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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zicronapine open-label lead-in 10 mg daily | Experimental |
| |
| Zicronapine 10 mg daily | Experimental |
| |
| Zicronapine 20 mg once weekly | Experimental |
| |
| Zicronapine 30 mg once weekly | Experimental |
| |
| Zicronapine 45 mg once weekly | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zicronapine open-label lead-in 10 mg daily | Drug | Encapsulated tablet ,10 mg, once daily, open-label |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
Other inclusion and exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| US002 | Garden Grove | California | 92845 | United States | ||
| US003 |
46 patients were initially enrolled in a 3-week open-label study period. The 42 patients who completed the open-label period were subsequently randomized to a 5-week double-blind period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Zicronapine Open-label 10 mg Daily | Zicronapine open-label 10 mg daily: Encapsulated tablet ,10 mg, once daily, open-label |
| FG001 | Zicronapine Basis Dose 10 mg Daily | Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Open-label |
|
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| Zicronapine 10 mg daily | Drug | Encapsulated tablet, 10 mg, once daily, double-blind |
|
|
| Zicronapine 20 mg once weekly | Drug | Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind |
|
|
| Zicronapine 30 mg once weekly | Drug | Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind |
|
|
| Zicronapine 45 mg once weekly | Drug | Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind |
|
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| 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). | 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. | 8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period) |
| National City |
| California |
| 91950 |
| United States |
| US004 | San Diego | California | 92102 | United States |
| US001 | Rockville | Maryland | 20850 | United States |
| FG002 | Zicronapine Low Dose 20 mg Once Weekly | Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind |
| FG003 | Zicronapine Med Dose 30 mg Once Weekly | Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind |
| FG004 | Zicronapine High Dose 45 mg Once Weekly | Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind |
| COMPLETED |
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| NOT COMPLETED |
|
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| Double-blind |
|
|
Baseline characteristics for the 4 patients enrolled in the open-label period but not randomized to the double blinded period, are reported in the first (open-label) study arm. Baseline characteristics for the 42 patients who were subsequently randomized to the double-blind period are reported across the last four (randomized) study arms.
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| ID | Title | Description |
|---|---|---|
| BG000 | Zicronapine Open-label 10 mg Daily | Zicronapine open-label 10 mg daily: Encapsulated tablet ,10 mg, once daily, open-label |
| BG001 | Zicronapine 10 mg Daily | Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind |
| BG002 | Zicronapine 20 mg Once Weekly | Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind |
| BG003 | Zicronapine 30 mg Once Weekly | Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind |
| BG004 | Zicronapine 45 mg Once Weekly | Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Height | Mean | Standard Deviation | cm |
| |||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| BMI | Mean | Standard Deviation | kg/m2 |
| |||||||||||||||
| Waist circumference | Mean | Standard Deviation | cm |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | 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. | Posted | Number | participants | 11 weeks for open-label period; 13 weeks for double-blind period |
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| Secondary | 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). | All patients who were randomized to the double-blind study period, who took at least one dose of drug, and who had at least one valid PANSS assessment were included in the analysis. | Posted | Mean | Standard Error | units on a scale | 8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period) |
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| Secondary | 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). | All patients who were randomized to the double-blind study period, who took at least one dose of drug, and who had at least one valid PANSS assessment were included in the full analysis set (FAS) | Posted | Mean | Standard Error | units on a scale | 8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period) |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | All patients who were randomized to the double-blind study period, who took at least one dose of drug, and who had at least one valid PANSS assessment were included in the full analysis set (FAS) | Posted | Mean | Standard Deviation | units on a scale | 8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind 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)
Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zicronapine Open-label 10 mg Daily | Zicronapine open-label 10 mg daily: Encapsulated tablet ,10 mg, once daily, open-label | 0 | 46 | 8 | 46 | ||
| EG001 | Zicronapine Basis Dose 10 mg Daily | Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind | 0 | 11 | 8 | 11 | ||
| EG002 | Zicronapine Low Dose 20 mg Once Weekly | Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind | 1 | 10 | 4 | 10 | ||
| EG003 | Zicronapine Med Dose 30 mg Once Weekly | Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind | 1 | 11 | 4 | 11 | ||
| EG004 | Zicronapine High Dose 45 mg Once Weekly | Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind | 1 | 10 | 9 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Schizophrenia | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular Tachycardia | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
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| Abdominal Discomfort | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Non-Cardiac Chest Pain | General disorders | MedDRA (14.1) | Systematic Assessment |
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| Pain | General disorders | MedDRA (14.1) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Accidental Overdose | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
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| Limb Injury | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
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| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
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| Alanine Aminotransferase Increased | Investigations | MedDRA (14.1) | Systematic Assessment |
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| Aspartate Aminotransferase Increased | Investigations | MedDRA (14.1) | Systematic Assessment |
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| Weight Decreased | Investigations | MedDRA (14.1) | Systematic Assessment |
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| Weight Increased | Investigations | MedDRA (14.1) | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
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| Musculoskeletal Stiffness | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
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| Rheumatoid Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
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| Trismus | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
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| Sedation | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
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| Tardive Dyskinesia | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
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| Drug Abuse | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
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| Libido Decreased | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
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| Psychotic Disorder | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
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| Schizophrenia | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
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| Pruritus Generalised | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
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| Treatment Noncompliance | Social circumstances | MedDRA (14.1) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study director | H. Lundbeck A/S | LundbeckClinicalTrials@Lundbeck.com |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| Protocol Violation |
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| Withdrawal by Subject |
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| Administrative or other |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
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| More than one race |
|
| Unknown or Not Reported |
|
Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind |
| OG003 | Zicronapine High Dose 45 mg Once Weekly | Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind |
|
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| OG003 | Zicronapine High Dose 45 mg Once Weekly | Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind |
|
|
| OG003 | Zicronapine High Dose 45 mg Once Weekly | Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind |
|
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