Efficacy of Lu 31-130 in Patients With Schizophrenia
A Double-blind, Randomised, Parallel-group, Placebo-controlled Study of the Safety, Tolerability and Efficacy Following Sequential Dose Regimens of Lu 31-130 to Patients With Schizophrenia
2 other identifiers
interventional
280
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 schizophrenia
Started Mar 2007
Typical duration for phase_2 schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 7, 2008
CompletedFirst Posted
Study publicly available on registry
October 8, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedNovember 8, 2016
November 1, 2016
2.6 years
October 7, 2008
November 7, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety: Adverse events, clinical safety laboratory tests (including liver biochemistry tests), metabolic parameters (including blood lipids, blood glucose weight, waist circumference), abnormal movements
8
Secondary Outcomes (1)
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
8 weeks
Study Arms (6)
Zicronapine. Study Part A
EXPERIMENTALZicronapine. Study Part B
EXPERIMENTALZicronapine. Study Part C
EXPERIMENTALZicronapine. Study Part D
EXPERIMENTALZicronapine. Study Part E
EXPERIMENTAL2A, 2B, 2C, 2D, 2E
PLACEBO COMPARATORInterventions
Study Part A: 3mg; orally, film-coated tablets, once daily, 8 weeks
Study Part A, B, C, D and E: Placebo; orally, film-coated tablets, once daily, 8 weeks
Eligibility Criteria
You may qualify if:
- The patient has a primary diagnosis of schizophrenia
- The patient experiences clinically significant symptoms
- The patient did not experience an acute exacerbation requiring hospitalisation within the last 6 months
- The patient's medication has been stable for at least 4 weeks prior screening
- The subject has normal serum values of parameters associated with liver function
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H. Lundbeck A/Slead
Study Sites (1)
DE001
Munich, 80336, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Email contact via H. Lundbeck A/S
LundbeckClinicalTrials@lundbeck.com
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2008
First Posted
October 8, 2008
Study Start
March 1, 2007
Primary Completion
October 1, 2009
Study Completion
November 1, 2009
Last Updated
November 8, 2016
Record last verified: 2016-11