Sustained Release Levodopa/Carbidopa for Parkinson's Disease

Overseen By Clinical Research, RN

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Minnesota

Disqualifiers: Pregnancy, Inability to fast

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 6 hours

6 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of administering levodopa and carbidopa, common medications for Parkinson's disease. The aim is to determine if this new oral method can maintain steady blood levels of these medicines, potentially reducing movement problems in those with advanced Parkinson's. The trial includes two experimental treatments that deliver the medicine continuously through the mouth. Healthy individuals not on regular medication and able to fast for 6 hours may be suitable candidates for this study. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to contribute to groundbreaking advancements in Parkinson's treatment.

Do I have to stop taking my current medications for the trial?

Yes, you must not be taking medications regularly to participate in this trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that levodopa and carbidopa are commonly used to treat Parkinson's disease by replacing dopamine, a brain chemical that is low in people with this condition. Studies have found that these drugs are generally well-tolerated.

For the new oral formulations A and B, previous studies indicate that more than 1200 mg per day of levodopa and carbidopa can be safely administered using a continuous release method. This method involves placing the medication in the mouth for slow absorption.

No specific safety issues have been reported for these new formulations. However, since these treatments remain in early-stage research, they are just beginning human testing for safety and effectiveness. This phase of research primarily focuses on determining if the treatment is safe and how it works in the body. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatment options for Parkinson's disease, which typically involve oral tablets that provide intermittent dosing of levodopa and carbidopa, this new oral formulation offers a continuous release system. This innovative delivery method uses an oral device placed between the cheek and gum to ensure both transmucosal and gastrointestinal absorption. Researchers are excited about this approach because it could offer more stable symptom control by maintaining consistent medication levels in the body, potentially reducing the common motor fluctuations experienced with current treatments.

What evidence suggests that this trial's treatments could be effective for Parkinson's disease?

Research shows that levodopa and carbidopa often treat Parkinson's disease by replacing dopamine, which patients usually lack. This trial will test two new oral formulations of carbidopa-levodopa, labeled formulation A and formulation B. Studies have found that these new oral versions stabilize drug levels in the blood. This steady release can lead to longer-lasting effects and fewer daily doses, helping manage symptoms like movement problems. Previous research also suggests that these new versions can offer the same or better benefits compared to traditional methods. These findings make the new versions promising for improved symptom control in Parkinson's disease. ^{1 2 3 6 7}

Who Is on the Research Team?

Khalaf Bushara, MD,FRCP

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for people with Parkinson's Disease who have been officially diagnosed and are experiencing motor fluctuations. Participants must be able to give consent and fast before joining the study.

Inclusion Criteria

I have been diagnosed with Parkinson's disease.

I experience changes in my ability to move.

Exclusion Criteria

I am unable to give consent for my own medical treatment.

Inability to fast

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the novel oral carbidopa-levodopa formulation to achieve sustained blood levels

6 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• levodopa/carbidopa oral formulation A
• levodopa/carbidopa oral formulation B
• levodopa/carbidopa oral formulation C

Trial Overview The study tests three different oral formulations of levodopa/carbidopa (A, B, C) to see which one maintains steady levels in the blood better, aiming to reduce motor issues in Parkinson's patients.

How Is the Trial Designed?

Group I: levodopa/carbidopa oral formulation B Experimental Treatment 1 Intervention

LD/CD will be delivered using an oral device placed in the oral/buccal cavity (between cheek and gum of lower jaw) and delivers continuous release of CD and LD for both transmucosal and gastrointestinal absorption.

Group II: levodopa/carbidopa oral formulation A Experimental Treatment 1 Intervention

LD/CD will be delivered using an oral device placed in the oral/buccal cavity (between cheek and gum of lower jaw) and delivers continuous release of CD and LD for both transmucosal and gastrointestinal absorption.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05471609

Sustained Release Oral Formulation for Treatment of ... The aim of this study is to determine the efficacy of a novel oral carbidopa-levodopa formulation in achieving a sustained blood level of levodopa and carbidopa ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5784558/

Extended-release oral capsule of carbidopa–levodopa in ... Patients taking this formulation can expect longer duration of action and fewer doses per day, similar clinical improvement when compared to other levodopa ...

3. nature.com nature.com/articles/s41598-024-78145-4

Non-invasive, continuous oral delivery of solid levodopa ... In this exemplary study, a continuously extruded semisolid paste of 63% by weight 4:1 levodopa-carbidopa was engineered for managing Parkinson's ...

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK482140/

Levodopa (L-Dopa) - StatPearls - NCBI Bookshelf - NIH Levodopa is the precursor to dopamine. Most commonly, clinicians use levodopa as a dopamine replacement agent for the treatment of Parkinson disease.

5. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2808496

IPX203 vs Immediate-Release Carbidopa-Levodopa for ... The results of this study suggest that IPX203 vs immediate-release carbidopa-levodopa may be useful in patients with Parkinson disease and motor fluctuations.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK554552/

Carbidopa - StatPearls - NCBI Bookshelf - NIH Carbidopa is a medication used in the management and treatment of Parkinson disease (PD). It is in the decarboxylase inhibitor class of drugs.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04006210

Efficacy, Safety and Tolerability Study of ND0612 vs. Oral ... Safety and efficacy of continuous subcutaneous levodopa-carbidopa infusion (ND0612) for Parkinson's disease with motor fluctuations (BouNDless): a phase 3 ...