Fexofenadine as Adjuvant Therapy in Parkinson Disease

Tanta University

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Parkinson Disease

Treatments: Drug: Levodopa/carbidopa; Drug: Fexofenadine

Study type: Interventional

Funder types: Other

Identifiers

NCT06785298

3245

Details and patient eligibility

About

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.

Enrollment: 46 estimated patients

Sex: All

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

control arm

Active Comparator group

Description:

will receive their standard dopamine replacement therapy for 6 months.

Treatment:

Drug: Levodopa/carbidopa

Fexofenadine group

Active Comparator group

Description:

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

Treatment:

Drug: Fexofenadine

Drug: Levodopa/carbidopa