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| Name | Class |
|---|---|
| Cognitive Research Corporation | INDUSTRY |
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The objective of this study is to assess the safety and efficacy of 3 different doses of CTP-692 administered once daily (QD) for 12 weeks to adult participants with schizophrenia on stable dopaminergic antipsychotic medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants received CTP-692 matched-placebo powder for oral solution, once daily (QD) for up to 12 weeks. |
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| CTP-692 1 gram QD | Experimental | Participants received CTP-692 1 gram powder for oral solution, QD for up to 12 weeks. |
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| CTP-692 2 grams QD | Experimental | Participants received CTP-692 2 grams powder for oral solution, QD for up to 12 weeks. |
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| CTP-692 4 grams QD | Experimental | Participants received CTP-692 4 grams powder for oral solution, QD for up to 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTP-692 | Drug | Administered as powder for oral solution. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12 | PANSS measures symptom severity in participants with schizophrenia. PANSS includes 30 items (7 items for positive symptoms, 7 items for negative symptoms, and 16 items for general psychopathology symptoms), and each item is rated with 1 to 7 points. The PANSS is scored by summation of ratings across items such that the score ranges are 7 to 49 for each of the Positive and Negative Scales and 16 to 112 for the General Psychopathology Scale. The PANSS total score is a sum of scores from all the 30 items and the scores range from 30 to 210, where a higher score represents more severe symptoms, and lower scores represent a better quality of life in participants with schizophrenia. A negative change from baseline indicates low severity of symptoms. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 12 | The CGI-S rating scale is a commonly used measure of symptom severity and treatment response. CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment and the score ranges from 1 to 7: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. A higher score represents more severe symptoms. A negative change from baseline indicates low severity of symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Woodland International Research Group, LLC | Little Rock | Arkansas | 72211 | United States | ||
| Woodland Research Northwest, LLC |
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521 participants were screened, out of which 326 participants with schizophrenia who were on a stable dopaminergic antipsychotic medication were enrolled and randomized.
Participants were enrolled at study centers in the United States from 26 November 2019 to 22 December 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received CTP-692 matched-placebo powder for oral solution, once daily (QD) for up to 12 weeks. |
| FG001 | CTP-692 1 Gram QD | Participants received CTP-692 1 gram powder for oral solution, QD for up to 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 14, 2020 | Dec 4, 2023 |
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| Placebo | Drug | Administered as powder for oral solution. |
|
| Baseline, Week 12 |
| Change From Baseline in Personal and Social Performance (PSP) Scale at Week 12 | PSP scale is a measure of the personal and social functioning of participants with psychiatric disorders within four domains: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Each domain was assessed on a 6-point scale: 1 = absent, 2 = mild, 3 = manifest, 4 = marked, 5 = severe, and 6 = very severe. The final global score is defined according to a summary instruction table converting four domain scores into a single, overall rating from 1 to 100: 71 to 100 represent mild degree of difficulty; 31 to 70 represent varying degrees of disability, and 1 to 30 represent functioning so poorly as to require intensive supervision. Higher scores represent better personal and social function. A positive change from baseline indicates better personal and social function. | Baseline, Week 12 |
| Rogers |
| Arkansas |
| 72758 |
| United States |
| Synexus Clinical Research US, Inc. | Cerritos | California | 90703 | United States |
| ProScience Research Group | Culver City | California | 90230 | United States |
| Collaborative Neuroscience Network, LLC | Garden Grove | California | 92845 | United States |
| Synergy San Diego | Lemon Grove | California | 91945 | United States |
| Pacific Research Partners, LLC | Oakland | California | 94607 | United States |
| Collaborative Neuroscience Network, LLC | Torrance | California | 90502 | United States |
| Innovative Clinical Research, Inc. | Lauderhill | Florida | 33319 | United States |
| Behavioral Clinical Research, Inc. | North Miami | Florida | 33161 | United States |
| Synexus Clinical Research US, Inc. | Atlanta | Georgia | 30328 | United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | United States |
| Uptown Research Institute, LLC | Chicago | Illinois | 60640 | United States |
| Pillar Clinical Research, LLC | Lincolnwood | Illinois | 60712 | United States |
| CBH Health, LLC | Gaithersburg | Maryland | 20877 | United States |
| Arch Clinical Trials, LLC | St Louis | Missouri | 63118 | United States |
| Altea Research Institute | Las Vegas | Nevada | 89102 | United States |
| Hassman Research Institute | Berlin | New Jersey | 08009 | United States |
| Hassman Research Institute | Marlton | New Jersey | 08053 | United States |
| Neurobehavioral Research, Inc. | Cedarhurst | New York | 11516 | United States |
| Synexus Clinical Research US, Inc. | Jamaica | New York | 11432 | United States |
| Carolina Clinical Trials, Inc. | Charleston | South Carolina | 29407 | United States |
| Donald J. Garcia Jr., MD, PA | Austin | Texas | 78737 | United States |
| Community Clinical Research, Inc. | Austin | Texas | 78754 | United States |
| InSite Clinical Research, LLC | DeSoto | Texas | 75115 | United States |
| Pillar Clinical Research, LLC | Richardson | Texas | 75080 | United States |
| FG002 | CTP-692 2 Grams QD | Participants received CTP-692 2 grams powder for oral solution, QD for up to 12 weeks. |
| FG003 | CTP-692 4 Grams QD | Participants received CTP-692 4 grams powder for oral solution, QD for up to 12 weeks. |
| Safety Population | Safety population included all participants who received at least one dose of study medication. |
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| Efficacy Population | Efficacy population included all participants who received the study medication and had at least one available post-baseline Positive and Negative Syndrome Scale (PANSS) assessment. |
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| COMPLETED |
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| NOT COMPLETED |
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Safety population included all participants who received at least one dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received CTP-692 matched placebo powder for oral solution, QD for up to 12 weeks. |
| BG001 | CTP-692 1 Gram QD | Participants received CTP-692 1 gram powder for oral solution, QD for up to 12 weeks. |
| BG002 | CTP-692 2 Grams QD | Participants received CTP-692 2 grams powder for oral solution, QD for up to 12 weeks. |
| BG003 | CTP-692 4 Grams QD | Participants received CTP-692 4 grams powder for oral solution, QD for up to 12 weeks. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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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 | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12 | PANSS measures symptom severity in participants with schizophrenia. PANSS includes 30 items (7 items for positive symptoms, 7 items for negative symptoms, and 16 items for general psychopathology symptoms), and each item is rated with 1 to 7 points. The PANSS is scored by summation of ratings across items such that the score ranges are 7 to 49 for each of the Positive and Negative Scales and 16 to 112 for the General Psychopathology Scale. The PANSS total score is a sum of scores from all the 30 items and the scores range from 30 to 210, where a higher score represents more severe symptoms, and lower scores represent a better quality of life in participants with schizophrenia. A negative change from baseline indicates low severity of symptoms. | Efficacy population included all participants who received the study medication and had at least one available post-baseline PANSS assessment. 'Number of participants analyzed' indicates the number of participants with data available for analysis at the specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 12 |
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| Secondary | Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 12 | The CGI-S rating scale is a commonly used measure of symptom severity and treatment response. CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment and the score ranges from 1 to 7: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. A higher score represents more severe symptoms. A negative change from baseline indicates low severity of symptoms. | Efficacy population included all participants who received the study medication and had at least one available post-baseline PANSS assessment. 'Number of participants analyzed' indicates the number of participants with data available for analysis at the specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 12 |
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| Secondary | Change From Baseline in Personal and Social Performance (PSP) Scale at Week 12 | PSP scale is a measure of the personal and social functioning of participants with psychiatric disorders within four domains: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Each domain was assessed on a 6-point scale: 1 = absent, 2 = mild, 3 = manifest, 4 = marked, 5 = severe, and 6 = very severe. The final global score is defined according to a summary instruction table converting four domain scores into a single, overall rating from 1 to 100: 71 to 100 represent mild degree of difficulty; 31 to 70 represent varying degrees of disability, and 1 to 30 represent functioning so poorly as to require intensive supervision. Higher scores represent better personal and social function. A positive change from baseline indicates better personal and social function. | Efficacy population included all participants who received the study medication and had at least one available post-baseline PANSS assessment. 'Number of participants analyzed' indicates the number of participants with data available for analysis at the specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 12 |
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All-cause mortality: Screening up to the last follow-up visit (approximately 18 weeks); Adverse events: From the first dose of study medication up to the last follow-up visit (approximately 13 weeks)
All-cause mortality: All randomized participants included all participants who were randomized in the study.
Adverse events: Safety population included all participants who received at least one dose of study medication.
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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 | Placebo | Participants received CTP-692 matched placebo powder for oral solution, QD for up to 12 weeks. | 0 | 81 | 0 | 81 | 3 | 81 |
| EG001 | CTP-692 1 Gram QD | Participants received CTP-692 1 gram powder for oral solution, QD for up to 12 weeks. | 0 | 81 | 1 | 81 | 5 | 81 |
| EG002 | CTP-692 2 Grams QD | Participants received CTP-692 2 grams powder for oral solution, QD for up to 12 weeks. | 0 | 85 | 0 | 85 | 6 | 85 |
| EG003 | CTP-692 4 Grams QD | Participants received CTP-692 4 grams powder for oral solution, QD for up to 12 weeks. | 0 | 79 | 1 | 78 | 7 | 78 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| Psychotic disorder | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
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| Appendicectomy | Surgical and medical procedures | MedDRA 23.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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If an Investigator wants to publish study data or results, the publication or presentation must be provided to Concert for review at least 60 days in advance. If Concert needs to file a patent application prior to publication, the publication can be delayed up to 90 days from Sponsor providing notice to the investigator of such need.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Colleen E. Hamilton | Concert Pharmaceuticals, Inc. | 781-860-0045 | AAclinicaltrial_inquiries@concertpharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 2, 2020 | Dec 4, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Black or African American |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| Other |
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| Change From Baseline at Week 12 |
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| MMRM |
MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction. |
| 0.3920 |
| LS Mean Difference |
| 1.5 |
| Standard Error of the Mean |
| 1.8 |
| 2-Sided |
| 95 |
| -2.0 |
| 5.0 |
| Superiority |
| MMRM | MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction. | 0.1444 | LS Mean Difference | 2.6 | Standard Error of the Mean | 1.8 | 2-Sided | 95 | -0.9 | 6.0 | Superiority |
Participants received CTP-692 2 grams powder for oral solution, QD for up to 12 weeks. |
| OG003 | CTP-692 4 Grams QD | Participants received CTP-692 4 grams powder for oral solution, QD for up to 12 weeks. |
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| OG002 | CTP-692 2 Grams QD | Participants received CTP-692 2 grams powder for oral solution, QD for up to 12 weeks. |
| OG003 | CTP-692 4 Grams QD | Participants received CTP-692 4 grams powder for oral solution, QD for up to 12 weeks. |
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