Home » Trials » SLCTR/2020/024
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
-
SLCTR Registration Number
SLCTR/2020/024
Date of Registration
The date of last modification
Jan 31, 2024
Trial Status
Scientific Title of Trial
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
Public Title of Trial
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
Disease or Health Condition(s) Studied
Schizophrenia
Scientific Acronym
N/A
Public Acronym
N/A
Brief title
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
Universal Trial Number
U1111-1260-8404
Any other number(s) assigned to the trial and issuing authority
2020-000439-32 - EudraCT CTRI -CTRI/2020/09/027959
What is the research question being addressed?
What is 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
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Dose comparison
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 2
Intervention(s) planned
•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 preliminary efficacy of evenamide as add-on treatment in patients with treatment resistant schizophrenia 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). Intervention NW3509 Fixed oral doses of 30 mg BID orally for 46 weeks therapy of NW-3509 (Evenamide)
Inclusion 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
Primary outcome(s)
|
1.
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
• 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 Schizophrenia (CDSS). |
[ 46 weeks ] |
Secondary outcome(s)
|
1.
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 ] |
Target number/sample size
Globally 100, Locally 21
Countries of recruitment
India, Italy, Malaysia, Sri Lanka
Anticipated start date
2021-03-01
Anticipated end date
2022-04-01
Date of first enrollment
2021-05-03
Date of study completion
2023-11-12
Recruitment status
Complete: follow up complete
Funding source
Newron Pharmaceuticals S.p.A.
Regulatory approvals
Approved by the NMRA, Ministry of Health, Sri Lanka
Status
Approved
Date of Approval
2020-08-06
Approval number
P/25/05/2020
Details of Ethics Review Committee
| Name: | University of Kelaniya |
| Institutional Address: | Ethics- Review Committee, Faculty of Medicine, University of Kelaniya |
| Telephone: | 011-2961267 |
| Email: | ercmed@kln.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Prof Shehan Williams
Consultant Psychiatrist
Colombo North Teaching Hospital, Ragama
+94774301303
shehan@kln.ac.lk
Contact Person for Public Queries
Prof Shehan Williams
Consultant Psychiatrist
Colombo North Teaching Hospital, Ragama
+94774301303
shehan@kln.ac.lk
Primary study sponsor/organization
Dr Ravi Anand/Newron Pharmaceuticals S.p.A
Chief Medical Officer
Via Ludovico Ariosto 21, 20091 Bresso (Milano), Italy
+39-02-6103461
ravi@anand.ch
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
Yes
Protocol version and date
Protocol No. NW-3509/015/II/2019 Amendment 1, 13 February 2020
Protocol URL
Results summary available
No
Date of posting results
Date of study completion
2023-11-12
Final sample size
Date of first publication
Link to results
Brief summary of results
