Sustained Release Oral Formulation for Treatment of Parkinson's Disease

Early Phase 1

Suspended

• Conditions: Idiopathic Parkinson Disease
• Interventions: Drug: levodopa/carbidopa oral formulation C; Drug: levodopa/carbidopa oral formulation A; Drug: levodopa/carbidopa oral formulation B

• Registration Number: NCT05471609
• Lead Sponsor: University of Minnesota

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-20
• Study First Submitted QC: 2022-07-20
• Study First Posted: 2022-07-25
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-04
• Study Start: 2025-06-15
• Primary Completion: 2026-06-16
• Study Completion: 2026-06-16

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Diagnosed with idiopathic PD
• Experiencing motor fluctuations

Exclusion Criteria

• Inability to consent for thmeselves
• Inability to fast

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
levodopa/carbidopa oral formulation C	levodopa/carbidopa oral formulation C	LD/CD will be delivered using an assembly of nested sachets made of permeable material. The assembly is placed in the oral/buccal cavity (between cheek and gum of lower jaw) and delivers continuous release of CD and LD for both transmucosal and gastrointestinal absorption. Outer sachet contains 50mg CD/200mg LD and inner sachet contains 50mg CD /200mg LD.
levodopa/carbidopa oral formulation A	levodopa/carbidopa oral formulation A	LD/CD will be delivered using an assembly of nested sachets made of permeable material. The assembly is placed in the oral/buccal cavity (between cheek and gum of lower jaw) and delivers continuous release of CD and LD for both transmucosal and gastrointestinal absorption. Outer sachet contains 100mg CD/100mg LD and inner sachet contains 0mg CD /300mg LD.
levodopa/carbidopa oral formulation B	levodopa/carbidopa oral formulation B	LD/CD will be delivered using an assembly of nested sachets made of permeable material. The assembly is placed in the oral/buccal cavity (between cheek and gum of lower jaw) and delivers continuous release of CD and LD for both transmucosal and gastrointestinal absorption. Outer sachet contains 100mg CD/0mg LD and inner sachet contains 0mg CD /400mg LD.

Primary Outcome Measures

Name	Time	Method
Carbidopa/levodopa serum level Efficacy of the delivery method	5 times, every 60 mins for a total of 6 hours after administration	Carbidopa/levodopa serum level

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States