Clinical Trials Logo
  1. Home
  2. Idiopathic Parkinson Disease
  3. NCT05471609
  4. Details
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
See also
  Status Clinical Trial Phase
Completed NCT04202757 - Intravenous Plasma Treatment for Parkinson's Disease Early Phase 1
Not yet recruiting NCT05103618 - Effect of Meditation and Controls and Subjects With Parkinson's Disease on Brain Activity Measured by fMRI With FDOPA Phase 2
Completed NCT03700684 - Voice Treatment for Parkinson's Disease N/A
Completed NCT05027620 - Feasibility of Motor-cognitive Home Training for Parkinson's Disease Using eHealth Technology N/A
Completed NCT03652363 - GDNF in ideopathicParkinsons Disease Phase 2
Recruiting NCT02960464 - tDCS for Treatment of Depression in Parkinson's Disease N/A
Completed NCT05699161 - Adipose-derived Stromal Vascular Fraction Cells to Treat Parkinson Phase 1/Phase 2
Completed NCT03944785 - Clinical Outcome Assessment of Parkinson's Disease Patients Treated With XADAGO (Safinamide)
Completed NCT01227265 - Placebo Controlled Study of Preladenant in Participants With Moderate to Severe Parkinson's Disease (P07037) Phase 3
Terminated NCT01215227 - An Active-Controlled Extension Study to NCT01155466 [P04938] and NCT01227265 [P07037] (P06153) Phase 3
Withdrawn NCT05832775 - Study to Assess the Safety of MRx0029 or MRx0005 Compared to Placebo, in People With Parkinson's Phase 1
Active, not recruiting NCT02780895 - Parkinsonian Brain Repair Using Human Stem Cells Phase 1
Recruiting NCT01860794 - Evaluation of Safety and Tolerability of Fetal Mesencephalic Dopamine Neuronal Precursor Cells for Parkinson's Disease Phase 1/Phase 2
Terminated NCT02393027 - Quantification of Dopamine Active Transporter (DAT) in Humans: Validation of a New Radiophamaceutical, the [18F] LBT-999 Early Phase 1
Completed NCT02373072 - A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of PF-06649751 in Subjects With Idiopathic Parkinson's Disease Phase 1
Completed NCT02445651 - Physiological Effects of Nutritional Support in Patients With Parkinson's Disease N/A
Completed NCT00437125 - Study on the Tolerability of Duloxetine in Depressed Patients With Parkinson's Disease Phase 4
Completed NCT02723396 - Sleep, Awake & Move - Part I
Completed NCT00599339 - Transdermal Rotigotine User Surveillance Study
Completed NCT00160576 - Levetiracetam Treatment in Adult Subjects With Parkinson's Disease Experiencing Troublesome Dyskinesias Phase 2