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

9 septembre 2026 mis à jour par: safia bano

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

88

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Saad A Malik, MBBS
  • Numéro de téléphone: +92-3005107713
  • E-mail: saadazhar@live.com

Lieux d'étude

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • Recrutement
        • Mayo Hospital Lahore
        • Sous-enquêteur:
          • Ahsan Numan, FCPS,FAAN,FRCP,PhD
        • Contact:
        • Chercheur principal:
          • Saad A Malik, MBBS
        • Sous-enquêteur:
          • Safia Bano, FCPS, PhD Scholar

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Benzhexol
Participants 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.
Médicament: Benzhexol
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.
Comparateur actif: Procyclidine
Participants 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.
Médicament: Procyclidine
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change from Baseline in Total Tremor Subset Score of the MDS-UPDRS Part III at 2 Weeks
Délai: 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.
From Baseline to Week 2

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Total Number of Side Effects
Délai: 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.
From Baseline to 6 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

safia bano

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 septembre 2026

Achèvement primaire (Estimé)

1 juillet 2027

Achèvement de l'étude (Estimé)

1 juillet 2027

Dates d'inscription aux études

Première soumission

3 septembre 2026

Première soumission répondant aux critères de contrôle qualité

3 septembre 2026

Première publication (Réel)

9 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

14 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 751/RC/KEMU

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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