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Parkinson DiseasePhase 2NCT04476017

A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Parkinson's Disease Mild Cognitive Impairment (PD-MCI)

A Phase 2 study testing SAGE-718 in people with Parkinson Disease and Cognitive Dysfunction, run by Supernus Pharmaceuticals, Inc. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 50 to 75 years
Conditions the study is for
Parkinson Disease, Cognitive Dysfunction
What is being tested?
SAGE-718
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
4 sitesUnited States
Study dates
31 Jul 2020to 25 Mar 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Meet the following criteria for PD-MCI: Have a confirmed diagnosis of idiopathic PD according to 2015 Movement Disorder Society (MDS) clinical diagnostic criteria; Meet MDS Task Force Criteria for MCI in PD.
  • Have a score of 20 to 25 (inclusive) on the Montreal Cognitive Assessment (MoCA) at Screening.
  • Meet criteria for Hoehn \& Yahr Stage I to III (mild to moderate motor severity) at Screening.
  • Have stable motor symptoms for at least 4 weeks prior to screening, in the opinion of the investigator.

Who cannot join

  • Have a diagnosis of dementia of any etiology, including but not limited to: Dementia associated with PD (probable or possible), Dementia with Lewy Bodies, Alzheimer's Dementia, and Vascular Dementia.
  • Have any indication of parkinsonism other than idiopathic PD.
  • In the opinion of the investigator, be experiencing unpredictable fluctuations in motor and/or nonmotor symptoms associated with PD.
  • Have an ongoing central nervous system condition other than idiopathic PD, including active neurologic and/or nonremitted psychiatric disorders, in the opinion of the investigator.
  • Have a history of brain surgery, deep brain stimulation, a significant head injury causing loss of consciousness greater than 30 minutes, or hospitalization due to a brain injury.
  • Have experienced significant psychotic symptoms within the past 3 months, including those associated with PD medications, as determined by the investigator.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Sage Investigational Site

    Chicago, Illinois, 60612

  • Sage Investigational Site

    Long Beach, California, 90806

  • Sage Investigational Site

    Port Charlotte, Florida, 33980

  • Sage Investigational Site

    West Palm Beach, Florida, 33407

Other trials in United States

About this study

Official title: An Open-Label Evaluation of the Safety and Tolerability of SAGE-718 in Participants With Parkinson's Disease Mild Cognitive Impairment

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).

Being tested
SAGE-718
Keywords
Parkinson's Disease, Cognitive Dysfunction, SAGE-718
Medical subject headings
Parkinson Disease, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAGE-718Drug

    Oral tablets.

Study groups in NCT04476017
Study groupRoleWhat they receive
Part A: SAGE-718 3 mgExperimentalParticipants received SAGE-718 3 milligrams (mg) tablets, once daily with food in the morning for 14 days.
Receives: Drug: SAGE-718
Part B: SAGE-718 3 mgExperimentalParticipants received SAGE-718 3 mg tablets, once daily with food in the morning for 28 days.
Receives: Drug: SAGE-718

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From first dose of study drug up to 28 days

  2. 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.

    Measured: From first dose of study drug up to 42 days

Secondary outcomes (4)

  1. 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.

    Measured: From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B

  2. 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.

    Measured: From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B

  3. 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.

    Measured: From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B

  4. 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.

    Measured: From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2020
  2. Study start31 Jul 2020
  3. Primary completion25 Mar 2022
  4. Study completion25 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
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.
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04476017
Sponsor's protocol ID
718-CNP-201
Status last verified
Jul 2023
First submitted
15 Jul 2020
Last updated
15 Sep 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SAGE-718 in people with Parkinson Disease and Cognitive Dysfunction, run by Supernus Pharmaceuticals, Inc. at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) (time frame: From first dose of study drug up to 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04476017.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.

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