The goal of this clinical trial is to explore the effect of FDA-approved antiseizure drugs in the brain connectivity patterns of severe and moderate acute brain injury patients with suppression of consciousness. The main questions it aims to answer are:
Does the antiseizure medication reduce the functional connectivity of seizure networks, as identified by resting state functional MRI (rs-fMRI), within this specific target population?
What is the prevalence of seizure networks in patients from the target population, both with EEG suggestive and not suggestive of epileptogenic activity?
Participants will have a rs-fMRI and those with seizure networks will receive treatment with two antiseizure medications and a post-treatment rs-fMRI. Researchers will compare the pretreatment and post-treatment rs-fMRIs to see if there are changes in the participant's functional connectivity including seizure networks and typical resting state networks.

Start Date20 Nov 2023

Sponsor / Collaborator

The University of North Carolina at Chapel Hill

NCT03586089 / TerminatedNot Applicable

PHENObarbital for the MANagement of Severe Acute ALcohol Withdrawal Syndrome (PHENOMANAL): a Prospective Randomized Feasibility Study.

Severe acute alcohol withdrawal syndrome is a potentially life-threatening condition characterized by agitation, confusion, abnormal heart rhythms and seizures. Typically, clinicians treat the symptoms of alcohol withdrawal with a class of medications known as benzodiazepines (e.g., Valium). These medications have a short duration of activity and require repeated administration, often every hour or less, to reduce the symptoms of alcohol withdrawal. Many patients suffer complications related to inadequate treatment of alcohol withdrawal (e.g., abnormal heart rhythms, aspiration, seizures) resulting in admission to an intensive care unit and prolonged hospital stay, all of which increase healthcare costs. Although alcohol withdrawal is common, especially among disadvantaged (e.g., homeless) patients, limited funding is available to advance the care of patients suffering from alcohol withdrawal. A safe and effective treatment for severe alcohol withdrawal would benefit patients and our healthcare system.
Phenobarbital is an inexpensive, commonly available medication that is typically used to treat seizures. A key advantage of phenobarbital is that its calming effect lasts for a long period of time and it can be given as a 'one-time-dose' intravenously, so that it both prevents and treats withdrawal symptoms and reduces the need for repeated benzodiazepines. Through better symptom control, phenobarbital is expected to reduce the costs and complications of alcohol withdrawal. At present, physicians rarely use phenobarbital for this purpose, and additional research is needed for this medication to become part of routine care in clinical practice.
The PHENOMANAL pilot trial will assess safety and whether clinicians can administer a single dose of phenobarbital intravenously, in addition to benzodiazepines, compared to benzodiazepines alone for treating patients with severe alcohol withdrawal. This information will inform the design of a larger clinical trial. For patients, the PHENOMANAL trial has the potential to revolutionize how patients suffering from severe alcohol withdrawal are treated. For society and the healthcare system, phenobarbital is expected to reduce the complications and costs associated with severe alcohol withdrawal.

Start Date11 Jun 2021

Sponsor / Collaborator

Unity Health Toronto

NCT04320940 / TerminatedPhase 3

A Randomized, Double-Blind, Controlled Study to Assess the Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures

This is a randomized, double-blind, parallel-group, Phase 3 study to evaluate the efficacy of the administration of phenobarbital sodium injection in neonates who have suffered from electrographic or electroclinical seizure. As neonatal seizures can have long-term adverse effects, including death, placebo-controlled studies are not appropriate for this population. This study is designed to show intravenous phenobarbital is effective at preventing subsequent seizures by demonstrating greater efficacy at a higher dose compared to a lower dose.

Start Date12 Mar 2021

Sponsor / Collaborator

NEMA Research, Inc.

100 Clinical Results associated with Phenobarbital Sodium

100 Translational Medicine associated with Phenobarbital Sodium

100 Patents (Medical) associated with Phenobarbital Sodium

530

Literatures (Medical) associated with Phenobarbital Sodium

01 Apr 2023·JPMA. The Journal of the Pakistan Medical Association

Tissue Inhibitor Of Metalloproteinase 3 As A Potential Staging Biomarker In Hepatocellular Carcinoma.

Article

Author: Eldomany, Ramadan Ahmed ; Zakaria, Sherin ; Abass Mohammad, Shimaa Ali ; Abdel-Hamid, Nabil Mohie

Objectives:

To assessthe potential role of tissue inhibitor of metalloproteinase 3 as a staging marker of hepatocellular carcinoma.

Method:

The experimental study was conducted at Faculty of Pharmacy, Kafrelsheikh University, Egypt, from December 2020 to March 2022 after approval from the Faculty of Pharmacy, Kafrelsheikh University, Egypt, and comprised male albino rats. The subjects were divided into 4 groups. The control group was administrated a single intraperitoneal injection of normal saline, while the other groups were generated post-induction of hepatocellular carcinoma. The induction was done by injecting rats intraperitoneally with a single dose of 200mg/kg diethyl nitrosamine, followed by the administration of 0.05% phenobarbital sodium in drinking water daily. Rats were euthanised at 8, 16 and 24 weeks after the injection to obtain three groups related to the 3 stages of hepatocellular carcinoma. Serum was used for measuring the alpha protein level. Liver homogenates were used for the assessment of the hepatic tissue inhibitor of metalloproteinase 3 expression, B-cell lymphoma 2-associated X protein expression, and the hepatic content of matrix metalloproteinase -9 and cyclin D1. Data was analysed using Graph Prism 8.

RESULTS:

Of the 24 rats with weight range 120-130g, 6(25%) were in each of the 4 groups. The relative protein and messenger ribonucleic acid tissue inhibitor of metalloproteinase 3 expressions were significantly decreased in the intervention groups compared to the control group, with more decline as the hepatocellular carcinoma stage increased. The matrix metalloproteinase -9 and cyclin D1 concentrations and the relative hepatic protein Ki67 expression were significantly raised in the intervention groups compared to the control group (p<0.05). The relative expression of hepatic B-cell lymphoma 2-associated X protein was markedly decreased in the intervention groups compared to the control group (p<0.05).

CONCLUSIONS:

Tissue inhibitor of metalloproteinase 3 might be a promising diagnostic and staging biomarker in hepatocellular carcinoma.

01 Jan 2023·Regulatory toxicology and pharmacology : RTP

Feasibility study for a downsized comparative thyroid assay with measurement of brain thyroid hormones and histopathology in rats: Case study with 6-propylthiouracil and sodium phenobarbital at high dose

Article

Author: Yamada, Tomoya ; Hojo, Hitoshi ; Tomiyama, Naruto ; Takahashi, Naofumi ; Iwashita, Katsumasa ; Ogata, Keiko ; Aoyama, Hiroaki ; Kosaka, Tadashi ; Fukuda, Takako ; Sato, Akira ; Suto, Hidenori ; Minami, Kenta

Concern has been raised that thyroid hormone disruptors (THDs) may potentially interfere with the developing brain, but effects of mild suppression of maternal THs by environmental contaminants on neonatal brain development are not fully understood. The comparative thyroid assay (CTA) is a screening test for offspring THDs, but it requires several animals and is criticized that reliance on serum THs alone as predictive markers of brain malfunction is inadequate. To verify feasibility of the downsized CTA but additional examination of brain THs levels and histopathology, we commenced internal-validation studies. This paper presents the data of the study where 6-propylthiouracil (6-PTU, 10 ppm) and sodium phenobarbital (NaPB, 1000 ppm) were dosed by feeding from gestational days (GD)6-20, and from GD6 to lactation day 21. The modified CTA detected 6-PTU-induced severe (>70%) suppression of serum THs in dams, with >50% suppressed serum/brain TH levels in offspring and brain heterotopia in postnatal day 21 pups. The modified CTA also detected NaPB-induced mild (<35%) suppression of serum THs in dams, with mild (<35%) reduction of serum/brain TH levels in fetuses but not in pups. These findings suggest that the modified CTA may have a potential as a screening test for offspring THDs.

29 Dec 2022·Journal of Chromatographic ScienceQ4 · CHEMISTRY

Validated Smart Different Chromatographic Methods for Selective Quantification of Acefylline Piperazine, Phenobarbital Sodium and Methylparaben Additive in Bulk and Pharmaceutical Dosage Form

Q4 · CHEMISTRY

Article

Author: Mostafa, Nadia M ; Algmaal, Shrouk E ; El Saharty, Yasser S ; Boltia, Shereen A

Abstract:

Two chromatographic methods have been proposed for the simultaneous determination of acefylline piperazine (ACEF) and phenobarbital (PHENO) in presence of methylparaben as additive in pharmaceutical dosage form. The first method was thin-layer chromatography. The separation was achieved using silica gel as stationary phase and chloroform: methanol: glacial acetic acid (2.0, 8.0 and 0.1, by volume) as a developing system at 254 nm. Accurate determination of both drugs was attained over the concentration range of 0.5–25 μg/band. The second method was based on the use of reversed phase liquid chromatography with diode array detection, by which the proposed components were separated on a reversed phase C18 analytical column using methanol: water (60: 40, by volume) as a mobile phase with flow rate of 0.8 mL/min at 214 nm in a concentration range of 0.5–100 μg/mL. The proposed chromatographic methods were practiced successfully for the determination of ACEF and PHENO in pharmaceutical dosage form. Both methods were validated according to the International Conference on Harmonization guidelines and statistically compared with a reported high-performance liquid chromatograph method. Planar chromatography has never been proposed in the literature for ACEF and PHENO determination besides the proposed columnar chromatographic method using an isocratic eco-friendly mobile phase.

News (Medical) associated with Phenobarbital Sodium

19 Sep 2023

·www.outsourcing-pharma.com

Pharmanovia acquires 11 of Sanofi's CNS brands expanding its global reach

Spanning four therapy areas – psycholeptic, anxiolytic, anti-epileptic and anti-psychotic, the brands fall within the unmet ongoing needs sector associated with CNS disorders. Clobazam is from a class of drug called benzodiazepines and can be used to treat anxiety, with or without insomnia or certain psychiatric conditions, in certain patients. The acquired brands include Frisium, Sentil, Urbanyl, Urbanil, Urbanol, Urbadan, Noiafren and Castilium. Frisium may also be used as adjunctive therapy in epilepsy. Phenobarbital with the brand name Gardenal is used as an anti-convulsant to treat all forms of epilepsy except absence seizures. Cyamemazine (brand name Tercian) is used to treat certain types of psychotic conditions, anxiety in patients where other treatments have failed and also some types of depression in combination with another anti-depressant. Prochlorperazine (brand name Stemetil) is used to treat vertigo, and nausea and vomiting due to various causes. It may also be used for other conditions such as schizophrenia, acute mania and as an adjunct to the short-term management of anxiety. Dr James Burt, Pharmanovia CEO, said: “Sanofi’s decision to divest this established CNS portfolio, with leading brands such as Frisium and Gardenal, to Pharmanovia is recognition of our neurology expertise, our capabilities in lifecycle management and reputation of being a trusted divestment partner. “We’re excited to use this knowledge and our global platform to ensure these important medicines not only continue to be available to the millions of patients who need them, but - through our lifecycle management - continue to evolve to meet patient needs. googletag.cmd.push(function () { googletag.display('text-ad1'); }); “Through this acquisition, we are not only building depth in geography, but we’re also bringing in products that have a clear synergy with our existing portfolio and the core sub-therapy focuses of mental health and epilepsy, where there continues to be significant unmet need.” It should be noted that not all of the acquired treatments have been approved in every market and local indications can be checked, for example, Tercian is currently only available in France. Pharmanovia is listed as a lifecycle management healthcare company and focuses on making medicines to improve the lives of patients globally. The company says this is achieved through enhancing already established medicines by ‘rediscovering, repurposing or re-engineering iconic brands to improve patient outcomes and experiences both through in-house development and strategic partnerships.’ Sanofi says it is dedicated to transforming the practice of medicine ‘by working to turn the impossible into the possible’. It aims to provide potentially life-changing treatment options and life-saving vaccine protection to millions of people around the world.

AcquisitionDrug Approval

18 Sep 2023

·www.biospace.com

Pharmanovia Acquires Global Central Nervous System (CNS) Portfolio From Sanofi

Deal sees Pharmanovia acquire 11 brands within CNS, including Frisium® (clobazam) and Gardenal® (phenobarbital) Portfolio available in 60+ markets and deepens our CNS footprint in Brazil, South Africa, France and Italy Strong CNS franchise fits with Pharmanovia’s existing neurology portfolio and commercial capabilities BASILDON, England--(BUSINESS WIRE)-- PRESS RELEASE – FOR TRADE, BUSINESS AND MEDICAL MEDIA ONLY This press release features multimedia. View the full release here: James Burt, CEO, Pharmanovia (Photo: Business Wire) Pharmanovia, a global pharmaceutical company that commercialises novel medicines and revitalises, extends and expands the lifecycle of established medicines, has today announced the expansion of its neurology portfolio with the acquisition of 11 central nervous system (CNS) brands from global healthcare company, Sanofi. The brands span four therapy areas of ongoing unmet need associated with CNS disorders - psycholeptic, anxiolytic, anti-epileptic and anti-psychotic. Clobazam is from a class of drug called benzodiazepines and can be used to treat anxiety, with or without insomnia or certain psychiatric conditions, in certain patients.1 The acquired brands include Frisium®, Sentil®, Urbanyl®, Urbanil®, Urbanol®, Urbadan®, Noiafren® and Castilium®*. Frisium® may also be used as adjunctive therapy in epilepsy.1 Phenobarbital (brand: Gardenal®*) is used as an anti-convulsant to treat all forms of epilepsy except absence seizures.2 Cyamemazine (brand: Tercian®*†) is used to treat certain types of psychotic conditions, anxiety in patients where other treatments have failed and also some types of depression in combination with another anti-depressant.3 Prochlorperazine (brand: Stemetil®*) is used to treat vertigo, and nausea and vomiting due to various causes. It may also be used for other conditions such as schizophrenia, acute mania and as an adjunct to the short-term management of anxiety.4,5 Dr James Burt, Pharmanovia CEO, commented: “Sanofi’s decision to divest this established CNS portfolio, with leading brands such as Frisium® and Gardenal®, to Pharmanovia is recognition of our neurology expertise, our capabilities in lifecycle management and reputation of being a trusted divestment partner. We’re excited to use this knowledge and our global platform to ensure these important medicines not only continue to be available to the millions of patients who need them, but - through our lifecycle management - continue to evolve to meet patient needs.” “Through this acquisition, we are not only building depth in geography, but we’re also bringing in products that have a clear synergy with our existing portfolio and the core sub-therapy focuses of mental health and epilepsy, where there continues to be significant unmet need.” -Ends- Notes to editors *Not all indications are approved in every market. For local indications it is advised to check the local approved label. †Tercian® is only available in France. About Pharmanovia Pharmanovia is a global lifecycle management healthcare company. Our purpose is to make medicines fit for tomorrow, to improve the lives of patients globally. We do this by enhancing established medicines by rediscovering, repurposing or re-engineering iconic brands to improve patient outcomes and experiences both through in-house development and strategic partnerships. Our diverse and growing team operate in over 160 countries across the globe, delivering high-quality solutions, ethically and sustainably, across our four core therapeutic areas – Endocrinology, Neurology, Cardiovascular and Oncology. For more information about Pharmanovia, please visit About Sanofi Sanofi is an innovative global healthcare company, driven by one purpose: to chase the miracles of science to improve people’s lives. Its team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. Sanofi provides potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the centre of its ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY. References 1 - Frisium Summary of Product Characteristics, – last accessed 11.9.2023 2 - Phenobarbital Sodium Injection Summary of Product Characteristics, - last accessed 11.9.2023 3 - Terican Summary of Product Characteristics, – last accessed 11.9.2023 4 - Stemetil Injection Summary of Product Characteristics, - last accessed 11.9.2023 5 - Stemetil Tablets Summary of Product Characteristics, - last accessed 11.9.2023 COR2023PR00207 – Date of Preparation – 14.9.2023 View source version on businesswire.com: Contacts Alison Dyson, Director of Communications, Pharmanovia +44 7442 256310/alison.dyson@pharmanovia.com or pharmanovia@67health.co.uk Source: Pharmanovia Smart Multimedia Gallery Photo James Burt, CEO, Pharmanovia (Photo: Business Wire) Logo View this news release and multimedia online at:

Acquisition

100 Deals associated with Phenobarbital Sodium

External Link

KEGG	Wiki	ATC	Drug Bank
D00701	Phenobarbital Sodium	N03AA02	DB01174

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Epilepsy, Benign Neonatal	US	Sun Pharmaceutical Industries, Inc.	17 Nov 2022
Epilepsy	JP	Nobelpharma Co., Ltd.	16 Oct 2008
Spasms, Infantile	JP	Nobelpharma Co., Ltd.	16 Oct 2008
Hyperbilirubinemia	CN	Grand Pharmaceutical Group	01 Jan 1981
Hyperbilirubinemia	CN	Tianjin Jinyao Pharmaceutical Co., Ltd.	01 Jan 1981
Hyperbilirubinemia	CN	Youhua Pharmaceutical (Leshan) Co Ltd	01 Jan 1981
Hyperbilirubinemia	CN	Chengdu Pharmaceutical Co. Ltd.	01 Jan 1981
Seizures	CN	Youhua Pharmaceutical (Leshan) Co Ltd	01 Jan 1981
Seizures	CN	Tianjin Jinyao Pharmaceutical Co., Ltd.	01 Jan 1981
Seizures	CN	Chengdu Pharmaceutical Co. Ltd.	01 Jan 1981
Seizures	CN	Grand Pharmaceutical Group	01 Jan 1981
Sedation	JP	Takata Seiyaku Co., Ltd.	04 Mar 1980
Sedation	JP	Hisamitsu Pharmaceutical Co., Inc.	04 Mar 1980
Seizures, Febrile	JP	Takata Seiyaku Co., Ltd.	04 Mar 1980
Seizures, Febrile	JP	Hisamitsu Pharmaceutical Co., Inc.	04 Mar 1980
Sleep Initiation and Maintenance Disorders	JP	Takata Seiyaku Co., Ltd.	04 Mar 1980
Sleep Initiation and Maintenance Disorders	JP	Hisamitsu Pharmaceutical Co., Inc.	04 Mar 1980

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04320940 (CTgov)	Phase 3	Epilepsy, Benign Neonatal	4	Phenobarbital Sodium Injection (Phenobarbital Sodium Injection 20mg)	siixesforl(onmkgysphw) = imcdngrlor uqpfjlbeze (uvvenoqoog, vvqpxcvdvw - ryvvescpsz) View more	-	26 Oct 2023
				Phenobarbital Sodium Injection (Phenobarbital Sodium Injection 40mg)	siixesforl(onmkgysphw) = ysfpezftys uqpfjlbeze (uvvenoqoog, nryrjoploc - ynazymfmtz) View more

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