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Parkinson Disease (PD)NCT07810296

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

A study testing Benzhexol and Procyclidine in people with Parkinson Disease (PD), run by safia bano at 1 site in Pakistan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 70 years
Conditions the study is for
Parkinson Disease (PD)
What is being tested?
Benzhexol and Procyclidine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 sitePakistan
Study dates
Sep 2026to Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Cognitive or behavioral abnormalities.
  • Lower urinary tract symptoms.
  • Benign prostatic hyperplasia.
  • Angle-closure glaucoma.
  • Cardiac disease.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Saad A Malik, MBBS contact

+92-3005107713

saadazhar@live.com

Pakistan1 site, 1 recruiting
  • Mayo Hospital Lahore

    Lahore, Punjab Province, 54000

    Saad A Malik, MBBS, +92-3005107713, saadazhar@live.com

    Saad A Malik, MBBS

    Recruiting

Other trials in Pakistan

About this study

Official title: Comparison of Effectiveness of Benzhexol and Procyclidine in Improving Tremor in Tremor Predominant Parkinson's Disease Patients

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.

Read the 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.

Being tested
Benzhexol, Procyclidine
Keywords
Tremor, Tremor-Predominant Parkinson Disease, Benzhexol, Procyclidine, Anticholinergic
Medical subject headings
Parkinson Disease, Tremor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BenzhexolDrug

    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.

  • ProcyclidineDrug

    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.

Study groups in NCT07810296
Study groupRoleWhat they receive
BenzhexolExperimentalParticipants will receive benzhexol in addition to levodopa/carbidopa therapy. Benzhexol will be started at 2 mg on day 1, increased to 2 mg twice daily on day 4 and to 2 mg three times daily on day 7. The dose will subsequently be adjusted according to resolution of tremor or development of side effects. If tremor resolves, benzhexol will be continued at the effective dose; if intolerable side effects develop, the dose will be reduced and subsequently stopped if side effects persist. Participants will be followed for 6 months with assessments at baseline, 2 weeks, 3 months, and 6 months.
Receives: Drug: Benzhexol
ProcyclidineActive comparatorParticipants will receive procyclidine in addition to levodopa/carbidopa therapy. Procyclidine will be started at 2.5 mg three times daily on day 1, increased 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 resolution of tremor or development of side effects. If tremor resolves, procyclidine will be continued at the effective dose; if intolerable side effects develop, the dose will be reduced and subsequently stopped if side effects persist. Participants will be followed for 6 months with assessments at baseline, 2 weeks, 3 months, and 6 months.
Receives: Drug: Procyclidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From Baseline to Week 2

Secondary outcomes (1)
  1. 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.

    Measured: From Baseline to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07810296
Sponsor's protocol ID
751/RC/KEMU
Status last verified
Sep 2026
First submitted
3 Sep 2026
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Habib, Md. Ahsan & Alamgir, ASM & Dey, Subash Kanti & Alam, Afroja & Asafuddoula, Ahmed & Rizvi, Abu. (2016). Effect of Trihexiphenidyl and Procyclidine for the management of resting tremor. Bangladesh Medical Journal. 44. 72-75. 10.3329/bmj.v44i2.27241.

  • Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stern MB, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, van Hilten JJ, LaPelle N; Movement Disorder Society UPDRS Revision Task Force. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008 Nov 15;23(15):2129-70. doi: 10.1002/mds.22340.

    PubMed 19025984
  • Sahoo LK, Holla VV, Batra D, Prasad S, Bhattacharya A, Kamble N, Yadav R, Pal PK. Comparison of effectiveness of trihexyphenidyl and levodopa on motor symptoms in Parkinson's disease. J Neural Transm (Vienna). 2020 Dec;127(12):1599-1606. doi: 10.1007/s00702-020-02257-0. Epub 2020 Oct 9.

    PubMed 33037478
  • Barrett MJ, Sargent L, Nawaz H, Weintraub D, Price ET, Willis AW. Antimuscarinic Anticholinergic Medications in Parkinson Disease: To Prescribe or Deprescribe? Mov Disord Clin Pract. 2021 Oct 8;8(8):1181-1188. doi: 10.1002/mdc3.13347. eCollection 2021 Nov.

    PubMed 34765683
  • Lees A, Tolosa E, Stocchi F, Ferreira JJ, Rascol O, Antonini A, Poewe W. Optimizing levodopa therapy, when and how? Perspectives on the importance of delivery and the potential for an early combination approach. Expert Rev Neurother. 2023 Jan;23(1):15-24. doi: 10.1080/14737175.2023.2176220. Epub 2023 Feb 10.

    PubMed 36729395
  • Vazquez-Velez GE, Zoghbi HY. Parkinson's Disease Genetics and Pathophysiology. Annu Rev Neurosci. 2021 Jul 8;44:87-108. doi: 10.1146/annurev-neuro-100720-034518.

    PubMed 34236893
  • Peng S, Liu P, Wang X, Li K. Global, regional and national burden of Parkinson's disease in people over 55 years of age: a systematic analysis of the global burden of disease study, 1991-2021. BMC Neurol. 2025 Apr 23;25(1):178. doi: 10.1186/s12883-025-04191-8.

    PubMed 40269818
  • Ou Z, Pan J, Tang S, Duan D, Yu D, Nong H, Wang Z. Global Trends in the Incidence, Prevalence, and Years Lived With Disability of Parkinson's Disease in 204 Countries/Territories From 1990 to 2019. Front Public Health. 2021 Dec 7;9:776847. doi: 10.3389/fpubh.2021.776847. eCollection 2021.

    PubMed 34950630

Questions about this trial

What is this clinical trial studying?

A study testing Benzhexol and Procyclidine in people with Parkinson Disease (PD), run by safia bano at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Saad A Malik, MBBS (+92-3005107713, saadazhar@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Total Tremor Subset Score of the MDS-UPDRS Part III at 2 Weeks (time frame: From Baseline to Week 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07810296, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.

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