A Study to Evaluate SAGE-217 in Participants With Parkinson's Disease

Biogen

Status and phase: Completed; Phase 2

Conditions: Parkinson Disease

Treatments: Drug: Antiparkinsonian Agent(s); Drug: SAGE-217; Drug: Levodopa

Study type: Interventional

Funder types: Industry

Identifiers

NCT03000569

217-PRK-201

Details and patient eligibility

About

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

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

Part A: Antiparkinsonian Agent(s) Followed by SAGE-217

Experimental group

Description:

Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14.

Treatment:

Drug: Levodopa

Drug: SAGE-217

Part B: Antiparkinsonian Agent(s) + SAGE-217

Experimental group

Description:

Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food.

Treatment:

Drug: Antiparkinsonian Agent(s)

Drug: SAGE-217