Comparison of Benzhexol and Procyclidine for Tremor in Tremor-Predominant Parkinson's Disease

ConditionParkinson Disease (PD)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age40-70

Sponsorsafia bano

About this trial

The goal of this clinical trial is to compare benzhexol and procyclidine for improving tremor in adults with tremor-predominant Parkinson's disease who are taking levodopa. Researchers will compare the two medicines to determine whether benzhexol provides similar improvement in tremor to procyclidine and to assess their side effects. Participants will be randomly assigned to receive either benzhexol or procyclidine in addition to their usual levodopa treatment. Motor symptoms and side effects will be assessed before treatment and at 2 weeks, 3 months, and 6 months.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed Parkinson's disease according to the Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's Disease, with predominant tremor at presentation.

Hoehn and Yahr stage 1, 2, or 3.

Any gender.

Age 40 to 70 years.

Disqualifiers

Cognitive or behavioral abnormalities.

Lower urinary tract symptoms.

Benign prostatic hyperplasia.

Angle-closure glaucoma.

Trial design

Design model

Parallel

Treatments tested in this trial

Benzhexol
Drug
Benzhexol will be administered orally. Treatment will start at 2 mg on day 1, increase to 2 mg twice daily on day 4, and increase to 2 mg three times daily on day 7. The dose will subsequently be adjusted according to tremor response and tolerability. Treatment will continue for up to 6 months unless stopped because of persistent intolerable side effects.
Procyclidine
Drug
Procyclidine will be administered orally. Treatment will start at 2.5 mg three times daily on day 1, increase to 5 mg in the morning plus 2.5 mg in the afternoon and evening on day 3, then to 5 mg in the morning and afternoon with 2.5 mg in the evening on day 5, and finally up to 5 mg three times daily on day 7. The dose will subsequently be adjusted according to tremor response and tolerability. Treatment will continue for up to 6 months unless stopped because of persistent intolerable side effects.

Treatment groups

88 Participants

are divided into 2 treatment groups

Group A: BenzhexolExperimental treatment 1 intervention

Group B: ProcyclidineActive comparator 1 intervention

Trial outcomes

Primary outcomes

Change from Baseline in Total Tremor Subset Score of the MDS-UPDRS Part III at 2 Weeks

The total tremor subset score is the sum of Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III tremor items: postural tremor of the right hand, postural tremor of the left hand, kinetic tremor of right hand, kinetic tremor of left hand, rest tremor amplitude of the right upper extremity, rest tremor amplitude of the left upper extremity, rest tremor amplitude of the right lower extremity, rest tremor amplitude of the left lower extremity, rest tremor amplitude of the lip/jaw, and constancy of rest tremor. The minimum score is 0 and maximum score is 40 for tremor subset scores with a lower score indicating better function. Change from baseline will be calculated as the baseline total score minus the total score at 2 weeks, with a greater positive change representing greater improvement in tremor.

Time frame

From Baseline to Week 2

Secondary outcomes

Total Number of Side Effects

The total number of side effects reported or observed in participants in the benzhexol and procyclidine groups during the study will be recorded and compared between the two treatment groups. Side effects will be assessed and documented during follow-up visits.

Time frame

From Baseline to 6 months

Sponsors and contacts

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safia bano

Lead sponsor

King Edward Medical University

Sponsor institution

Source ClinicalTrials.gov

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