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AVP-786 for Schizophrenia

Phase 2 & 3
Waitlist Available
Research Sponsored by Avanir Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; week 15
Awards & highlights

Study Summary

This trial will test a new drug, AVP-786, to see if it can improve negative symptoms of schizophrenia better than a placebo.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline; week 15
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; week 15 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline to Week 15 in the Positive and Negative Syndrome Scale (PANSS) Marder Negative Factors Score
Secondary outcome measures
Change from Baseline to Week 15 in the Negative Symptom Assessment-16 (NSA-16) Global Negative Symptom Score
Change from Baseline to Week 15 in the Patient Global Impression of Change (PGI-C) Score
Change from Baseline to Week 15 in the Patient Global Impression of Severity (PGI-S) Score

Side effects data

From 2019 Phase 3 trial • 387 Patients • NCT02442765
8%
Fall
4%
Diarrhoea
4%
Agitation
3%
Urinary tract infection
3%
Dizziness
3%
Somnolence
2%
Arthralgia
2%
Electrocardiogram QT prolonged
2%
Nasopharyngitis
2%
Skin abrasion
2%
Upper respiratory tract infection
1%
Tendonitis
1%
Sinus arrhythmia
1%
Fatigue
1%
Malaise
1%
Ligament sprain
1%
Lethargy
1%
Insomnia
1%
Aggression
1%
Rash
1%
Fungal infection
1%
Headache
1%
White blood cells urine positive
1%
Hot flush
1%
Hypertension
1%
Pulmonary embolism
1%
Arthritis
1%
Neck pain
1%
Foot fracture
1%
Malnutrition
1%
Bradycardia
1%
Diplopia
1%
Constipation
1%
Laceration
1%
Muscle rupture
1%
Deep vein thrombosis
1%
Poor dental condition
1%
Coronary artery disease
1%
Tinnitus
1%
Eye allergy
1%
Contusion
1%
Spinal compression fracture
1%
Influenza like illness
1%
Non-cardiac chest pain
1%
Influenza
1%
Cellulitis
1%
Muscle strain
1%
Rib fracture
1%
Flank pain
1%
Decreased appetite
1%
Muscle spasms
1%
Synovitis
1%
Hallucination
1%
Hypnopompic hallucination
1%
Asthma
1%
Chronic obstructive pulmonary disease
1%
Haematoma
1%
Eczema
1%
Leukocytosis
1%
Neutrophil count increased
1%
Blood pressure increased
1%
Glycosylated haemoglobin increased
1%
Iron deficiency anaemia
1%
Diverticulum
1%
Gastroenteritis
1%
White blood cell count increased
1%
Acne
1%
Sinus bradycardia
1%
Ventricular extrasystoles
1%
Bundle branch block left
1%
Dyspepsia
1%
Sinusitis
1%
Pneumonia
1%
Acute kidney injury
1%
Abdominal pain
1%
Gastrooesophageal reflux disease
1%
Toothache
1%
Anal fissure
1%
Feeling cold
1%
Animal scratch
1%
Arthropod bite
1%
Type 2 diabetes mellitus
1%
Osteoarthritis
1%
Back pain
1%
Musculoskeletal chest pain
1%
Musculoskeletal pain
1%
Skin cancer
1%
Syncope
1%
Decreased vibratory sense
1%
Hyperreflexia
1%
Presyncope
1%
Abnormal behaviour
1%
Abnormal dreams
1%
Nephrolithiasis
1%
Pulmonary mass
100%
80%
60%
40%
20%
0%
Study treatment Arm
AVP-786-28
Placebo
AVP-786-18

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AVP-786Experimental Treatment1 Intervention
AVP-786 capsules will be administered orally twice a day over a 15-week period.
Group II: PlaceboPlacebo Group1 Intervention
Placebo capsules will be administered orally twice a day over a 15-week period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AVP-786
2017
Completed Phase 3
~1340

Find a Location

Who is running the clinical trial?

Avanir PharmaceuticalsLead Sponsor
31 Previous Clinical Trials
13,065 Total Patients Enrolled
1 Trials studying Schizophrenia
145 Patients Enrolled for Schizophrenia
Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor
245 Previous Clinical Trials
166,859 Total Patients Enrolled
64 Trials studying Schizophrenia
18,840 Patients Enrolled for Schizophrenia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many different hospitals are a part of this clinical trial?

"There are a total of 46 clinical research sites taking part in this study. These locations include Miami Lakes, San Bernardino, Doral and 43 other centres."

Answered by AI

Are new participants still being accepted into this trial?

"The information available on clinicaltrials.gov supports that this research is ongoing and looking for subjects. The study was originally published on February 15th, 2019 with the most recent update being October 26th, 2022. There are a total of 46 different sites where the trial is recruiting patients from with the goal of finding 370 individuals in total."

Answered by AI

Is this research project only enrolling participants who are 18 years of age or older?

"Eligible patients for this clinical trial must be between 18-60 years old. There are 47 other trials recruiting patients who are underaged and 174 that focus on an elderly demographic."

Answered by AI

Could I possibly take part in this experiment?

"Eligible participants for this trial must have a diagnosis of schizophrenia and be between 18-60 years old. Currently, the goal is to recruit 370 individuals."

Answered by AI

How many individuals are being monitored in this research?

"In order to have statistically significant results, this study requires 370 individuals that meet the pre-specified inclusion criteria. If you are eligible and interested in participating, patients can sign up at Clinical Research Site #840-084 in Miami Lakes or Clinical Research Site# 840-081 in San Bernardino."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
Louisiana
How old are they?
18 - 65
What site did they apply to?
Clinical Research Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Negative Symptoms of Schizophrenia
2019. "Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Negative Symptoms of Schizophrenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03896945.
~22 spots leftby Apr 2025
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