A Phase 2 interventional study of Zicronapine and Zicronapine in Schizophrenia, sponsored by H. Lundbeck A/S. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-11-08.
Sponsored by H. Lundbeck A/S · Phase 2, Interventional, and Treatment
The main purpose with the study is to evaluate the efficacy and safety of Lu 31-130 in patients suffering from schizophrenia compared to placebo.
Schizophrenia is a serious and disabling mental disorder that affects approximately 1% of the world's population. Antipsychotic drugs remain the cornerstone in the pharmacotherapy of schizophrenia. However, none of the available drugs is ideal, in particular because of their complex safety profile and the limited effectiveness against certain symptoms of the disease. Thus, only one dimension of the morbidity, that is, the positive symptoms, can be expected to respond to treatment whereas negative symptoms and cognitive deficits are, at best, only marginally targeted.
Given this, there is no doubt that the current antipsychotic drugs leave much room for improvement and call for new, more effective pharmacotherapies in the treatment of schizophrenia. In the current study, patients suffering from schizophrenia and experiencing clinically significant symptoms of the disease will be included. In the current study, eligible patients will be randomised in a 2:1 ratio to blinded treatment with either Lu 31-130 (3, 5, 7, 10 or 14 mg/day) or placebo for 8 weeks. The study includes 5 parts with increasing doses of Lu 31-130 (Part A [3 mg/day], B [5 mg/day], C [7 mg/day], D [10 mg/day], and E [14 mg/day]). A decision to initiate Part B [5 mg/day of Lu 31-130], C [7 mg/day of Lu 31-130] or D [10 mg/day of Lu 31-130] will be based on safety and tolerability of the previous study part. Dependent on the safety, tolerability and PK data from Part D the study may proceed with Part E. The efficacy and the safety of Lu 31-130 will be evaluated in comparison to the pooled placebo group from all 5 study parts.
3,470 studies on the registry are indexed under Schizophrenia; 471 are open to participants now.
This study's enrollment of 280 is above the median of 70 across 2,871 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →H. Lundbeck A/S is the lead sponsor of 218 studies on the registry; 10 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 10 (30%) have results posted.
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Inclusion Criteria:
Drug: Zicronapine
Drug: Zicronapine
Drug: Zicronapine
Drug: Zicronapine
Drug: Zicronapine
Drug: Placebo
Study Part A: 3mg; orally, film-coated tablets, once daily, 8 weeks
Also known as: Lu 31-130
Study Part B: 5mg; orally, film-coated tablets, once daily, 8 weeks
Also known as: Lu 31-130
Study Part C: 7mg; orally, film-coated tablets, once daily, 8 weeks
Also known as: Lu 31-130
Study Part D: 2 x 5mg; orally, film-coated tablets, once daily, 8 weeks
Also known as: Lu 31-130
Study Part E: 2 x 7mg; orally, film-coated tablets, once daily, 8 weeks
Also known as: Lu 31-130
Study Part A, B, C, D and E: Placebo; orally, film-coated tablets, once daily, 8 weeks
Safety: Adverse events, clinical safety laboratory tests (including liver biochemistry tests), metabolic parameters (including blood lipids, blood glucose weight, waist circumference), abnormal movements
Time frame: 8
Efficacy: Change in the Positive and Negative Syndrome Scale (PANSS) score from baseline to Week 8 as compared to placebo, change from baseline in Clinical Global Impression/Improvement (CGI-S/I) scores as compared to placebo
Time frame: 8 weeks
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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H. Lundbeck A/S