Clinical trial NCT02769793: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson Disease
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: SMG-SNU Boramae Medical Center
name: Samsung Medical Center
First posted: 2016-05-12
Enrollment: 40
Sex: ALL
Minimum age (years): 31
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in the time to ON after first morning dose using 3-day PD diary
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in the The Unified Parkinson Disease Rating Scale (UPDRS)
timeFrame: 4 weeks
measure: Change in the The Unified Dyskinesia Rating Scale (UDyskRS)
timeFrame: 4 weeks
measure: Change in the The Schwab & England Activity of daily living scale (SEADL)
timeFrame: 4 weeks
measure: Change in the The Parkinson Disease Questionnaire-39 (PDQ-39)
timeFrame: 4 weeks
measure: Change in the Patient global improvement (PGI)
timeFrame: 4 weeks
measure: Change in the Clinician global improvement (CGI)
timeFrame: 4 weeks
measure: Change in the K-Minimental status examination (K-MMSE)
timeFrame: 4 weeks
measure: Change in the Total ON time, total OFF time using 3-day PD diary
timeFrame: 4 weeks
Other outcomes:
measure: relationship between delayed ON and response to investigational drugs and the Helicobactor pylori serology and index for atrophic gastritis
timeFrame: at baseline and after 4 weeks of each treatment arm
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
Study officials:
affiliation: SMG-SNU Boramae Medical Center
name: Jee-Young Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: