NW-3509/008A/II/2020; Protocol Version: 2.0, 04 May 2021

• Research type

  Research Study

• Full title

  A Phase II/III, prospective, multi-center, randomized, 4-week, double-blind, placebo-controlled study, designed to determine the safety, tolerability, EEG effects and efficacy of oral doses of 30 mg bid of evenamide (NW-3509) in patients with chronic schizophrenia who are symptomatic on their current second-generation antipsychotic (aripiprazole, clozapine, quetiapine, olanzapine, paliperidone, or risperidone) medication.

• IRAS ID

  302345

• Contact name

  Antonio Metastasio

• Contact email

  antonio.metastasio@nhs.net

• Sponsor organisation

  Newron Pharmaceuticals S.p.A.

• Eudract number

  2020-006062-36

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  0 years, 4 months, 2 days

• Research summary

  A Phase II/III, prospective, multi-center, randomized, 4-week, double-blind, placebo-controlled study, designed to determine the safety, tolerability, EEG effects and efficacy of oral doses of 30 mg bid of evenamide (NW-3509) in patients with chronic schizophrenia who are symptomatic on their current second-generation antipsychotic (aripiprazole, clozapine, quetiapine, olanzapine, paliperidone, or risperidone) medication.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  21/LO/0653

• Date of REC Opinion

  12 Nov 2021

• REC opinion

  Further Information Favourable Opinion