Sustained Release Oral Formulation for Treatment of Parkinson's Disease

Study Overview
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Brief Summary
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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.

Official Title
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Sustained Release Oral Formulation for Treatment of Parkinson's Disease

Conditions
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Idiopathic Parkinson Disease

Intervention / Treatment
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* Drug: levodopa/carbidopa oral formulation A
* Drug: levodopa/carbidopa oral formulation B
* Drug: levodopa/carbidopa oral formulation C


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with idiopathic PD Experiencing motor fluctuations Exclusion Criteria: Inability to consent for thmeselves Inability to fast

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: 3 different assemblies with 3 different formulations (A,B & C) will be used.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: levodopa/carbidopa oral formulation A<br>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<br>* Outer sachet 100mg CD/100mg LD and inner sachet 0mg CD /300mg LD<br>|
| Experimental: levodopa/carbidopa oral formulation B<br>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<br>* Outer sachet 100mg CD/0mg LD and inner sachet 0mg CD /400mg LD<br>|
| Experimental: levodopa/carbidopa oral formulation C<br>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<br>* Outer sachet 50mg CD/200mg LD and inner sachet 50mg CD /200mg LD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Idiopathic Parkinson Disease, levodopa/carbidopa