Safety and Efficacy of Brilaroxazine (RP5063) in Schizophrenia

Conditions

• Schizophrenia

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Accepted

Interventions

• Brilaroxazine — DRUG
  RP5063, a new chemical entity (NCE), is a novel multimodal neuromodulator intended for treating schizophrenia and comorbid conditions. This drug is an investigational drug and has not been approved for treatment or marketing. RP5063 belongs to a class of third generation antipsychotics called Dopamine-Serotonin System Stabilizers. The chemical name of the RP5063 active pharmaceutical ingredient (API) is 6-(4-(4-(2,3-dichlorophenyl)-piperazin-1-yl)-butoxy)-2H-benzo\[b\]\[1,4\]oxazin-3(4H)-one hydrochloride.
• Placebo — OTHER
  RP5063 matching Placebo

Study Details

This study is to evaluate the effect and safety of Brilaroxazine in patients with acute schizophrenia compared to the placebo short and long-term. Brilaroxazine will be given at fixed doses of 15 mg or 50 mg once daily over 4 weeks, then in the long-term flexible doses 15-50mg daily over a period of 52 weeks.

Key Dates

Start date

Jan 24, 2022

Status verified

Dec 2024

Primary completion

Feb 28, 2025

Completion

Feb 28, 2025

Study Design

Enrollment

690 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: RP5063 15 mg once daily
  administered OD for 28 days then flexibly 15-50mg over a period of 52 weeks.
• Active Comparator: RP5063 (brilaroxazine) 50 mg once daily
  administered OD for 28 days, then flexibly 15-50mg over a period of 52 weeks
• Placebo Comparator: Placebo
  administered OD for 28 days.

Primary Outcome Measure

Double Blind Safety and Efficacy of Brilaroxazine (RP5063) [ Time Frame: 28 days ]

Central Contacts

• Medical Director
  +1 4085018881
  [email protected]

Locations (18)

Find similar trials in Phoenix, AZ

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