SchizophreniaPhase 2NCT01377233

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

A Phase 2 study testing Zicronapine open-label lead-in 10 mg daily, Zicronapine 10 mg daily and Zicronapine 20 mg once weekly in people with Schizophrenia, run by H. Lundbeck A/S at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Schizophrenia
What is being tested?: Zicronapine open-label lead-in 10 mg daily, Zicronapine 10 mg daily and Zicronapine 20 mg once weekly
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 4 sitesUnited States
Study dates: Jul 2011to Feb 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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
Other inclusion and exclusion criteria may apply.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

US002
Garden Grove, California, 92845
US003
National City, California, 91950
US001
Rockville, Maryland, 20850
US004
San Diego, California, 92102

Other trials in United States

About this study

Official title: A Randomised, Double-blind, Parallel-group, Explorative Study of the Safety, Tolerability, and Pharmacokinetics of Daily Dosing Compared to Weekly Dosing of Zicronapine in Patients With Schizophrenia

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.

Read the detailed description

The study includes 2 treatment periods. The open-label run-in period will begin at patient enrolment and continue for 3 weeks, during which all patients will receive once daily treatment with zicronapine. The double-blind period will begin at patient randomization and continue for 5 weeks, during which the patients will be assigned to one group receiving once daily treatment with zicronapine and 3 groups receiving once weekly treatment with zicronapine.

Conditions: Schizophrenia
Being tested: Zicronapine open-label lead-in 10 mg daily, Zicronapine 10 mg daily, Zicronapine 20 mg once weekly, Zicronapine 30 mg once weekly, Zicronapine 45 mg once weekly
Keywords: Schizophrenia, Antipsychotic, Zicronapine, Lu 31-310
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Zicronapine open-label lead-in 10 mg dailyDrug
Also called Lu 31-130
Encapsulated tablet ,10 mg, once daily, open-label
Zicronapine 10 mg dailyDrug
Also called Lu 31-130
Encapsulated tablet, 10 mg, once daily, double-blind
Zicronapine 20 mg once weeklyDrug
Also called Lu 31-130
Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
Zicronapine 30 mg once weeklyDrug
Also called Lu 31-130
Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
Zicronapine 45 mg once weeklyDrug
Also called Lu 31-130
Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind

Study groups in NCT01377233
Study group	Role	What they receive
Zicronapine open-label lead-in 10 mg daily	Experimental	Not described Receives: Drug: Zicronapine open-label lead-in 10 mg daily
Zicronapine 10 mg daily	Experimental	Not described Receives: Drug: Zicronapine 10 mg daily
Zicronapine 20 mg once weekly	Experimental	Not described Receives: Drug: Zicronapine 20 mg once weekly
Zicronapine 30 mg once weekly	Experimental	Not described Receives: Drug: Zicronapine 30 mg once weekly
Zicronapine 45 mg once weekly	Experimental	Not described Receives: Drug: Zicronapine 45 mg once weekly

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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
The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 that indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. The PANSS total score was the sum of the rating scores for 7 positive subscale items, 7 negative subscale items, and 16 general psychopathology subscale items from the PANSS panel. PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
Measured: 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
The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses their clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).
Measured: 8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period)
Clinical Global Impression Improvement Scale (CGI-I)
The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment is made independent of whether the rater believes the improvement is drug-related or not.
Measured: 8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2011Feb 2012

First posted21 Jun 2011 (estimated)
Study startJul 2011
Primary completionFeb 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SchizophreniaStudies of the same condition, open and under way.
More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01377233
Sponsor's protocol ID: 13946A
Status last verified: Feb 2016
First submitted: 20 Jun 2011
Last updated: 22 Mar 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-blind, Parallel-group, Explorative Study of the Safety, Tolerability, and Pharmacokinetics of Daily Dosing Compared to Weekly Dosing of Zicronapine in Patients With Schizophrenia
ClinicalTrials.gov ID: NCT01377233
Acronym / sponsor ID: 13946A
Conditions: Schizophrenia
Keywords: Schizophrenia, Antipsychotic, Zicronapine, Lu 31-310
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: H. Lundbeck A/SIndustry (pharma, biotech, devices)
Study start: Jul 2011
Primary completion: Feb 2012 (actual)
First posted: 21 Jun 2011 (estimated)
Results: Posted 22 Mar 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
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

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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)

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Zicronapine open-label lead-in 10 mg dailyAlso: Lu 31-130Encapsulated tablet ,10 mg, once daily, open-label	Drug	Zicronapine open-label lead-in 10 mg daily
Zicronapine 10 mg dailyAlso: Lu 31-130Encapsulated tablet, 10 mg, once daily, double-blind	Drug	Zicronapine 10 mg daily
Zicronapine 20 mg once weeklyAlso: Lu 31-130Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind	Drug	Zicronapine 20 mg once weekly
Zicronapine 30 mg once weeklyAlso: Lu 31-130Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind	Drug	Zicronapine 30 mg once weekly
Zicronapine 45 mg once weeklyAlso: Lu 31-130Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind	Drug	Zicronapine 45 mg once weekly

Primary outcome

Number of Patients With Adverse Events as a Measure of Safety and Tolerability
Time frame: 11 weeks for open-label period; 13 weeks for double-blind period
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)

3 secondary outcomes

Positive and Negative Syndrome Scale (PANSS) Total and Subscales Change From Baseline
Time frame: 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
Time frame: 8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period)
Clinical Global Impression Improvement Scale (CGI-I)
Time frame: 8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period)

Results and safety

Results posted to the registry on 22 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Zicronapine Open-label 10 mg Daily	46	42
Zicronapine Basis Dose 10 mg Daily	0	0
Zicronapine Low Dose 20 mg Once Weekly	0	0
Zicronapine Med Dose 30 mg Once Weekly	0	0
Zicronapine High Dose 45 mg Once Weekly	0	0

Primary outcome: Number of Patients With Adverse Events as a Measure of Safety and Tolerability

Time frame: 11 weeks for open-label period; 13 weeks for double-blind period. Number. Unit: participants

Measure	Zicronapine Open-label 10 mg Daily n = 46	Zicronapine Basis Dose 10 mg Daily n = 11	Zicronapine Low Dose 20 mg Once Weekly n = 10	Zicronapine Med Dose 30 mg Once Weekly n = 11	Zicronapine High Dose 45 mg Once Weekly n = 10
Value	12	8	4	4	9

Population analysed: Adverse events for the 46 patients enrolled in the open-label period are reported in the first (open-label) study arm. Adverse events for the 42 patients (out of the 46 enrolled) who were subsequently randomized to the double-blind period are reported across the last four (randomized) study arms.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Zicronapine Open-label 10 mg Daily	0 of 46 (0%)	8 of 46 (17.4%)	Not reported
Zicronapine Basis Dose 10 mg Daily	0 of 11 (0%)	8 of 11 (72.7%)	Not reported
Zicronapine Low Dose 20 mg Once Weekly	1 of 10 (10%)	4 of 10 (40%)	Not reported
Zicronapine Med Dose 30 mg Once Weekly	1 of 11 (9.1%)	4 of 11 (36.4%)	Not reported
Zicronapine High Dose 45 mg Once Weekly	1 of 10 (10%)	9 of 10 (90%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Email contact via H. Lundbeck A/S study director

LundbeckClinicalTrials@lundbeck.com

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Adverse Events as a Measure of Safety and Tolerability (time frame: 11 weeks for open-label period; 13 weeks for double-blind period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01377233.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2016.