We invite our patients to participate in clinical trials, which evaluate the effectiveness of novel therapies and offer access to emerging treatment options.
Clinical Trials Mount Sinai Movement Disorders Center January 2023:
Parkinson’s Disease
A randomized, double-blind, placebo controlled study to evaluate the effects of SAGE 718 in Parkinson’s disease Cognitive Impairment
Sponsor: SAGE Therapeutics
Synopsis: This is a study for patients meeting criteria for PD-MCI. Patients in the study will be randomized to one of two treatment arms. In one treatment arm participants will receive SAGE-719 capsules, orally, once daily in the morning for 42 days. In the second treatment arm participants will receive SAGE-718-matching placebo capsules, orally, once daily in the morning for 42 days. There is a 70 day follow up period. Patients will be required to complete study scales related to Parkinson’s disease. Patients will be required to undergo ECGs and laboratory testing.
Study Contacts: Amina Castro, 212-523-8364, email: amina.castro@mountsinai.org
PI: Joohi Jimenez-Shahed, MD, 212-523-8854, email: joohi.jimenez-shahed@mountsinai.org
A 6-month prospective, randomized, double-blind, placebo-controlled clinical trial investigating the efficacy, safety, and tolerability of two different doses of buntanetap or placebo in patients with early Parkinson’s disease
Sponsor: Annovis Bio
Synopsis: The study will be 6-month placebo-controlled and double-blinded: subjects, investigators and the sponsor will be blinded to the subjects’ treatment.
Qualified subjects will be randomly assigned at a 1:1:1 ratio to one of three treatment arms: buntanetap 10 mg, buntanetap 20 mg, and placebo, through an Interactive Randomization System, after a screening period of up to 42 days.
MDS-UPDRS, PGIC, CGIS, WAIS coding, and MMSE will be assessed by trained clinicians. All efforts will be made to ensure subjects will be assessed by the same clinician throughout the study. Participants should stop SOC Parkinson’s medications 12 hrs before clinical visits to ensure clinical OFF-state during visit. .
Study Contacts: Amina Castro, 212-523-8364, email: amina.castro@mountsinai.org
PI: Joohi Jimenez-Shahed, MD, 212-523-8854, email: joohi.jimenez-shahed@mountsinai.org
A double-blind, placebo-controlled, randomized, Phase 2a study with oral UCB0599 in study participants with early Parkinson’s disease
Sponsor: UCB Biopharma
Synopsis: This is a study for early stage, untreated Parkinson’s disease patients with disease duration of less than two years. Participants will be randomized to one of 3 treatment arms: UCB0599 360 mg/day, UCB0559 180 mg/day, or placebo. The study includes a screening period of 3-6 weeks, an 18-month treatment period, and an SFU Period of 1 month for a total duration of approximately 21 months. Patients will be required to complete study scales related to Parkinson’s disease. Patients will be required to undergo an MRI at screening, serial DAT scans throughout the study, ECGs and laboratory testing.
Study Contacts:
Jamie Ades, 212-241-9038, email: jamie.ades@mssm.edu
Nenad Stojiljkovic, 212-241-5329, email: nenad.stojiljkovic@mssm.edu
Joan Bratton, 212-241-0279, email: joan.bratton@mssm.edu
PI: Winona Tse, MD, 212-241-6960, email: winona.tse@mssm.edu
Essential Tremor
A phase 2 double blind, placebo controlled dose response study of SAGE 324 for treatment of essential tremor
Sponsor: Sage Therapeutics
Synopsis: This is a study for untreated Essential Tremor patients with disease duration of at least 3 years. Participants will be randomized to one of four treatment arms: SAGE-324 15 mg/day, SAGE-324 30 mg/day, SAGE-324 60 mg/day, or SAGE-324-matched placebo tablets. This study is 4.5 months in duration. Patients will be required to complete rating scales. Patients will be required to undergo ECGs and laboratory testing.
Study Contacts:
Ricardo Renvill, 212-844-6055, email: ricardo.renvill@mountsinai.org
Tara Fitzgerald, 212-844-6839, email: tara.fitzgerald@mountsinai.org
PI: Matthew Swan, MD, 212-844-6925, email: matthew.swan@mountsinai.org
Sage-324 for treatment of Essential Tremor
Sponsor: Sage Therapeutics, Inc.
Phase: Phase 2, randomized, double blind, placebo-controlled study.
Study Drug: SAGE-324 oral drug is a positive allosteric modulator of A-type γ-aminobutyric acid-gated chloride channel (GABAA) receptors (4 groups: 15 mg, 30mg, 60 mg, placebo-patients have 75% chance of receiving drug).
Potential risks: somnolence, feeling of relaxation, and dizziness.
Length of Study: Approximately 4.5 months. Patients should expect to come every 2 weeks.
Procedures: In-clinic examinations, blood work, neuropsychology tests and assessments, EKG, videotaping of TETRAS exams. Bi-weekly phone call follow-ups.
Target Patient Population: 18-80 years, isolated tremor syndrome with BILATERAL UPPER LIMB action tremor, At least 3 years duration, with or without tremor in other locations (e.g., head, voice, or lower limbs). No other neurological signs, such as dystonia, ataxia, or parkinsonism, etc. MUST BE WILLING TO COME OFF ALL TREMOR MEDICATIONS
Efficacy and Safety of BIIB122 in Participants with Parkinson’s Disease (LUMA)
Sponsor: Biogen Idec Research Limited.
Phase: Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled.
Study Drug: BIIB122 is a selective, orally bioavailable, central nervous system–penetrant, reversible kinase inhibitor of LRRK2 (patients have a 50% chance of receiving BIIB122).
Potential Risks: headache, back pain, common cold, fatigue, nausea, vomiting, muscle pain, dizziness, diarrhea, flu-like symptoms, and difficulty sleeping.
Length of Study: 146 weeks (slightly less than 3 years)
Procedures: In-clinic examinations, blood work and urine analysis, neuropsychology tests and assessments, digital assessments, EKG, genetic testing, collection of CSF, pulmonary function tests, optional biofluid study and DaT/SPECT imaging.
Target Population: 30 to 80 years old, clinical diagnosis of PD within 2 years of screening, preferably untreated with PD medication, or treated with PD medication for at most 30 days, or treated with a stable dose of PD monotherapy (MAO-B inhibitor or levodopa). Absent of LRRK2 variant.
Study Contacts: Tara Fitzgerald , 212-844-6839, email: tara.Fitzgerald@mountisnai.org
PI: Matthew Swan MD, email: Matthew.swan@mountsinai.org