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

NCT03189563 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: DA-9805-PD-001
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Change in Motor MDS-UPDRS Score From Baseline at Week 12

  Analysis of the Change from Baseline in the sum of the Movement Disorders Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part II, Part III and Part IV at week 12. (Change from baseline = Post Baseline Measurement - Baseline Measurement) MDS-UPDRS is a multimodal scale assessing both impairment and disability and is separated into 4 subscales. Each parkinsonian sign or symptom is rated on a 5-point severity scale (ranging from 0 to 4). The maximum total UPDRS score is 272, indicating the worst possible disability from PD. Part I: This assesses non-motor experiences of daily living (13 items, Score range: 0\~52) Part II: This assesses motor experiences of daily living (13 items, Score range: 0\~52) Part III: This assesses the motor signs of PD (33 items, Score range: 0\~132) Part IV: This assesses motor complications, dyskinesias and motor fluctuations using historical and objective information (6 items, Score range: 0\~26)

  12 weeks

Secondary Outcomes (10)

• Change in Total MDS- UPDRS Score

  12 weeks

• Change in MDS-UPDRS Subscale scores_Part I

  12 weeks

• Change in S&E Total Score

  12 weeks

• Change in PDQ-39 Score- Summary Index

  12 weeks

• Change in H&Y Total Score at Week 12

  12 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

placebo, tid

Other: Placebo

DA-9805 low

EXPERIMENTAL

DA-9805 45mg

Drug: DA-9805 45mg

DA-9805 high

EXPERIMENTAL

DA-9805 90mg

Drug: DA-9805 90mg

Interventions

DA-9805 45mg DRUG

DA-9805 15mg tid

Also known as: DA-9805

DA-9805 low

DA-9805 90mg DRUG

DA-9805 30mg tid

Also known as: DA-9805

DA-9805 high

Placebo OTHER

Placebo, tid

Placebo

Eligibility Criteria

• Age: 30 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dong-A ST Co., Ltd.: lead

Study Sites (1)

HealthPartners Institute

Bloomington, Minnesota, 55425, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

DA-9805

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Xiaofei Du
• Organization: Dong-A ST

duxiaofeicat@donga.co.kr

82-2-92-8457

Study Officials

• Sotirios A Parashos, MD, PhD

  HealthPartners Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 16, 2017
• Study Start: February 6, 2018
• Primary Completion: April 10, 2019
• Study Completion: April 10, 2019
• Last Updated: May 24, 2022
• Results First Posted: May 24, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)