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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Levodopa dispersible

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

Group Type EXPERIMENTAL

Levodopa dispersible

Intervention Type DRUG

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

Levodopa

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

Group Type ACTIVE_COMPARATOR

Levodopa

Intervention Type DRUG

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

Interventions

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Levodopa dispersible

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

Intervention Type DRUG

Levodopa

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

Intervention Type DRUG

Other Intervention Names

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Madopar dispersible Madopar

Eligibility Criteria

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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

Minimum Eligible Age

31 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No