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CTRI Trial Data PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Thu, 23 Sep 2021 09:34:23 GMT) CTRI Number CTRI/2020/09/027537 [Registered on: 02/09/2020] - Trial Registered Prospectively Last Modified On 20/09/2021 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 A pilot, open-label, rater-blinded, randomized, parallel-group, multi-center study to evaluate the Study 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. Secondary IDs if Any Secondary ID Identifier 2020-000437-41 EudraCT NW-3509/014/II/2019; Protocol Version: 2.0 Protocol Number dated 10 Dec 2019 Details of Principal Details of Principal Investigator Investigator or overall Name Shiv Issar Trial Coordinator (multi-center study) 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 [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Shiv Issar Query) 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 [email protected] Details Contact Details Contact Person (Public Query) 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 page 1 / 7 PDF of Trial CTRI Website URL - http://ctri.nic.in 110002 India Phone 9868167119 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Newron Pharmaceuticals SpA Primary Sponsor Primary Sponsor Details Name Newron Pharmaceuticals SpA Address Via Antonio Meucci, 3 20091 Bresso (Milano) Italy Type of Sponsor Pharmaceutical industry-Global Details of Secondary Name Address Sponsor CliniRx Research Pvt Ltd Patriot House, 4th Floor, 3 BSZ Marg, New Delhi-110002 Countries of List of Countries Recruitment India Italy Malaysia Sri Lanka Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Vikhram Ahana Hospital LLP Department of 9443772233 Ramasubramanian Psychiatry, No. 11, Subburam Street, vikhram@ahanahospita Gandhi ls.in NagarDepartment of Psychiatry, No. 11, Subburam Street, Gandhi Nagar, Madurai-625020 Madurai Madurai TAMIL NADU Dr Susanta Kumar All India Institute of Department of 8054831604 Padhy Medical Sciences Psychiatry, Sijua, Patrapada, [email protected] Bhubaneswar n Cuttack ORISSA Dr Gundugurti Prasad Asha Hospital Department of 9985900005 Rao Psychiatry, Road No.14, Banjara Hills, [email protected] Hyderabad-500034 Hyderabad Hyderabad TELANGANA Dr Ranjive Mahajan Dayanand Medical Department of 9872655006 College & Hospital Psychiatry, Research & Development Centre, [email protected] Dayanand Medical College and Hospital, Tagore Nagar, Civil Lines - 141001 Ludhiana page 2 / 7 PDF of Trial CTRI Website URL - http://ctri.nic.in Ludhiana PUNJAB Dr Radhika Reddy Help Hospitals Private D. No. 27-29-23, 9848229798 Limited Behind Victoria Museum, Governorpet, [email protected] Vijayawada, Andhra m Pradesh Vizianagaram ANDHRA PRADESH Dr PN Suresh Kumar IQRAA Psychiatric Care Department of 9447218825 and Rehabilitation Psychiatry, IQRAA Centre International Hospital [email protected] and Research center, Near Vyapar Bhavan, Civil Station (PO), Eranhipalam-673020 Kozhikode Kozhikode KERALA Dr Supriya Hegde Mangala Hospital and Department of 9845338287 Mangala Kidney Psychiatry, Mangala Foundation Hospital and Mangala [email protected] Kidney Foundation, m Vajra Hills, Kadri Road -575003 Mangalore Mysore KARNATAKA Dr Sandeep Grover Post Graduate Institute Department of 9316138997 of Medical Education Psychiatry, Nehru and Research Hospital, Department of drsandeepg2002@yaho Psychiatry, Cobalt o.com Block, PGIMER, 160012-Chandigarh Patiala Chandigarh CHANDIGARH Dr Sanjeev Saoji Saoji Tupkari Hospital Department of 9922957746 Psychiatry, Saoji Tupkari Hospital4, Vijay [email protected] Nagar, Garkheda m Aurangabad MAHARASHTRA Dr Rajeev Mehta Sir Ganga Ram Department of 9312273235 Hospital Psychiatry, SGRH Marg, Rajender Nagar, [email protected] New Delhi, 110060 m North West DELHI Dr Ramanathan Sri Ramachandra Department of 9841019910 Sathianathan Hospital Psychiatry, Sri Ramachandra sathianathen6@yahoo. University, No:1 com Ramachandra Nagar, Porur – 600116 Chennai Chennai TAMIL NADU Dr Johnson Pradeep St Johns Medical Department of 9632175933 College hospital Psychiatry, St Johns page 3 / 7 PDF of Trial CTRI Website URL - http://ctri.nic.in Medical College & drjohnsonpradeep@gm Hospital, St Johns ail.com National Academy of health Science, Sarjapur Main Road, 560034 Bangalore Bangalore KARNATAKA Dr Umesh Nagapurkar Sujata Birla Hospital Department of 9823146088 and Medical Research Psychiatry, Nashik Centre Road, Nashik 422101 [email protected] Nashik m MAHARASHTRA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Drug Trial Ethics Submittted/Under No Date Specified No Committee, Dayanand Review Medical College and Hospital Ethics Committee Asha Approved 25/02/2020 No Hospital Ethics committee, Submittted/Under No Date Specified No Radianz Healthcare Review and Research Institute Ethics Submittted/Under No Date Specified No Committee, PGIMER Review Institutional ethics Approved 06/02/2020 No committee, IQRAA International Hospital and Research center Institutional Ethics Approved 11/03/2020 No Committee, Sri Ramachandra Medical College and Research Institute Institutional Ethics Submittted/Under No Date Specified No Committee, St. John’s Review Medical College Hospital, Mangala Institutional Submittted/Under No Date Specified No Ethics Committee, Review Mangala Hospital and Mangala Kidney Foundation Saoji Tupkari Hospital Submittted/Under No Date Specified No Ethics Committee Review Regulatory Clearance Status Date Status from DCGI Approved/Obtained 18/02/2020 Health Condition / Health Type Condition Problems Studied Patients Other psychotic disorder not due to a substance or known physiological condition Intervention / Type Name Details Comparator Agent Intervention NW3509 Fixed oral doses of 7.5, 15 mg BID orally for 6 weeks therapy of NW-3509 (Evenamide) page 4 / 7 PDF of Trial CTRI Website URL - http://ctri.nic.in Comparator Agent NW3509 Fixed oral doses of 30 mg BID orally for 6 weeks therapy of NW-3509 (Evenamide) Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 99.00 Year(s) Gender Both Details Psychiatric<br/> 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]<br/> 4. Has been diagnosed with schizophrenia within the past 10 years.<br/> 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.<br/> 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]).<br/> 7. Has a PANSS total score ? 70 at screening and baseline.<br/> 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).<br/> 9. Has a Global Assessment of Functioning (GAF) scale total score ? 50.<br/> 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.<br/> 11. Current level of symptoms has been present for at least one month, but not exceeding one year. Exclusion Criteria Exclusion Criteria 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
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