A long-term clinical study using Evenamide (orally taken new drug without masking its strength) to determine its safety, tolerability and efficacy in patients with treatment resistant schizophrenia, not befitting adequately 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

SLCTR

Registry ID

SLCTR/2020/024

Enrollment

Unknown

Registered

2020-11-16

Start date

2021-03-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Schizophrenia

Interventions

•Study setting: Colombo North Teaching Hospital This is a 46-week, open-label, multi-center, extension to study NW-3509/014/II/2019 designed to evaluate the long-term safety, tolerability and prelimi

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient completed 6 weeks of treatment in Study NW-3509/014/II/2019 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: 1) Protocol violation during 014 study. 2) Worsening of suicidal risk during 014 study 3) Moderate/severe neurological side effects during 014 study 4) Worsening of schizophrenia symptoms during study 014 5) Non compliance with dosing of study medication during 014

Design outcomes

Primary

Measure	Time frame
Safety Evaluation: Safety will be assessed by the following: •Adverse events (AEs) •Vital signs systolic/diastolic blood pressure, pulse, body temperature, respiratory rate, body weight, BMI, waist circumference) •Laboratory evaluations -Haematology: Hematocrit, hemoglobin, RBC count, WBC count, differential WBC count, platelets -Blood Chemistry Sodium, Potassium, Chloride, Bicarbonate, Calcium, Glucose, BUN, Creatinine, total bilirubin, Albumin triglycerides, AST, ALT, alkaline phosphatase, GGT, LDH, total cholesterol, HDL, LDL, VLDL, CPK, total protein -Urinalysis pH, specific gravity, Protein, glucose, ketones, RBC, WBC, casts, Nitrites, bilirubin, hemoglobin -Serum prolactin •ECG •Special Diagnostic Tests (evaluated at Screening and/or Baseline) Thyroid function: TSH, free triiodothyronine (T3), and free thyroxine (T4) (Screening) - Virology: Hepatitis B and C; HIV (Screening) - Urine drug screen (Screening, Baseline and final visit) - Alcohol breath test (Baseline) - Serum prolactin (Baseline and final visit) - Serum/urine pregnancy test (Screening, Baseline and final visit) •Physical Examination General appearance, skin, neck (including thyroid), eyes and ears, nose, mouth, throat, lungs, heart, abdomen, back, lymph nodes, extremities •Neurological Examination: Evaluation of the mental status, cranial nerves, muscle strength and tone, reflexes, the sensory system, coordination and gait •A standard eye examination Visual acuity (Snellen chart), visual field, eye muscles, pupillary response, fundus, tonometry, eyelids, cornea, conjunctiva, sclera and iris will be performed. The examination should be performed by a physician at the site who has the appropriate experience and training. If a clinically significant abnormality is noted that requires expert follow-up, an Ophthalmologist or Optometrist should be consulted. •Seizure checklist •Extrapyramidal Symptom Rating Scale - Abbreviated version (ESRS-A) •Calgary Depression Scale for Schizo	—

Measure

Time frame

Safety Evaluation: Safety will be assessed by the following: •Adverse events (AEs) •Vital signs systolic/diastolic blood pressure, pulse, body temperature, respiratory rate, body weight, BMI, waist circumference) •Laboratory evaluations -Haematology: Hematocrit, hemoglobin, RBC count, WBC count, differential WBC count, platelets -Blood Chemistry Sodium, Potassium, Chloride, Bicarbonate, Calcium, Glucose, BUN, Creatinine, total bilirubin, Albumin triglycerides, AST, ALT, alkaline phosphatase, GGT, LDH, total cholesterol, HDL, LDL, VLDL, CPK, total protein -Urinalysis pH, specific gravity, Protein, glucose, ketones, RBC, WBC, casts, Nitrites, bilirubin, hemoglobin -Serum prolactin •ECG •Special Diagnostic Tests (evaluated at Screening and/or Baseline) Thyroid function: TSH, free triiodothyronine (T3), and free thyroxine (T4) (Screening) - Virology: Hepatitis B and C; HIV (Screening) - Urine drug screen (Screening, Baseline and final visit) - Alcohol breath test (Baseline) - Serum prolactin (Baseline and final visit) - Serum/urine pregnancy test (Screening, Baseline and final visit) •Physical Examination General appearance, skin, neck (including thyroid), eyes and ears, nose, mouth, throat, lungs, heart, abdomen, back, lymph nodes, extremities •Neurological Examination: Evaluation of the mental status, cranial nerves, muscle strength and tone, reflexes, the sensory system, coordination and gait •A standard eye examination Visual acuity (Snellen chart), visual field, eye muscles, pupillary response, fundus, tonometry, eyelids, cornea, conjunctiva, sclera and iris will be performed. The examination should be performed by a physician at the site who has the appropriate experience and training. If a clinically significant abnormality is noted that requires expert follow-up, an Ophthalmologist or Optometrist should be consulted. •Seizure checklist •Extrapyramidal Symptom Rating Scale - Abbreviated version (ESRS-A) •Calgary Depression Scale for Schizo

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Secondary

Measure	Time frame
Preliminary Efficacy Evaluations Preliminary Efficacy will be assessed by the following measures: • Positive and Negative Syndrome Scale (PANSS) total score - mean change from baseline to endpoint • Clinical Global Impression Severity of illness (CGI-S ) – mean change from baseline to endpoint • Clinical Global Impression Change (CGI-C )– proportion of patients with improvement from baseline to endpoint (score of 1, 2 or 3), and mean score at endpoint • PANSS – Positive Symptoms total score – mean change from baseline to endpoint • PANSS – General Psychopathology total score – mean change from baseline to endpoint • Level of Functioning (LOF) – mean change from baseline to endpoint • PANSS – Negative Symptoms total score – mean change from baseline to endpoint. [46 weeks]	—

Measure

Time frame

Preliminary Efficacy Evaluations Preliminary Efficacy will be assessed by the following measures: • Positive and Negative Syndrome Scale (PANSS) total score - mean change from baseline to endpoint • Clinical Global Impression Severity of illness (CGI-S ) – mean change from baseline to endpoint • Clinical Global Impression Change (CGI-C )– proportion of patients with improvement from baseline to endpoint (score of 1, 2 or 3), and mean score at endpoint • PANSS – Positive Symptoms total score – mean change from baseline to endpoint • PANSS – General Psychopathology total score – mean change from baseline to endpoint • Level of Functioning (LOF) – mean change from baseline to endpoint • PANSS – Negative Symptoms total score – mean change from baseline to endpoint. [46 weeks]

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Countries

India,Italy,Malaysia,Sri Lanka

Contacts

Public ContactProf Shehan Williams

Consultant Psychiatrist

shehan@kln.ac.lk

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026