| CTRI Number |
CTRI/2020/09/027959 [Registered on: 22/09/2020] Trial Registered Prospectively |
| Last Modified On: |
02/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
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. |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2020-000439-32 |
EudraCT |
| NW-3509/015/II/2019; Protocol Version: 3.0 |
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
|
| No of Sites = 12 |
| 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
TAMIL NADU |
9443772233
vikhram@ahanahospitals.in |
| Dr Gundugurti Prasad Rao |
Asha Hospital |
Department of Psychiatry, Road No.14, Banjara Hills, Hyderabad-500034
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
PUNJAB |
9872655006
ranjive@yahoo.com |
| Dr Radhika Reddy |
Help Hospitals |
Department of Psychiatry, # 27-29-23, Beside Victoria Museum, M.G. Road, Vijayawada – 520 002
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
Chandigarh
CHANDIGARH |
9316138997
drsandeepg2002@yahoo.com |
| Dr Sanjeev Saoji |
Saoji Tupkari Hospital |
Department of Psychiatry, 4, Vijay Nagar,Garkheda,Aurangabad
Aurangabad
MAHARASHTRA |
9922957746
sanjeev.saoji@gmail.com |
| Dr Mohan Dhyani |
Shri Mahant Indiresh Hospital |
Department of Psychiatry,Shri Mahant Indiresh Hospital, Patel Nagar, Dehradun, Uttarakhand
Dehradun
UTTARANCHAL |
9997688192
dhyani.mohan@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,Sujata Birla Hospital and Medical Research Centre,
Nashik Road, Nashik- 422101,
Nashik
MAHARASHTRA |
9823146088
umeshanjali@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Drug Trial Ethics Committee, Dayanand Medical College and Hospital |
Approved |
| Ethics Committee Asha Hospital |
Submittted/Under Review |
| Ethics committee, Radianz Healthcare and Research |
Submittted/Under Review |
| Institute Ethics Committee, PGIMER |
Approved |
| Institutional ethics committee, IQRAA International Hospital and Research center |
Approved |
| Institutional Ethics Committee, Sri Ramachandra Medical College and Research Institute |
Submittted/Under Review |
| Institutional Ethics Committee, St. John’s Medical College Hospital, |
Approved |
| Mangala Institutional Ethics Committee, Mangala Hospital and Mangala Kidney Foundation |
Approved |
| Saoji Tupkari Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F208||Other schizophrenia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NW-3509 |
Fixed oral doses of 7.5, 15 mg BID orally for 46 weeks therapy of NW-3509 (Evenamide) |
| Intervention |
NW3509 |
Fixed oral doses of 30 mg BID orally for 46 weeks therapy of NW-3509 (Evenamide) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
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). |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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. |
46 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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. |
46 Weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="54"
Final Enrollment numbers achieved (Total)= "144"
Final Enrollment numbers achieved (India)="127" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/10/2020 |
| Date of Study Completion (India) |
11/10/2024 |
| Date of First Enrollment (Global) |
15/10/2020 |
| Date of Study Completion (Global) |
11/10/2024 |
|
Estimated Duration of Trial
|
Years="0"
Months="11"
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 46-week, open-label, multi-center, extension to Study NW-3509/014/II/2019 (Study 014) designed to evaluate the long-term safety, tolerability and preliminary efficacy of evenamide as add-on treatment in patients with TRS on a stable therapeutic dose of an antipsychotic. In Study 014, 50 patients are to be randomized equally (1:1) to the 7.5 mg bid and 15 mg bid doses (approximately 25 in each group), and 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 randomization will continue, with a total of approximately 50 patients being enrolled in each of the three treatment groups. If the 30 mg bid group is not added, the 150 patients will be randomly assigned (1:1) to the 7.5 and 15 mg bid treatment groups (approximately 75 in each group). |