Pharmacogenomic Contribution to the Biotransformation of Trihexyphenidyl and Development of a Precision Dosing Model for Children With Dystonia and Cerebral Palsy

This study looks at how a medicine called trihexyphenidyl works in children with dystonic cerebral palsy. The study aims to understand how trihexyphenidyl is broken down and used in the body of pediatric patients and whether this is impacted by a person's genetics. Information from this study will also be used to design future clinical trials.

Start Date15 Oct 2024

Sponsor / Collaborator

The Children's Mercy Hospital

[+1]

CTR20233418 / CompletedNot Applicable

盐酸苯海索片在健康受试者中单中心、随机、开放、两制剂、单次给药、两周期、双交叉空腹/餐后生物等效性试验

[Translation] A single-center, randomized, open-label, two-dose, single-dose, two-period, double-crossover fasting/fed bioequivalence study of trihexyphenidyl hydrochloride tablets in healthy subjects

主要目的：以药代动力学参数作为主要终点评价指标，分别比较在空腹餐后状态下口服受试制剂盐酸苯海索片（规格：2mg，持证商：海鸿恒隆（海南）生物科技有限公司）与参比制剂盐酸苯海索片（规格：2mg，持证商：WATSON LABORATORIES INC INC，商品名：Trihexyphenidyl Hydrochloride ® ）后在健康受试者体内的药代动力学行为，评价两种制剂的生物等效性。次要目的：观察受试制剂盐酸苯海索片和参比制剂盐酸苯海索片在健康受试者中的安全性。

[Translation]

Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation index, the pharmacokinetic behavior of the test preparation Trihexyphenidyl Hydrochloride Tablets (Specification: 2mg, licensee: Haihong Henglong (Hainan) Biotechnology Co., Ltd.) and the reference preparation Trihexyphenidyl Hydrochloride Tablets (Specification: 2mg, licensee: WATSON LABORATORIES INC INC, trade name: Trihexyphenidyl Hydrochloride ® ) were compared in healthy subjects after oral administration in the fasting state, and the bioequivalence of the two preparations was evaluated. Secondary purpose: To observe the safety of the test preparation Trihexyphenidyl Hydrochloride Tablets and the reference preparation Trihexyphenidyl Hydrochloride Tablets in healthy subjects.

Start Date01 Nov 2023

Sponsor / Collaborator

Haihong Henglong (Hainan) Biotechnology Co., Ltd.

CTR20212180 / CompletedNot Applicable

盐酸苯海索片在健康受试者中单中心、开放、均衡、随机、单剂量、双周期、双交叉空腹和餐后状态下的生物等效性试验

[Translation] A single-center, open-label, balanced, randomized, single-dose, two-period, double-crossover bioequivalence study of trihexyphenidyl hydrochloride tablets in healthy subjects under fasting and fed conditions

主要目的：空腹及餐后给药条件下，比较湖南中南制药有限责任公司提供的盐酸苯海索片（规格：2 mg/片）与Watson Pharma Private Limited生产的盐酸苯海索片（规格：2 mg/片）在健康成年人群中吸收程度和速度的差异，评价其生物等效性。次要目的：评价空腹及餐后给药条件下，受试制剂和参比制剂盐酸苯海索片（2 mg/片）在健康受试者中的安全性。

[Translation]

Primary objective: To compare the differences in the extent and rate of absorption of Benhexyphenidyl Hydrochloride Tablets (Specification: 2 mg/tablet) provided by Hunan Zhongnan Pharmaceutical Co., Ltd. and Benhexyphenidyl Hydrochloride Tablets (Specification: 2 mg/tablet) produced by Watson Pharma Private Limited in healthy adults under fasting and postprandial administration conditions, and to evaluate their bioequivalence. Secondary objective: To evaluate the safety of the test preparation and the reference preparation Benhexyphenidyl Hydrochloride Tablets (2 mg/tablet) in healthy subjects under fasting and postprandial administration conditions.

Start Date07 Sep 2021

Sponsor / Collaborator

Hunan Zhongnan Pharmaceutical Co., Ltd.

100 Clinical Results associated with Trihexyphenidyl Hydrochloride

100 Translational Medicine associated with Trihexyphenidyl Hydrochloride

100 Patents (Medical) associated with Trihexyphenidyl Hydrochloride

927

Literatures (Medical) associated with Trihexyphenidyl Hydrochloride

01 Dec 2024·Journal of Pediatric Genetics

A Rare Case of Neuronal Ceroid Lipofuscinosis-Type 1 (NCL-1) with Vitamin D-Dependent Rickets-Type 1 (VDDR-1), Complex 1 Mitochondrial Deficiency, and Mixed Variant—Checkerboard and Phylloid Type of Pigmentary Mosaicism

Article

Author: Santhoshkumar, Rashmi ; Chikara, Surendra K. ; Mittal, Pallavi ; Gowda, Vykuntaraju K. ; Chickabasaviah, Yasha ; Srinivasan, Varunvenkat M. ; Vishwanathan, Gurudatta Baraka ; Vamyanmane, Dhananjaya K. ; Srinivas, Sahana M. ; K., Anusha Raj

Abstract Introduction Neuronal ceroid lipofuscinosis-type 1 (NCL-1) is a neurodegenerative lysosomal storage disorder. Vitamin D-dependent rickets type 1 (VDDR-1) is a rare cause of refractory rickets. Here, we report an unusual association of NCL-1 with VDDR-1. Case A 3-year-old boy presented with a history of seizures from 45 days of life, delayed development, and loss of attained milestones at 20 months of age, along with progressive vision impairment since 1 year. Examination showed a failure to thrive, microcephaly, rachitic rosary, checkerboard and phylloid type of pigmentary mosaicism, fundus showed disc pallor with generalized narrowing of arterioles, bilateral retinitis pigmentosa, spasticity and dystonia, brisk reflexes, extensor plantar, and left choreoathetoid movements. Investigations showed hypocalcemia (7.8 mg/dL), normal phosphorus (3.9 mg/dL), elevated alkaline phosphatase (508.8 U/L), elevated parathyroid hormone (513.35 pg/mL), low 1,25-dihydroxy-vitamin D (9.93 pg/mL), and normal renal function. The child had metabolic acidosis, elevated ammonia (403.9 micromol/L), lactate (95 mg/dL, normal range 4.5–19.8 mg/dL), and creatine phosphokinase (432 U/L) level, and normal tandem mass spectroscopy. X-ray wrist showed healing vitamin deficiency rickets. Abnormal electroencephalogram was suggestive of low voltage activity. Magnetic resonance imaging brain showed gross cerebral and cerebellar atrophy. A muscle biopsy showed scattered atrophic fibers and several ultrastructural granular osmiophilic deposits and some mitochondrial aggregates of varying size were observed. Mitochondrial respiratory chain enzyme assay exhibited complex-1 deficiency (activity < 30%). Genetic analysis showed two pathogenic mutations: homozygous nonsynonymous variation c.674T > C in exon 7 of the PPT1 gene and a homozygous frameshift variation c.1178_1179delAA in exon 7 of CYP27B1 confirming the diagnosis of NCL-1 with VDDR-1. The child was treated with a low protein diet, levetiracetam, clonazepam, trihexyphenidyl, haloperidol, calcium supplement, calcitriol, and sodium benzoate; some improvement in clinical and biochemical parameters was noted on follow-up. Conclusion This is a novel association of NCL-1 with VDDR-1 associated with complex-1 mitochondrial deficiency which has previously not been reported in the literature.

01 Dec 2024·Asian Journal of Psychiatry

Addressing the misuse and abuse of trihexyphenidyl

Letter

Author: Okeleji, Lateef Olabisi ; Okeleji, Olabisi Lateef ; Ajayi, Ayodeji Folorunsho ; Folorunsho, Ajayi Ayodeji

10 Nov 2024·West African journal of medicine

CONTRIBUTION OF PHYSIOTHERAPY IN PSYCHIATRY: CASE OF A PATIENT SUFFERING OF DYSTONIA DUE TO ANTIPSYCHOTICS AT THE SAINT JOHN OF GOD MENTALHEALTH CENTRE IN LOMÉ-TOGO.

Article

Author: Dassa, K S ; Sossa, A S ; Kanekatou, S ; Atchou, B ; Patayodi, E P ; Affo, C ; Salifou, S

IntroductionAntipsychotic-induced dystonia is a neurological side-effect and can be very disabling. Treatment is multidisciplinary, including physiotherapy.ObjectiveThe aim was to show the contribution of physiotherapy in the management of people suffering from dystonia secondary to antipsychotics.MethodThe Saint John of God Mental Health Centre in Lomé was used as the study setting. This involved a descriptive study about a case of cervical dystonia induced by antipsychotics, from 13 July to 30 August 2020.ResultsOur observation concerned a male patient, aged 55 years, suffering from a persistent delirious disorder, on a poorly documented treatment, admitted for cervical dystonia and persistent delirium. A physiotherapy assessment revealed neck pain rated at 5/10, reduced neck muscle strength, and an inability to keep the neck stable at rest. He was started on olanzapine 20mg tablet a day, haloperidol decanoas injectable 50mg/month, and trihexyphenidyl 5mg tablet in the morning. Physiotherapy treatment consisted of 14 sessions using various techniques including passive-active stretching of the neck and head muscles. The evolution was marked by a significant regression of involuntary neck movements and an improvement in the patient's quality of life.ConclusionPhysiotherapy should be more involved in the management of dystonia in psychiatric practice.

100 Deals associated with Trihexyphenidyl Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D00787	Trihexyphenidyl Hydrochloride	N04AA01	DB00376

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Dyskinesias	JP	Towa Pharmaceutical Co., Ltd.	31 Mar 1986
Akathisia, Drug-Induced	JP	Pfizer Japan, Inc.	18 Aug 1953
Parkinson Disease	JP	Pfizer Japan, Inc.	18 Aug 1953

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