribulin (MORAb-202) in participants with selected tumor types (ovarian cancer \[OC\], endometrial cancer \[EC\], non-small cell lung carcinoma \[NSCLC\], triple-negative breast cancer \[TNBC\]), and (2) in dose-confirmation part: to evaluate preliminary efficacy measured by objective response rate (ORR) of farletuzumab ecteribulin (MORAb-202) in participants with OC and EC at selected doses and to further evaluate the safety and tolerability of farletuzumab ecteribulin (MORAb-202) and (3) dose-optimization part. (divided in two parts: Part A \[OC and EC participants\] and Part B \[OC only\]): Part A: to evaluate other farletuzumab ecteribulin (MORAb-202) treatment regimens for safety, tolerability and preliminary efficacy in participants with OC and EC; to evaluate the addition of short course of oral corticosteroids following every dose of farletuzumab ecteribulin (MORAb-202) administered every 21 days; and to select treatment regimens with farletuzumab ecteribulin (MORAb-202) for further evaluation in Part B. Part B: to evaluate the safety and tolerability of different doses of farletuzumab ecteribulin (MORAb-202) as monotherapy and in combination with lenvatinib and to determine the recommended dose (RD) of farletuzumab ecteribulin (MORAb-202) as monotherapy and in combination with lenvatinib.

The primary purpose of this study is to evaluate the optimal doses of E2086 compared to placebo in participants with narcolepsy for reduction of excessive daytime sleepiness (EDS) as assessed by Mean Sleep Latency (MSL) (measured from the first 4 maintenance of wakefulness tests \[MWTs\]).

The primary purpose of this study is to provide continued access of lorcaserin to participants with Dravet syndrome and other refractory epilepsies.