alogabat (RG7816) / Roche - LARVOL DELTA

A 12-Week Placebo-Controlled Study to Investigate the Efficacy, Safety, and Tolerability of RO7017773 in Participants Aged 15-45 Years With Autism Spectrum Disorder (ASD) (clinicaltrials.gov) - P2 | N=103 | Completed | Sponsor: Hoffmann-La Roche | Active, not recruiting ➔ Completed

Trial completion • Autism Spectrum Disorder • Genetic Disorders

Study to Investigate the Pharmacokinetics and Safety and to Provide Proof of Mechanism of Alogabat in Children and Adolescents Aged 5-17 Years With Angelman Syndrome (AS) With Deletion Genotype. (clinicaltrials.gov) - P2 | N=56 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Mar 2025 ➔ Sep 2025 | Trial primary completion date: Mar 2025 ➔ Sep 2025

Trial completion date • Trial primary completion date • UBE3A

A 12-Week Placebo-Controlled Study to Investigate the Efficacy, Safety, and Tolerability of RO7017773 in Participants Aged 15-45 Years With Autism Spectrum Disorder (ASD) (clinicaltrials.gov) - P2 | N=103 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Recruiting ➔ Active, not recruiting

Enrollment closed • Autism Spectrum Disorder • Genetic Disorders

A 12-Week Placebo-Controlled Study to Investigate the Efficacy, Safety, and Tolerability of RO7017773 in Participants Aged 15-45 Years With Autism Spectrum Disorder (ASD) (clinicaltrials.gov) - P2 | N=105 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Dec 2023 ➔ May 2024 | Trial primary completion date: Dec 2023 ➔ May 2024

Trial completion date • Trial primary completion date • Autism Spectrum Disorder • Genetic Disorders

Study to Investigate the Pharmacokinetics and Safety and to Provide Proof of Mechanism of Alogabat in Children and Adolescents Aged 5-17 Years With Angelman Syndrome (AS) With Deletion Genotype. (clinicaltrials.gov) - P2 | N=56 | Recruiting | Sponsor: Hoffmann-La Roche | Phase classification: P2a ➔ P2

Phase classification • UBE3A

Study to Investigate the Pharmacokinetics and Safety and to Provide Proof of Mechanism of Alogabat in Children and Adolescents Aged 5-17 Years With Angelman Syndrome (AS) With Deletion Genotype (clinicaltrials.gov) - P2a | N=56 | Recruiting | Sponsor: Hoffmann-La Roche | Initiation date: Mar 2025 ➔ Jul 2023

Trial initiation date • UBE3A

Study to Investigate the Pharmacokinetics and Safety and to Provide Proof of Mechanism of Alogabat in Children and Adolescents Aged 5-17 Years With Angelman Syndrome (AS) With Deletion Genotype (clinicaltrials.gov) - P2a | N=56 | Recruiting | Sponsor: Hoffmann-La Roche | Not yet recruiting ➔ Recruiting | Initiation date: Jun 2023 ➔ Mar 2025

Enrollment open • Trial initiation date • UBE3A

Study to Investigate the Pharmacokinetics and Safety and to Provide Proof of Mechanism of Alogabat in Children and Adolescents Aged 5-17 Years With Angelman Syndrome (AS) With Deletion Genotype (clinicaltrials.gov) - P2a | N=56 | Not yet recruiting | Sponsor: Hoffmann-La Roche | Initiation date: Jan 2023 ➔ Jun 2023

Trial initiation date • UBE3A

Study to Investigate the Pharmacokinetics and Safety and to Provide Proof of Mechanism of Alogabat in Children and Adolescents Aged 5-17 Years With Angelman Syndrome (AS) With Deletion Genotype (clinicaltrials.gov) - P2a | N=56 | Not yet recruiting | Sponsor: Hoffmann-La Roche

New P2a trial • UBE3A

A Study to Investigate the Efficacy, Safety and Tolerability of RO7017773 in Participants Aged 15 to 45 Years with Autism Spectrum Disorder (ASD) STUDIO DI FASE II RANDOMIZZATO, IN DOPPIO CIECO, CONTROLLATO CON PLACEBO, PER VALUTARE L’EFFICACIA E LA SICUREZZA RO7017773 IN PARTECIPANTI DI ETÀ COMPRESA TRA 15 E 45 ANNI AFFETTI DA DISTURBO DELLO SPETTRO AUTISTICO (ASD) (clinicaltrialsregister.eu) - P2; N=105; Ongoing; Sponsor: F. HOFFMANN - LA ROCHE LTD.

Clinical • New P2 trial • Autism Spectrum Disorder • Genetic Disorders • Psychiatry

A 12-Week Placebo-Controlled Study to Investigate the Efficacy, Safety, and Tolerability of RO7017773 in Participants Aged 15-45 Years With Autism Spectrum Disorder (ASD) (clinicaltrials.gov) - P2; N=105; Recruiting; Sponsor: Hoffmann-La Roche; N=210 ➔ 105

Clinical • Enrollment change • Autism Spectrum Disorder • Genetic Disorders

A 12-Week Placebo-Controlled Study to Investigate the Efficacy, Safety, and Tolerability of RO7017773 in Participants Aged 15-45 Years With Autism Spectrum Disorder (ASD) (clinicaltrials.gov) - P2; N=210; Recruiting; Sponsor: Hoffmann-La Roche; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Autism Spectrum Disorder • Genetic Disorders

A 12-Week Placebo-Controlled Study to Investigate the Efficacy, Safety, and Tolerability of RO7017773 in Participants Aged 15-45 Years With Autism Spectrum Disorder (ASD) (clinicaltrials.gov) - P2; N=210; Not yet recruiting; Sponsor: Hoffmann-La Roche; Initiation date: Nov 2020 ➔ Mar 2021

Clinical • Trial initiation date • Autism Spectrum Disorder • Genetic Disorders

A 12-Week Placebo-Controlled Study to Investigate the Efficacy, Safety, and Tolerability of RO7017773 in Participants Aged 15-45 Years With Autism Spectrum Disorder (ASD) (clinicaltrials.gov) - P2; N=210; Not yet recruiting; Sponsor: Hoffmann-La Roche; Trial completion date: Dec 2023 ➔ Sep 2023; Initiation date: Jun 2020 ➔ Oct 2020; Trial primary completion date: Dec 2023 ➔ Sep 2023

Clinical • Trial completion date • Trial initiation date • Trial primary completion date • Autism Spectrum Disorder • Genetic Disorders

A 12-Week Placebo-Controlled Study to Investigate the Efficacy, Safety, and Tolerability of RO7017773 in Participants Aged 15-45 Years With Autism Spectrum Disorder (ASD) (clinicaltrials.gov) - P2; N=210; Not yet recruiting; Sponsor: Hoffmann-La Roche

Clinical • New P2 trial

A 2 Part Study to Assess the Relative Bioavailability of Tablet Formulation Compared to Capsule Formulation and the Effect of Food and Taste Assessment on the Tablet Formulation in Healthy Participants (clinicaltrials.gov) - P2; N=24; Completed; Sponsor: Hoffmann-La Roche; Active, not recruiting ➔ Completed

Clinical • Trial completion

A 2 Part Study to Assess the Relative Bioavailability of Tablet Formulation Compared to Capsule Formulation and the Effect of Food and Taste Assessment on the Tablet Formulation in Healthy Participants (clinicaltrials.gov) - P2; N=24; Active, not recruiting; Sponsor: Hoffmann-La Roche; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

A 2 Part Study to Assess the Relative Bioavailability of Tablet Formulation Compared to Capsule Formulation and the Effect of Food and Taste Assessment on the Tablet Formulation in Healthy Participants (clinicaltrials.gov) - P2; N=24; Recruiting; Sponsor: Hoffmann-La Roche; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

A 2 Part Study to Assess the Relative Bioavailability of Tablet Formulation Compared to Capsule Formulation and the Effect of Food and Taste Assessment on the Tablet Formulation in Healthy Participants (clinicaltrials.gov) - P2; N=24; Not yet recruiting; Sponsor: Hoffmann-La Roche

Clinical • New P2 trial

A Study to Investigate the Effect of CYP3A Inhibition on the Pharmacokinetics of RO7017773 in Healthy Participants (clinicaltrials.gov) - P1; N=4; Completed; Sponsor: Hoffmann-La Roche; Recruiting ➔ Completed; N=18 ➔ 4

Clinical • Enrollment change • Trial completion