An open-label, multi-center, extension study to evaluate the long-term safety, tolerability and preliminary efficacy of Evenamide as add-on treatment in patients with treatment-resistant schizophrenia (TRS) not responding adequately to their current antipsychotic medication.

Phase 1

• Conditions: Schizophrenia not responding adequately to current antipsychotic treatment; MedDRA version: 20.0Level: LLTClassification code 10072913Term: Treatment-resistant schizophreniaSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2020-000439-32-IT
• Lead Sponsor: EWRON PHARMACEUTICALS SPA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-21
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Patients must meet the following inclusion criteria to be eligible for enrollment into the study:
1. Patient completed 6 weeks of treatment in Study 014.
2. Patient has provided written informed consent for this extension study.
3. If female, patient is not of childbearing potential, pregnant or breastfeeding. For inclusion, female patients must be post-menopausal (age 50 or older with confirmed amenorrhea for >12 months), surgically sterilized, or protected with adequate contraception (barrier method or hormonal contraceptive).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 143
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7

Exclusion Criteria

The presence of any of the following will exclude a patient from study enrollment:
1. Patient violated any requirement of the protocol in Study 014 that would put him/her at risk for continuing treatment with evenamide in Study 015.
2. In the Investigator’s opinion, the patient had a significant worsening of risk for suicidality during Study 014.
3. Patient is experiencing any moderate/severe neurological side effects, other than pre-existing EPS related to antipsychotic treatment prior to enrolling in Study 014.
4. Patient has shown significant worsening of his/her symptoms of schizophrenia between baseline and the final assessment during the 6-week treatment period in Study 014, such that continuing treatment in Study 015 is considered undesirable.
5. Patient demonstrated substantial non-compliance with dosing of the study medication in Study 014.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified