Kiryu

Researchers are evaluating the safety and effectiveness of ONO-2020 in adults aged 55 to 90 years with agitation linked to Alzheimers Disease dementia. This phase 2a, randomized, placebo-controlled study is conducted across multiple centers in Japan and aims to better understand how ONO-2020 affects agitation symptoms in this population. Participants will be randomly assigned to receive either two ONO-2020 tablets or two placebo tablets once daily. The treatment period lasts up to 12 weeks, during which patients are hospitalized from 21 days before treatment starts through the treatment phase. The study is designed as a double-blind, parallel-group trial to compare ONO-2020 against placebo. Throughout the study, researchers will monitor changes in agitation using the Cohen-Mansfield Agitation Inventory CMAI and assess safety through vital signs, ECG measurements, laboratory tests, and the Columbia-Suicide Severity Rating Scale. Additional assessments include cognitive function tests and daily living activity scores. The study will continue safety monitoring up to 16 weeks, with the primary evaluation of agitation changes by week 12.

This research aims to evaluate the efficacy and safety of rimegepant compared to a placebo as a preventive treatment for migraine in children and adolescents aged 6 to under 18 years with episodic migraine. It focuses on reducing the frequency of migraine days over a 12-week period, particularly in young patients who experience mild to moderate disruption in daily activities due to migraine. The study is designed as a Phase 3 randomized, double-blind trial to assess this preventive approach. Participants will be randomly assigned to receive either rimegepant at doses of 75mg or 50mg two 25mg orally disintegrating tablets or a matching placebo with the same dosing options. The treatment phase lasts 12 weeks in a double-blind manner, followed by a safety and tolerability evaluation over a total of 72 weeks. The study includes sequential treatment with careful monitoring of migraine frequency and medication use during this period. Throughout the trial, participants will be monitored for migraine days per month, reduction in migraine frequency, and quality of life as measured by the Pediatric Quality of Life Inventory PedsQL. Researchers will also assess the use of acute migraine medications, hepatic-related adverse events, and overall safety. The primary outcome focuses on the change in migraine days during the 12-week treatment phase. Participants adherence and safety will be tracked throughout the treatment and follow-up periods, lasting up to nearly 10 years until study completion.

Researchers are evaluating the safety and effectiveness of BHV-3000 rimegepant compared to a placebo for treating moderate to severe migraine attacks in children and adolescents aged 6 to under 18 years. This Phase 3 clinical trial focuses on acute migraine treatment in a pediatric population, aiming to measure pain freedom two hours after dosing and other migraine-related symptoms to understand how well the treatment works in this age group. Participants receive either BHV-3000 rimegepant 75 mg or 50 mg orally disintegrating tablet ODT, or a matching placebo tablet. The study uses a randomized, double-blind design where participants are assigned to one of these groups. The trial monitors the effects of the medication shortly after administration and compares outcomes between the active drug and placebo groups. During the study, participants will be assessed for pain relief, freedom from the most bothersome migraine symptoms, and need for rescue medication within 24 to 48 hours after treatment. Researchers will also evaluate sustained pain freedom and the ability to function normally following the migraine attack. Various outcome measures include pain and symptom assessments at 2 hours post-dose, along with tracking medication use and migraine impact. The trial lasts until the primary completion date in January 2029, with ongoing safety and efficacy monitoring throughout.