BP1.3656 / Bioprojet - LARVOL DELTA

Proof of Concept Study Evaluating BP1.3656 in Patients With Fatigue Following Ischemic Stroke (clinicaltrials.gov) - P2 | N=5 | Terminated | Sponsor: Bioprojet | N=54 ➔ 5 | Trial completion date: Jun 2024 ➔ Feb 2024 | Recruiting ➔ Terminated | Trial primary completion date: Jun 2024 ➔ Feb 2024; Lack of recruitment

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Cardiovascular • Fatigue • Ischemic stroke

Proof of Concept Study Evaluating BP1.3656 in Patients With Fatigue Following Ischemic Stroke (clinicaltrials.gov) - P2 | N=54 | Recruiting | Sponsor: Bioprojet | Trial completion date: Jun 2023 ➔ Jun 2024 | Trial primary completion date: Jun 2023 ➔ Jun 2024

Trial completion date • Trial primary completion date • Cardiovascular • Fatigue • Ischemic stroke

Role of BP1.3656 on Alcohol Responses (clinicaltrials.gov) - P2 | N=37 | Completed | Sponsor: Centre for Addiction and Mental Health | Recruiting ➔ Completed

Trial completion • Addiction (Opioid and Alcohol) • CORIN

Proof of Concept Study Evaluating BP1.3656 in Patients With Fatigue Following Ischemic Stroke (clinicaltrials.gov) - P2 | N=54 | Recruiting | Sponsor: Bioprojet | Not yet recruiting ➔ Recruiting | Trial completion date: Mar 2023 ➔ Jun 2023 | Initiation date: Mar 2022 ➔ Sep 2022 | Trial primary completion date: Mar 2023 ➔ Jun 2023

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Cardiovascular • Fatigue • Ischemic stroke

Proof of Concept Study Evaluating BP1.3656 in Patients With Fatigue Following Ischemic Stroke (clinicaltrials.gov) - P2 | N=54 | Not yet recruiting | Sponsor: Bioprojet

New P2 trial • Cardiovascular • Fatigue • Ischemic stroke

Randomized Clinical Trial Evaluating BP1.3656 Versus Placebo For Alcohol Use Disorder Treatment (clinicaltrials.gov) - P2; N=210; Completed; Sponsor: Bioprojet; Recruiting ➔ Completed; N=129 ➔ 210; Trial completion date: Mar 2020 ➔ Nov 2021; Trial primary completion date: Mar 2020 ➔ Nov 2021

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Addiction (Opioid and Alcohol)

Role of BP1.3656 on Alcohol Responses (clinicaltrials.gov) - P2; N=40; Recruiting; Sponsor: Centre for Addiction and Mental Health; Not yet recruiting ➔ Recruiting; Trial completion date: Aug 2021 ➔ Aug 2022; Trial primary completion date: Aug 2021 ➔ Aug 2022

Enrollment open • Trial completion date • Trial primary completion date • Addiction (Opioid and Alcohol)

Role of BP1.3656 on Alcohol Responses (clinicaltrials.gov) - P2; N=40; Not yet recruiting; Sponsor: Centre for Addiction and Mental Health

New P2 trial

A Multisite Randomized Clinical Trial Evaluating BP1.3656 Versus Placebo For Alcohol Use Disorder Treatment (clinicaltrialsregister.eu) - P2; N=129; Ongoing; Sponsor: BIOPROJET PHARMA

New P2 trial • Addiction (Opioid and Alcohol) • Biosimilar • CNS Disorders

Randomized Clinical Trial Evaluating BP1.3656 Versus Placebo For Alcohol Use Disorder Treatment (clinicaltrials.gov) - P2; N=129; Recruiting; Sponsor: Bioprojet; Trial completion date: Jun 2019 ➔ Mar 2020; Trial primary completion date: Jun 2019 ➔ Mar 2020

Clinical • Trial completion date • Trial primary completion date