Clinical trial NCT03000569: A Study to Evaluate SAGE-217 in Participants With Parkinson's Disease
Official title: A Phase 2, Two-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SAGE-217 in Subjects With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson Disease
Keywords: Parkinson's
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2016-12-22
Enrollment: 29
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study assesses the safety, tolerability, pharmacokinetics and efficacy of SAGE-217 in 29 participants with moderate to severe Parkinson's Disease.

Detailed description: Part A of the study is an open-label design with dosing of Levodopa for 3 days followed by SAGE-217 for 4 days.

Part B of the study is an open-label design with evening dosing of SAGE-217 for 7 days as an adjunct to antiparkinsonian agent(s).

This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.

Eligibility 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

Primary outcomes:
measure: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) - Part A
timeFrame: Day 1 to Day 14
measure: Percentage of Participants With TEAEs, Graded by Severity - Part A
timeFrame: Day 1 to Day 14
measure: Change From Baseline (CFB) in Basophils - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Basophils to Leukocytes Ratio [Percentage (%)] - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Eosinophils - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Eosinophils to Leukocytes Ratio (%) - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Erythrocytes - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Hematocrit - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Hemoglobin - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Leukocytes - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Lymphocytes - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Lymphocytes to Leukocytes Ratio (%) - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Monocytes - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Monocytes to Leukocytes Ratio (%) - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Neutrophils- Part A
timeFrame: Day 1 to Day 14
measure: CFB in Neutrophils to Leukocytes Ratio (%) - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Platelets - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Reticulocytes - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Reticulocytes to Erythrocytes Ratio (%) - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Activated Partial Thromboplastin Time - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Prothrombin International Normalized Ratio - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Prothrombin Time - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Alanine Aminotransferase - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Albumin - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Alkaline Phosphatase - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Aspartate Aminotransferase - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Bicarbonate - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Bilirubin - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Calcium - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Chloride - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Creatinine - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Lipase - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Magnesium - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Phosphate - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Potassium - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Protein - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Sodium - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Urate - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Urea Nitrogen - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Specific Gravity - Part A
timeFrame: Day 1 to Day 14
measure: CFB in pH - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Temperature - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Heart Rate - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Respiratory Rate - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Supine Systolic Blood Pressure - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Standing Systolic Blood Pressure - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Supine Diastolic Blood Pressure - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Standing Diastolic Blood Pressure - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Pulse Oximetry- Part A
timeFrame: Day 1 to Day 14
measure: CFB in Electrocardiogram (ECG) Mean Heart Rate - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Aggregate PR Interval - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Aggregate RR Interval - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Aggregate QT Interval - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Aggregate QRS Duration - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Aggregate QTcF Interval - Part A
timeFrame: Day 1 to Day 14
measure: CFB in Stanford Sleepiness Scale (SSS) Score - Part A
timeFrame: Day 1 to Day 14
measure: 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
timeFrame: Day 1 to Day 14
measure: CFB in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II/III Score - Part B
timeFrame: Baseline, Days 1 to 6 (12 and 23 hours postdose), Day 7 (12 hours postdose), Day 14
Secondary outcomes:
measure: MDS-UPDRS Part III Total Score - Part A
timeFrame: Days 1 to 7 (2, 4, 8, and 12 hours postdose), Day 8 and Day 14
measure: CFB in the MDS-UPDRS Part III Total Score - Part B
timeFrame: Baseline, Days 1 to 6 (12 and 23 hours postdose), Day 7 (12 hours postdose), Day 14
measure: CFB in the MDS-UPDRS Part I Total Score - Part B
timeFrame: Baseline, Day 7 (12 hours postdose), Day 14
measure: CFB in the MDS-UPDRS Part II Total Score - Part B
timeFrame: Baseline, Days 1 to 6 (12 and 23 hours postdose), Day 7 (12 hours postdose), Day 14
measure: CFB in the MDS-UPDRS Part I-IV Total Score - Part B
timeFrame: Baseline, Day 7 (12 hours postdose), Day 14
measure: Percentage of Participants With TEAEs - Part B
timeFrame: Day 1 to Day 14
measure: Percentage of Participants With TEAEs, Graded by Severity - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Basophils - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Basophils to Leukocytes Ratio (%) - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Eosinophils - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Eosinophils to Leukocytes Ratio (%) - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Erythrocytes - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Hematocrit - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Hemoglobin - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Leukocytes - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Lymphocytes - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Lymphocytes to Leukocytes Ratio (%) - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Monocytes - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Monocytes to Leukocytes Ratio (%) - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Neutrophils - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Neutrophils to Leukocytes Ratio (%) - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Platelets - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Reticulocytes - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Reticulocytes to Erythrocytes Ratio (%) - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Activated Partial Thromboplastin Time - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Prothrombin International Normalized Ratio - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Prothrombin Time - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Alanine Aminotransferase - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Albumin - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Alkaline Phosphatase - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Aspartate Aminotransferase - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Bicarbonate - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Bilirubin - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Calcium - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Chloride - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Creatinine - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Lipase - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Magnesium - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Phosphate - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Potassium - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Protein - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Sodium - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Urate - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Urea Nitrogen - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Specific Gravity - Part B
timeFrame: Day 1 to Day 14
measure: CFB in pH - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Temperature - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Heart Rate - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Respiratory Rate - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Supine Systolic Blood Pressure - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Standing Systolic Blood Pressure - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Supine Diastolic Blood Pressure - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Standing Diastolic Blood Pressure - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Pulse Oximetry - Part B
timeFrame: Day 1 to Day 14
measure: CFB in ECG Mean Heart Rate - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Aggregate PR Interval - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Aggregate RR Interval - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Aggregate QT Interval - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Aggregate QRS Duration - Part B
timeFrame: Day 1 to Day 14
measure: CFB in Aggregate QTcF Interval - Part B
timeFrame: Day 1 to Day 14
measure: Percentage of Participants With a Response of 'Yes' to Any C-SSRS Suicidal Ideation or Suicidal Behavior Item - Part B
timeFrame: Day 1 to Day 14
Other outcomes:
Locations:
city: Panorama City
country: United States
facility: Sage Investigational Site
state: California
city: Jacksonville
country: United States
facility: Sage Investigational Site
state: Florida
city: Miami
country: United States
facility: Sage Investigational Site
state: Florida
city: Miami
country: United States
facility: Sage Investigational Site
state: Florida
city: Orlando
country: United States
facility: Sage Investigational Site
state: Florida
city: Winter Park
country: United States
facility: Sage Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Sage Investigational Site
state: Georgia
city: Farmington Hills
country: United States
facility: Sage Investigational Site
state: Michigan
city: Berlin
country: United States
facility: Sage Investigational Site
state: New Jersey
city: Houston
country: United States
facility: Sage Investigational Site
state: Texas
city: Orem
country: United States
facility: Sage Investigational Site
state: Utah
Study officials:
References: