Swiss Restless Legs Syndrome Trial (SRLS) A Double-blind, Randomised, Crossover Trial Investigating the Efficacy and Safety of the Dopamine Agonist Pramipexole (Sifrol®, 0.25-0.75 mg Per Day) Versus Levodopa / Benserazide (Madopar® DR, 125-375 mg Per Day) in Patients With Restless Legs Syndrome

The primary objective of this study is to determine that pramipexole (Sifrol) 0.25 mg to 0.75 mg daily is not inferior to levodopa 100 mg to 300 mg (in combination with benserazide 25mg to 75mg = Madopar DR) daily in the treatment of patients with idiopathic restless legs syndrome fulfilling the International Diagnostic Criteria. The efficacy parameters include an objective measure of the leg movements during the time spent in bed, and a quantitative clinical assessment of the severity of RLS, in the form of the RLS-score. In addition, the efficacy evaluations aim at comparing the impact of pramipexole and levodopa on outcome measures such as quality of life and sleep.

Start Date01 Feb 2003

Sponsor / Collaborator

Boehringer Ingelheim GmbH

100 Clinical Results associated with Benserazide

100 Translational Medicine associated with Benserazide

100 Patents (Medical) associated with Benserazide

948

Literatures (Medical) associated with Benserazide

01 Oct 2024·NEUROCHEMICAL RESEARCH

Neuroprotective Effects Exerted by a Combination of Selected Lactic Acid Bacteria in a Mouse Parkinsonism Model under Levodopa-Benserazide Treatment

Article

Author: Pérez Visñuk, Daiana ; LeBlanc, Jean Guy ; de Moreno de LeBlanc, Alejandra

Alterations of the microbiota-gut-brain axis has been associated with intestinal and neuronal inflammation in Parkinson's disease (PD). The aim of this work was to study some mechanisms associated with the neuroprotective effect of a combination (MIX) of lactic acid bacteria (LAB) composed by Lactiplantibacillus plantarum CRL2130 (riboflavin overproducing strain), Streptococcus thermophilus CRL808 (folate producer strain), and CRL807 (immunomodulatory strain) in cell cultures and in a chronic model of parkinsonism induced with 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP) in aged mice, and under levodopa-benserazide treatment. In vitro, N2a differentiated neurons were exposed to the neurotoxin 1-methyl-4-phenylpyridinium (MPP+) and treated with intracellular bacterial extracts or with conditioned media from BV-2 cells exposed to the bacterial extracts. In vivo, motor skills, tyrosine hydrolase (TH) in brain and cytokine concentrations in serum and in brain were evaluated. The study of the faecal microbiota and the histology of the small intestine was also performed. The results showed that the neuroprotective effect associated with LAB MIX administration did not interfere with levodopa-benserazide treatment. This effect could be associated with the antioxidant and immunomodulatory potential of the LAB selected in the MIX, and was associated with the significant improvement in the motor tests and a higher number of TH + cells in the brain. In addition, LAB MIX administration was associated with modulation of the immune response. LAB administration decreased intestinal damage with an increase in the villus length /crypt depth ratio. Finally, the administration of the LAB MIX in combination with levodopa-benserazide treatment was able to partially revert the intestinal dysbiosis observed in the model, showing greater similarity to the profiles of healthy controls, and highlighting the increase in the Lactobacillaceae family. Different mechanisms of action would be related to the protective effect of the selected LAB combination which has the potential to be evaluated as an adjuvant for conventional PD therapies.

01 Sep 2024·NEUROLOGICAL SCIENCES

CACNA1A variant associated with generalized dystonia

Article

Author: Ledda, Claudia ; Rinaldi, Domiziana ; Lopiano, Leonardo ; Tangari, Marta Maria ; Dematteis, Francesca ; Artusi, Carlo Alberto ; Rizzone, Mario Giorgio

INTRODUCTION:

CACNA1A gene variants are correlated with different disorders, including episodic ataxia type 2, spinocerebellar ataxia type 6, and familial hemiplegic migraine type 1. Despite dystonia not being a typical manifestation of CACNA1A variants, there are reports indicating a link between this gene mutation and dystonic features.

METHODS:

We report the case of a patient with a novel missense variant of the CACNA1A gene presenting headache, head and arm tremor, dystonia, episodic painful focal dystonic attacks, and unexplained falls.

RESULTS:

A 57-year-old woman presented with a history of neck dystonia, head and arm tremor, and headaches since age 15. In 2017, she progressively developed dystonic tremor of the head and arms with an unremarkable brain MRI. In 2018 she experienced worsening of tremor and developed painful dystonic attacks, resistant to treatments including clonazepam, trihexyphenidyl, baclofen, and levodopa/benserazide. Botulinum toxin injections for neck dystonia provided limited benefit. The next-generation sequencing exam revealed a CACNA1A gene missense variant (NM_023035.2:c.1630C > T; p.Arg544Trp). In 2021 we observed a worsening of dystonia, accompanied by weight loss, mood changes, and unexplained falls. Deep brain stimulation was considered but ruled out due to cortical atrophy and mild cognitive deficits revealed by the neuropsychological examination.

DISCUSSION:

Only a few studies reported dystonia as part of the clinical features in carriers of CACNA1A mutations. This case points out the relevance of a need to expand the literature on voltage-dependent P/Q-type Ca2 + channels' role in dystonia's pathogenesis and stresses the complex phenotype-genotype presentation of CACNA1A mutation.

01 Sep 2024·MOVEMENT DISORDERS

Oxycodone or Higher Dose of Levodopa for the Treatment of Parkinsonian Central Pain: OXYDOPA Trial

Article

Author: Thobois, Stephane ; Rousseau, Vanessa ; Fabbri, Margherita ; Rouaud, Tiphaine ; Fluchère, Fréderique ; Maltête, David ; Drapier, Sophie ; Ory‐Magne, Fabienne ; Sommet, Agnes ; Castelnovo, Giovanni ; Brefel‐Courbon, Christine ; Salhi, Hayet ; Ansquer, Solene ; Harroch, Estelle ; Lagha‐Boukbiza, Ouhaid ; Frismand, Solene ; Devos, David ; Corvol, Jean Christophe ; Rascol, Olivier ; Tir, Melissa ; Marques, Ana ; Thalamas, Claire

Abstract:

Background:

Among the different types of pain related to Parkinson's disease (PD), parkinsonian central pain (PCP) is the most disabling.

Objectives:

We investigated the analgesic efficacy of two therapeutic strategies (opioid with oxycodone‐ prolonged‐release (PR) and higher dose of levodopa/benserazide) compared with placebo in patients with PCP.

Methods:

OXYDOPA was a randomized, double‐blind, double‐dummy, placebo‐controlled, multicenter parallel‐group trial run at 15 centers within the French NS‐Park network. PD patients with PCP (≥30 on the Visual Analogue Scale [VAS]) were randomly assigned to receive oxycodone‐PR (up to 40 mg/day), levodopa/benserazide (up to 200 mg/day) or matching placebo three times a day (tid) for 8 weeks at a stable dose, in add‐on to their current dopaminergic therapy. The primary endpoint was the change in average pain intensity over the previous week rated on VAS from baseline to week‐10 based on modified intention‐to‐treat analyses.

Results:

Between May 2016 and August 2020, 66 patients were randomized to oxycodone‐PR (n = 23), levodopa/benserazide (n = 20) or placebo (n = 23). The mean change in pain intensity was −17 ± 18.5 on oxycodone‐PR, −8.3 ± 11.1 on levodopa/benserazide, and −14.3 ± 18.9 in the placebo groups. The absolute difference versus placebo was −1.54 (97.5% confidence interval [CI], −17.0 to 13.90; P = 0.8) on oxycodone‐PR and +7.79 (97.5% CI, −4.99 to 20.58; P = 0.2) on levodopa/benserazide. Similar proportions of patients in each group experienced all‐cause adverse events. Those leading to study discontinuation were most frequently observed with oxycodone‐PR (39%) than levodopa/benserazide (5%) or placebo (15%).

Conclusions:

The present trial failed to demonstrate the superiority of oxycodone‐PR or a higher dose of levodopa in patients with PCP, while oxycodone‐PR was poorly tolerated. © 2024 The Author(s). Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.

100 Deals associated with Benserazide

External Link

KEGG	Wiki	ATC	Drug Bank
-	Benserazide	-	DB12783

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Anemia, Sickle Cell	Phase 2	US	PHOENICIA BIOSCIENCES, INC.	05 Oct 2020
Anemia, Sickle Cell	Phase 2	CA	PHOENICIA BIOSCIENCES, INC.	05 Oct 2020
Beta-Thalassemia	Phase 2	US	PHOENICIA BIOSCIENCES, INC.	05 Oct 2020
Beta-Thalassemia	Phase 2	CA	PHOENICIA BIOSCIENCES, INC.	05 Oct 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis