Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Negative Symptoms of Schizophrenia

Recruiting at 119 trial locations

Overseen By Nadine Knowles

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Avanir Pharmaceuticals

Must be taking: Atypical antipsychotics

Must not be taking: Anticholinergics

Disqualifiers: Major depressive disorder, Pseudo-parkinsonism, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 15 weeks

136 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called AVP-786 to see if it can help people with schizophrenia who have negative symptoms like lack of motivation and social withdrawal. The study will compare AVP-786 to another group to check its benefits.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be stable on a second-generation atypical antipsychotic drug to participate.

What safety data exists for the treatment known as AVP-786 or similar names?

The research articles provided do not contain specific safety data for AVP-786 or its related names. They discuss general safety pharmacology methods and placebo controls but do not provide direct safety information for this treatment. ^{1 2 3 4 5}

Eligibility Criteria

Inclusion Criteria

Participants who meet the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) diagnostic criteria for schizophrenia confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I) Version 7.0.2

Participants must have well-controlled positive symptoms and prominent negative symptoms as defined by Positive and Negative Syndrome Scale (PANSS) criteria.

Participants currently receiving a second-generation atypical antipsychotic drug (SGA) are eligible if they are stable and adherent to their dosing schedule.

Exclusion Criteria

Participants with pseudo-parkinsonism secondary to their ongoing antipsychotic medication

Participants currently using anticholinergic medications

Participants recently hospitalized as in-patients

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AVP-786 or placebo capsules administered orally twice a day

15 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• AVP-786
• Placebo

Participant Groups

Group I: AVP-786 Experimental Treatment 1 Intervention

AVP-786 capsules will be administered orally twice a day over a 15-week period.

Group II: Placebo Placebo Group 1 Intervention

Placebo capsules will be administered orally twice a day over a 15-week period.

Who Is Running the Clinical Trial?

Avanir Pharmaceuticals

Lead Sponsor

Trials

32

Recruited

12,100+

Otsuka Pharmaceutical Development & Commercialization, Inc.

Lead Sponsor

Trials

271

Recruited

170,000+

John Kraus

Otsuka Pharmaceutical Development & Commercialization, Inc.

Chief Medical Officer since 2023

MD, PhD

Tarek Rabah

Otsuka Pharmaceutical Development & Commercialization, Inc.

Chief Executive Officer since 2022

BS in Biology and BA in Business from the American University of Beirut, MBA from McGill University

Findings from Research

A new checklist called TIDieR-Placebo has been developed to improve the reporting of placebo or sham interventions in clinical trials, ensuring that researchers clearly describe these components alongside active treatments.

The checklist was created through expert consultation and aims to enhance the transparency of trial results, which is crucial for accurately assessing the benefits and harms of active interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls. Howick, J., Webster, RK., Rees, JL., et al.[2020]

In a study involving 100 patients undergoing lumbar spine fusion surgeries, batroxobin and its combination with tranexamic acid significantly reduced both intraoperative and postoperative blood loss compared to a placebo.

The mean intraoperative blood loss was lowest in the batroxobin group (268.32 mL) and the combination group (256.96 mL), indicating their effectiveness, while no significant differences were found in blood transfusion needs or complications like deep vein thrombosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety of Batroxobin, Tranexamic Acid and a Combination in Reduction of Blood Loss in Lumbar Spinal Fusion Surgery. Nagabhushan, RM., Shetty, AP., Dumpa, SR., et al.[2021]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Analysis of pharmacology data and the prediction of adverse drug reactions and off-target effects from chemical structure. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

An overview of some pharmacological methods used in safety pharmacology studies. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety of Batroxobin, Tranexamic Acid and a Combination in Reduction of Blood Loss in Lumbar Spinal Fusion Surgery. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Short-term effects of dry needling of thenar muscles in manual laborers with carpal tunnel syndrome: a pilot, randomized controlled study. [2023]