Vinpocetine in Patients With Parkinsonian Disease

NCT07229664 — Phase 2 / Phase 3, Recruiting, 60 participants, Tanta University

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

RegistryNCT07229664
StatusRecruiting
PhasePhase 2 / Phase 3
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment60 (Estimated)
SponsorTanta University (Other)
ConditionsParkinson Disease
InterventionsLevodopa Carbidopa, Vinpocetine (Drug)
Datesstart 2025-11-10, primary completion 2026-11-20 (estimated), completion 2027-11-20 (estimated), first posted 2025-11-17, last updated 2025-12-10
Locations1 site in Egypt

Related Papers Related Patents Related Grants Related Experts
All trials for Parkinson Disease All trials of Levodopa Carbidopa All trials of Vinpocetine

-Summary

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

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+Arms and interventions

ArmTypeInterventionsDescription
Control groupActive comparatorDrug: Levodopa CarbidopaControl group (Levo-dopa group, n =30) who will receive levodopa/carbidopa (125/12.5 mg) three times daily for 6 months
Vinpocetine groupActive comparatorDrug: Levodopa Carbidopa; Drug: VinpocetinePatients will receive levodopa/carbidopa (125/12.5 mg) three times daily plus vinpocetine 10 mg three times daily for 6 months
  • Levodopa Carbidopa (Drug): 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.
  • Vinpocetine (Drug): 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

+Outcome measures

Primary outcomes

  • Change in The Unified Parkinson's Disease Rating Scale (UPDRS). [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.

Secondary outcomes

  • changes in serum biomarkers [6 months]: The secondary endpoint is estimated by changes in serum biomarkers such as α-synuclein and Toll like receptor 4

+Eligibility

Sex: All, ages: 50 Years to 70 Years

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

+Locations (1)

FacilityCityCountryStatus
Tanta UnuversityTantaEgyptRecruiting