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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 11 December 2023
Main ID:  NCT03000569
Date of registration: 28/11/2016
Prospective Registration: Yes
Primary sponsor: Biogen
Public title: A Study to Evaluate SAGE-217 in Participants With Parkinson's Disease
Scientific title: A Phase 2, Two-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SAGE-217 in Subjects With Parkinson's Disease
Date of first enrolment: November 30, 2016
Target sample size: 29
Recruitment status: Completed
URL:  https://clinicaltrials.gov/ct2/show/NCT03000569
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Key inclusion & exclusion criteria

Inclusion Criteria:

- Participant has a diagnosis of idiopathic Parkinson's Disease (Hoehn and Yahr Stage 2
or Stage 3) with a duration of less than 7 years prior to screening [Part A]

- Participant has a diagnosis of idiopathic Parkinson's Disease (Hoehn and Yahr Stage
1-4, assessed during the "on" period) [Part B]

- Participant is on a stable dose (at least 1 month prior to baseline visit) of an
antiparkinsonian agent and is willing to remain on this dose for the duration of the
study

Exclusion Criteria:

- Participant has early (Hoehn and Yahr Stage 1) or advanced (Hoehn and Yahr Stage 4 or
Stage 5) Parkinson's Disease [Part A]

- Participant has advanced (Hoehn and Yahr Stage 5) Parkinson's Disease [Part B]

- Participant with presence of drug-induced parkinsonism, metabolic identified
neurogenetic disorders, encephalitis, or other atypical Parkinsonian syndromes

- Participant with medical history of electroconvulsive therapy or stereotaxic brain
surgery for Parkinson's Disease

- Participant with medical history of suicide attempt within 2 years of screening or
current suicidal ideation

- Participant with medical history of impulse control disorder



Age minimum: 40 Years
Age maximum: 75 Years
Gender: All
Health Condition(s) or Problem(s) studied
Parkinson Disease
Intervention(s)
Drug: Levodopa
Drug: Antiparkinsonian Agent(s)
Drug: SAGE-217
Primary Outcome(s)
CFB in Activated Partial Thromboplastin Time - Part A [Time Frame: Day 1 to Day 14]
CFB in Aggregate QRS Duration - Part A [Time Frame: Day 1 to Day 14]
CFB in Eosinophils to Leukocytes Ratio (%) - Part A [Time Frame: Day 1 to Day 14]
CFB in Lipase - Part A [Time Frame: Day 1 to Day 14]
CFB in Lymphocytes to Leukocytes Ratio (%) - Part A [Time Frame: Day 1 to Day 14]
CFB in Standing Diastolic Blood Pressure - Part A [Time Frame: Day 1 to Day 14]
CFB in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II/III Score - Part B [Time Frame: Baseline, Days 1 to 6 (12 and 23 hours postdose), Day 7 (12 hours postdose), Day 14]
Percentage of Participants With a Response of 'Yes' to Any Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation or Suicidal Behavior Item - Part A [Time Frame: Day 1 to Day 14]
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) - Part A [Time Frame: Day 1 to Day 14]
CFB in Bilirubin - Part A [Time Frame: Day 1 to Day 14]
CFB in Creatinine - Part A [Time Frame: Day 1 to Day 14]
CFB in Heart Rate - Part A [Time Frame: Day 1 to Day 14]
CFB in Phosphate - Part A [Time Frame: Day 1 to Day 14]
CFB in Potassium - Part A [Time Frame: Day 1 to Day 14]
CFB in Sodium - Part A [Time Frame: Day 1 to Day 14]
CFB in Standing Systolic Blood Pressure - Part A [Time Frame: Day 1 to Day 14]
CFB in Stanford Sleepiness Scale (SSS) Score - Part A [Time Frame: Day 1 to Day 14]
CFB in Aggregate PR Interval - Part A [Time Frame: Day 1 to Day 14]
CFB in Aggregate QT Interval - Part A [Time Frame: Day 1 to Day 14]
CFB in Monocytes - Part A [Time Frame: Day 1 to Day 14]
CFB in Protein - Part A [Time Frame: Day 1 to Day 14]
CFB in Aspartate Aminotransferase - Part A [Time Frame: Day 1 to Day 14]
CFB in Basophils to Leukocytes Ratio [Percentage (%)] - Part A [Time Frame: Day 1 to Day 14]
CFB in Electrocardiogram (ECG) Mean Heart Rate - Part A [Time Frame: Day 1 to Day 14]
CFB in Hematocrit - Part A [Time Frame: Day 1 to Day 14]
CFB in Platelets - Part A [Time Frame: Day 1 to Day 14]
CFB in Prothrombin International Normalized Ratio - Part A [Time Frame: Day 1 to Day 14]
CFB in Supine Diastolic Blood Pressure - Part A [Time Frame: Day 1 to Day 14]
CFB in Calcium - Part A [Time Frame: Day 1 to Day 14]
CFB in Erythrocytes - Part A [Time Frame: Day 1 to Day 14]
CFB in pH - Part A [Time Frame: Day 1 to Day 14]
CFB in Aggregate QTcF Interval - Part A [Time Frame: Day 1 to Day 14]
CFB in Alanine Aminotransferase - Part A [Time Frame: Day 1 to Day 14]
CFB in Alkaline Phosphatase - Part A [Time Frame: Day 1 to Day 14]
CFB in Eosinophils - Part A [Time Frame: Day 1 to Day 14]
CFB in Leukocytes - Part A [Time Frame: Day 1 to Day 14]
CFB in Magnesium - Part A [Time Frame: Day 1 to Day 14]
CFB in Respiratory Rate - Part A [Time Frame: Day 1 to Day 14]
CFB in Temperature - Part A [Time Frame: Day 1 to Day 14]
CFB in Urate - Part A [Time Frame: Day 1 to Day 14]
CFB in Urea Nitrogen - Part A [Time Frame: Day 1 to Day 14]
Change From Baseline (CFB) in Basophils - Part A [Time Frame: Day 1 to Day 14]
CFB in Aggregate RR Interval - Part A [Time Frame: Day 1 to Day 14]
CFB in Albumin - Part A [Time Frame: Day 1 to Day 14]
CFB in Monocytes to Leukocytes Ratio (%) - Part A [Time Frame: Day 1 to Day 14]
CFB in Neutrophils- Part A [Time Frame: Day 1 to Day 14]
CFB in Reticulocytes - Part A [Time Frame: Day 1 to Day 14]
CFB in Specific Gravity - Part A [Time Frame: Day 1 to Day 14]
CFB in Pulse Oximetry- Part A [Time Frame: Day 1 to Day 14]
Percentage of Participants With TEAEs, Graded by Severity - Part A [Time Frame: Day 1 to Day 14]
CFB in Bicarbonate - Part A [Time Frame: Day 1 to Day 14]
CFB in Chloride - Part A [Time Frame: Day 1 to Day 14]
CFB in Hemoglobin - Part A [Time Frame: Day 1 to Day 14]
CFB in Lymphocytes - Part A [Time Frame: Day 1 to Day 14]
CFB in Neutrophils to Leukocytes Ratio (%) - Part A [Time Frame: Day 1 to Day 14]
CFB in Prothrombin Time - Part A [Time Frame: Day 1 to Day 14]
CFB in Reticulocytes to Erythrocytes Ratio (%) - Part A [Time Frame: Day 1 to Day 14]
CFB in Supine Systolic Blood Pressure - Part A [Time Frame: Day 1 to Day 14]
Secondary Outcome(s)
CFB in Aggregate RR Interval - Part B [Time Frame: Day 1 to Day 14]
CFB in Bilirubin - Part B [Time Frame: Day 1 to Day 14]
CFB in Monocytes to Leukocytes Ratio (%) - Part B [Time Frame: Day 1 to Day 14]
CFB in Reticulocytes - Part B [Time Frame: Day 1 to Day 14]
CFB in Urea Nitrogen - Part B [Time Frame: Day 1 to Day 14]
CFB in Alanine Aminotransferase - Part B [Time Frame: Day 1 to Day 14]
CFB in Aspartate Aminotransferase - Part B [Time Frame: Day 1 to Day 14]
CFB in ECG Mean Heart Rate - Part B [Time Frame: Day 1 to Day 14]
CFB in Eosinophils to Leukocytes Ratio (%) - Part B [Time Frame: Day 1 to Day 14]
CFB in Specific Gravity - Part B [Time Frame: Day 1 to Day 14]
CFB in Supine Diastolic Blood Pressure - Part B [Time Frame: Day 1 to Day 14]
CFB in Aggregate PR Interval - Part B [Time Frame: Day 1 to Day 14]
CFB in Aggregate QRS Duration - Part B [Time Frame: Day 1 to Day 14]
CFB in Eosinophils - Part B [Time Frame: Day 1 to Day 14]
CFB in Leukocytes - Part B [Time Frame: Day 1 to Day 14]
CFB in Monocytes - Part B [Time Frame: Day 1 to Day 14]
CFB in Phosphate - Part B [Time Frame: Day 1 to Day 14]
CFB in Potassium - Part B [Time Frame: Day 1 to Day 14]
CFB in Standing Diastolic Blood Pressure - Part B [Time Frame: Day 1 to Day 14]
CFB in Supine Systolic Blood Pressure - Part B [Time Frame: Day 1 to Day 14]
CFB in the MDS-UPDRS Part II Total Score - Part B [Time Frame: Baseline, Days 1 to 6 (12 and 23 hours postdose), Day 7 (12 hours postdose), Day 14]
CFB in Bicarbonate - Part B [Time Frame: Day 1 to Day 14]
CFB in Neutrophils - Part B [Time Frame: Day 1 to Day 14]
CFB in Creatinine - Part B [Time Frame: Day 1 to Day 14]
CFB in Heart Rate - Part B [Time Frame: Day 1 to Day 14]
CFB in Aggregate QTcF Interval - Part B [Time Frame: Day 1 to Day 14]
CFB in Alkaline Phosphatase - Part B [Time Frame: Day 1 to Day 14]
CFB in Albumin - Part B [Time Frame: Day 1 to Day 14]
CFB in Chloride - Part B [Time Frame: Day 1 to Day 14]
CFB in Activated Partial Thromboplastin Time - Part B [Time Frame: Day 1 to Day 14]
CFB in Aggregate QT Interval - Part B [Time Frame: Day 1 to Day 14]
Percentage of Participants With TEAEs - Part B [Time Frame: Day 1 to Day 14]
CFB in Lymphocytes to Leukocytes Ratio (%) - Part B [Time Frame: Day 1 to Day 14]
CFB in Neutrophils to Leukocytes Ratio (%) - Part B [Time Frame: Day 1 to Day 14]
CFB in Platelets - Part B [Time Frame: Day 1 to Day 14]
CFB in Standing Systolic Blood Pressure - Part B [Time Frame: Day 1 to Day 14]
CFB in Temperature - Part B [Time Frame: Day 1 to Day 14]
CFB in the MDS-UPDRS Part I Total Score - Part B [Time Frame: Baseline, Day 7 (12 hours postdose), Day 14]
CFB in the MDS-UPDRS Part III Total Score - Part B [Time Frame: Baseline, Days 1 to 6 (12 and 23 hours postdose), Day 7 (12 hours postdose), Day 14]
MDS-UPDRS Part III Total Score - Part A [Time Frame: Days 1 to 7 (2, 4, 8, and 12 hours postdose), Day 8 and Day 14]
Percentage of Participants With a Response of 'Yes' to Any C-SSRS Suicidal Ideation or Suicidal Behavior Item - Part B [Time Frame: Day 1 to Day 14]
Percentage of Participants With TEAEs, Graded by Severity - Part B [Time Frame: Day 1 to Day 14]
CFB in Hematocrit - Part B [Time Frame: Day 1 to Day 14]
CFB in Lipase - Part B [Time Frame: Day 1 to Day 14]
CFB in pH - Part B [Time Frame: Day 1 to Day 14]
CFB in Protein - Part B [Time Frame: Day 1 to Day 14]
CFB in Prothrombin Time - Part B [Time Frame: Day 1 to Day 14]
CFB in Urate - Part B [Time Frame: Day 1 to Day 14]
CFB in Basophils to Leukocytes Ratio (%) - Part B [Time Frame: Day 1 to Day 14]
CFB in Hemoglobin - Part B [Time Frame: Day 1 to Day 14]
CFB in Magnesium - Part B [Time Frame: Day 1 to Day 14]
CFB in Prothrombin International Normalized Ratio - Part B [Time Frame: Day 1 to Day 14]
CFB in Pulse Oximetry - Part B [Time Frame: Day 1 to Day 14]
CFB in Respiratory Rate - Part B [Time Frame: Day 1 to Day 14]
CFB in Basophils - Part B [Time Frame: Day 1 to Day 14]
CFB in Calcium - Part B [Time Frame: Day 1 to Day 14]
CFB in Reticulocytes to Erythrocytes Ratio (%) - Part B [Time Frame: Day 1 to Day 14]
CFB in Sodium - Part B [Time Frame: Day 1 to Day 14]
CFB in Erythrocytes - Part B [Time Frame: Day 1 to Day 14]
CFB in Lymphocytes - Part B [Time Frame: Day 1 to Day 14]
CFB in the MDS-UPDRS Part I-IV Total Score - Part B [Time Frame: Baseline, Day 7 (12 hours postdose), Day 14]
Secondary ID(s)
217-PRK-201
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 23/11/2020
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT03000569
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