Fexofenadine as Adjuvant Therapy in Parkinson Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-10

Study Completion Date

2026-12-20

Brief Summary

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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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Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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control arm

will receive their standard dopamine replacement therapy for 6 months.

Group Type ACTIVE_COMPARATOR

Levodopa/carbidopa

Intervention Type 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 group

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

Group Type ACTIVE_COMPARATOR

Levodopa/carbidopa

Intervention Type 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

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No