Phase II / III, open-label, extension study designed to determine the long-term safety, tolerability and efficacy of evenamide (NW-3509) in patients with psychiatric disorders who participated in previous trials with evenamide.

Phase 1

• Conditions: Patients with psychiatric disorders who participated in a previous trial with evenamide.; MedDRA version: 20.0Level: SOCClassification code 10037175Term: Psychiatric disordersSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 20.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 21.1Level: PTClassification code 10057667Term: Bipolar disorderSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2021-002093-34-IT
• Lead Sponsor: EWRON PHARMACEUTICALS SPA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-31
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

- Patient completed the specified treatment period in their prior evenamide study
-Patient has provided informed consent for this extension study
- If female, the patient must have a negative pregnancy test at baseline and must not be lactating (If of childbearing potential, the patient agrees to continue using a highly effective method of contraception, (i.e., a method that can achieve a failure rate of less than 1% per year when used consistently and correctly) during the trial until the final follow-up visit. A woman is considered to be of non-childbearing potential if she meets one of the following criteria: is post-menopausal has no uterus, ovaries or fallopian tubes. Women who are taking hormone replacement therapy (HRT) must use contraception (as described above) during the trial. Sexual abstinence is not an acceptable method of contraception.
-Male patients who are not sterilized must agree to not have sex without using a condom, if their partner is a woman of childbearing potential, during the trial (from the first dose until the final follow-up visit). Male patients must also agree not to attempt to father a child and must not donate sperm from the first dose until the final follow-up visit.
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 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

1.Patient demonstrated substantial non-compliance with any requirement of the protocol in the prior study, as judged by the Investigator, that would put him/her at risk for continuing treatment in Study 020;
2.In the Investigator’s opinion, the patient had a significant worsening of risk for suicidality during the prior study;
3.Patient is experiencing any moderate/severe neurological adverse events;
4.Patient has shown significant worsening of symptoms of his/her psychiatric disorder between baseline and the final assessment during the treatment period in the prior study;
5.Patient demonstrated substantial non-compliance with dosing of the study medication or the concomitant psychotropic medication in the prior study, as judged by the Investigator.

Study & Design

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