A long term clinical study to determine safety, tolerability and efficacy of drug called Evenamide which is taken orally, by patients with treatment resistant schizophrenia having inadequate benefit from their current antipsychotic medication.

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.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/09/027959

Enrollment

Registered

2020-09-22

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F208- Other schizophrenia

Interventions

Intervention1: NW3509: Fixed oral doses of 30 mg BID orally for 46 weeks therapy of NW-3509 (Evenamide) Control Intervention1: NW-3509: Fixed oral doses of 7.5, 15 mg BID orally for 46 weeks therapy o

Eligibility

Inclusion criteria

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).

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
To evaluate the long-term safety and tolerability of evenamide given orally in patients with treatment-resistant schizophrenia (TRS) not responding adequately to their current antipsychotic medication.Timepoint: 46 weeks	—

Secondary

Measure	Time frame
To evaluate preliminary long-term efficacy of evenamide, based on symptoms of schizophrenia, as assessed by the Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression - Change from baseline (CGI-C) and Severity of illness (CGI-S); • To determine the long-term effect of evenamide on daily functioning, based on changes on the Strauss-Carpenter Level of Functioning (LOF) scale.Timepoint: 46 Weeks	—

Measure

Time frame

To evaluate preliminary long-term efficacy of evenamide, based on symptoms of schizophrenia, as assessed by the Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression - Change from baseline (CGI-C) and Severity of illness (CGI-S); • To determine the long-term effect of evenamide on daily functioning, based on changes on the Strauss-Carpenter Level of Functioning (LOF) scale.Timepoint: 46 Weeks

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Countries

India, Italy, Malaysia, Sri Lanka

Contacts

Public ContactShiv Issar

CliniRx Research Pvt Ltd

shiv.issar@clinirx.com9868167119

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026