Fexofenadine as Adjuvant Therapy in Parkinson Disease

January 17, 2026 updated by: Ihab Elsayed Hassan, Tanta University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Tanta, Egypt, 31511
        • Recruiting
        • Tanta University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control arm
will receive their standard dopamine replacement therapy for 6 months.
Drug: Levodopa/carbidopa
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
Active Comparator: Fexofenadine group
will receive Fexofenadine 180 mg once daily together with their standard dopamine replacement therapy for 6 months
Drug: Levodopa/carbidopa
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
Drug: Fexofenadine
Fexofenadine is a second-generation antihistamine that does not penetrate the CNS and has the least CNS side effects among the second-generation antihistamines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Collaborators

Prof. Sahar Kamal Hegazy (Sahar K. Hegazy) Professor and Head of Clinical Pharmacy Department Faculty of Pharmacy Tanta University
Dr. Raed Ahmed Abdelmaboud Lecturer of Neurology-Neuropsychiatry Department Faculty of Medicine Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2024

Primary Completion (Estimated)

December 10, 2026

Study Completion (Estimated)

December 20, 2026

Study Registration Dates

First Submitted

November 25, 2024

First Submitted That Met QC Criteria

January 17, 2025

First Posted (Actual)

January 21, 2025

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 17, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3245

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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