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NCT05471609 Clinical Trial

Sustained Release Oral Formulation for Treatment of Parkinson's Disease

Idiopathic Parkinson Disease Clinical Trial

Official title:
Sustained Release Oral Formulation for Treatment of Parkinson's Disease

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT05471609
Other study ID #
Secondary ID
Status Suspended
Phase Early Phase 1
First received
Last updated
Start date June 15, 2024
Est. completion date June 16, 2025

Study information
Verified date May 2024
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Achieving sustained blood levels of carbidopa/levodopa has been a challenge in the treatment of PD and although levodopa remains the most commonly used drug, motor fluctuations remain a major disability especially in advanced Parkinson's disease. The aim of this study is to determine the efficacy of a novel oral carbidopa-levodopa formulation in achieving a sustained blood level of levodopa and carbidopa in PD.

Recruitment information / eligibility
Status Suspended
Enrollment 6
Est. completion date June 16, 2025
Est. primary completion date June 16, 2025
Accepts healthy volunteers No
Gender All
Age group 55 Years to 75 Years
Eligibility Inclusion Criteria: - Diagnosed with idiopathic PD - Experiencing motor fluctuations Exclusion Criteria: - Inability to consent for thmeselves - Inability to fast

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• levodopa/carbidopa oral formulation A
Outer sachet 100mg CD/100mg LD and inner sachet 0mg CD /300mg LD
• levodopa/carbidopa oral formulation B
Outer sachet 100mg CD/0mg LD and inner sachet 0mg CD /400mg LD
• levodopa/carbidopa oral formulation C
Outer sachet 50mg CD/200mg LD and inner sachet 50mg CD /200mg LD

Locations
Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (1)
Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Carbidopa/levodopa serum level Efficacy of the delivery method Carbidopa/levodopa serum level 5 times, every 60 mins for a total of 6 hours after administration
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