17303A - Lu AF35700 in patients with schizophrenia
Research type
Research Study
Full title
Interventional, randomized, double-blind, active-controlled study of the efficacy of Lu AF35700 in patients with early-in-disease or late-in-disease treatment-resistant schizophrenia
IRAS ID
234953
Contact name
James Hunter MacCabe
Contact email
Sponsor organisation
Lundbeck
Eudract number
2017-000788-34
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
116335 (US), IND
Duration of Study in the UK
1 years, 2 months, 6 days
Research summary
Approximately 170 study subjects with early-in-disease or late-in-disease treatment-resistant schizophrenia, at approximately 40 study centres in the United States, Europe and Japan will take part in this study.
The duration of participation in the study is expected to be 23 weeks.The purpose of this study is to see whether Lu AF35700, referred to as the “study drug’, is safe and effective for the possible treatment of treatment-resistant schizophrenia.
The study drug is an experimental drug. “Experimental” means that the study drug is currently being tested and is not approved for sale by any health authority (government authorities) such as the US Food and Drug Administration (FDA) or European Medicines Agency (EMA).
The study drug, Lu AF35700, is a capsule of 10 mg. The study drug will be compared to risperidone or olanzapine. Therefore, the participants may also receive risperidone or olanzapine in the study. Risperidone and olanzapine are approved anti-psychotic medications for the treatment of schizophrenia. These medications come in capsule form and are identical to the study drug in appearance. A participant will receive study medication taken as 2 identical capsules, once per day, throughout the study.
The treatment is blinded throughout the study, which means participants will not know what treatment they will receive. During the study the treatment is containing either study drug, risperidone or olanzapine.In order to keep the blinding of the treatments, placebo capsules are also used. Placebo is a dummy treatment that looks like the study medication but contains no active substance. One of the capsules of study medication may contain placebo at some time during this study.
The study will consist of 4 Periods:
• Screening Period (up to 3 weeks)
• Period A – Prospective Confirmation Period (6 weeks)
• Period B – Double-blind Treatment Period (8 weeks)
• Safety Follow-Up Period (6 weeks)REC name
South Central - Oxford B Research Ethics Committee
REC reference
17/SC/0578
Date of REC Opinion
9 Jan 2018
REC opinion
Further Information Favourable Opinion