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NCT Number: NCT06785298

Fexofenadine as Adjuvant Therapy in Parkinson Disease

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Tanta University

Tanta, 31511, Egypt

Location status: Recruiting

Location contact

Ihab Elsayed Hassan, MSC

CONTACT

[email protected]

01067831661

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levodopa/carbidopa

Drug

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

Drug

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

Primary outcomes

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

    Time frame: 6 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ihab Elsayed Hassan, Doctor

CONTACT

[email protected]

0201067831661

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Clinical Study to Evaluate the Possible Efficacy and Safety of Fexofenadine in Patients With Parkinson's Disease Treated With Conventional Treatment

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2025
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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