Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Clintrex Research Corporation | UNKNOWN |
| TFS Trial Form Support | INDUSTRY |
| Clinical Data Science GmbH | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DopaFuse Delivery System 50mg LD/hr or 68mg LD/hr flow rate | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| continuous oral delivery of levodopa/carbidopa | Combination Product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Variability in plasma concentration of levodopa as assessed with the Levodopa Fluctuation Index (Cmax-Cmin)/Caverage) | Comparing Day 2 to Day 1 in steady state (4-12 hours). Fluctuation index will also be calculated by the hour. | pre-dose and every 30 minutes for 12 hours on Days 1 and 2. |
| Treatment Emergent Adverse Events | Screening to Day 29 | |
| Serious Adverse Events | Screening to Day 29 | |
| Treatment Emergent Adverse Events leading to discontinuation | Screening to Day 29 | |
| Percent of participants that complete study | Screening to Day 29 | |
| Difference in OFF time between Days 1 and 15, based on in-person investigator ratings | Investigator-rated assessment of motor state (ON or OFF) pre-dose and every 30 minutes for 12 hours. | Day 1 compared to Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Coefficient of variation (CV) for plasma levodopa. | This will be calculated between 4 and 12 hours on Days 1 and 2 comparing DopaFuse and oral levodopa tablets. | pre-dose and every 30 minutes for 12 hours on Days 1 and 2. |
| Variability in plasma concentration of levodopa as assessed with the Levodopa Fluctuation Index (Cmax-Cmin)/Caverage). |
| Measure | Description | Time Frame |
|---|---|---|
| A comparison of the subgroups who are H. pylori positive and negative will be performed as an exploratory analysis. | Screening to Day 15 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ephraim Heller, MBA | SynAgile Corporation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Raffaele Cassino | Cassino | 03043 | Italy | |||
| Centro Parkinson, Policlinico Tor Vergata |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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. |
| 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. |
| Levodopa and Carbidopa peak plasma concentration (Cmax) | 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. |
| Variability in plasma levodopa comparing Dopafuse and oral levodopa tablets based on fluctuation index and CV in participants who are H. pylori negative/positive | 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. |
| Questionnaire for Impulse Control Disorders in Parkinson's Disease Rating Scale (QUIP-RS) | Screening to Day 29 |
| Columbia - Suicide Severity Rating Scale (C-SSRS) | Screening to Day 29 |
| Difference in OFF Time between Day 1 and Day 3 | Investigator-rated assessment of motor state (ON or OFF) pre-dose and every 30 minutes for 12 hours. | Day 1 and Day 3 |
| Difference in ON Time without troublesome dyskinesia between Days 1, 3 and 15 | Investigator-rated assessment of motor state (ON or OFF) pre-dose and every 30 minutes for 12 hours. | Days 1, 3, and 15 |
| Difference in ON Time with troublesome (severe) dyskinesia between Days 1, 3 and 15 | Investigator-rated assessment of motor state (ON or OFF) pre-dose and every 30 minutes for 12 hours. | Days 1, 3 and 15 |
| Change in Unified Parkinson's Disease Rating Scale Part III at 6 hours after morning dose between Days 1, 3 and 15 | Days 1, 3 and 15 |
| Levodopa and Carbidopa time to maximum plasma concentration (Tmax) | 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. |
| Levodopa and Carbidopa area under the plasma concentration versus time curve (AUC) | 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. |
| Rome |
| 00133 |
| Italy |
| IRCCS San Raffaele Pisana | Rome | 00163 | Italy |
| Centre Hospitalier de Luxembourg | Luxembourg | Luxembourg |
| Neuroscience Centre (CINAC) | Móstoles | 28938 | Spain |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002230 | Carbidopa |
| ID | Term |
|---|---|
| D008750 | Methyldopa |
| D004295 | Dihydroxyphenylalanine |
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D006834 | Hydrazines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
Not provided
Not provided