Sustained Release Oral Formulation for Treatment of Parkinson's Disease

Sponsor

University of Minnesota (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05471609

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Parkinson Disease	Drug: levodopa/carbidopa oral formulation A Drug: levodopa/carbidopa oral formulation B Drug: levodopa/carbidopa oral formulation C	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

6 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

3 different assemblies with 3 different formulations (A,B & C) will be used.3 different assemblies with 3 different formulations (A,B & C) will be used.

Masking:

Double (Participant, Investigator)

Masking Description:

Double-blinded

Primary Purpose:

Treatment

Official Title:

Sustained Release Oral Formulation for Treatment of Parkinson's Disease

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Aug 2, 2023

Anticipated Study Completion Date :

Aug 2, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: levodopa/carbidopa oral formulation A Outer sachet 100mg CD/100mg LD and inner sachet 0mg CD /300mg LD
Experimental: 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.	Drug: levodopa/carbidopa oral formulation B Outer sachet 100mg CD/0mg LD and inner sachet 0mg CD /400mg LD
Experimental: 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.	Drug: levodopa/carbidopa oral formulation C Outer sachet 50mg CD/200mg LD and inner sachet 50mg CD /200mg LD

Arm

Intervention/Treatment

Experimental: 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.

Drug: levodopa/carbidopa oral formulation A

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

Experimental: levodopa/carbidopa oral formulation B

Drug: levodopa/carbidopa oral formulation B

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

Experimental: 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.

Drug: levodopa/carbidopa oral formulation C

Outer sachet 50mg CD/200mg LD and inner sachet 50mg CD /200mg LD

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosed with idiopathic PD
Experiencing motor fluctuations

Exclusion Criteria:

Inability to consent for thmeselves
Inability to fast

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

University of Minnesota

Investigators

Principal Investigator: Khalaf Bushara, MD,FRCP, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Minnesota

ClinicalTrials.gov Identifier:

NCT05471609

Other Study ID Numbers:

First Posted:

Jul 25, 2022

Last Update Posted:

Jul 25, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Minnesota

Idiopathic Parkinson Disease

levodopa/carbidopa

Additional relevant MeSH terms:

Parkinson Disease

Levodopa

Carbidopa

Study Results

No Results Posted as of Jul 25, 2022