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Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Negative Symptoms of 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 up to 5 years

Summary

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.

Eligible Conditions
  • Schizophrenia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2019 Phase 3 trial • 387 Patients • NCT02442765
9%
Fall
6%
Diarrhoea
6%
Urinary tract infection
6%
Headache
4%
Somnolence
3%
Agitation
3%
Nausea
3%
Vomiting
3%
Contusion
3%
Dizziness
3%
Sinus bradycardia
2%
Oedema peripheral
2%
Laceration
2%
Electrocardiogram QT prolonged
2%
Osteoarthritis
2%
Dehydration
1%
Delirium
1%
Weight increased
1%
Blood alkaline phosphatase increased
1%
Myalgia
1%
Hot flush
1%
Abdominal pain
1%
Non-cardiac chest pain
1%
Epididymitis
1%
Hypokalaemia
1%
Sepsis
1%
Hip fracture
1%
Rib fracture
1%
Spinal compression fracture
1%
Lipase increased
1%
White blood cell count increased
1%
Cerebrovascular accident
1%
Hydroureter
1%
Nephrotic syndrome
1%
Leukocytosis
1%
Thrombocytopenia
1%
Anaemia
1%
Atrial fibrillation
1%
Ear pain
1%
Meniere's disease
1%
Conjunctival hyperaemia
1%
Conjunctivitis allergic
1%
Rectal haemorrhage
1%
Fatigue
1%
Asthenia
1%
Pain
1%
Upper respiratory tract infection
1%
Cellulitis
1%
Acute sinusitis
1%
Diverticulitis
1%
Gastroenteritis viral
1%
Pharyngitis
1%
Vaginal infection
1%
Skin abrasion
1%
Craniocerebral injury
1%
Hand fracture
1%
Neutrophil count increased
1%
Blood urea increased
1%
Blood glucose increased
1%
Blood lactate dehydrogenase increased
1%
Crystal urine
1%
Electrocardiogram abnormal
1%
Fungal test positive
1%
Gamma-glutamyltransferase increased
1%
Glucose urine present
1%
Haemoglobin decreased
1%
Lymphocyte count increased
1%
Decreased appetite
1%
Hyperglycaemia
1%
Hyperkalaemia
1%
Hyperlipasaemia
1%
Hypomagnesaemia
1%
Malnutrition
1%
Arthralgia
1%
Bursitis
1%
Basal cell carcinoma
1%
Lethargy
1%
Dyskinesia
1%
Metabolic encephalopathy
1%
Tremor
1%
Spontaneous penile erection
1%
Chronic obstructive pulmonary disease
1%
Pneumonia aspiration
1%
Cough
1%
Dyspnoea
1%
Dyspnoea exertional
1%
Epistaxis
1%
Rash
1%
Hypertension
1%
Back pain
1%
Fracture pain
1%
Hypertensive crisis
1%
Bundle branch block left
1%
Haemothorax
1%
Pneumothorax spontaneous
1%
Arthritis infective
1%
Orthostatic hypotension
1%
Alcohol poisoning
1%
Femoral neck fracture
1%
Electrocardiogram ST segment depression
1%
Ischaemic stroke
1%
Syncope
1%
Constipation
1%
Gastrooesophageal reflux disease
1%
Toothache
1%
Dry mouth
1%
Faecal incontinence
1%
Pneumonia
1%
Muscular weakness
1%
Balance disorder
1%
Nephrolithiasis
1%
Pollakiuria
1%
Gait disturbance
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
AVP-786-18
AVP-786-28

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
11,986 Total Patients Enrolled
1 Trials studying Schizophrenia
145 Patients Enrolled for Schizophrenia
Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor
265 Previous Clinical Trials
168,962 Total Patients Enrolled
81 Trials studying Schizophrenia
21,759 Patients Enrolled for Schizophrenia
~20 spots leftby Dec 2025
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