Study of the Safety, Tolerability, and Pharmacokinetics of Once Weekly Zicronapine in Patients With Schizophrenia

NCT01377233 | Completed Phase 2 Results DMC

• 1 other identifier: 13946A
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 4

Brief Summary

The main purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of once weekly dosing of zicronapine, compared to daily dosing of zicronapine.

Conditions

Schizophrenia

Keywords

Schizophrenia; Antipsychotic; Zicronapine; Lu 31-310

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Adverse Events as a Measure of Safety and Tolerability

  Number of patients with treatment-emergent adverse events during each of the two study periods plus corresponding safety follow-up period. Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total)

  11 weeks for open-label period; 13 weeks for double-blind period

Secondary Outcomes (3)

• Positive and Negative Syndrome Scale (PANSS) Total and Subscales Change From Baseline

  8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period)

• Clinical Global Impression Severity Scale (CGI-S) Change From Baseline

  8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period)

• Clinical Global Impression Improvement Scale (CGI-I)

  8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period)

Study Arms (5)

Zicronapine open-label lead-in 10 mg daily

EXPERIMENTAL

Drug: Zicronapine open-label lead-in 10 mg daily

Zicronapine 10 mg daily

EXPERIMENTAL

Drug: Zicronapine 10 mg daily

Zicronapine 20 mg once weekly

EXPERIMENTAL

Drug: Zicronapine 20 mg once weekly

Zicronapine 30 mg once weekly

EXPERIMENTAL

Drug: Zicronapine 30 mg once weekly

Zicronapine 45 mg once weekly

EXPERIMENTAL

Drug: Zicronapine 45 mg once weekly

Interventions

Zicronapine open-label lead-in 10 mg daily DRUG

Encapsulated tablet ,10 mg, once daily, open-label

Also known as: Lu 31-130

Zicronapine open-label lead-in 10 mg daily

Zicronapine 10 mg daily DRUG

Encapsulated tablet, 10 mg, once daily, double-blind

Also known as: Lu 31-130

Zicronapine 10 mg daily

Zicronapine 20 mg once weekly DRUG

Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind

Also known as: Lu 31-130

Zicronapine 20 mg once weekly

Zicronapine 30 mg once weekly DRUG

Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind

Also known as: Lu 31-130

Zicronapine 30 mg once weekly

Zicronapine 45 mg once weekly DRUG

Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind

Also known as: Lu 31-130

Zicronapine 45 mg once weekly

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR)
• A score of \<=4 (moderately ill) on Clinical Global Impression - Severity of Illness (CGI-S) scale
• A total score \>=60 on Positive and Negative Syndrome Scale (PANSS)
• A score of \<=4 (moderate) on PANSS items: P7 (hostility) AND G8 (uncooperativeness)

You may not qualify if:

• Acute exacerbation requiring hospitalization within the last 3 months OR requiring change of antipsychotic medication within the last 4 weeks
• Diagnosis or history of substance dependence or substance abuse according to DSM-IV-TR within the last 3 months
• Significant risk of harming himself/herself or others
• Positive serology for hepatitis A, B, C, or HIV
• Present condition that might compromise liver function
• Medical or neurological disorder or treatment that could interfere with study treatment or compliance
• Previous exposure to zicronapine

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (4)

US002

Garden Grove, California, 92845, United States

Location

US003

National City, California, 91950, United States

Location

US004

San Diego, California, 92102, United States

Location

US001

Rockville, Maryland, 20850, United States

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Study director
• Organization: H. Lundbeck A/S

LundbeckClinicalTrials@Lundbeck.com

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2011
• First Posted: June 21, 2011
• Study Start: July 1, 2011
• Primary Completion: February 1, 2012
• Last Updated: March 22, 2016
• Results First Posted: March 22, 2016

Record last verified: 2016-02

Locations

US (4)