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SchizophreniaPhase 2NCT04461119

Study to Determine the Safety, Tolerability, and Efficacy of Evenamide in Patients With Chronic Schizophrenia

A Phase 2 study testing Evenamide in people with Schizophrenia, run by Newron Pharmaceuticals SPA at 14 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This 4-week study will evaluate the safety, tolerability and preliminary evidence of efficacy of evenamide (7.5,and 15 mg and placebo, bid) treatment in outpatients with chronic schizophrenia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Schizophrenia
What is being tested?
Evenamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
138 participants
Where
14 sitesin 2 countries
Study dates
16 Jun 2020to 13 Mar 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Demographics
  • Age - 18 years, or older
  • Sex - male, or non-childbearing potential female unless practicing adequate contraception
  • Psychiatric
  • Has a current diagnosis of schizophrenia in accordance with DSM-5.
  • Has been treated with antipsychotics for at least 2 years.
Show all 13Show fewer
  • Has a total score on the PANSS < 80.
  • Has a Clinical Global Impression - Severity of disease (CGI-S) rating of mildly, moderately or moderately severely ill (score of 3, 4 or 5).
  • Needs antipsychotic treatment and is currently receiving a stable dose (minimally for 4 weeks prior to screening) of aripiprazole, clozapine, quetiapine, olanzapine, paliperidone, or risperidone (at least 2 mg risperidone dose-equivalent)
  • Current symptoms have been stably present for at least one month
  • Procedural
  • Patient resides at home or in a residential care facility
  • If taking clozapine, patient agrees to blood monitoring

Who cannot join

  • Psychiatric
  • Severity of current episode of psychosis requires that the patient be hospitalized. Patients who are chronically hospitalized or in psychiatric day-care, whose hospitalization is for logistic reasons and not due to the severity of their illness, will be eligible for the study.
  • Severity of psychosis is rated severe or higher (CGI-S of 6 or greater).
  • Known suicidal risk. A "yes" response on the C-SSRS Suicidal Ideation Item 4 or Item 5, or a "yes" response on any of the five C-SSRS Suicidal Behavior items, at screening, or a suicide attempt within the past 6 months, excludes the patient from the study.
  • Patients with a diagnosis of Treatment resistance
  • History of neuroleptic malignant syndrome, priapism.
Show all 30Show fewer
  • Current moderate or severe tardive dyskinesia.
  • Medical Status
  • Abnormal epileptiform phenomena (3 per second spike and slow wave discharges) observed on screening EEG. History or current diagnosis of epilepsy or seizure disorder (other than febrile seizures in childhood)
  • Insulin-dependent diabetes mellitus
  • History or current diagnosis of any neurodegenerative illnesses
  • Loss of 500 ml or more of blood during the 3-month period before study enrollment, e.g. as a donor
  • Cardiovascular
  • A current diagnosis of severe or unstable cardiovascular disease
  • Any clinically significant ECG abnormality
  • Abnormal vital signs
  • Laboratory abnormalities
  • Clinically significant abnormalities in routine laboratory examinations
  • History and/or presence of hepatitis B and/or C
  • Positive results from the HIV serology.
  • Positive results of the drug and alcohol tests
  • Clinically significant or unstable hypothyroidism or hyperthyroidism
  • Concomitant therapy
  • Treatment with SSRIs that are moderate/potent inhibitors of CYP2D6 (e.g. fluoxetine)
  • Treatment with drugs capable of inducing/inhibiting hepatic enzyme metabolism
  • Current treatment with sodium channel blockers
  • Exposure to any investigational drug within 5 weeks or 5 half-lives (whichever is longer) prior to screening
  • A known exaggerated pharmacological sensitivity or hypersensitivity to drugs similar to evenamide (e.g. lamotrigine, carbamazepine, oxcarbazepine, topiramate, etc.), or any components of the evenamide or matching placebo capsules
  • Treatment with a drug or treatment known to cause major organ system toxicity, e.g. tamoxifen, within 4 weeks, or received radiation therapy or a drug with cytotoxic potential, e.g. chemotherapy, during the past year
  • Electroconvulsive therapy (ECT) or treatment with a transcranial magnetic stimulation (TMS) device within 6 months prior to screening

Trial locations and contacts

14 sites in 2 countries.

14 sites in 2 countries

India11 sites

  • Post Graduate Institute of Medical Education and Research

    Chandigarh, Punjab, 160012

  • Sri Ramachandra Medical College, Department of Psychiatry

    Chennai, Tamil Nadu, 600116

  • Asha Hospital

    Hyderabad, Telangana, 500034

  • St. John's Medical College Hospital

    Koramangala, Karnataka

  • IQRAA Psychiatry Care and Rehabilitation Centre

    Kozhikode, Kerala

  • Dayanand Medical College & Hospital

    Ludhiana, Punjab

  • Ahana Hospital LLP

    Madurai, Tamil Nadu

  • Mangala Hospital and Mangala Kidney Foundation, Department of Psychiatry

    Mangalore, Karnataka

  • Deenanath Mangeshkar Hospital Research Center

    Pune, Maharashtra

  • Sujata Birla Hospital

    Pune, Maharashtra

  • Help Hospitals Clinical Research Department

    Vijayawada, Andhra Pradesh, 520002

Other trials in India

United States3 sites

  • Community Clinical Research CCR

    Austin, Texas, 78754

  • CBH Health, LLC

    Gaithersburg, Maryland, 20877

  • Behavioral Research Specialists, LLC

    Glendale, California, 91206

Other trials in United States

About this study

Official title: A Phase II, Randomized, 4-Week, Double-Blind, Placebo-Controlled, Multiple-Dose Study, Designed to Determine the Safety, Tolerability, EEG Effects and Preliminary Efficacy of Fixed Oral Doses of 7.5 and 15 MG BID of Evenamide in Patients With Chronic Schizophrenia Who Are Symptomatic on Their Current Second-Generation Antipsychotic Medication

This 4-week study will evaluate the safety, tolerability and preliminary evidence of efficacy of evenamide (7.5,and 15 mg and placebo, bid) treatment in outpatients with chronic schizophrenia.

Read the detailed description

This is a prospective, 4-week, randomized, double-blind, placebo-controlled, study designed to evaluate the safety, tolerability, EEG effects, and preliminary efficacy of two fixed oral doses of evenamide of 7.5 mg and 15 mg bid (15 and 30 mg/day) in outpatients with chronic schizophrenia who are receiving treatment at constant doses of one of the following atypical antipsychotics: aripiprazole, clozapine, quetiapine, olanzapine, paliperidone or risperidone. Approximately 120 patients will be randomized in a 1:1:1 ratio to receive either evenamide 7.5 or 15 mg, or placebo, given bid.

Conditions
Schizophrenia
Being tested
Evenamide, Placebo
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EvenamideDrug

    Also called NW-3509

    oral capsules for 4 weeks of treatment

  • PlaceboDrug

    oral capsules for 4 weeks of treatment

Study groups in NCT04461119
Study groupRoleWhat they receive
Evenamide 7.5 mg bidExperimentalEvenamide capsules 7.5 mg BID for a total of 28 dosing days
Receives: Drug: Evenamide
Evenamide 15 mg bidExperimentalEvenamide capsules 15.0 mg BID for a total of 28 dosing days
Receives: Drug: Evenamide
PlaceboPlacebo comparatorMatching placebo capsules BID for a total of 28 dosing days
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability - incidence of Treatment-Emergent Adverse Events [TEAEs], Serious Adverse Events [AEs], and Adverse Events leading to discontinuation [ADOs]

    Comparison will be made between the evenamide and placebo groups in the proportion of patients experiencing Serious Adverse Events [SAEs], Adverse Events leading to discontinuation [ADOs] and, Treatment-Emergent Adverse Events [TEAEs].

    Measured: 4 Week study

  2. Change from baseline in Positive and Negative Syndrome Scale [PANSS] total score

    Efficacy measure of mean change from baseline to endpoint of Positive and Negative Syndrome Scale [PANSS] total score: this is a 30-item scale that was designed to assess various symptoms of schizophrenia each rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology).

    Measured: 4 Week study

Secondary outcomes (6)

  1. Key secondary - Change from baseline in clinical global impression severity of Illness [CGI-S] score

    Efficacy measure by mean change from baseline top endpoint of the Clinical Global Impression Severity of Illness [CGI-S]: the investigator rates the severity of a subject's condition on a 7-point scale ranging from 1 (no symptoms) to 7 (very severe).

    Measured: 4 Week study

  2. Rating at endpoint on the CGI - Change from baseline (CGI-C)

    Efficacy measured by Clinical Global Impression of Change [CGI-C]: 7-point scale requiring the clinician to rate how much the patient's illness has improved at endpoint relative to the baseline state (score of 1, 2, 3); CGI-C ranges from 1 (very much improved) to 7 (very much worse), with a score of 4 indicating "no change".

    Measured: 4 Week study

  3. Evaluate plasma drug concentrations over time for evenamide and its major metabolite, (3-butoxy-phenyl)-acetic acid

    Determine the multiple-dose plasma concentrations of evenamide and its major metabolite, (3-butoxy-phenyl)-acetic acid, at the doses tested.

    Doses of evenamide to be evaluated in this study, compared to placebo, will be 7.5 mg bid, and 15 mg bid, with key information being collected at or near the time of the predicted maximal plasma concentration (Tmax) for evenamide.

    Measured: 4 Week study

  4. Comparison of plasma drug concentrations over time for evenamide and its major metabolite, (3-butoxy-phenyl)-acetic acid between the dosing arms 7.5 mg BID and 15.0 mg BID

    Determine if the PK parameters are dose proportional. Doses of evenamide to be evaluated in this study, compared to placebo, will be 7.5 mg bid, and 15 mg bid, with key information being collected at or near the time of the predicted maximal plasma concentration (Tmax) for evenamide.

    Measured: 4 Week study

  5. Efficacy - changes in daily functioning

    Determine the effect of evenamide, compared to placebo, on daily functioning, based on changes on the Strauss-Carpenter Level of Functioning (LOF) scale; The LOF is a semi-structured, clinician-administered scale of nine items. The individual items fall into four domains, with higher scores on a 5-point scale (0 - 4) reflecting better functioning. The subscales are Social Contacts (frequency and quality of social contacts), Work (quantity and quality of useful work), Symptomatology (absence of symptoms and recent hospitalization), and Function (ability to meet basic needs, fullness of life, and overall level of function). A total score is calculated as the sum of the raw scores across the nine items.

    Measured: 4 Week study

  6. Efficacy - rating score of patient satisfaction with the study medication

    Determine the patient's satisfaction with the study medication, compared to their previous treatment, based on improvements on the Medication Satisfaction Questionnaire (MSQ) which is a single-item, 7-point Likert-type scale for patients with schizophrenia to rate their satisfaction with their antipsychotic medication.

    The patient's response to the question "Overall, how satisfied are you with your current antipsychotic medication(s)?" is rated by the clinician as follows: 1 = extremely dissatisfied, 2 = very dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = very satisfied, and 7 = extremely satisfied

    Measured: 4 Week study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2020
  2. Study start16 Jun 2020
  3. Primary completion20 Feb 2021
  4. Study completion13 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
138 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04461119
Sponsor's protocol ID
NW-3509/008/II/2019
Status last verified
May 2021
First submitted
19 Jun 2020
Last updated
20 May 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Evenamide in people with Schizophrenia, run by Newron Pharmaceuticals SPA at 14 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in India, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability - incidence of Treatment-Emergent Adverse Events [TEAEs], Serious Adverse Events [AEs], and Adverse Events leading to discontinuation [ADOs] (time frame: 4 Week study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04461119.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2021.

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