Carvedilol for Parkinson's Disease

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Cedars-Sinai Medical Center

Must not be taking: Beta-blockers

Disqualifiers: Dementia, Severe depression, Heart failure, Hypertension, Diabetes, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 3 years

15 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using beta-adrenergic antagonists (a type of medication that affects the heart and blood vessels).

Is carvedilol safe for use in humans?

Carvedilol has been studied for its safety in humans under various brand names like Coreg and Eucardic, primarily for heart-related conditions. It is generally considered safe, with known side effects including dizziness, fatigue, and low blood pressure, but specific safety data for its use in Parkinson's Disease is limited to animal studies. ^{1 2 3 4 5}

How does the drug Carvedilol differ from other treatments for Parkinson's disease?

Carvedilol is unique because it is a beta-blocker, which is typically used for heart conditions, but it may help manage tremors in Parkinson's disease. Unlike traditional Parkinson's treatments like levodopa, which have limited effects on tremors, beta-blockers like Carvedilol could offer an alternative approach by targeting the adrenergic system. ^{2 6 7 8 9}

What is the purpose of this trial?

The purpose of this study is to investigate the long-term effects of treatment with the adrenergic blocker carvedilol on serial DaTscan, a dopamine transporter (DAT) single photon emission computerized tomography (SPECT) imaging technique in a population of subjects with defined pre-motor Parkinson's disease risks (i.e., REM sleep Behavior Disorder (RBD) and at least one among hyposmia, constipation, depression and color vision abnormality) and abnormal 123I-Metaiodobenzylguanidine (MIBG) scintigraphy.

Research Team

Michele L Lima Gregorio, MD, FAAN

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

This trial is for people with early Parkinson's Disease who may also have REM Sleep Behavior Disorder and other pre-motor symptoms but do not suffer from severe depression or conditions like recent heart attacks, diabetes, certain heart blocks, cardiomyopathy, pericarditis, severe sleep apnea, low heart rates with symptoms, stroke within the last month, severe liver dysfunction or failure. Participants must be able to consent and should not be on beta-blockers.

Inclusion Criteria

Enrolled in the study "The Effect of Adrenergic Blocker Therapy on Cardiac and Striatal Transporter Uptake in Pre-Motor and Symptomatic Parkinson's Disease" (Pro#00053136)

I understand the details of the clinical trial and can consent to participate.

Exclusion Criteria

I have asthma or experience bronchospasm.

I am allergic to iodine or the medication used in this study.

I am currently taking beta-blocker medication.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive carvedilol treatment and undergo MIBG scan, DAT scan, and NM-MRI every six months

3 years

Every 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Carvedilol

Trial Overview The study tests the long-term effects of Carvedilol (a medication that affects the body's response to nerve impulses in certain parts of the body) on brain imaging techniques in patients at risk for Parkinson’s disease. It focuses on changes observed through DaTscan SPECT imaging and MIBG scintigraphy.

Participant Groups

Group I: carvedilol therapy Experimental Treatment 1 Intervention

Twice daily oral doses of adrenergic blocker 12.5 mg or 25mg, according to patient tolerability.

Carvedilol is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Coreg for:

• Hypertension
• Heart failure
• Left ventricular dysfunction following myocardial infarction

Approved in European Union as Dilatrend for:

• Hypertension
• Heart failure
• Left ventricular dysfunction following myocardial infarction

Approved in Canada as Eucardic for:

• Hypertension
• Heart failure
• Left ventricular dysfunction following myocardial infarction

Approved in Japan as Carloc for:

• Hypertension
• Heart failure
• Left ventricular dysfunction following myocardial infarction

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Findings from Research

In a long-term study involving 419 participants with early and advanced Parkinson's disease, ropinirole extended release was found to be safe, with no new or unexpected safety concerns over a median exposure of 1275 days.

Most participants (87%) experienced at least one adverse event, with common issues including back pain and hallucinations, but a majority preferred the once-daily dosing regimen over more frequent dosing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term, open-label, safety study of once-daily ropinirole extended/prolonged release in early and advanced Parkinson's disease. Makumi, CW., Asgharian, A., Ellis, J., et al.[2016]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Neuroprotective repositioning and anti-tau effect of carvedilol on rotenone induced neurotoxicity in rats: Insights from an insilico& in vivo anti-Parkinson's disease study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Safety, Tolerability, and Pharmacokinetics of Mevidalen (LY3154207), a Centrally Acting Dopamine D1 Receptor-Positive Allosteric Modulator, in Patients With Parkinson Disease. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Long-term, open-label, safety study of once-daily ropinirole extended/prolonged release in early and advanced Parkinson's disease. [2016]

4. Germany pubmed.ncbi.nlm.nih.gov

[Practical experience on improving activities of daily living competence in Parkinson's patients treated with ropinirole. Results of a applied study]. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

The safety of ropinirole, a selective nonergoline dopamine agonist, in patients with Parkinson's disease. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Beta2-Adrenoceptor Agonists in Parkinson's Disease and Other Synucleinopathies. [2021]

7. Poland pubmed.ncbi.nlm.nih.gov

[Effect of Coretal Polfa (Oxprenolol) on parkinsonian tremor and benign essential tremor]. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Beta-blocker therapy for tremor in Parkinson's disease. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Metoprolol in the treatment of neuroleptic-induced tremor: case report. [2013]