Efficacy of Levodopa/Benserazide Dispersible Tablet on Response Fluctuations in PD Patients With Delayed ON

Overview

The purpose of this study is to determine whether levodopa/benserazide dispersible is effective in the adjunctive treatment of Parkinson's disease (PD) patients with delayed ON.

Full Title of Study: “Efficacy of Levodopa/Benserazide Dispersible Tablet on Response Fluctuations in Parkinson’s Disease Patients With Delayed ON: a Multicenter Randomized Open-label Cross-over Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2018

Detailed Description

Delayed ON is one of the motor complications of advanced PD patients that effect of anti-parkinsonian medication is delayed more than 40 minutes after intake. In the most severe cases, the effect does not appear even until next medication schedule, so called "No ON" status. It is important to manage delayed ON properly because it can interfere motor functions and quality of life of PD patients.

Levodopa/benserazide dispersible can be absorbed rapidly in the intestine, so theoretically it can break the poor response to conventional treatment of PD patients with delayed ON. However, this has not been proven by clinical trials till now.

Interventions

  • Drug: Levodopa dispersible
    • Levodopa dispersible 100mg/tablet, PO, 1 tablet in the morning, once daily for 4 weeks (crossover)
  • Drug: Levodopa
    • Levodopa 100mg/tablet, PO, 1 tablet in the morning, once daily for 4 weeks (crossover)

Arms, Groups and Cohorts

  • Experimental: Levodopa dispersible
    • Levodopa dispersible 100mg/tablet, PO, 1 tablet in the morning, once daily for 4 weeks (crossover)
  • Active Comparator: Levodopa
    • Levodopa 100mg/tablet, PO, 1 tablet in the morning, once daily for 4 weeks (crossover)

Clinical Trial Outcome Measures

Primary Measures

  • Change in the time to ON after first morning dose using 3-day PD diary
    • Time Frame: 4 weeks
    • A specialized 3-day PD diary will be distributed to the patients 3 days prior to each visit. This diary will evaluate the latency of ON after intake of the study medication.

Secondary Measures

  • Change in the The Unified Parkinson Disease Rating Scale (UPDRS)
    • Time Frame: 4 weeks
  • Change in the The Unified Dyskinesia Rating Scale (UDyskRS)
    • Time Frame: 4 weeks
  • Change in the The Schwab & England Activity of daily living scale (SEADL)
    • Time Frame: 4 weeks
  • Change in the The Parkinson Disease Questionnaire-39 (PDQ-39)
    • Time Frame: 4 weeks
  • Change in the Patient global improvement (PGI)
    • Time Frame: 4 weeks
  • Change in the Clinician global improvement (CGI)
    • Time Frame: 4 weeks
  • Change in the K-Minimental status examination (K-MMSE)
    • Time Frame: 4 weeks
  • Change in the Total ON time, total OFF time using 3-day PD diary
    • Time Frame: 4 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Male or female patients between 31 and 80 years
  • Parkinson disease (PD) was diagnosed by United Kingdom Parkinson disease brain bank criteria
  • Patients receiving stable Levodopa treatment at least 2 weeks prior to baseline visit
  • Delayed ON was confirmed by a specialized PD diary that records change in motor symptoms 90 minute after the first morning dose. Delayed ON is defined as delay of more than 40 minutes after the first morning dose for resolution of OFF state or experience of no ON state at least 1 per week.

Exclusion Criteria

  • Existence of cognitive decline hard to participate in the clinical trial or K-Minimental Status Exam score 24 or less
  • Any contraindication of blood sampling
  • Subjects with clinically significant psychiatric illness
  • Subjects with a cancer or severe medical illness
  • Lactating, pregnant, or possible pregnant
  • History of malignant melanoma
  • Subjects with narrow-angle glaucoma
  • Subjects with hypersensitivity to levodopa or benserazide
  • Subjects treated with non-selective monoamine oxidase (MAO)-B inhibitors
  • Subjects with peptic ulcer, colitis, or gastrointestinal disease

Gender Eligibility: All

Minimum Age: 31 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Collaborator
    • SMG-SNU Boramae Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jee-Young Lee, Associate Professor – Seoul National University Hospital
  • Overall Official(s)
    • Jee-Young Lee, MD, PhD, Principal Investigator, SMG-SNU Boramae Medical Center
  • Overall Contact(s)
    • Jee-Young Lee, MD, PhD, wieber77@gmail.com

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