DNS-7801 vs. Placebo in Parkinson's Disease

NCT03306329 | Terminated Phase 2 FDA Drug

• 1 other identifier: DNS-7801-201
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 9

Brief Summary

This is a randomized, double-blind, two-part placebo-controlled parallel group outpatient treatment study that will utilize standard Parkinson's Disease measures to evaluate the effect of DNS-7801

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (2)

• Part A: Maximal change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III from predose

  2-days

• Part B: Change in OFF time from Baseline to Day 28 on home PD diary

  28-days

Secondary Outcomes (10)

• Part A: Safety of DNS-7801 evaluating the number of Treatment Emergent Adverse Events (TEAEs) at each study visit

  17-days

• Part A: Score on the Columbia Suicide Severity Rating Scale (C-SSRS) as assessed at each study visit

  17-days

• Part A: Tolerability of DNS-7801 assessed by discontinuation due to TEAE(s) [percent completers] at Day 10

  10-days

• Part B: Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III from Baseline to Day 28

  28-days

• Part B: Change in ON time without troublesome dyskinesia from Baseline to Day 28

  28-days

Study Arms (3)

DNS-7801 (low-dose)

EXPERIMENTAL

Drug: DNS-7801 (low-dose)

DNS-7801 (high-dose)

EXPERIMENTAL

Drug: DNS-7801 (high dose)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

DNS-7801 (low-dose) DRUG

DNS-7801 (low-dose) tablets administered once daily.

DNS-7801 (low-dose)

DNS-7801 (high dose) DRUG

DNS-7801 (high dose) tablets administered once daily.

DNS-7801 (high-dose)

Placebo DRUG

Placebo tablets administered once daily

Placebo

Eligibility Criteria

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

You may qualify if:

• Subjects who are diagnosed with Parkinson's disease as defined by the United Kingdom PD Society Brain Bank Criteria for the Diagnosis of PD.
• Modified Hoehn and Yahr Staging ≤ 3 in ON state.
• Mini Mental State Examination Score ≥ 26.
• Subjects must currently have a good response to levodopa and be receiving a stable dose of levodopa ( at least 4 doses per day of standard levodopa or ≥ 3 doses per day of Rytary™ (Carbidopa and levodopa Extended-Release Capsules) for at least 4 weeks prior to screening).
• Subjects must experience motor fluctuations with at least 2 hours of OFF periods each day in the awake time.
• Subjects must experience predictable early morning OFF periods.
• Subjects must be able to come to the clinic in the practically defined OFF state.
• Subject must have achieved the following results for home PD diary training, practice diary collection, and Baseline diary recordings (PART B ONLY):
• During a diary concordance session with an approved PD diary trainer/rater (minimum 4 hours), subject achieved at least 80% overall diary concordance, including at least 1 OFF interval.
• Returned a valid 2-day (i.e., 2 consecutive 24-hour periods) practice home PD diary (as defined below).
• Returned valid diary recordings preceding the Baseline Visit that indicated at least 2 hours of OFF time on each of the 2 days.
• All anti-parkinsonian medications must be maintained at a stable dose for at least 4 weeks prior to the initial Screening Visit with the exception of monoamine oxidase-B inhibitors, which must be maintained at a stable level for at least 8 weeks prior to the screening visit.

You may not qualify if:

• Diagnosis of secondary or an atypical Parkinsonian syndrome.
• Subject has severe disabling dyskinesia.
• Subject has clinically significant psychosis or hallucinations or history of psychosis in past 6 months.
• History of previous neurosurgery for PD.
• Currently or previously on Duopa/Duodopa.
• Currently on apomorphine or have received apomorphine within 30 days prior to baseline.
• The subject has a diagnosis or history of a substance related disorder (excluding nicotine and caffeine), including alcohol related disorder (Diagnostic and Statistical Manual of Mental Disorders 5 criteria) during the 12 months prior to the Screening Visit.
• The subject has tested positive at the Screening Visit for drugs of abuse (e.g., opiates, cannabinoids, methadone, cocaine, and amphetamines \[including ecstasy\]).
• Any medical (including acute or chronic pain), surgical, or psychiatric condition, laboratory value, or concomitant medication which, in the opinion of the Investigator or the eligibility reviewer, makes the subject unsuitable for study entry or potentially unable to complete all aspects of the study.
• Suicidal ideation within 1 year prior to the Screening Visit as evidenced by answering "yes" to Questions 4 or 5 on the suicidal ideation portion of the Columbia Suicide Severity Rating Scale (C-SSRS) or attempted suicide within the last 5 years.
• Subjects with a current major depressive episode or a Beck Depression Inventory-II score of \> 19. Subjects receiving treatment for depression with antidepressants may be enrolled if they have been on a stable daily dose of the antidepressant for at least 8 weeks before the Baseline Visit.
• Exposure to neuroleptics (antipsychotic drugs) for more than 1 month within the past 2 years, or any exposure within the past year.
• Any malignancy in the 5 years prior to randomization (excluding basal cell carcinoma of the skin or cervical carcinoma in situ that have been successfully treated).
• Current or previous diagnosis of malignant melanoma or the presence of any suspicious skin lesion based on physical exam findings.
• Subjects, who, for any reason, are judged by the Investigator to be inappropriate for this study, including subjects who are unable to communicate or cooperate with the Investigator or who have/had a clinically significant illness or abnormal physical examination that may compromise safety of the subject during the trial or affect ability of the subject to adhere to study procedures

Sponsors & Collaborators

• Dart NeuroScience, LLC: lead

Study Sites (9)

Collaborative Neuroscience Network

Long Beach, California, 90806, United States

Location

SC3 Research

Pasadena, California, 91105, United States

Location

Rocky Mountain Movement Disorders Center

Englewood, Colorado, 80113, United States

Location

Parkinsons Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, 33486, United States

Location

University of South Florida Parkinson's Disease and Movement Disorders Center

Tampa, Florida, 33613, United States

Location

Quest Research Institute

Farmington, Michigan, 48334, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

The Neurological Institute PA

Charlotte, North Carolina, 28204, United States

Location

Premier Clinical Research

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Philip Perera, MD

  Dart NeuroScience, LLC

  STUDY DIRECTOR

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: September 25, 2017
• First Posted: October 11, 2017
• Study Start: September 13, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: February 1, 2018

Record last verified: 2018-01

Locations

US (9)