NCT01955564 is a Phase 1 clinical trial of NW-3509a in Schizophrenia, sponsored by Newron Pharmaceuticals SPA.

Who is sponsoring NCT01955564?

NCT01955564 is sponsored by Newron Pharmaceuticals SPA.

What drugs are being tested in NCT01955564?

Interventions in NCT01955564: NW-3509a.

What condition does NCT01955564 study?

NCT01955564 studies Schizophrenia.

Is NCT01955564 still recruiting?

NCT01955564 is currently completed. Last updated 6 April 2017.

Are results published for NCT01955564?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-04-06 · How we verify

NCT01955564

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase I, Prospective, Randomized, Double-blind, Placebo-controlled, Sequential-cohort, Escalating, Single-dose Study Designed to Determine the Maximum Tolerated Oral Dose of NW-3509A in Healthy, Male Volunteers.

Completed Phase 1 Results posted Last updated 6 April 2017

What this trial tests

Phase 1 trial testing NW-3509a in Schizophrenia in 54 participants. Completed in 1 February 2015.

Timeline

1 June 2013

Primary endpoint
1 September 2014

1 February 2015

Quick facts

Lead sponsor	Newron Pharmaceuticals SPA
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	54
Start date	1 June 2013
Primary completion	1 September 2014
Estimated completion	1 February 2015
Sites	1 location across United States

Drugs / interventions tested

NW-3509a — full drug profile →

Conditions studied

Schizophrenia — all drugs for Schizophrenia →

Sponsor

Newron Pharmaceuticals SPA — full company profile →

Who can join

Adults 18 to 45, male only, with Schizophrenia. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Physical Examination Shift Table
Time frame: Day -1(pre-dose) through Day 8 (Discharge)
Physical examinations were carried out on the following: Lymph nodes, mouth, neck, nervous system, nose, skin and throat.

Sponsor's own description

This is a prospective, 8-day, randomized, double-blind, placebo-controlled, sequential-cohort study designed to evaluate the safety, tolerability, and MTD of single escalating oral doses of NW-3509A in healthy male volunteers. Six independent cohorts of 12 volunteers each will participate in this study, with the first 9 volunteers in each cohort to qualify being randomized to receive study medication and the remaining 3 to be used as backups/ alternates. In each cohort, 6 subjects will be randomly assigned to receive NW-3509A and 3 subjects will receive placebo.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Schizophrenia

Currently open trials in the same condition.

NCT07424404 — A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Au · Phase 3 · recruiting
NCT07467993 — Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia · Phase 2 · recruiting
NCT07379827 — Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT) · recruiting
NCT06758414 — CBT-CP for Veterans With SMI · NA · recruiting
NCT07395206 — Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Dis · NA · recruiting

Other Newron Pharmaceuticals SPA trials

Trials by the same sponsor.

NCT07184619 — Evenamide, a Glutamate Release Modulator, as Add-On to Standard of Care in Subjects With Documented Treatment-Resistant · Phase 3 · recruiting
NCT04461119 — Study to Determine the Safety, Tolerability, and Efficacy of Evenamide in Patients With Chronic Schizophrenia · Phase 2 · completed
NCT02790034 — Evaluation of the Efficacy, Safety, and Tolerability of Sarizotan in Rett Syndrome With Respiratory Symptoms · Phase 2, PHASE3 · terminated
NCT01019824 — Efficacy and Safety of Ralfinamide in Patients With Chronic Neuropathic Low Back Pain · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01955564 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Newron Pharmaceuticals SPA
Last refreshed: 6 April 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01955564.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing