Clinical TrialNeurodegenerative DisordersKetamineUnknown status

Phase I Open-label Study of Low-dose Ketamine Infusion Treatment in Levodopa-Induced Dyskinesia in Parkinson’s Disease

Single-group, open-label Phase I study (n=9 actual) assessing tolerability and efficacy of low-dose IV ketamine infusions for Levodopa-Induced Dyskinesia in Parkinson's disease.

Target Enrollment
9 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

This single-group, open-label Phase I trial evaluates low-dose intravenous ketamine infusions for treatment of levodopa-induced dyskinesia (LID) in people with Parkinson's disease, measuring acute and post-infusion effects up to weeks 2–6.

Primary outcomes include change in dyskinesia diaries and UDysRS scores; secondary measures assess duration of off/on states, pain, quality of life, and other PD symptoms per UPDRS.

Study Arms & Interventions

Ketamine infusion

experimental

Intravenous ketamine infusions with rates ranging 0.05–0.30 mg/kg/hr.

Interventions

  • Ketamine
    via IV• intermittent infusion

    IV infusion rate 0.05–0.30 mg/kg/hr; intermittent dosing per protocol.

Participants

Ages
30 – 85
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Patients diagnosed with Parkinson's Disease as defined by the UK Parkinson's Disease Society Brain Bank Criteria
  • Be male or female between ages 30-85
  • Be on at least two years of treatment of levodopa of at least 400 mg or 4mg/kg daily
  • Have levodopa induced dyskinesia for at least 2 hours per day
  • Have been on stable doses of all anti-Parkinson's medications for 30 days and be willing to remain on the same doses throughout the course of the study
  • The subject/caregiver must demonstrate ability to complete an accurate home diary based on training and evaluation (visit 2)
  • Female subjects not of childbearing potential (infertile due to surgical sterilization, congenital anomaly, or post-menopausal as defined in protocol)
  • Men with WOCBP partners must agree to effective contraception or abstinence and refrain from sperm donation for duration of study and 90 days after last dose.

Exclusion Criteria

  • Exclusion Criteria:
  • Diagnosis of an atypical or secondary parkinsonian syndrome
  • Lack of documented response to levodopa
  • Prior exposure to ketamine within the last one year
  • Significant history of premorbid psychiatric illness other than depression
  • Currently taking psychotropic medications with significant dopamine receptor blocking effects (exceptions noted in protocol)
  • Use of antipsychotic medications (with specified exceptions) in the 6 months prior to screening or during study
  • Cognitive impairment (MoCA score ≤20)
  • History of drug or alcohol dependence or abuse
  • History of visual or auditory hallucinations (visual hallucinations acceptable if scored ≤2 on UPDRS II)
  • Serious or unstable medical condition increasing risk per investigator
  • Pregnancy or lactation or positive pregnancy test at screening
  • Baseline BP >160/95 (average of three readings at screening)
  • History of arrhythmia, unstable angina, or significant cardiac dysfunction
  • Significant CNS disease other than PD that may affect cognition or ability to complete study (e.g., other dementias such as Alzheimer's disease)
  • History in last 6 months of TIA or stroke
  • History of intracerebral hemorrhage due to hypertension or hypertensive encephalopathy
  • Any other reason investigator considers subject unsuitable for study.

Study Details

  • Status
    Unknown status
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment9 participants
  • Timeline
    Start: 2022-08-25
    End: 2023-08-25
  • Compound
    Ketamine
  • Topic
    Neurodegenerative Disorders

Locations

Scott J Sherman — Tucson, Arizona, United States

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