Vinpocetine in Patients With Parkinsonian Disease

December 3, 2025 updated by: Mostafa Bahaa, Tanta University

Clinical Study to Evaluate Safety and Effectiveness of Vinpocetine in Patients With Parkinsonian Disease

The clinical manifestations of Parkinson's disease (PD), a chronic neurodegenerative condition, include resting tremor, hypokinesia, bradykinesia, stiffness and postural instability. These motor symptoms are caused by a selective loss and degeneration of dopaminergic neurons in the substantia nigra pars compacta (SNpc) region, which leads to a dopamine (DA) insufficiency in the striatum

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Tanta, Egypt, 31527
        • Recruiting
        • Tanta Unuversity
        • Sub-Investigator:
          • Mostafa M Bahaa, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Age ≥ 50 years Both male and female will be included Negative pregnancy test and effective contraception. Diagnosed Parkinson's disease patient taking Levodopa

Exclusion Criteria:

Secondary causes of parkinsonism Patients taking anti-inflammatory drugs Atypical parkinsonian syndromes Prior stereotaxic surgery for Parkinson's disease Pregnancy and lactation Cardiovascular disease patients Patients with coagulation disorders Suffering from active malignancy Addiction to alcohol and / or drugs Known allergy to the studied medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
Control group (Levo-dopa group, n =30) who will receive levodopa/carbidopa (125/12.5 mg) three times daily for 6 months
Drug: Levodopa Carbidopa
Carbidopa/levodopa, also known as levocarb and co-careldopa, is the combination of the two medications carbidopa and levodopa. It is primarily used to manage the symptoms of Parkinson's disease.
Active Comparator: Vinpocetine group
Patients will receive levodopa/carbidopa (125/12.5 mg) three times daily plus vinpocetine 10 mg three times daily for 6 months
Drug: Levodopa Carbidopa
Carbidopa/levodopa, also known as levocarb and co-careldopa, is the combination of the two medications carbidopa and levodopa. It is primarily used to manage the symptoms of Parkinson's disease.
Drug: Vinpocetine
VIN, a phosphodiesterase-1 (PDE1) inhibitor, reduces oxidative stress and neuroinflammation and is used clinically for cerebrovascular disease and dementia. In PD, VIN increases dopamine levels, protects dopaminergic neurons, reverses motor impairments, and reduces inflammatory mediators

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in The Unified Parkinson's Disease Rating Scale (UPDRS).
Time Frame: 6 months
The unified Parkinson's disease rating scale is used to follow the longitudinal course of Parkinson's disease. The UPD rating scale is the most commonly used scale in the clinical study of Parkinson's disease.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in serum biomarkers
Time Frame: 6 months
The secondary endpoint is estimated by changes in serum biomarkers such as α-synuclein and Toll like receptor 4
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2025

Primary Completion (Estimated)

November 20, 2026

Study Completion (Estimated)

November 20, 2027

Study Registration Dates

First Submitted

November 13, 2025

First Submitted That Met QC Criteria

November 13, 2025

First Posted (Estimated)

November 17, 2025

Study Record Updates

Last Update Posted (Actual)

December 10, 2025

Last Update Submitted That Met QC Criteria

December 3, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5469

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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