A Phase 3 Study to Assess the Efficacy and Safety of Midbrain Dopaminergic Neuronal Cell Therapy [Bemdaneprocel] for Patients with Parkinsons Disease [PD] (NCT06944522)

Study BRT-DA01-301 is a Phase 3, multicenter, randomized, sham surgery-controlled, double-blind study in approximately 102 participants with PD, of whom at least 30 are ?60 years of age at informed consent. Participants, care partners, investigators at the clinical sites (with the exception of pre-identified unblinded clinical site personnel), outcome assessors, care providers outside of the surgical team, and the sponsor (with the exception of pre-identified unblinded sponsor personnel) will be blinded to the study intervention.

Trial phase

Phase 3

Trial participation type

This trial is for clinical research of something other than a drug or device.

Principal investigator

Prof Dominic Thyagarajan

Key inclusion data

Inclusion: Diagnosis of clinically established PD; Age >45 <75; Receiving medical therapy for the treatment of PD symptoms; ?2.5 hours of daily OFF-time, as measured by the average of PD diaries collected over 3 consecutive days; Hoehn and Yahr stage of 2 to 3 in the off-medication state at screening; Score of ?30 on MDS-UPDRS Part III in the off-medication state. Exclusion: PD presenting with recurrent falls, defined as ?3 incidents of a fall over the 12 months prior to informed consent; Any current or relevant previous history of serious, severe, or unstable physical, neurological, or psychiatric illness.