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The primary purpose of this two-part study was to evaluate the safety and tolerability of SAGE-718 and its effects on cognitive, neuropsychiatric, and motor symptoms in participants with Parkinson's disease mild cognitive impairment (PD-MCI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: SAGE-718 3 mg | Experimental | Participants received SAGE-718 3 milligrams (mg) tablets, once daily with food in the morning for 14 days. |
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| Part B: SAGE-718 3 mg | Experimental | Participants received SAGE-718 3 mg tablets, once daily with food in the morning for 28 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAGE-718 | Drug | Oral tablets. |
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| Measure | Description | Time Frame |
|---|---|---|
| Part A: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) | An adverse event (AE) was any untoward medical occurrence in a participant administered with a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IP whether or not related to the product. An AE can include any undesirable medical condition, even if no study treatment has been administered. TEAEs were defined as an AE with an onset date on or after the date of the first dose of IP or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study. Percentages are rounded off to the nearest single decimal. | From first dose of study drug up to 28 days |
| Part B: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) | An AE was any untoward medical occurrence in a participant administered with a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IP whether or not related to the product. An AE can include any undesirable medical condition, even if no study treatment has been administered. TEAEs were defined as an AE with an onset date on or after the date of the first dose of IP or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study. Percentages are rounded off to the nearest single decimal. | From first dose of study drug up to 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Part A and B: Percentage of Participants With Clinically Significant Changes in Vital Sign Measurements | Vital signs included temperature, respiratory rate, heart rate (supine and standing), systolic blood pressure (supine and standing) and diastolic blood pressure (supine and standing). Percentage of participants with clinically significant change in vital signs measurements which were deemed clinically significant by the investigator were reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sage Investigational Site | Long Beach | California | 90806 | United States | ||
| Sage Investigational Site |
Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
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Participants were enrolled in the study at 4 investigative sites in the United States and took part in the study that ran from 31 July 2020 to 25 March 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A: SAGE-718 3 mg | Participants received SAGE-718 3 milligrams (mg) tablets, once daily with food in the morning for 14 days in Part A of study. |
| FG001 | Part B: SAGE-718 3 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part A (28 Days) |
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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 29, 2021 | Jul 20, 2023 |
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The study had two parts: Part A and Part B with unique participants for each study part. Part B was started after Part A was completed.
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| From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B |
| Part A and B: Percentage of Participants With Clinically Significant Changes in Laboratory Assessments | Laboratory tests assessments included hematology, biochemistry, coagulation and urinalysis. Percentage of participants with clinically significant change in laboratory assessments which were deemed clinically significant by the investigator were reported. | From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B |
| Part A and B: Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Measurements | Supine 12-lead ECGs were performed in triplicate and the standard intervals (heart rate, PR interval, QRS duration, QT interval, and corrected QT interval by Fridericia [QTcF]). Percentage of participants with clinically significant change in ECG measurements which were deemed clinically significant by the investigator were reported. | From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B |
| Part A and B: Percentage of Participants With a Response of 'Yes' to Any Suicidal Ideation or Suicidal Behaviors Item Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) | The C-SSRS scale consisted of a baseline evaluation (at screening) that assessed the lifetime experience of participants with suicidal ideation (SI) and suicidal behavior (SB) and a postbaseline evaluation that focused on suicidality since the last study visit. The C-SSRS included "yes" or "no"' responses for assessment of suicidal ideation and behavior as well as numeric ratings for the severity of ideation, if present (from 1 to 5, with 5 being the most severe). The C-SSRS SI items involved wish to be dead, non-specific active suicidal thoughts, active SI with any methods, active SI with some intent and active SI with a specific plan. The C-SSRS SB items involved preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt (non-fatal) and completed suicide. Percentage of participants with a response of 'yes' are reported for both suicidal ideation and behavior in this OM. | From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B |
| Port Charlotte |
| Florida |
| 33980 |
| United States |
| Sage Investigational Site | West Palm Beach | Florida | 33407 | United States |
| Sage Investigational Site | Chicago | Illinois | 60612 | United States |
Participants received SAGE-718 3 mg tablets, once daily with food in the morning for 28 days in Part B of study.
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| NOT COMPLETED |
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| Part B (42 Days) |
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Safety Set included all participants who were administered investigational product (IP).
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A: SAGE-718 3 mg | Participants received SAGE-718 3 mg tablets, once daily with food in the morning for 14 days in Part A of study. |
| BG001 | Part B: SAGE-718 3 mg | Participants received SAGE-718 3 mg tablets, once daily with food in the morning for 28 days in Part B of study. |
| BG002 | 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 (NIH/OMB) | 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 | Part A: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) | An adverse event (AE) was any untoward medical occurrence in a participant administered with a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IP whether or not related to the product. An AE can include any undesirable medical condition, even if no study treatment has been administered. TEAEs were defined as an AE with an onset date on or after the date of the first dose of IP or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study. Percentages are rounded off to the nearest single decimal. | Safety Set included all participants who were administered IP. | Posted | Number | percentage of participants | From first dose of study drug up to 28 days |
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| Primary | Part B: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) | An AE was any untoward medical occurrence in a participant administered with a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IP whether or not related to the product. An AE can include any undesirable medical condition, even if no study treatment has been administered. TEAEs were defined as an AE with an onset date on or after the date of the first dose of IP or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study. Percentages are rounded off to the nearest single decimal. | Safety Set included all participants who were administered IP. | Posted | Number | percentage of participants | From first dose of study drug up to 42 days |
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| Secondary | Part A and B: Percentage of Participants With Clinically Significant Changes in Vital Sign Measurements | Vital signs included temperature, respiratory rate, heart rate (supine and standing), systolic blood pressure (supine and standing) and diastolic blood pressure (supine and standing). Percentage of participants with clinically significant change in vital signs measurements which were deemed clinically significant by the investigator were reported. | Safety Set included all participants who were administered IP. | Posted | Number | percentage of participants | From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B |
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| Secondary | Part A and B: Percentage of Participants With Clinically Significant Changes in Laboratory Assessments | Laboratory tests assessments included hematology, biochemistry, coagulation and urinalysis. Percentage of participants with clinically significant change in laboratory assessments which were deemed clinically significant by the investigator were reported. | Safety Set included all participants who were administered IP. | Posted | Number | percentage of participants | From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B |
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| Secondary | Part A and B: Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Measurements | Supine 12-lead ECGs were performed in triplicate and the standard intervals (heart rate, PR interval, QRS duration, QT interval, and corrected QT interval by Fridericia [QTcF]). Percentage of participants with clinically significant change in ECG measurements which were deemed clinically significant by the investigator were reported. | Safety Set included all participants who were administered IP. | Posted | Number | percentage of participants | From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B |
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| Secondary | Part A and B: Percentage of Participants With a Response of 'Yes' to Any Suicidal Ideation or Suicidal Behaviors Item Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) | The C-SSRS scale consisted of a baseline evaluation (at screening) that assessed the lifetime experience of participants with suicidal ideation (SI) and suicidal behavior (SB) and a postbaseline evaluation that focused on suicidality since the last study visit. The C-SSRS included "yes" or "no"' responses for assessment of suicidal ideation and behavior as well as numeric ratings for the severity of ideation, if present (from 1 to 5, with 5 being the most severe). The C-SSRS SI items involved wish to be dead, non-specific active suicidal thoughts, active SI with any methods, active SI with some intent and active SI with a specific plan. The C-SSRS SB items involved preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt (non-fatal) and completed suicide. Percentage of participants with a response of 'yes' are reported for both suicidal ideation and behavior in this OM. | Safety Set included all participants who were administered IP. | Posted | Number | percentage of participants | From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B |
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From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B
Safety Set included all participants who were administered IP.
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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 | Part A: SAGE-718 3 mg | Participants received SAGE-718 3 mg tablets, once daily with food in the morning for 14 days in Part A of study. | 0 | 11 | 0 | 11 | 5 | 11 |
| EG001 | Part B: SAGE-718 3 mg | Participants received SAGE-718 3 mg tablets, once daily with food in the morning for 28 days in Part B of study. | 0 | 7 | 0 | 7 | 1 | 7 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Large intestine polyp | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
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| Asthenia | General disorders | MedDRA (23.0) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (23.0) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
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| Eye contusions | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
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| Skin laceration | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
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| Activated partial thromboplastin time prolonged | Investigations | MedDRA (23.0) | Systematic Assessment |
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| International normalized ratio increased | Investigations | MedDRA (23.0) | Systematic Assessment |
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| Leukocyturia | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
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| Parkinsonism | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
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The PI can either be a party and subject to the same restrictions as the institution, or if not a party, the restrictions are described on the face of the contract (i.e., PI is a contractor of the institution; PI is part of a larger group of study personnel; institution has contracted with or otherwise bound all study personnel under confidentiality obligations and requirements to vest intellectual property to the institution).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Monitor | Sage Therapeutics | (617) 299-8380 | info@sagerx.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 6, 2022 | May 9, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive 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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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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Participants received SAGE-718 3 mg tablets, once daily with food in the morning for 28 days in Part B of study.
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