A Study Comparing Propranolol and Amantadine for Reducing Tremors in People With Parkinson's Disease

NCT07113015 | Completed

• 1 other identifier: MultanMDC1
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

Parkinson's disease is a common brain disorder in older adults that causes tremors (shaking), stiffness, and problems with movement. Among these symptoms, tremors-especially those that occur at rest-can be distressing and interfere with daily life. This study aims to compare two commonly used medications, propranolol and amantadine, to determine which one is more effective and safer in reducing tremors in people with Parkinson's disease. This clinical trial was conducted with 220 adults aged 50 to 80 years who had a confirmed diagnosis of Parkinson's disease and noticeable resting tremors. Participants were randomly assigned to receive either propranolol or amantadine for 12 weeks, while continuing their usual Parkinson's medications. Tremor severity was measured using a standard scoring tool known as the Unified Parkinson's Disease Rating Scale (UPDRS). Quality of life and side effects were also closely monitored. The hypothesis is that propranolol would be more effective in reducing tremor severity than amantadine, though it might be associated with more side effects. Both medications were given in tablet form, twice daily, and doses were adjusted based on patient response and tolerance. At the end of the study, both groups showed improvement, but propranolol was more effective at reducing tremors. However, it caused more side effects such as tiredness and dizziness. Quality of life improved in both groups with no major difference between them. This study may help doctors decide which medication is more suitable for treating tremors in Parkinson's disease, based on the patient's health status and side effect tolerance.

Conditions

Parkinson Disease (PD); Tremor

Keywords

Amantadine; Parkinson's Disease; Propranolol; Motor Symptoms; Tremors

Outcome Measures

Primary Outcomes (1)

• Change in tremor severity

  This measure assessed the severity of resting tremor using Part III (Motor Examination) of the Unified Parkinson's Disease Rating Scale (UPDRS). Each tremor item was scored from 0 to 4, with higher scores reflecting greater severity. The change in tremor scores from baseline to week 12 was used to evaluate and compare the efficacy of propranolol and amantadine in reducing tremor severity among participants with Parkinson's disease.

  From baseline to 12 weeks after intervention initiation

Study Arms (2)

Group Propranolol

ACTIVE COMPARATOR

Received 40 mg of propranolol administered orally twice daily, with dose titration permitted based on clinical response and tolerability, not exceeding 80 mg/day. PD medications remained unchanged during the trial.

Drug: propranolol

Group Amantadine

ACTIVE COMPARATOR

Received 100 mg of amantadine administered orally twice daily, with dose titration permitted based on clinical response and tolerability, not exceeding 200 mg/day. PD medications remained unchanged during the trial.

Drug: Amantadine

Interventions

propranolol DRUG

40 mg orally twice daily, titrated up to a maximum of 80 mg/day.

Also known as: Inderal, Non-selective beta-blocker

Group Propranolol

Amantadine DRUG

100 mg orally twice daily, titrated up to a maximum of 200 mg/day.

Also known as: Symmetrel, NMDA receptor antagonist

Group Amantadine

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• UK Parkinson's Disease Society Brain Bank criteria \[7\] - Parkinson's Disease.
• Aged between 50 and 80 years.
• Significant (resting tremor score, defined as η ≥2 on the UPDRS Part III).
• At least 4 weeks prior to the study, a stable regimen of PD medication.

You may not qualify if:

• Severe bradycardia, history of asthma, or heart block (used instead of the propranolol group).
• History of seizures or significant renal impairment (Amantadine group).
• Cigarette smoking, pregnant or breastfeeding women.
• Patients with MMSE \< 24.
• Participation in another clinical trial at the same time.

Sponsors & Collaborators

• Multan Medical And Dental College: lead

Study Sites (1)

Multan Medical and Dental College

Multan, Punjab Province, 60000, Pakistan

Location

MeSH Terms

Conditions

Parkinson Disease; Tremor

Interventions

Propranolol; Amantadine; GluN2C-2D antagonist UBP145

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Adamantane; Bridged-Ring Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 2, 2025
• First Posted: August 8, 2025
• Study Start: July 5, 2024
• Primary Completion: December 2, 2024
• Study Completion: December 2, 2024
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

PA (1)