Evenamide in patients with treatment-resistant schizophrenia not responding to antipsychotics
Research type
Research Study
Full title
A Phase III, 52-week, prospective, randomized, double-blind, placebo-controlled, parallel-group, multi-center study, with a primary efficacy endpoint at 12 weeks, to determine the efficacy, safety, and tolerability of fixed doses of 15 mg bid and 30 mg bid of evenamide as add-on in patients with documented treatment-resistant schizophrenia, which is not adequately controlled by a stable therapeutic dose of the patient’s current antipsychotic medication(s)
IRAS ID
1011808
Contact name
Ravi Anand
Contact email
Sponsor organisation
Newron Pharmaceuticals S.p.A.
Eudract number
2024-519836-18
Research summary
The purpose of this study is to learn how well the medicine called “evenamide” works at doses of 15 or 30 mg taken twice a day, whether it is safe, and how the body responds to it in patients with schizophrenia who are not benefitting from the current available medications, a condition called “treatment-resistant schizophrenia”.
In this study, evenamide will be tested as an add-on therapy, which means that it will be given in addition to the patients’ current antipsychotic medications. Evenamide will be compared to a placebo (a pill that looks the same but contains no active ingredients) to find out whether it can provide additional benefits when added to the usual treatment for schizophrenia in patients who are not responding to their current antipsychotic medications.
About 600 subjects will participate in this clinical study worldwide. Eligible subjects in this study are adults aged 18 years or older, diagnosed with schizophrenia whose symptoms are not improving despite taking antipsychotic medications. Subjects can participate if they have someone (“caregiver”) to assist them in complying with the study requirements. Subjects cannot participate in the study if they have a psychiatric diagnosis other than treatment-resistant schizophrenia, or if they suffer from a medical condition that may pose a risk.
After a 6-week screening, eligible participants will be assigned by chance to receive either evenamide at doses of 15 mg or 30 mg twice daily, or a placebo, in addition to their current antipsychotics. Neither the participant, the study doctor, nor the Sponsor will know which treatment is assigned to the participant. The treatment period lasts 52 weeks, with a primary endpoint at 12 weeks to evaluate evenamide effectiveness, safety, and body response in patients with treatment-resistant schizophrenia. Efficacy and safety will also be assessed at Weeks 26 and 52. A safety follow-up will occur after the final dose, or if participants discontinue early.REC name
South Central - Berkshire Research Ethics Committee
REC reference
25/SC/0128
Date of REC Opinion
14 May 2025
REC opinion
Further Information Favourable Opinion