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

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02769793
Collaborator
SMG-SNU Boramae Medical Center (Other), Samsung Medical Center (Other)
40
Enrollment
2
Locations
2
Arms
42
Actual Duration (Months)
20
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 1, 2015
Actual Primary Completion Date :
Aug 1, 2018
Actual Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Levodopa dispersible

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

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

    		•
    Active Comparator: Levodopa

    Levodopa 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)
    Other Names:
  • Madopar

    		•

    Outcome Measures

    Primary Outcome Measures

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

    1. Change in the The Unified Parkinson Disease Rating Scale (UPDRS) [4 weeks]

      a scale for assessment of parkinsonian symptom severity in PD patients

    2. Change in the The Unified Dyskinesia Rating Scale (UDyskRS) [4 weeks]

      a scale for assessment of levodopa-induced dyskinesia in PD patients

    3. Change in the The Schwab & England Activity of daily living scale (SEADL) [4 weeks]

      a scale for activity of daily living assessment

    4. Change in the The Parkinson Disease Questionnaire-39 (PDQ-39) [4 weeks]

      a scale for health-related quality of life in PD patients

    5. Change in the Patient global improvement (PGI) [4 weeks]

      patient-centered assessment of global improvement

    6. Change in the Clinician global improvement (CGI) [4 weeks]

      clinician's assessment for global improvement

    7. Change in the K-Minimental status examination (K-MMSE) [4 weeks]

      global cognition assessment

    8. Change in the Total ON time, total OFF time using 3-day PD diary [4 weeks]

      a severity assessment index for PD patients with motor fluctuation

    Other Outcome Measures

    1. relationship between delayed ON and response to investigational drugs and the Helicobactor pylori serology and index for atrophic gastritis [at baseline and after 4 weeks of each treatment arm]

      whether delayed ON and treatment response are affected by H.pylori status

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    31 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Samsung Medical Center Seoul Korea, Republic of
    2 SMG-SNU Boramae Medical Center Seoul Korea, Republic of

    Sponsors and Collaborators

    • Seoul National University Hospital
    • SMG-SNU Boramae Medical Center
    • Samsung Medical Center

    Investigators

    • Principal Investigator: Jee-Young Lee, MD, PhD, SMG-SNU Boramae Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jee-Young Lee, Clinical Professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT02769793
    Other Study ID Numbers:
    • 16-2015-52
    First Posted:
    May 12, 2016
    Last Update Posted:
    May 7, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Parkinson Disease
    Levodopa
    Benserazide
    Benserazide, levodopa drug combination

    Study Results

    No Results Posted as of May 7, 2021