Assessing the Pharmacokinetics, Safety, Tolerability and Efficacy of Continuous Oral Levodopa Via the DopaFuse® Delivery System in Parkinson's Disease Patients

NCT ID: NCT04778176

Last Updated: 2022-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-16
• Study Completion Date: 2022-08-02

Brief Summary

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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

continuous oral delivery of levodopa/carbidopa

Intervention Type: 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.

Interventions

continuous oral delivery of levodopa/carbidopa

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.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of Parkinson's Disease consistent with UK Brain Bank Criteria

2. Age at least 30 years old at time of consent

3. 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)

4. Suitable for oral retainer wear

5. A good response to Levodopa, as assessed by the Investigator

6. At least 2 hours of wearing OFF time per day, as reported by the participant

7. Predictable early morning OFF periods, in the judgement of the participant and the Investigator

8. 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.

9. A modified Hoehn and Yahr of ≤ 3 in the ON state at screening

10. A stable regimen of anti-PD medications for the last 28 days prior to Screening

11. A Mini-Mental State Examination (MMSE) Score ≥26

12. Capable of giving signed informed consent

13. Approved for entry into the study by the Enrollment Authorization Committee (EAC)

Exclusion Criteria

1. Atypical or secondary Parkinson's Disease

2. Severe Dyskinesia that might interfere with study performance in the judgement of Investigator

3. Clinically significant dysphagia or sialorrhea that might interfere with administration of study intervention in the judgement of the Investigator

4. Use of extended release levodopa within 28 days prior to screening

5. 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.

6. Presence of clinically significant orthostatic hypotension at screening, in the opinion of Investigator or the EAC

7. 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.

8. History of psychosis or hallucinations in the past six months

9. Any malignancy in the past 5 years (excluding basal cell carcinoma of the skin or cervical carcinoma in situ that have been successfully treated.)

10. Current or previous diagnosis of malignant melanoma or the presence of any suspicious skin lesion based on physical exam findings

11. Unable to give blood required for the study

12. History of allergic reaction to plastics

13. LD infusion therapy (i.e. Duodopa); current or previous continuous apomorphine infusion treatment.

14. Participation in any other clinical trial <30 days prior to screening visit.

15. Presence of two third molars ("wisdom teeth") on the upper dentition

16. 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.

17. Participants taking non-selective monoamine oxidase (MAO) inhibitors

18. 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

19. Participants with narrow-angle glaucoma

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clintrex Research Corporation

UNKNOWN

Sponsor Role: collaborator

TFS Trial Form Support

INDUSTRY

Sponsor Role: collaborator

Clinical Data Science GmbH

UNKNOWN

Sponsor Role: collaborator

SynAgile Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ephraim Heller, MBA

Role: STUDY_CHAIR

SynAgile Corporation

Locations

San Raffaele Cassino

Cassino, , Italy

Centro Parkinson, Policlinico Tor Vergata

Rome, , Italy

IRCCS San Raffaele Pisana

Rome, , Italy

Centre Hospitalier de Luxembourg

Luxembourg, , Luxembourg

Neuroscience Centre (CINAC)

Móstoles, , Spain

Countries

Italy; Luxembourg; Spain

Other Identifiers

TP-0007

Identifier Type: -

Identifier Source: org_study_id