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NCT02624167
A Phase IIA, Prospective, Randomized, Double-blind, Multiple-dose Study of NW-3509A in Chronic Schizoprhenia Patients Not Responding to Their Current Anti-psychotic Medication
Phase 2 trial testing NW-3509A in Chronic Schizophrenia in 90 participants. Completed in 1 January 2017.
1 December 2016
Quick facts
| Lead sponsor | Newron Pharmaceuticals SPA |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 90 |
| Start date | 1 December 2015 |
| Primary completion | 1 December 2016 |
| Estimated completion | 1 January 2017 |
| Sites | 5 locations across United States, India |
Drugs / interventions tested
- NW-3509A — full drug profile →
- Placebo
Conditions studied
- Chronic Schizophrenia — all drugs for Chronic Schizophrenia →
Sponsor
Newron Pharmaceuticals SPA — full company profile →
Who can join
Adults 18 to 65, any sex, with Chronic Schizophrenia. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
To evaluate the safety and tolerability of NW-3509A in patients with schizophrenia on a stable dose of their current antipsychotic medication (aripiprazole or risperidone).
Time frame: 27 days
To evaluate the safety and tolerability of NW-3509A given as an oral dose range of 30 to 50 mg/day (15 to 25 mg, BID) in patients with schizophrenia on a stable dose of their current antipsychotic medication (aripiprazole or risperidone).
Sponsor's own description
A 4-week Phase IIa study to evaluate the safety and tolerability and efficacy of NW-3509A in patients with chronic schizophrenia that are not responding adequately to their current antipsychotic medication (aripiprazole or risperidone). NW-3509A is given as an oral dose range of 15 to 25 mg, BID in a 1:1 ratio.
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:
- PubMed search for NCT02624167
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Chronic Schizophrenia
Currently open trials in the same condition.
- NCT06349369 — Effect of tDCS on Inflammatory Biomarkers in Chronic Schizophrenia · 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)
- Trial protocol + status: ClinicalTrials.gov NCT02624167 (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: 13 March 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/NCT02624167.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing