Parkinson Disease (PD)
Conditions
Keywords
Tremor, Tremor-Predominant Parkinson Disease, Benzhexol, Procyclidine, Anticholinergic
Brief summary
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.
Detailed description
This randomized clinical trial will compare the effectiveness of benzhexol and procyclidine in improving tremor in patients with tremor-predominant Parkinson's disease who are receiving levodopa therapy. Eligible participants will be adults aged 40 to 70 years with clinically diagnosed Parkinson's disease, predominant tremor at presentation, Hoehn and Yahr stage 1, 2, or 3, and resting tremor while receiving levodopa/carbidopa monotherapy. Participants with cognitive or behavioral abnormalities, lower urinary tract symptoms, benign prostatic hyperplasia, angle-closure glaucoma, or cardiac disease will be excluded. Participants will be randomly assigned to one of two treatment groups. Group A will receive benzhexol and Group B will receive procyclidine, in addition to their existing levodopa treatment. Benzhexol will be started at 2 mg on the first day, increased to 2 mg twice daily on day 4 and to 2 mg three times daily on day 7, with subsequent dose adjustment according to tremor response and tolerability. Procyclidine will be started at 2.5 mg three times daily on day 1, increased according to the protocol to a maximum of 5 mg three times daily by day 7, with subsequent dose adjustment according to tremor response and tolerability. Motor symptoms will be assessed using Part III of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS-III). The primary assessment will focus on the total tremor subset score comprising the following eight items: postural tremor of the right hand, postural tremor of the 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. Improvement will be assessed as the absolute change in the total tremor subset score from baseline, with the primary comparison made at the 2-week follow-up. The study aims to determine whether benzhexol provides at least similar improvement in tremor compared with procyclidine. Participants will be assessed at baseline and at 2 weeks, 3 months, and 6 months after treatment initiation. MDS-UPDRS-III assessments will be performed by an independent observer, and adverse effects and tolerability of the study medications will be assessed and documented at follow-up visits. The planned study enrollment is 88 participants, with 44 participants allocated to each treatment group. The study will be conducted in the Department of Neurology, Mayo Hospital, Lahore.
Interventions
DRUGBenzhexol
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.
DRUGProcyclidine
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.
Sponsors
safia bano
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Participants will be randomly assigned to one of two parallel treatment groups. Group A will receive benzhexol and Group B will receive procyclidine in addition to levodopa therapy. Participants will be followed for 6 months, with assessments at baseline, 2 weeks, 3 months, and 6 months.
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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. * Receiving levodopa/carbidopa monotherapy for Parkinson's disease, with resting tremor present.
Exclusion criteria
* Cognitive or behavioral abnormalities. * Lower urinary tract symptoms. * Benign prostatic hyperplasia. * Angle-closure glaucoma. * Cardiac disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Total Tremor Subset Score of the MDS-UPDRS Part III at 2 Weeks | From Baseline to Week 2 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Side Effects | From Baseline to 6 months | 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. |
Countries
Pakistan
Contacts
CONTACTSaad A Malik, MBBS
Outcome results
None listed