search
Back to results

Sustained Release Oral Formulation for Treatment of Parkinson's Disease

Primary Purpose

Idiopathic Parkinson Disease

Status
Not yet recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
levodopa/carbidopa oral formulation A
levodopa/carbidopa oral formulation B
levodopa/carbidopa oral formulation C
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Parkinson Disease focused on measuring Idiopathic Parkinson Disease, levodopa/carbidopa

Eligibility Criteria

55 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with idiopathic PD
  • Experiencing motor fluctuations

Exclusion Criteria:

  • Inability to consent for thmeselves
  • Inability to fast

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

levodopa/carbidopa oral formulation A

levodopa/carbidopa oral formulation B

levodopa/carbidopa oral formulation C

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Carbidopa/levodopa serum level Efficacy of the delivery method
Carbidopa/levodopa serum level

Secondary Outcome Measures

Full Information

First Posted
July 20, 2022
Last Updated
August 22, 2023
Sponsor
University of Minnesota
search

1. Study Identification

Unique Protocol Identification Number
NCT05471609
Brief Title
Sustained Release Oral Formulation for Treatment of Parkinson's Disease
Official Title
Sustained Release Oral Formulation for Treatment of Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
December 2, 2024 (Anticipated)
Study Completion Date
December 2, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Parkinson Disease
Keywords
Idiopathic Parkinson Disease, levodopa/carbidopa

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
3 different assemblies with 3 different formulations (A,B & C) will be used.
Masking
ParticipantInvestigator
Masking Description
Double-blinded
Allocation
Randomized
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
levodopa/carbidopa oral formulation A
Arm Type
Experimental
Arm Description
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.
Arm Title
levodopa/carbidopa oral formulation B
Arm Type
Experimental
Arm Description
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.
Arm Title
levodopa/carbidopa oral formulation C
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
levodopa/carbidopa oral formulation A
Intervention Description
Outer sachet 100mg CD/100mg LD and inner sachet 0mg CD /300mg LD
Intervention Type
Drug
Intervention Name(s)
levodopa/carbidopa oral formulation B
Intervention Description
Outer sachet 100mg CD/0mg LD and inner sachet 0mg CD /400mg LD
Intervention Type
Drug
Intervention Name(s)
levodopa/carbidopa oral formulation C
Intervention Description
Outer sachet 50mg CD/200mg LD and inner sachet 50mg CD /200mg LD
Primary Outcome Measure Information:
Title
Carbidopa/levodopa serum level Efficacy of the delivery method
Description
Carbidopa/levodopa serum level
Time Frame
5 times, every 60 mins for a total of 6 hours after administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with idiopathic PD Experiencing motor fluctuations Exclusion Criteria: Inability to consent for thmeselves Inability to fast
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diane Hutter, RN
Phone
612-625-2350
Email
hutte019@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khalaf Bushara, MD,FRCP
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diane Hutter, RN
Phone
612-625-2350
Email
hutte019@umn.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Sustained Release Oral Formulation for Treatment of Parkinson's Disease

We'll reach out to this number within 24 hrs