NCT02769793

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4 parkinson-disease

Timeline
Completed

Started Jun 2015

Longer than P75 for phase_4 parkinson-disease

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

May 7, 2021

Status Verified

May 1, 2021

Enrollment Period

3.2 years

First QC Date

May 9, 2016

Last Update Submit

May 4, 2021

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 weeks

Secondary Outcomes (8)

  • Change in the The Unified Parkinson Disease Rating Scale (UPDRS)

    4 weeks

  • Change in the The Unified Dyskinesia Rating Scale (UDyskRS)

    4 weeks

  • Change in the The Schwab & England Activity of daily living scale (SEADL)

    4 weeks

  • Change in the The Parkinson Disease Questionnaire-39 (PDQ-39)

    4 weeks

  • Change in the Patient global improvement (PGI)

    4 weeks

  • +3 more secondary outcomes

Other Outcomes (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

Study Arms (2)

Levodopa dispersible

EXPERIMENTAL

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

Drug: Levodopa dispersible

Levodopa

ACTIVE COMPARATOR

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

Drug: Levodopa

Interventions

Levodopa dispersibleDRUG

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

Also known as: Madopar dispersible
Levodopa dispersible
LevodopaDRUG

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

Also known as: Madopar
Levodopa

Eligibility Criteria

Age31 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Samsung Medical Center

Seoul, South Korea

Location

SMG-SNU Boramae Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Levodopabenserazide, levodopa drug combination

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

DihydroxyphenylalanineCatecholaminesAminesOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsTyrosine

Study Officials

  • Jee-Young Lee, MD, PhD

    SMG-SNU Boramae Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

May 9, 2016

First Posted

May 12, 2016

Study Start

June 1, 2015

Primary Completion

August 1, 2018

Study Completion

December 1, 2018

Last Updated

May 7, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(2)