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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Levodopa dispersible
Levodopa
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

31 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical Center
  • SMG-SNU Boramae Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Levodopa dispersible

Levodopa

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in the time to ON after first morning dose using 3-day PD diary
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 Outcome Measures

Change in the The Unified Parkinson Disease Rating Scale (UPDRS)
a scale for assessment of parkinsonian symptom severity in PD patients
Change in the The Unified Dyskinesia Rating Scale (UDyskRS)
a scale for assessment of levodopa-induced dyskinesia in PD patients
Change in the The Schwab & England Activity of daily living scale (SEADL)
a scale for activity of daily living assessment
Change in the The Parkinson Disease Questionnaire-39 (PDQ-39)
a scale for health-related quality of life in PD patients
Change in the Patient global improvement (PGI)
patient-centered assessment of global improvement
Change in the Clinician global improvement (CGI)
clinician's assessment for global improvement
Change in the K-Minimental status examination (K-MMSE)
global cognition assessment
Change in the Total ON time, total OFF time using 3-day PD diary
a severity assessment index for PD patients with motor fluctuation

Full Information

First Posted
May 9, 2016
Last Updated
May 4, 2021
Sponsor
Seoul National University Hospital
Collaborators
SMG-SNU Boramae Medical Center, Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02769793
Brief Title
Efficacy of Levodopa/Benserazide Dispersible Tablet on Response Fluctuations in PD Patients With Delayed ON
Official Title
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
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
SMG-SNU Boramae Medical Center, Samsung Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Levodopa dispersible
Arm Type
Experimental
Arm Description
Levodopa dispersible 100mg/tablet, PO, 1 tablet in the morning, once daily for 4 weeks (crossover)
Arm Title
Levodopa
Arm Type
Active Comparator
Arm Description
Levodopa 100mg/tablet, PO, 1 tablet in the morning, once daily for 4 weeks (crossover)
Intervention Type
Drug
Intervention Name(s)
Levodopa dispersible
Other Intervention Name(s)
Madopar dispersible
Intervention Description
Levodopa dispersible 100mg/tablet, PO, 1 tablet in the morning, once daily for 4 weeks (crossover)
Intervention Type
Drug
Intervention Name(s)
Levodopa
Other Intervention Name(s)
Madopar
Intervention Description
Levodopa 100mg/tablet, PO, 1 tablet in the morning, once daily for 4 weeks (crossover)
Primary Outcome Measure Information:
Title
Change in the time to ON after first morning dose using 3-day PD diary
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change in the The Unified Parkinson Disease Rating Scale (UPDRS)
Description
a scale for assessment of parkinsonian symptom severity in PD patients
Time Frame
4 weeks
Title
Change in the The Unified Dyskinesia Rating Scale (UDyskRS)
Description
a scale for assessment of levodopa-induced dyskinesia in PD patients
Time Frame
4 weeks
Title
Change in the The Schwab & England Activity of daily living scale (SEADL)
Description
a scale for activity of daily living assessment
Time Frame
4 weeks
Title
Change in the The Parkinson Disease Questionnaire-39 (PDQ-39)
Description
a scale for health-related quality of life in PD patients
Time Frame
4 weeks
Title
Change in the Patient global improvement (PGI)
Description
patient-centered assessment of global improvement
Time Frame
4 weeks
Title
Change in the Clinician global improvement (CGI)
Description
clinician's assessment for global improvement
Time Frame
4 weeks
Title
Change in the K-Minimental status examination (K-MMSE)
Description
global cognition assessment
Time Frame
4 weeks
Title
Change in the Total ON time, total OFF time using 3-day PD diary
Description
a severity assessment index for PD patients with motor fluctuation
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
relationship between delayed ON and response to investigational drugs and the Helicobactor pylori serology and index for atrophic gastritis
Description
whether delayed ON and treatment response are affected by H.pylori status
Time Frame
at baseline and after 4 weeks of each treatment arm

10. Eligibility

Sex
All
Minimum Age & Unit of Time
31 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jee-Young Lee, MD, PhD
Organizational Affiliation
SMG-SNU Boramae Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
SMG-SNU Boramae Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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