- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04778176
Assessing the Pharmacokinetics, Safety, Tolerability and Efficacy of Continuous Oral Levodopa Via the DopaFuse® Delivery System in Parkinson's Disease Patients (SCOL)
August 9, 2022 updated by: SynAgile Corporation
The purpose of this study is to evaluate whether the DopaFuse System can reduce the fluctuation of plasma levodopa levels compared to participants' standard intermittent doses of oral LD/CD tablets (background treatment).
It will also assess whether the system is safe, well tolerated, and can relieve motor symptoms.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Cassino, Italy, 03043
- San Raffaele Cassino
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Rome, Italy, 00163
- IRCCS San Raffaele Pisana
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Rome, Italy, 00133
- Centro Parkinson, Policlinico Tor Vergata
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Luxembourg, Luxembourg
- Centre Hospitalier de Luxembourg
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Móstoles, Spain, 28938
- Neuroscience Centre (CINAC)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of Parkinson's Disease consistent with UK Brain Bank Criteria
- Age at least 30 years old at time of consent
- Male and Female participants (Women of child-bearing potential (WOCB) are eligible for participation if they are not pregnant or breastfeeding and agree to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 30 days after the last dose of study treatment)
- Suitable for oral retainer wear
- A good response to Levodopa, as assessed by the Investigator
- At least 2 hours of wearing OFF time per day, as reported by the participant
- Predictable early morning OFF periods, in the judgement of the participant and the Investigator
- Taking 400-1,200 mg of LD/CD per day in at least 4 doses, with stable dosing for the last 28 days prior to screening.
- A modified Hoehn and Yahr of ≤ 3 in the ON state at screening
- A stable regimen of anti-PD medications for the last 28 days prior to Screening
- A Mini-Mental State Examination (MMSE) Score ≥26
- Capable of giving signed informed consent
- Approved for entry into the study by the Enrollment Authorization Committee (EAC)
Exclusion Criteria:
- Atypical or secondary Parkinson's Disease
- Severe Dyskinesia that might interfere with study performance in the judgement of Investigator
- Clinically significant dysphagia or sialorrhea that might interfere with administration of study intervention in the judgement of the Investigator
- Use of extended release levodopa within 28 days prior to screening
- Any clinically significant medical, surgical, or psychiatric condition; laboratory value or ECG result which, in the opinion of the Investigator, makes the participant unsuitable for study entry or potentially unable to complete all aspects of the study.
- Presence of clinically significant orthostatic hypotension at screening, in the opinion of Investigator or the EAC
- Suicidal ideation within 1 year prior to the Screening Visit as evidenced by answering "yes" to Questions 4 or 5 on the suicidal ideation portion of the Columbia Suicide Severity Rating Scale (C-SSRS) or attempted suicide within the last 5 years.
- History of psychosis or hallucinations in the past six months
- Any malignancy in the past 5 years (excluding basal cell carcinoma of the skin or cervical carcinoma in situ that have been successfully treated.)
- Current or previous diagnosis of malignant melanoma or the presence of any suspicious skin lesion based on physical exam findings
- Unable to give blood required for the study
- History of allergic reaction to plastics
- LD infusion therapy (i.e. Duodopa); current or previous continuous apomorphine infusion treatment.
- Participation in any other clinical trial <30 days prior to screening visit.
- Presence of two third molars ("wisdom teeth") on the upper dentition
- Participants who, for any reason, are judged by the Investigator or the EAC to be inappropriate for this study, including participants who are unable to communicate or cooperate with the Investigator or who have/had a clinically significant illness or abnormal physical examination that may compromise safety of the participant during the trial or affect ability of the participant to adhere to study procedures.
- Participants taking non-selective monoamine oxidase (MAO) inhibitors
- Participants with known hypersensitivity to the active ingredients (levodopa, carbidopa) or excipients (Benzoic Acid, Disodium Edetate, Medium Chain Triglycerides, Poloxamer 188) of the drug paste
- Participants with narrow-angle glaucoma
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: DopaFuse Delivery System 50mg LD/hr or 68mg LD/hr flow rate
Either 50mg/13mg LD/CD per hour or 68mg/17mg LD/CD per hour flow rate based upon Subject's standard levodopa (LD) dose.
Subjects will routinely wear each container for approximately 5 hours (3 containers per day).
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The system consists of a reusable custom dental retainer, its case, and a pre-filled, single-use container which continuously releases levodopa/carbidopa into the back of the mouth.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Variability in plasma concentration of levodopa as assessed with the Levodopa Fluctuation Index (Cmax-Cmin)/Caverage)
Time Frame: pre-dose and every 30 minutes for 12 hours on Days 1 and 2.
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Comparing Day 2 to Day 1 in steady state (4-12 hours).
Fluctuation index will also be calculated by the hour.
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pre-dose and every 30 minutes for 12 hours on Days 1 and 2.
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Treatment Emergent Adverse Events
Time Frame: Screening to Day 29
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Screening to Day 29
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Serious Adverse Events
Time Frame: Screening to Day 29
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Screening to Day 29
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Treatment Emergent Adverse Events leading to discontinuation
Time Frame: Screening to Day 29
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Screening to Day 29
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Percent of participants that complete study
Time Frame: Screening to Day 29
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Screening to Day 29
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Difference in OFF time between Days 1 and 15, based on in-person investigator ratings
Time Frame: Day 1 compared to Day 15
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Investigator-rated assessment of motor state (ON or OFF) pre-dose and every 30 minutes for 12 hours.
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Day 1 compared to Day 15
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Coefficient of variation (CV) for plasma levodopa.
Time Frame: pre-dose and every 30 minutes for 12 hours on Days 1 and 2.
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This will be calculated between 4 and 12 hours on Days 1 and 2 comparing DopaFuse and oral levodopa tablets.
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pre-dose and every 30 minutes for 12 hours on Days 1 and 2.
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Variability in plasma concentration of levodopa as assessed with the Levodopa Fluctuation Index (Cmax-Cmin)/Caverage).
Time Frame: pre-dose and every 30 minutes for 12 hours on Days 1 and 2. Pre-dose and at 30 minute intervals for two hours, and at one-hour intervals for the remainder of the 12 hours on Day 3.
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Comparing Day 3 to Day 1, as well as Day 2 (0-12 hours) to Day 1. Fluctuation index will also be calculated by the hour.
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pre-dose and every 30 minutes for 12 hours on Days 1 and 2. Pre-dose and at 30 minute intervals for two hours, and at one-hour intervals for the remainder of the 12 hours on Day 3.
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Levodopa and Carbidopa peak plasma concentration (Cmax)
Time Frame: pre-dose and every 30 minutes for 12 hours on Days 1 and 2. Pre-dose and at 30 minute intervals for two hours, and at one-hour intervals for the remainder of the 12 hours on Day 3.
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pre-dose and every 30 minutes for 12 hours on Days 1 and 2. Pre-dose and at 30 minute intervals for two hours, and at one-hour intervals for the remainder of the 12 hours on Day 3.
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Variability in plasma levodopa comparing Dopafuse and oral levodopa tablets based on fluctuation index and CV in participants who are H. pylori negative/positive
Time Frame: pre-dose and every 30 minutes for 12 hours on Days 1 and 2. Pre-dose and at 30 minute intervals for two hours, and at one-hour intervals for the remainder of the 12 hours on Day 3.
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pre-dose and every 30 minutes for 12 hours on Days 1 and 2. Pre-dose and at 30 minute intervals for two hours, and at one-hour intervals for the remainder of the 12 hours on Day 3.
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Questionnaire for Impulse Control Disorders in Parkinson's Disease Rating Scale (QUIP-RS)
Time Frame: Screening to Day 29
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Screening to Day 29
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Columbia - Suicide Severity Rating Scale (C-SSRS)
Time Frame: Screening to Day 29
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Screening to Day 29
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Difference in OFF Time between Day 1 and Day 3
Time Frame: Day 1 and Day 3
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Investigator-rated assessment of motor state (ON or OFF) pre-dose and every 30 minutes for 12 hours.
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Day 1 and Day 3
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Difference in ON Time without troublesome dyskinesia between Days 1, 3 and 15
Time Frame: Days 1, 3, and 15
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Investigator-rated assessment of motor state (ON or OFF) pre-dose and every 30 minutes for 12 hours.
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Days 1, 3, and 15
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Difference in ON Time with troublesome (severe) dyskinesia between Days 1, 3 and 15
Time Frame: Days 1, 3 and 15
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Investigator-rated assessment of motor state (ON or OFF) pre-dose and every 30 minutes for 12 hours.
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Days 1, 3 and 15
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Change in Unified Parkinson's Disease Rating Scale Part III at 6 hours after morning dose between Days 1, 3 and 15
Time Frame: Days 1, 3 and 15
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Days 1, 3 and 15
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Levodopa and Carbidopa time to maximum plasma concentration (Tmax)
Time Frame: pre-dose and every 30 minutes for 12 hours on Days 1 and 2. Pre-dose and at 30 minute intervals for two hours, and at one-hour intervals for the remainder of the 12 hours on Day 3.
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pre-dose and every 30 minutes for 12 hours on Days 1 and 2. Pre-dose and at 30 minute intervals for two hours, and at one-hour intervals for the remainder of the 12 hours on Day 3.
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Levodopa and Carbidopa area under the plasma concentration versus time curve (AUC)
Time Frame: pre-dose and every 30 minutes for 12 hours on Days 1 and 2. Pre-dose and at 30 minute intervals for two hours, and at one-hour intervals for the remainder of the 12 hours on Day 3.
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pre-dose and every 30 minutes for 12 hours on Days 1 and 2. Pre-dose and at 30 minute intervals for two hours, and at one-hour intervals for the remainder of the 12 hours on Day 3.
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Other Outcome Measures
Outcome Measure |
Time Frame |
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A comparison of the subgroups who are H. pylori positive and negative will be performed as an exploratory analysis.
Time Frame: Screening to Day 15
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Screening to Day 15
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Ephraim Heller, MBA, SynAgile Corporation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 16, 2021
Primary Completion (ACTUAL)
July 21, 2022
Study Completion (ACTUAL)
August 2, 2022
Study Registration Dates
First Submitted
February 22, 2021
First Submitted That Met QC Criteria
February 26, 2021
First Posted (ACTUAL)
March 2, 2021
Study Record Updates
Last Update Posted (ACTUAL)
August 10, 2022
Last Update Submitted That Met QC Criteria
August 9, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Parkinson Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Dopamine Agents
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Aromatic Amino Acid Decarboxylase Inhibitors
- Levodopa
- Carbidopa
Other Study ID Numbers
- TP-0007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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