A Randomized, Double-Blind, 6-Way Crossover Study to Determine the Abuse Potential of Tozadenant Relative to D-Amphetamine and Placebo When Administered Orally in Healthy, Non-Dependent, Recreational Polydrug Users With Stimulant Experience, Under Fed Conditions

This will be a single-dose, randomized, double-blind, active- and placebo-controlled, double dummy, 6-way crossover study to determine the abuse potential of tozadenant relative to d-amphetamine and placebo, when administered orally in healthy non-dependent, recreational polydrug users with stimulant experience, under fed conditions.
Each subject will participate in a medical Screening visit, a 4-day (3-night) qualification (drug discrimination) visit, six 3-day (2-night) treatment periods, and a follow-up visit.

Start Date18 Sep 2017

Sponsor / Collaborator

Biotie Therapies Oy

[+1]

NCT03212313 / TerminatedPhase 1

A Two-Part, Open-Label, Single-Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Tozadenant

This is a two-part, open label, single-dose study that will evaluate the PK of tozadenant in subjects with different degrees of hepatic impairment to the PK of a single-dose of tozadenant in healthy subjects.

Start Date30 Jun 2017

Sponsor / Collaborator

Biotie Therapies Oy

[+1]

NCT03051607 / TerminatedPhase 3

A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease Experiencing End of Dose "Wearing-Off"

Phase 3, international, multicenter, open-label 12 month safety study.

Start Date10 Apr 2017

Sponsor / Collaborator

Biotie Therapies Oy

[+1]

100 Clinical Results associated with Tozadenant

100 Translational Medicine associated with Tozadenant

100 Patents (Medical) associated with Tozadenant

Literatures (Medical) associated with Tozadenant

01 Jun 2023·The Journal of pediatrics

Adverse Effects of α-2 Adrenergic Agonists and Stimulants in Preschool-age Attention-deficit/Hyperactivity Disorder: A Developmental–Behavioral Pediatrics Research Network Study

Article

Author: Loe, Irene M ; Friedman, Sandra ; Barbaresi, William ; Vanderbilt, Douglas ; Shults, Justine ; Cacia, Jaclyn ; Mittal, Shruti ; Deavenport-Saman, Alexis ; Blum, Nathan J ; LaRosa, Angela ; Bax, Ami ; Harstad, Elizabeth

OBJECTIVES:

To characterize and compare the type and frequency of a range of common and uncommon adverse effects (AEs) associated with α-2 adrenergic agonist (A2A) and stimulant treatment of attention-deficit/hyperactivity disorder at preschool-age as well as to evaluate the impact of age on common AEs.

STUDY DESIGN:

This was a retrospective electronic medical record review of children <72 months of age (n = 497) evaluated at outpatient developmental-behavioral pediatric practices at 7 US academic medical centers within the Developmental-Behavioral Pediatrics Research Network. Data on AEs were abstracted for children who had treatment initiated by a developmental-behavioral pediatrician with an A2A or stimulant medication between January 2013 and July 2017; follow-up was complete by February 2019.

RESULTS:

A2A and stimulants had distinctive AE profiles. A2A compared with stimulants had a greater proportion with daytime sleepiness and headaches; stimulants had significantly greater proportions for most other AE, including moodiness/irritability, difficulty with sleep, appetite suppression, stomachaches, skin picking/repetitive behaviors, withdrawn behavior, and weight loss. Younger age was associated with disruptive behavior and difficulty with sleep.

CONCLUSIONS:

Stimulants had a greater rate of most AEs compared with A2A. AE profiles, together with efficacy, should inform clinical decision-making. Prospective randomized clinical trials are needed to fully compare efficacy and AE profiles of A2A and stimulants.

01 Sep 2022·The Science of the total environmentQ2 · ENVIRONMENTAL SCIENCE & ECOLOGY

Climate change simulation and trend analysis of extreme precipitation and floods in the mesoscale Rur catchment in western Germany until 2099 using Statistical Downscaling Model (SDSM) and the Soil & Water Assessment Tool (SWAT model)

Q2 · ENVIRONMENTAL SCIENCE & ECOLOGY

Article

Author: Korres, Wolfgang ; Eingrüber, Nils

Due to climate change and global warming, speed and intensity of the hydrological cycle will accelerate. In order to carry out regional risk assessment, integrated water resources management and flood protection, far reaching predictions and future scenarios of climate change effects on extreme precipitation and flooding are of particular relevance. In this study, trends in frequencies of extreme precipitation and floods until 2099 are analysed for the German Rur catchment, which is half located in highlands and half in lowlands and therefore has a high topographical and climatological contrast. To predict future trends, coupled modeling is performed based on NCEP reanalysis data and a General Circulation Model (GCM). Assuming HadCM3 future emission scenarios A2a and B2a, an empirical Statistical Downscaling Model (SDSM) is developed and daily precipitation amounts are projected until 2099 by a stochastic weather generator. The generated precipitation data are used as an input for the ecohydrological Soil & Water Assessment Tool (SWAT model) to simulate daily water discharge until 2099. Statistical trend analyses are implemented based on three annual extreme precipitation indices (EPIs) and the magnitudes of ten flood return periods derived with GEV and Gumbel extreme value distributions for 109 30-year moving periods using regression analyses and Mann-Kendall tendency tests to check for significant trends in the frequencies until 2099. As a result, it could be demonstrated for all EPIs that the frequency of extreme precipitation in the upper Rur catchment will significantly increase by +33% to +51% until 2099 compared to the base period 1961-1990, whereas mostly non-significant negative trends of extreme precipitation can be projected in the lowlands. For runoff, it was found that the magnitudes of the ten flood return periods will significantly increase by +31% for B2a to +36% for A2a until 2099 compared to the base period.

01 Aug 2022·Journal of child and adolescent psychopharmacology

Association of Coexisting Conditions, Attention-Deficit/Hyperactivity Disorder Medication Choice, and Likelihood of Improvement in Preschool-Age Children: A Developmental Behavioral Pediatrics Research Network Study

Article

Author: Deavenport-Saman, Alexis ; Barbaresi, William ; Friedman, Sandra ; Shults, Justine ; Mittal, Shruti ; Cacia, Jaclyn ; Loe, Irene ; LaRosa, Angela ; Vanderbilt, Douglas L. ; Harstad, Elizabeth ; Blum, Nathan ; Bax, Ami

Objectives: To determine whether conditions coexisting with attention-deficit/hyperactivity disorder (ADHD) in preschool-age children are associated with choice of stimulants or alpha-2 adrenergic agonists (A2As) and/or likelihood of improvement in ADHD symptoms. Methods: A retrospective electronic health record review of 497 children from 7 Developmental Behavioral Pediatrics Research Network (DBPNet) sites. Children were <72 months when treated with medication for ADHD from January 1, 2013 to July 1, 2017. We abstracted coexisting conditions, initial medication prescribed, and whether the medication was associated with improvement in symptoms. Analysis of improvement was adjusted for clustering by clinician and site. Results: The median (interquartile range) child age at the time of initiation of ADHD medication was 62 (54-67) months. The most common coexisting conditions included language disorders (40%), sleep disorders (28%), disruptive behavior disorders (22.7%), autism spectrum disorder (ASD; 21.8%), and motor disorders (19.9%). No coexisting conditions were present in 17.1%; 1 in 36.8%, 2 in 26.8%, and ≥3 in 19.3%. Stimulants were initially prescribed for 322 (64.8%) and A2A for 175 (35.2%) children. Children prescribed stimulants were more likely to have no coexisting conditions than those prescribed A2A (22.3% vs. 7.4%; p < 0.001). Coexisting ASD and sleep disorder were associated with increased likelihood of starting A2As versus stimulants (p < 0.0005; p = 0.002). The association between medication treatment and improvement varied by number of coexisting conditions for 0, 1, 2, or ≥3, respectively (84.7%, 73.8%, 72.9%, 64.6%; p = 0.031). Children with ≥3 coexisting conditions were less likely to respond to stimulants than children with no coexisting conditions (67.4% vs. 79.9%; p = 0.037). Conclusions: Among preschool-age children with ADHD, those with ≥3 coexisting conditions were less likely to respond to stimulants than those with no coexisting conditions. This was not found for A2A, but further research is needed as very few children with no coexisting conditions were treated with A2A.

News (Medical) associated with Tozadenant

09 Dec 2017

·www.bioportfolio.com

Biotie Therapies Corp Pharmaceuticals Healthcare Deals and Alliances Profile [Report Updated: 27112017] Prices from USD $250

Summary Biotie Therapies Corp Biotie is a pharmaceutical company that discovers and develops new medicines for the treatment of various diseases. The company offers products for use in the treatment of neurodegenerative and psychiatric disorders such as parkinson's disease, alzheimer's disease, primary sclerosing cholangitis and other cognitive disorders; and inflammatory and fibrotic diseases. Its products under clinical development include Selincro, an opioid receptor ligand; Tozadenant, an innovative A2a antagonist; SYN120, a selective 5HT6 receptor antagonist; and BTT1023, a monoclonal antibody, among others. The company has presence in Finland and the US. Biotie is headquartered in Turku, Finland. Biotie Therapies Corp Pharmaceuticals Healthcare Deals and Alliances Profile provides you comprehensive data and trend analysis of the company's Mergers and Acquisitions MAs, partnerships and financings. The report provides detailed information on Mergers and Acquisitions, Equity/Debt Offerings, Private Equity, Venture Financing and Partnership transactions recorded by the company over a five year period. The report offers detailed comparative data on the number of deals and their value categorized into deal types, subsector and regions. GlobalData derived the data presented in this report from proprietary inhouse Pharma eTrack deals database, and primary and secondary research. Scope Financial Deals Analysis of the company's financial deals including Mergers and Acquisitions, Equity/Debt Offerings, Private Equity, Venture Financing and Partnerships. Deals by Year Chart and table displaying information encompassing the number of deals and value reported by the company by year, for a five year period. Deals by Type Chart and table depicting information including the number of deals and value reported by the company by type such as Mergers and Acquisitions, Equity/Debt Offering etc. Deals by Region Chart and table presenting information on the number of deals and value reported by the company by region, which includes North America, Europe, Asia Pacific, the Middle East and Africa and South and Central America. Deals by Subsector Chart and table showing information on the number of deals and value reported by the company, by subsector. Major Deals Information on the company's major financial deals. Each such deal has a brief summary, deal type, deal rationale; and deal financials and target Company's major public companies key financial metrics and ratios. Business Description A brief description of the company's operations. Key Employees A list of the key executives of the company. Important Locations and Subsidiaries A list and contact details of key centers of operation and subsidiaries of the company. Key Competitors A list of the key competitors of the company. Key Recent Developments A brief on recent news about the company. Reasons to Buy Get detailed information on the company's financial deals that enable you to understand the company's expansion/divestiture and fund requirements The profile enables you to analyze the company's financial deals by region, by year, by business segments and by type, for a five year period. Understand the company's business segments' expansion / divestiture strategy The profile presents deals from the company's core business segments' perspective to help you understand its corporate strategy. Access elaborate information on the company's recent financial deals that enable you to understand the key deals which have shaped the company Detailed information on major recent deals includes a summary of each deal, deal type, deal rationale, deal financials and Target Company's key financial metrics and ratios. Equip yourself with detailed information about the company's operations to identify potential customers and suppliers. The profile analyzes the company's business structure, locations and subsidiaries, key executives and key competitors. Stay uptodate on the major developments affecting the company Recent developments concerning the company presented in the profile help you track important events. Gain key insights into the company for academic or business research Key elements such as break up of deals into categories and information on detailed major deals are incorporated into the profile to assist your academic or business research needs. Note*: Some sections may be missing if data is unavailable for the company.

AntibodyAcquisition

100 Deals associated with Tozadenant

External Link

KEGG	Wiki	ATC	Drug Bank
D10174	Tozadenant	-	DB12203

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Parkinson Disease	Phase 3	AT	Biotie Therapies Oy	01 Jul 2015
Parkinson Disease	Phase 3	CZ	Biotie Therapies Oy	01 Jul 2015
Parkinson Disease	Phase 3	DE	Biotie Therapies Oy	01 Jul 2015
Parkinson Disease	Phase 3	IT	Biotie Therapies Oy	01 Jul 2015
Parkinson Disease	Phase 3	ES	Biotie Therapies Oy	01 Jul 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03051607 (CTgov)	Phase 3	Parkinson Disease	66	Tozadenant	topcbztbbm(dyljzfjeyj) = jnibrnvqkb xekxbomair (szltulglbu, cjfthyoiuf - rlklrntkcg) View more	-	03 May 2019
NCT02453386 (TOZ-PD, CTgov)	Phase 3	Parkinson Disease	449	placebo (Placebo BID)	qtnzmvntbe(vtobsnanbb) = mnhkpejmek eyhfidmoxk (rxvmbsnkaz, ltzuoriqom - armuoqgrbi) View more	-	26 Mar 2019
NCT02453386 (TOZ-PD, CTgov)	Phase 3	Parkinson Disease	449	tozadenant (Tozadenant 60 mg BID)	qtnzmvntbe(vtobsnanbb) = wbdnatoacx eyhfidmoxk (rxvmbsnkaz, mwudsgrrdr - kpchvpdzas) View more	-	26 Mar 2019
MDS2017	Phase 3	Hypotension, Orthostatic	-	TOZ 30 mg/kg	tkpnmsvebt(kwpvnizxqv) = zzosmquwly ocpfmkzzsi (kfgpmrdhyg )	-	04 Jun 2017
tozadenant study (MDS2017)	Not Applicable	Parkinson Disease	247	Tozadenant 60 mg	fzhbygktps(gpiiinwqfy) = icmjqaqlwy tnjhgxonir (dtvlhyudbr )	Positive	04 Jun 2017
tozadenant study (MDS2017)	Not Applicable	Parkinson Disease	247	Tozadenant 120 mg	fzhbygktps(gpiiinwqfy) = gaatcdyaqa tnjhgxonir (dtvlhyudbr )	Positive	04 Jun 2017

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