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

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02769793
• Other study ID #: 16-2015-52
• Status: Completed
• Phase: Phase 4
• Start date: June 2015
• Est. completion date: December 2018

Study information

• Verified date: May 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 31 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• Levodopa dispersible
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)

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	SMG-SNU Boramae Medical Center	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Seoul National University Hospital	Samsung Medical Center, SMG-SNU Boramae Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	relationship between delayed ON and response to investigational drugs and the Helicobactor pylori serology and index for atrophic gastritis	whether delayed ON and treatment response are affected by H.pylori status	at baseline and after 4 weeks of each treatment arm
Primary	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	Change in the The Unified Parkinson Disease Rating Scale (UPDRS)	a scale for assessment of parkinsonian symptom severity in PD patients	4 weeks
Secondary	Change in the The Unified Dyskinesia Rating Scale (UDyskRS)	a scale for assessment of levodopa-induced dyskinesia in PD patients	4 weeks
Secondary	Change in the The Schwab & England Activity of daily living scale (SEADL)	a scale for activity of daily living assessment	4 weeks
Secondary	Change in the The Parkinson Disease Questionnaire-39 (PDQ-39)	a scale for health-related quality of life in PD patients	4 weeks
Secondary	Change in the Patient global improvement (PGI)	patient-centered assessment of global improvement	4 weeks
Secondary	Change in the Clinician global improvement (CGI)	clinician's assessment for global improvement	4 weeks
Secondary	Change in the K-Minimental status examination (K-MMSE)	global cognition assessment	4 weeks
Secondary	Change in the Total ON time, total OFF time using 3-day PD diary	a severity assessment index for PD patients with motor fluctuation	4 weeks