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Parkinson's DiseasePhase 2SCOLNCT04778176

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

A Phase 2 study testing continuous oral delivery of levodopa/carbidopa in people with Parkinson's Disease, run by SynAgile Corporation at 5 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Parkinson's Disease
What is being tested?
continuous oral delivery of levodopa/carbidopa
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
5 sitesin 3 countries
Study dates
16 Jun 2021to 2 Aug 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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)

Who cannot join

  • 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
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  • 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

Trial locations and contacts

5 sites in 3 countries.

5 sites in 3 countries

Italy3 sites

  • San Raffaele Cassino

    Cassino, 03043

  • Centro Parkinson, Policlinico Tor Vergata

    Rome, 00133

  • IRCCS San Raffaele Pisana

    Rome, 00163

Other trials in Italy

Luxembourg1 site

  • Centre Hospitalier de Luxembourg

    Luxembourg

Other trials in Luxembourg

Spain1 site

  • Neuroscience Centre (CINAC)

    Móstoles, 28938

Other trials in Spain

About this study

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.

Being tested
continuous oral delivery of levodopa/carbidopa
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • continuous oral delivery of levodopa/carbidopaCombination 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.

Study groups in NCT04778176
Study groupRoleWhat they receive
DopaFuse Delivery System 50mg LD/hr or 68mg LD/hr flow rateExperimentalEither 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).
Receives: Combination Product: continuous oral delivery of levodopa/carbidopa

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: pre-dose and every 30 minutes for 12 hours on Days 1 and 2.

  2. Treatment Emergent Adverse Events

    Measured: Screening to Day 29

  3. Serious Adverse Events

    Measured: Screening to Day 29

  4. Treatment Emergent Adverse Events leading to discontinuation

    Measured: Screening to Day 29

  5. Percent of participants that complete study

    Measured: Screening to Day 29

  6. 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.

    Measured: Day 1 compared to Day 15

Secondary outcomes (12)

  1. 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.

    Measured: pre-dose and every 30 minutes for 12 hours on Days 1 and 2.

  2. Variability in plasma concentration of levodopa as assessed with the Levodopa Fluctuation Index (Cmax-Cmin)/Caverage).

    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.

    Measured: 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.

  3. Levodopa and Carbidopa peak plasma concentration (Cmax)

    Measured: 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.

  4. Variability in plasma levodopa comparing Dopafuse and oral levodopa tablets based on fluctuation index and CV in participants who are H. pylori negative/positive

    Measured: 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.

  5. Questionnaire for Impulse Control Disorders in Parkinson's Disease Rating Scale (QUIP-RS)

    Measured: Screening to Day 29

  6. Columbia - Suicide Severity Rating Scale (C-SSRS)

    Measured: Screening to Day 29

  7. 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.

    Measured: Day 1 and Day 3

  8. 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.

    Measured: Days 1, 3, and 15

  9. 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.

    Measured: Days 1, 3 and 15

  10. Change in Unified Parkinson's Disease Rating Scale Part III at 6 hours after morning dose between Days 1, 3 and 15

    Measured: Days 1, 3 and 15

  11. Levodopa and Carbidopa time to maximum plasma concentration (Tmax)

    Measured: 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.

  12. Levodopa and Carbidopa area under the plasma concentration versus time curve (AUC)

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2021
  2. Study start16 Jun 2021
  3. Primary completion21 Jul 2022
  4. Study completion2 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04778176
Sponsor's protocol ID
TP-0007
Acronym
SCOL
Status last verified
Aug 2022
First submitted
22 Feb 2021
Last updated
10 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Olanow CW, McIntyre D, Matarazzo M, Leinonen M, McGarry A, Kamp C, Kennedy J, Torti M, Kruger R, Obeso JA, Stocchi F, Heller E, Kieburtz K. Continuous Levodopa Delivery with an Intraoral Micropump System: An Open-Label Pharmacokinetics and Clinical Study. Mov Disord. 2024 Jun;39(6):945-954. doi: 10.1002/mds.29824. Epub 2024 May 2.

    PubMed 38698639

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing continuous oral delivery of levodopa/carbidopa in people with Parkinson's Disease, run by SynAgile Corporation at 5 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Italy, Luxembourg, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04778176, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022; AzTrials last refreshed its copy on 8 Nov 2026.

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