Safety and Efficacy of DA-9805 for Parkinson's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03189563
• Date of registration: 12/06/2017
• Prospective Registration: Yes
• Primary sponsor: Dong-A ST Co., Ltd.
• Public title: Safety and Efficacy of DA-9805 for Parkinson's Disease
• Scientific title: A Phase IIa, Randomized, Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of DA-9805 in Subjects With Parkinson's Disease
• Date of first enrolment: February 6, 2018
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03189563
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Sotirios A Parashos, MD, PhD
• Affiliation: HealthPartners Institute

Key inclusion & exclusion 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



Age minimum: 30 Years
Age maximum: 79 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Other: Placebo

Drug: DA-9805 90mg

Drug: DA-9805 45mg

Primary Outcome(s)

change in motor MDS-UPDRS score [Time Frame: 12 weeks]

Secondary Outcome(s)

Change in CGI-S [Time Frame: 12 weeks]

Change in S&E score [Time Frame: 12 weeks]

Change in CGI-I [Time Frame: 12 weeks]

Change in MDS-UPDRS subscale scores [Time Frame: 12 weeks]

Change in total MDS- UPDRS score [Time Frame: 12 weeks]

Change in H&Y [Time Frame: 12 weeks]

Change in PDQ-39 score [Time Frame: 12 weeks]

Secondary ID(s)

DA-9805-PD-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors