NCT06785298

Brief Summary

Parkinson's disease (PD) is a chronic, progressive neurological disorder characterized by both motor and non-motor symptoms. PD is the second most common neurodegenerative disorder after Alzheimer's disease and the most common movement disorder. PD has age-related pathology; it is present in 1-2% of the population over 60 years of age. The disease is characterized by a triad of disordered voluntary motor activity in the form of bradykinesia (slowness of movement) or even akinesia (absence of movement),rigidity and postural instability, and a resting tremor of the hands and less commonly the feet.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for phase_2 parkinson-disease

Timeline
8mo left

Started Dec 2024

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 Progress69%
Dec 2024Dec 2026

First Submitted

Initial submission to the registry

November 25, 2024

Completed
15 days until next milestone

Study Start

First participant enrolled

December 10, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 21, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2026

Expected
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2026

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

November 25, 2024

Last Update Submit

January 17, 2026

Conditions

Parkinson Disease

Keywords

Fexofenadine

Outcome Measures

Primary Outcomes (1)

  • The primary outcome is the change in quality of life in Parkinson's disease by Unified Parkinson's Disease Rating Scale

    The primary outcome is the change in quality of life in Parkinson's disease by Unified Parkinson's Disease Rating Scale

    6 months

Study Arms (2)

control arm

ACTIVE COMPARATOR

will receive their standard dopamine replacement therapy for 6 months.

Drug: Levodopa/carbidopa

Fexofenadine group

ACTIVE COMPARATOR

will receive Fexofenadine 180 mg once daily together with their standard dopamine replacement therapy for 6 months

Drug: Levodopa/carbidopaDrug: Fexofenadine

Interventions

Levodopa/carbidopaDRUG

A dopamine precursor, was first developed for the treatment of PD in the 1960s and continues to be the most-effective therapeutic agent for PD

Fexofenadine groupcontrol arm
FexofenadineDRUG

Fexofenadine is a second-generation antihistamine that does not penetrate the CNS and has the least CNS side effects among the second-generation antihistamines

Fexofenadine group

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, 31511, Egypt

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

carbidopa, levodopa drug combinationfexofenadine

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ihab Elsayed Hassan, Doctor

CONTACT

0201067831661ihassan@horus.edu.eg

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching Assistant

Study Record Dates

First Submitted

November 25, 2024

First Posted

January 21, 2025

Study Start

December 10, 2024

Primary Completion (Estimated)

December 10, 2026

Study Completion (Estimated)

December 20, 2026

Last Updated

January 21, 2026

Record last verified: 2026-01

Locations

EG(1)