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CTRI Number  CTRI/2020/09/027537 [Registered on: 02/09/2020] Trial Registered Prospectively
Last Modified On: 04/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   A clinical study to determine safety, tolerability and efficacy of drug called Evenamide which is taken orally, in patients with treatment resistant schizophrenia with inadequate benefit from their current antipsychotic medication.  
Scientific Title of Study   A pilot, open-label, rater-blinded, randomized, parallel-group, multi-center study to evaluate the safety, tolerability and preliminary efficacy of three add-on fixed doses of evenamide in patients with treatment-resistant schizophrenia (TRS) not responding adequately to their stable, therapeutically active dose of a single antipsychotic medication. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
2020-000437-41  EudraCT 
NW-3509/014/II/2019; Protocol Version: 2.0 dated 10 Dec 2019  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shiv Issar  
Designation  Head, Clinical and RA 
Affiliation  CliniRx Research Pvt Ltd  
Address  Patriot House, 4th Floor 3 BSZ Marg, New Delhi

Central
DELHI
110002
India 
Phone  9868167119  
Fax    
Email  shiv.issar@clinirx.com  
 
Details of Contact Person
Scientific Query  
Name  Shiv Issar  
Designation  Head, Clinical and RA 
Affiliation  CliniRx Research Pvt Ltd  
Address  Patriot House, 4th Floor 3 BSZ Marg, New Delhi

Central
DELHI
110002
India 
Phone  9868167119  
Fax    
Email  shiv.issar@clinirx.com  
 
Details of Contact Person
Public Query  
Name  Shiv Issar  
Designation  Head, Clinical and RA 
Affiliation  CliniRx Research Pvt Ltd  
Address  Patriot House, 4th Floor 3 BSZ Marg, New Delhi

Central
DELHI
110002
India 
Phone  9868167119  
Fax    
Email  shiv.issar@clinirx.com  
 
Source of Monetary or Material Support  
Newron Pharmaceuticals SpA 
 
Primary Sponsor  
Name  Newron Pharmaceuticals SpA 
Address  Via Antonio Meucci, 3 20091 Bresso (Milano) Italy 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
CliniRx Research Pvt Ltd   Patriot House, 4th Floor, 3 BSZ Marg, New Delhi-110002 
 
Countries of Recruitment     India
Italy
Malaysia
Sri Lanka  
Sites of Study
Modification(s)  
No of Sites = 13  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vikhram Ramasubramanian   Ahana Hospital LLP  Department of Psychiatry, No. 11, Subburam Street, Gandhi NagarDepartment of Psychiatry, No. 11, Subburam Street, Gandhi Nagar, Madurai-625020 Madurai
Madurai
TAMIL NADU 		 9443772233

vikhram@ahanahospitals.in 
Dr Susanta Kumar Padhy  All India Institute of Medical Sciences  Department of Psychiatry, Sijua, Patrapada, Bhubaneswar
Cuttack
ORISSA 		 8054831604

susanta.pgi30@yahoo.in 
Dr Gundugurti Prasad Rao  Asha Hospital   Department of Psychiatry, Road No.14, Banjara Hills, Hyderabad-500034 Hyderabad
Hyderabad
TELANGANA 		 9985900005

Prasad40@gmail.com 
Dr Ranjive Mahajan  Dayanand Medical College & Hospital   Department of Psychiatry, Research & Development Centre, Dayanand Medical College and Hospital, Tagore Nagar, Civil Lines - 141001 Ludhiana
Ludhiana
PUNJAB 		 9872655006

ranjive@yahoo.com 
Dr Radhika Reddy  Help Hospitals Private Limited  D. No. 27-29-23, Behind Victoria Museum, Governorpet, Vijayawada, Andhra Pradesh
Vizianagaram
ANDHRA PRADESH 		 9848229798

rrvemireddy@yahoo.com 
Dr PN Suresh Kumar  IQRAA Psychiatric Care and Rehabilitation Centre  Department of Psychiatry, IQRAA International Hospital and Research center, Near Vyapar Bhavan, Civil Station (PO), Eranhipalam-673020 Kozhikode
Kozhikode
KERALA 		 9447218825

drpnsuresh@gmail.com 
Dr Supriya Hegde  Mangala Hospital and Mangala Kidney Foundation  Department of Psychiatry, Mangala Hospital and Mangala Kidney Foundation, Vajra Hills, Kadri Road -575003 Mangalore
Mysore
KARNATAKA 		 9845338287

aroor.supriya@gmail.com 
Dr Sandeep Grover   Post Graduate Institute of Medical Education and Research  Department of Psychiatry, Nehru Hospital, Department of Psychiatry, Cobalt Block, PGIMER, 160012-Chandigarh Patiala
Chandigarh
CHANDIGARH 		 9316138997

drsandeepg2002@yahoo.com 
Dr Sanjeev Saoji  Saoji Tupkari Hospital  Department of Psychiatry, Saoji Tupkari Hospital4, Vijay Nagar, Garkheda
Aurangabad
MAHARASHTRA 		 9922957746

sanjeev.saoji@gmail.com 
Dr Rajeev Mehta  Sir Ganga Ram Hospital  Department of Psychiatry, SGRH Marg, Rajender Nagar, New Delhi, 110060
North West
DELHI 		 9312273235

drrajivmehta@gmail.com 
Dr Ramanathan Sathianathan  Sri Ramachandra Hospital   Department of Psychiatry, Sri Ramachandra University, No:1 Ramachandra Nagar, Porur – 600116 Chennai
Chennai
TAMIL NADU 		 9841019910

sathianathen6@yahoo.com 
Dr Johnson Pradeep  St Johns Medical College hospital  Department of Psychiatry, St Johns Medical College & Hospital, St Johns National Academy of health Science, Sarjapur Main Road, 560034 Bangalore
Bangalore
KARNATAKA 		 9632175933

drjohnsonpradeep@gmail.com 
Dr Umesh Nagapurkar  Sujata Birla Hospital and Medical Research Centre  Department of Psychiatry, Nashik Road, Nashik 422101
Nashik
MAHARASHTRA 		 9823146088

umeshanjali@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 9  
Name of Committee  Approval Status 
Drug Trial Ethics Committee, Dayanand Medical College and Hospital   Submittted/Under Review 
Ethics Committee Asha Hospital  Approved 
Ethics committee, Radianz Healthcare and Research   Submittted/Under Review 
Institute Ethics Committee, PGIMER  Submittted/Under Review 
Institutional ethics committee, IQRAA International Hospital and Research center   Approved 
Institutional Ethics Committee, Sri Ramachandra Medical College and Research Institute  Approved 
Institutional Ethics Committee, St. John’s Medical College Hospital,   Submittted/Under Review 
Mangala Institutional Ethics Committee, Mangala Hospital and Mangala Kidney Foundation  Submittted/Under Review 
Saoji Tupkari Hospital Ethics Committee   Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F28||Other psychotic disorder not due to a substance or known physiological condition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NW3509  Fixed oral doses of 30 mg BID orally for 6 weeks therapy of NW-3509 (Evenamide) 
Intervention  NW3509   Fixed oral doses of 7.5, 15 mg BID orally for 6 weeks therapy of NW-3509 (Evenamide)  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Psychiatric
3. Meets current DSM-5 criteria for schizophrenia. Other psychiatric disorders may be present only as lifetime diagnoses if they are not relevant to the current episode of schizophrenia. [see Exclusion criteria below]
4. Has been diagnosed with schizophrenia within the past 10 years.
5. Has shown treatment-resistance according to psychiatric history, with the last failed treatment documented in the patient’s clinical records. “Treatment-resistant Schizophrenia” (TRS) is defined as a persistence of significant clinical symptoms despite adequate doses of two standard antipsychotic medications (other than clozapine) from two different chemical classes, including at least one atypical antipsychotic, for at least 6 weeks of treatment each. The last failed treatment trial must be documented.
6. Has a Clinical Global Impression – Severity of disease (CGI-S) rating of moderately ill to severely ill (score of 4 to 6 [scale 1-7]).
7. Has a PANSS total score ≥ 70 at screening and baseline.
8. Has a score of 4 (moderate) or more on at least 2 of the following 4 PANSS symptoms of psychosis: P2 (Conceptual Disorganization), P3 (Hallucinatory Behavior), P6 (Suspiciousness/Persecution) and G9 (Unusual Thought Content); and a total score of at least 20 on the combined total of the PANSS symptom items: P1 (Delusions), P2 (Conceptual Disorganization), P3 (Hallucinatory Behavior), P4 (Excitement), P6 (Suspiciousness/Persecution), P7 (Hostility), and G9 (Unusual thought content).
9. Has a Global Assessment of Functioning (GAF) scale total score ≤ 50.
10. Is in need of anti-psychotic treatment and is currently receiving mono-therapy at a stable dose (minimally for 4 weeks prior to screening) at a minimal recommended therapeutic or higher dose of one antipsychotic (atypical or typical, other than clozapine). Current use of quetiapine at a dose of 150 mg or less at night as a soporific will not be considered polypharmacy.
11. Current level of symptoms has been present for at least one month, but not exceeding one year. 
 
ExclusionCriteria 
Details  Psychiatric
1. DSM-5 diagnosis of schizophreniform disorder (295.40), schizoaffective disorder (295.70), or other primary psychiatric diagnosis, such as bipolar disorder or major depressive disorder (depression will be assessed at screening and baseline using the Calgary Depression Scale for Schizophrenia (CDSS); a score of 7 or higher will be exclusionary).
2. History (within three months of study entry) or current diagnosis of Substance Use Disorder as defined by the DSM-5 criteria, with a severity of ‘moderate’ or ‘severe’, or patient is currently abusing drugs or alcohol or has done so in the past year. A history of nicotine or caffeine dependence is acceptable; and patients testing positive for THC on the urine drug screen will not be excluded from the study unless there is evidence of toxic psychosis.
3. Severity of current episode of psychosis requires that the patient be hospitalized. Patients who are chronically hospitalized or in psychiatric daycare, whose hospitalization is for logistic reasons and not due to the severity of their illness, will be eligible for the study.
4. Has a PANSS total score > 90 or a CGI-S rating of 7 (among the most extremely ill patients).
5. History or current diagnosis of other psychiatric or behavioral disorders that may interfere with the conduct or interpretation of the study.
6. Known suicidal risk, or a suicide attempt within the past 2 years, as assessed by the CDSS and/or by psychiatric history.
7. History of neuroleptic malignant syndrome, priapism or moderate or severe tardive dyskinesia. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the safety and tolerability of evenamide given orally at three fixed doses (7.5, 15 and 30 mg bid) in patients with treatment-resistant schizophrenia not responding adequately to a stable, therapeutic doses of their current antipsychotic medication.  6 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate preliminary efficacy of the three fixed doses 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 effect of evenamide on daily functioning, based on changes on the Strauss-Carpenter Level of Functioning (LOF) scale. 		 6 weeks 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "161"
Final Enrollment numbers achieved (India)="141" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   07/09/2020 
Date of Study Completion (India) 22/09/2023 
Date of First Enrollment (Global)  07/09/2020 
Date of Study Completion (Global) 22/09/2023 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This is a 6-week, open-label, randomized, rater-blinded, multi-center study designed to evaluate the safety, tolerability and preliminary efficacy of fixed doses of evenamide of 7.5 mg bid, 15 mg bid and 30 mg bid as add-on treatment in patients with treatment-resistant schizophrenia on a stable therapeutic dose of an antipsychotic. A minimum of 150 patients will be allocated equally to each of the three treatment groups (50 patients per group). Doses will be initiated in a stepwise fashion. Initially, only the 7.5 mg bid and 15 mg bid doses will be evaluated with a 1:1 randomization scheme. After 50 patients (25 patients in each treatment group) have been treated at these doses, key safety data from these patients will be reviewed by an independent safety monitoring board (ISMB). If this review of the data indicates there are no safety issues, the 30 mg bid dose group will be initiated, and an additional 100 patients will be randomly assigned (1:1:2) to the 7.5, 15 and 30 mg bid treatment groups, with 25, 25 and 50 patients, respectively, enrolled in each group. However, if a decision is made not to include the 30 mg bid dose group in the study, an additional 100 patients will be randomly assigned (1:1) to the 7.5 and 15 mg twice daily treatment groups for a total of 150 patients enrolled, with approximately 75 in each group. 
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