NCT07229664

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2 parkinson-disease

Timeline
19mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
Nov 2025Nov 2027

Study Start

First participant enrolled

November 10, 2025

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 17, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2027

Last Updated

December 10, 2025

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

November 13, 2025

Last Update Submit

December 3, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

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

    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 Outcomes (1)

  • changes in serum biomarkers

    6 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Vinpocetine group

ACTIVE COMPARATOR

Patients will receive levodopa/carbidopa (125/12.5 mg) three times daily plus vinpocetine 10 mg three times daily for 6 months

Drug: Levodopa CarbidopaDrug: Vinpocetine

Interventions

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.

Control groupVinpocetine group

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

Vinpocetine group

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta Unuversity

Tanta, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

carbidopa, levodopa drug combinationvinpocetine

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Double blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

November 13, 2025

First Posted

November 17, 2025

Study Start

November 10, 2025

Primary Completion (Estimated)

November 20, 2026

Study Completion (Estimated)

November 20, 2027

Last Updated

December 10, 2025

Record last verified: 2025-12

Locations