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Sustained Release Oral Formulation for Treatment of Parkinson's Disease

NCT05471609 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-07-10

No results posted yet for this study

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 normal volunteers.

Conditions

  • Healthy Volunteers

Interventions

DRUG

levodopa/carbidopa oral formulation A

Outer sachet 100mg CD/100mg LD and inner sachet 0mg CD /300mg LD

DRUG

levodopa/carbidopa oral formulation B

Outer sachet 100mg CD/0mg LD and inner sachet 0mg CD /400mg LD

Sponsors & Collaborators

Principal Investigators

  • Khalaf Bushara, MD,FRCP · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-12
Primary Completion
2026-06-16
Completion
2026-06-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05471609 on ClinicalTrials.gov