The primary purpose of the study is to evaluate the safety and tolerability of SAGE-718 softgel lipid capsule in participants with Huntington's Disease (HD)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
153
Oral softgel lipid capsules
Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs)
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered 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 (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE with onset after the start of IP, or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study.
Time frame: Up to 24 months
Number of Participants With at Least One TEAE by Severity
A TEAE is defined as an AE with onset after the start of IP, or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study. Severity was assessed as: Mild: symptoms barely noticeable to participant or does not make participant uncomfortable; does not influence performance or functioning; prescription drug not ordinarily needed for relief of symptoms. Moderate: symptoms of a sufficient severity to make participant uncomfortable; performance of daily activity is influenced; participant is able to continue in study; treatment for symptoms may be needed. Severe: symptoms cause severe discomfort; symptoms cause incapacitation or significant impact on participant's daily life; severity may cause cessation of treatment with IP; treatment for symptoms may be given and/or participant hospitalized. Participant with multiple instances of events is counted only once using maximum intensity.
Time frame: Up to 24 months
Number of Participants Who Withdrew From Study Due to TEAEs
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered 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 (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. A TEAE is defined as any AE with onset or after the start of IP or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study.
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Sage Investigational Site
Birmingham, Alabama, United States
Sage Investigational Site
Little Rock, Arkansas, United States
Sage Investigational Site
La Jolla, California, United States
Sage Investigational Site
Los Alamitos, California, United States
Sage Investigational Site
Los Angeles, California, United States
Sage Investigational Site
Sacramento, California, United States
Sage Investigational Site
Englewood, Colorado, United States
Sage Investigational Site
Washington D.C., District of Columbia, United States
Sage Investigational Site
Boca Raton, Florida, United States
Sage Investigational Site
Tampa, Florida, United States
...and 33 more locations
Time frame: Up to 24 months
Change From Baseline in Vital Signs: Blood Pressure
Vital signs parameter for blood pressure included systolic blood pressure (supine), systolic blood pressure (standing 1 minute), systolic blood pressure (standing 3 minutes), diastolic blood pressure (supine), diastolic blood pressure (standing 1 minute), and diastolic blood pressure (standing 3 minutes). Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline; Last Value on Study (up to 24 months)
Change From Baseline in Vital Signs: Heart Rate
Vital signs for heart rate included heart rate (supine), heart rate (standing 1 minute), and heart rate (standing 3 minute). Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline, Last value on study (up to 24 months)
Change From Baseline in Vital Signs: Respiratory Rate
Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline; Last value on study (up to 24 months)
Change From Baseline in Vital Signs: Temperature
Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline, Last value on study (up to 24 months)
Change From Baseline in Clinical Laboratory Parameters: Hematology - Basophils, Eosinophils, Erythrocytes, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets
Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline; Last value on study (up to 24 months)
Change From Baseline in Clinical Laboratory Parameters: Hematology- Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes
Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline, Last value on study (up to 24 months)
Change From Baseline in Clinical Laboratory Parameters: Hematology- Erythrocytes (Ery.) Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin
Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline, Last value on study (up to 24 months)
Change From Baseline in Clinical Laboratory Parameters: Hematology - Erythrocytes Mean Corpuscular Hemoglobin
Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline; Last value on study (up to 24 months)
Change From Baseline in Clinical Laboratory Parameters: Hematology - Erythrocytes Mean Corpuscular Volume
Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline, Last value on study (up to 24 months)
Change From Baseline in Clinical Laboratory Parameters: Hematology - Hematocrit
Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline, Last value on study (up to 24 months)
Change From Baseline in Clinical Laboratory Parameters: Biochemistry- Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase
Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline, Last value on study (up to 24 months)
Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen
HDL= high-density lipoprotein LDL= low-density lipoprotein Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline; Last value on study (up to 24 months)
Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Albumin and Protein
Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline; Last value on study (up to 24 months)
Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin
Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline; Last value on study (up to 24 months)
Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Thyrotropin
Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline; Last value on study (up to 24 months)
Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Thyroxine Free, Triiodothyronine Free
Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline; Last value on study (up to 24 months)
Change From Baseline in Clinical Laboratory Parameters: Urinalysis- Erythrocytes in Urine, Leukocytes in Urine, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells
Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline; Last value on study (up to 24 months)
Change From Baseline in Clinical Laboratory Parameters: Urinalysis- Hyaline Casts
Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline; Last value on study (up to 24 months)
Change From Baseline in Clinical Laboratory Parameters: Urinalysis- pH
Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline; Last value on study (up to 24 months)
Change From Baseline in Clinical Laboratory Parameters: Coagulation- Activated Partial Thromboplastin Time, Prothrombin Time
Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline; Last value on study (up to 24 months)
Change From Baseline in Clinical Laboratory Parameters: Coagulation- Prothrombin International (Intl) Normalized Ratio
Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline; Last value on study (up to 24 months)
Change From Baseline in Electrocardiograms (ECGs) Parameters: Mean Heart Rate
Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline; Last value on study (up to 24 months)
Change From Baseline in ECG Parameters - PR Interval Aggregate, QRS Duration Aggregate, QT Interval Aggregate and QTcF Interval Aggregate
Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline; Last value on study (up to 24 months)
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses
Columbia Suicide Severity Rating Scale evaluates and assesses the lifetime experience of participants with suicidal ideation (SI) and suicidal behavior (SB) and post-baseline evaluation that focuses on suicidality since last study visit. C-SSRS includes "yes" or "no"' responses for assessment of SI and SB as well as numeric ratings for severity of ideation. If present \[from 1 (minor physical damage) to 5 (death), with 5 being most severe\]. If any of the available assessments in suicidal behavior is Yes, the category is considered as 'Suicidal behavior'. If any of these available assessments in suicidal ideation is Yes but all available assessments in suicidal behavior is NO, the category is considered as 'Suicidal Ideation'. Data is reported for only those timepoints where there was a change in assessment (response) from Baseline. Baseline is the worst of assessments done in any question in SI/SB prior to first dose of IP, excluding lifetime assessment.
Time frame: Day 30, Day 60, Day 90, Day 365, Day 395, Safety Follow-up (up to 24 months)