Fexofenadine As Adjuvant Therapy in Parkinson Disease

Phase 2

Recruiting

• Conditions: Parkinson Disease
• Interventions: Drug: Levodopa/carbidopa; Drug: Fexofenadine

• Registration Number: NCT06785298
• Lead Sponsor: Tanta University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-25
• Study Start: 2024-12-10
• Study First Submitted QC: 2025-01-17
• Last Update Submitted: 2025-01-17
• Study First Posted: 2025-01-21
• Last Update Posted: 2025-01-21
• Primary Completion: 2026-12-10
• Study Completion: 2026-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Age ≥ 50 years. Both male and female will be included. Patients with Parkinson's disease on dopamine replacement therapy. Modified Hoehn and Yahr stage, MHY 1-4

Exclusion Criteria

• Atypical parkinsonism or drug-induced parkinsonism Breast feeding Pregnant women and women with planned pregnancy. Patients with significant liver and kidney function abnormalities. History/presence of acute heart disease Alcohol and / or drug abusers. Patients with known allergy to the study medications Other medical conditions that can interfere with results or endanger the participant.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control arm	Levodopa/carbidopa	will receive their standard dopamine replacement therapy for 6 months.
Fexofenadine group	Fexofenadine	will receive Fexofenadine 180 mg once daily together with their standard dopamine replacement therapy for 6 months
Fexofenadine group	Levodopa/carbidopa	will receive Fexofenadine 180 mg once daily together with their standard dopamine replacement therapy for 6 months

Primary Outcome Measures

Name	Time	Method
The primary outcome is the change in quality of life in Parkinson's disease by Unified Parkinson's Disease Rating Scale	6 months	The primary outcome is the change in quality of life in Parkinson's disease by Unified Parkinson's Disease Rating Scale

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, Egypt