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

  • STATUS
    Recruiting
  • days left to enroll
    71
  • participants needed
    24
  • sponsor
    SynAgile Corporation
Updated on 13 September 2021
levodopa
mini-mental state examination
mental state examination
carbidopa
motor symptoms

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.

Details
Condition Parkinson's disease, parkinson's, parkinson disease
Treatment continuous oral delivery of levodopa/carbidopa
Clinical Study IdentifierNCT04778176
SponsorSynAgile Corporation
Last Modified on13 September 2021

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note