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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 May 2021
• Main ID: NCT02769793
• Date of registration: 09/05/2016
• Prospective Registration: No
• Primary sponsor: Seoul National University Hospital
• Public title: Efficacy of Levodopa/Benserazide Dispersible Tablet on Response Fluctuations in PD Patients With Delayed ON
• Scientific 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
• Date of first enrolment: June 2015
• Target sample size: 40
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02769793
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Korea, Republic of

Contacts

• Name: Jee-Young Lee, MD, PhD
• Affiliation: SMG-SNU Boramae Medical Center

Key inclusion & exclusion 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



Age minimum: 31 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: Levodopa

Drug: Levodopa dispersible

Primary Outcome(s)

Change in the time to ON after first morning dose using 3-day PD diary [Time Frame: 4 weeks]

Secondary Outcome(s)

Change in the The Unified Dyskinesia Rating Scale (UDyskRS) [Time Frame: 4 weeks]

Change in the K-Minimental status examination (K-MMSE) [Time Frame: 4 weeks]

Change in the Total ON time, total OFF time using 3-day PD diary [Time Frame: 4 weeks]

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

Change in the The Schwab & England Activity of daily living scale (SEADL) [Time Frame: 4 weeks]

Change in the Clinician global improvement (CGI) [Time Frame: 4 weeks]

Change in the The Unified Parkinson Disease Rating Scale (UPDRS) [Time Frame: 4 weeks]

Change in the Patient global improvement (PGI) [Time Frame: 4 weeks]

Secondary ID(s)

16-2015-52

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Samsung Medical Center

SMG-SNU Boramae Medical Center