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The objective of this study is to evaluate the efficacy and safety of RP5063 relative to placebo for the treatment of schizophrenia or schizoaffective disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 15 mg RP5063 daily | Experimental | RP5063 15 mg once daily |
|
| 30 mg RP5063 daily | Experimental | RP5063 30 mg once daily |
|
| 50 mg RP5063 daily | Experimental | RP5063 50 mg once daily |
|
| Placebo | Placebo Comparator | Placebo once daily |
|
| aripiprazole | Active Comparator | aripiprazole 15 mg daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RP5063 | Drug | daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Schizophrenia Symptoms: Positive and Negative Syndrome Scale (PANSS) Total Score | PANSS total score comprises Positive (Delusions, Conceptual disorganization, Hallucinatory behavior, Excitement, Grandiosity, Suspiciousness/persecution, Hostility), Negative (Blunted affect, Emotional withdrawal, Poor rapport, Passive/apathetic social withdrawal, Difficulty in abstract thinking, Lack of spontaneity and flow of conversation, Stereotyped thinking), and General Psychopathology (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance) Scales. Scores are obtained by adding the ratings of each item in each scale. Range is 7-49 for Positive and Negative scores; 16-112 for General Psychopathology score; and 30-210 for Total score. Higher score reflects worse outcome; larger reduction from baseline reflects better outcome. | Baseline to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the Clinical Global Impression Scale - Severity (CGI-S) | Clinical Global Impression, Severity (CGI-S) is a single-item (7-point) scale that evaluates the overall severity of the subject's mental illness. Scores range from 1 (not ill at all) to 7 (among the most extremely ill). A reduction in score indicates an improvement in the subject's condition. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| M Cantillon | Fundacion REVIVA, Red de VIH del Valle del Cauca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reviva site | Philadelphia | Pennsylvania | 19039 | United States | ||
| Reviva site |
Subjects were screened over a period of 7 days in the site's in-patient facility. 270 subjects were recruited. Of these, 36 subjects did not meet the study eligibility criteria. Therefore, a total of 234 subjects were enrolled into the study.
270 Subjects with acute exacerbation Schizophrenia and Schizoaffective disorder were selected from multiple sites in USA, Moldova, India, Philippines and Malaysia between December 2011 and January 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | RP5063 15 mg | Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days. |
| FG001 | RP5063 30 mg | Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days. |
| FG002 | RP5063 50 mg | Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days. |
| FG003 | Aripiprazole 15 mg | Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days. |
| FG004 | Placebo | Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Baseline Analysis Population is the Safety Population (Total 233), which comprises all enrolled subjects (Total 234) who received at least one dose of study treatment. One Placebo subject was enrolled in the study but did not receive any study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | RP5063 15 mg | Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days. |
| BG001 | RP5063 30 mg | Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Measurement of Schizophrenia Symptoms: Positive and Negative Syndrome Scale (PANSS) Total Score | PANSS total score comprises Positive (Delusions, Conceptual disorganization, Hallucinatory behavior, Excitement, Grandiosity, Suspiciousness/persecution, Hostility), Negative (Blunted affect, Emotional withdrawal, Poor rapport, Passive/apathetic social withdrawal, Difficulty in abstract thinking, Lack of spontaneity and flow of conversation, Stereotyped thinking), and General Psychopathology (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance) Scales. Scores are obtained by adding the ratings of each item in each scale. Range is 7-49 for Positive and Negative scores; 16-112 for General Psychopathology score; and 30-210 for Total score. Higher score reflects worse outcome; larger reduction from baseline reflects better outcome. | The ITT population is comprised of participants who had received at least one dose of treatment, have baseline and at least one assessment of PANSS and CGI-S without major deviations at baseline. | Posted | Mean | Standard Deviation | scores on a scale | Baseline to Day 28 |
Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
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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 | RP5063 15 mg | Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated liver enzyme levels | Investigations | MedDRA (13.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marc Cantillon, M.D | Reviva Pharmaceuticals, Inc. | 408-960-2209 | mcantillon@revivapharma.com |
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000628491 | RP5063 |
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
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| placebo | Drug | daily |
|
| aripiprazole | Drug | daily |
|
|
| Baseline to Day 28 |
| Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Positive Subscale | The Positive Scale includes 7 Items (Delusions, Conceptual disorganization, Hallucinations, Hyperactivity, Grandiosity, Suspiciousness/persecution, Hostility) and is calculated by adding the subscale item scores to obtain results ranging from 7 to 49. A higher score reflects worse outcome and a larger reduction in the score from baseline reflects better treatment efficacy. | Baseline to Day 28 |
| Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Negative Subscale | The Negative Scale includes 7 items (Blunted affect, Emotional withdrawal, Poor rapport, Passive/apathetic social withdrawal, Difficulty in abstract thinking, Lack of spontaneity and flow of conversation, Stereotyped thinking) and is calculated by adding the negative subscale item scores to obtain results ranging from 7 to 49. Minimum score is 7, maximum score is 49. A higher score reflects worse outcome and a larger reduction in the score from baseline reflects better treatment efficacy. | Baseline to Day 28 |
| Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS General Psychopathology Subscale | The General Psychopathology Scale consists of 16 items (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance). The General Psychopathology score is obtained by adding the ratings of each item in the scale, with results ranging from 16 to 112. A higher score reflects worse outcome and a larger reduction in the score from baseline reflects better treatment efficacy. | Baseline to Day 28 |
| Bangalore |
| India |
| Reviva site | Chennai | India |
| Reviva site | Guntur | India |
| Reviva site | Jaipur | India |
| Reviva site | Kanpur | India |
| Reviva site | Lucknow | India |
| Reviva site | Mangalore | India |
| Reviva site | Johor Bahru | Malaysia |
| Reviva site | Kuala Lumpur | Malaysia |
| Reviva Site | Tanjung Rambutan | Malaysia |
| Reviva site | Chisinau | Moldova |
| Reviva site | Mandaluyong | Philippines |
| Reviva site | Mandurriao | Philippines |
| Reviva site | Subandaku | Philippines |
| Non-compliance |
|
| Abnormal laboratory findings |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| Adverse Event |
|
| Lack of Efficacy |
|
| Worsening of symptoms |
|
| Subject uncontrollable and abusive |
|
| Subject left hospital |
|
| BG002 | RP5063 50 mg | Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days. |
| BG003 | Aripiprazole 15 mg | Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days. |
| BG004 | Placebo | Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days. |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | RP5063 15 mg | Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days. |
| OG001 | RP5063 30 mg | Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days. |
| OG002 | RP5063 50 mg | Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days. |
| OG003 | Aripiprazole 15 mg | Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days. |
| OG004 | Placebo | Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days. |
|
|
| Secondary | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the Clinical Global Impression Scale - Severity (CGI-S) | Clinical Global Impression, Severity (CGI-S) is a single-item (7-point) scale that evaluates the overall severity of the subject's mental illness. Scores range from 1 (not ill at all) to 7 (among the most extremely ill). A reduction in score indicates an improvement in the subject's condition. | The ITT population is comprised of participants who had received at least one dose of treatment, have baseline and at least one assessment of PANSS and CGI-S without major deviations at baseline. | Posted | Mean | Standard Deviation | scores on a scale | Baseline to Day 28 |
|
|
|
| Secondary | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Positive Subscale | The Positive Scale includes 7 Items (Delusions, Conceptual disorganization, Hallucinations, Hyperactivity, Grandiosity, Suspiciousness/persecution, Hostility) and is calculated by adding the subscale item scores to obtain results ranging from 7 to 49. A higher score reflects worse outcome and a larger reduction in the score from baseline reflects better treatment efficacy. | The ITT population is comprised of participants who had received at least one dose of treatment, have baseline and at least one assessment of PANSS and CGI-S without major deviations at baseline. | Posted | Mean | Standard Deviation | scores on a scale | Baseline to Day 28 |
|
|
|
| Secondary | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Negative Subscale | The Negative Scale includes 7 items (Blunted affect, Emotional withdrawal, Poor rapport, Passive/apathetic social withdrawal, Difficulty in abstract thinking, Lack of spontaneity and flow of conversation, Stereotyped thinking) and is calculated by adding the negative subscale item scores to obtain results ranging from 7 to 49. Minimum score is 7, maximum score is 49. A higher score reflects worse outcome and a larger reduction in the score from baseline reflects better treatment efficacy. | The ITT population is comprised of participants who had receiving at least one dose of treatment, have baseline and at least one assessment of PANSS and CGI-S without major deviations at baseline. | Posted | Mean | Standard Deviation | scores on a scale | Baseline to Day 28 |
|
|
|
| Secondary | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS General Psychopathology Subscale | The General Psychopathology Scale consists of 16 items (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance). The General Psychopathology score is obtained by adding the ratings of each item in the scale, with results ranging from 16 to 112. A higher score reflects worse outcome and a larger reduction in the score from baseline reflects better treatment efficacy. | The ITT population is comprised of participants who had received at least one dose of treatment, have baseline and at least one assessment of PANSS and CGI-S without major deviations at baseline. | Posted | Mean | Standard Deviation | scores on a scale | Baseline to Day 28 |
|
|
|
| 1 |
| 58 |
| 29 |
| 58 |
| EG001 | RP5063 30 mg | Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days. | 1 | 59 | 30 | 59 |
| EG002 | RP5063 50 mg | Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days. | 1 | 58 | 37 | 58 |
| EG003 | Aripiprazole 15 mg | Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days. | 2 | 20 | 10 | 20 |
| EG004 | Placebo | Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days. | 0 | 38 | 23 | 38 |
| Sedation excessive | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Hyperprolactinaemia | Endocrine disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Oculogyric crisis | Eye disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Abscess limb | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Akathisia | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Burning sensation | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Extrapyramidal disorder | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Sedation | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Affective disorder | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Aggression | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Psychotic disorder | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Schizophrenia | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Social avoidant behavior | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
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| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Day 28 |
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| Day 28 |
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| Day 28 |
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| Day 28 |
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