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NCT01592110
A Pilot, Open-Label, Non-Randomized, Single Ascending Dose, Safety and Pharmacokinetic Trial With Injectable Risperidone-SABER and the DosePro Delivery System in Patients With Chronic, Stable Schizophrenia or Schizoaffective Disorder
Phase 1 trial testing risperidone-SABER in Schizophrenia in 40 participants. Completed in 1 April 2013.
1 April 2013
Quick facts
| Lead sponsor | Zogenix, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 1 July 2012 |
| Primary completion | 1 April 2013 |
| Estimated completion | 1 April 2013 |
| Sites | 1 location across United States |
Drugs / interventions tested
- risperidone-SABER — full drug profile →
- ZX003:risperidone-SABER and the DosePro System
- risperidone-SABER — full drug profile →
- Risperidone-SABER — full drug profile →
Conditions studied
- Schizophrenia — all drugs for Schizophrenia →
Sponsor
Zogenix, Inc. — full company profile →
Who can join
18 and older, any sex, with 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.
-
Number and percent of patients experiencing a treatment emergent adverse event following a single dose of risperidone-SABER
Time frame: Within 35 days post-dose -
Maximum plasma concentration, time of maximum plasma concentration and area under the concentration time curve for risperidone, 9-OH risperidone and active moiety (risperidone + 9-OH risperidone)
Time frame: Within 35 days post-dose
Sponsor's own description
This is a Phase 1, open-label study to evaluate the safety and pharmacokinetics (PK) of three doses of risperidone-SABER, administered with a needle and syringe or via the DosePro Needle-Free Delivery System in patients with chronic, stable schizophrenia.
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 NCT01592110
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT06758414 — CBT-CP for Veterans With SMI · NA · recruiting
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Other Zogenix, Inc. trials
Trials by the same sponsor.
- NCT05064878 — A Study to Investigate the Efficacy and Safety of ZX008 in Subjects With CDKL5 Deficiency Disorder · Phase 3 · active not recruiting
- NCT03936777 — A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults W · Phase 3 · completed
- NCT04398667 — European Non-interventional Study on Refractory Epilepsy With Developmental Delay · terminated
- NCT03780127 — ZX008 Expanded Access Protocol · approved for marketing
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 NCT01592110 (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 Zogenix, Inc.
- Last refreshed: 8 November 2022
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/NCT01592110.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing