Safety and Efficacy of DA-9805 for Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: DA-9805 45mg; DA-9805 90mg; Placebo
Intervention description: DA-9805 15mg tid; DA-9805 30mg tid; Placebo, tid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 61.0
Sex: All
Minimum age: 30 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      This is a phase IIa, first in human, randomized, double-blind, multicenter study to evaluate
      the safety, tolerability and efficacy of DA-9805 at 45mg, 90mg versus placebo in subjects
      diagnosed with early Parkinson's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects who are between 30 and 79 years old inclusive with a clinical
             diagnosis of Parkinson's disease as per UK Brain Bank Criteria for two (2) years or
             less at screening.

          -  Hoehn and Yahr I or II at screening.

          -  Subjects who are newly diagnosed & currently not on any Parkinson's disease medication
             (or) subjects who are on stable doses for at least 4 weeks prior to screening on
             Amantadine or anticholinergics for treatment of Parkinson's disease

             *Note: Subjects that had anti-parkinsonian medication (including levodopa, dopamine
             agonists, entacapone and monoamine oxidase-B inhibitors) discontinued at least 60 days
             prior to screening, e.g., for intolerance, may be considered eligible if all other
             eligibility requirements are met.

          -  Women of child-bearing potential should use reliable contraception. Acceptable methods
             of contraception include: surgical sterilization (e.g. bilateral tubal ligation),
             hormonal contraception (implantable, patch, and oral), and double-barrier methods
             (condom, diaphragm and spermicide are each considered a barrier). Women of
             child-bearing potential are defined as women physiologically capable of becoming
             pregnant, UNLESS they meet the following criteria:

             (1)Post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of
             spontaneous amenorrhea with serum Follicle Stimulating Hormone (FSH) levels > 40mIU/m,
             OR; (2)6 weeks post surgical bilateral oophorectomy with or without hysterectomy

          -  If a male and heterosexually active with a female of childbearing potential, the
             subject must agree to use a double barrier method of birth control (or must have been
             surgically sterilized) and to not donate sperm during the study.

          -  Without clinically significant abnormalities in physical exam, neurological exam and
             laboratory assessments (urine/blood routine, biochemical tests and ECG) which would
             exclude the subject from the study in the opinion of the Investigator. For Aspartate
             aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP)
             the screening levels should be ≤ 2 times upper limit normal

          -  Subject is capable of providing informed consent and is willing to sign the ICF prior
             to study Screening and agrees to comply with the study protocol requirements.

        Exclusion Criteria:

          -  Subject has an atypical parkinsonian syndrome or secondary parkinsonism (e.g., due to
             drugs, metabolic neurogenetic disorders, encephalitis, cerebrovascular disease or
             degenerative disease).

          -  Subjects with history of neurosurgical intervention for Parkinson's disease.

          -  Subjects who meet the DSM-V criteria at screening for bipolar disorder, major
             depressive disorder, psychotic disorders, or any other comorbid mental disorders that
             in the opinion of the Investigator may interfere with study conduct and results
             interpretation.

          -  Subjects with clinical diagnosis of dementia (MMSE score <24) as determined by the
             investigator using Mini-Mental State Examination (MMSE).

          -  Female subjects who are pregnant or breast feeding.

          -  Initiation of any anti-parkinsonian medication (including levodopa, dopamine agonists,
             entacapone and monoamine oxidase-B inhibitors) for the duration of the trial.

          -  Initiation of Amantadine or anticholinergics for newly diagnosed subjects or change in
             the dosage of Amantadine or anticholinergics during the trial for subjects who were on
             stable doses for 4 weeks prior to screening.

          -  Subjects who used investigational drugs or devices within 60 days prior to screening
             or investigational biologics within the last 6 months prior to screening.

          -  Subjects with a clinically significant or surgical condition, including major
             surgeries within 28 days prior to enrollment