A5004004308- Parkinson's Disease Mechanisms and Treatments
- Migraine and Headache Studies
- Neurological disorders and treatments
- Epilepsy research and treatment
- Botulinum Toxin and Related Neurological Disorders
- Pharmacological Effects and Toxicity Studies
- Trigeminal Neuralgia and Treatments
- Neuroscience and Neuropharmacology Research
- Attention Deficit Hyperactivity Disorder
- Sympathectomy and Hyperhidrosis Treatments
- Treatment of Major Depression
- Drug Transport and Resistance Mechanisms
- Hormonal Regulation and Hypertension
- Metabolism and Genetic Disorders
- Mental Health Research Topics
- Obsessive-Compulsive Spectrum Disorders
- Tryptophan and brain disorders
- Cholesterol and Lipid Metabolism
- Amino Acid Enzymes and Metabolism
- Autism Spectrum Disorder Research
- Ion Transport and Channel Regulation
- Pharmacogenetics and Drug Metabolism
- Chromatin Remodeling and Cancer
- Neurological Complications and Syndromes
- Ginkgo biloba and Cashew Applications
Takeda (United States)
2018-2025
Takeda (France)
2024
Takeda (Japan)
2020-2023
UCB Pharma (United States)
2015-2019
UCB Pharma (Belgium)
2015-2017
Kyowa Hakko Kirin (Singapore)
2016
Lundbeck (Italy)
2016
Novartis (Switzerland)
2016
UCB Pharma (United Kingdom)
2016
Merck Serono (Switzerland)
2016
Objective. To compare the efficacy and tolerability of sumatriptan nasal spray (NS; 5 mg, 10 20 mg) with placebo for treatment acute migraine in adolescents. Methods. A randomized, double-blind, placebo-controlled, single-attack study was conducted 653 US adolescents (12–17 years age). Patients at least a 6-month history migraine, who met International Headache Society criteria (with or without aura) were eligible participation. relief 2 hours postdose, complete relief, presence absence...
Background Impulse control disorders/other compulsive behaviours (‘ICD behaviours’) occur in Parkinson’s disease (PD), but prospective studies are scarce, and prevalence clinical characteristics of patients insufficiently defined. Objectives To assess the presence ICD over a 2-year period, evaluate patients’ characteristics. Methods A prospective, non-interventional, multicentre study (ICARUS (Impulse Control disorders And association neuRopsychiatric symptoms, cognition qUality life...
Pain is a troublesome nonmotor symptom of Parkinson's disease (PD). This double-blind exploratory pilot study (NCT01744496) was the first to specifically investigate effect dopamine agonist on PD-associated pain as primary outcome. Patients with advanced PD (ie, receiving levodopa) and at least moderate chronic (≥3 months, ≥4 points 11-point Likert scale) were randomized rotigotine (optimal/maximum dose ≤16 mg/24h) or placebo maintained for 12 weeks. Primary efficacy variable change in...
Abstract Objective Dravet syndrome (DS) and Lennox–Gastaut (LGS) are rare treatment‐resistant childhood epilepsies classed as developmental epileptic encephalopathies. ELEKTRA investigated the efficacy safety of soticlestat (TAK‐935) adjunctive therapy in children with DS or LGS (NCT03650452). Methods was a phase 2, randomized, double‐blind, placebo‐controlled study (≤300 mg twice daily, weight‐adjusted) (aged 2–17 years) DS, demonstrating three more convulsive seizures/month, LGS, four drop...
Abstract Several attempts have been made to enhance N-methyl-D-aspartate (NMDA) receptor function in schizophrenia, but they yielded mixed results. Luvadaxistat, a D-amino acid oxidase (DAAO) inhibitor that increases the glutamate co-agonist D-serine levels, is being developed for treatment of cognitive impairment associated with schizophrenia. We conducted biomarker study patients, assessing several endpoints related physiological outcomes NMDA modulation determine whether luvadaxistat...
Deficits in N-methyl-d-aspartate receptor (NMDAR) signaling are implicated the pathogenesis of schizophrenia. Luvadaxistat (TAK-831/NBI-1065844) is an investigational d-amino acid oxidase (DAAO) inhibitor that increases d-serine levels at NMDAR coagonist sites. INTERACT a phase 2 randomized, placebo-controlled study evaluated efficacy and safety three doses luvadaxistat, covering range DAAO occupancy levels, patients with schizophrenia persistent negative symptoms. The included 14-day,...
<b>Background: </b> Sumatriptan nasal spray may be particularly useful for patients whose nausea and vomiting preclude them from using oral migraine medication or who prefer not to use an injectable medication. The objective of this study was evaluate in two clinical studies the efficacy tolerability intranasal form sumatriptan acute treatment a single attack. International Headache Society-diagnosed adult migraineurs randomized, double-blind, parallel-group, multicenter (n = 409 436) used...
The efficacy and tolerability of naratriptan tablets (2.5 mg, 1 0.25 mg) compared with placebo in the acute treatment migraine were evaluated a randomized, double-blind, four-period crossover study. Five hundred eighty-six assessable patients received 2.5 595 591 602 placebo. Headache relief(moderate or severe pain reduced to mild none) 4 hours postdose was reported 68% after mg 57% 39% 33% (<i>p</i>< 0.001 versus mg). relief maintained 8, 12, 24 no use rescue medication second dose study...
Patients with Parkinson's disease (PD) may experience falls and/or fractures as a result of symptoms. There are limited data available from long-term studies estimating the incidence falls/fractures in patients PD. The objective was to compare rate PD non-PD US population. This retrospective study using US-based claims database (Truven Health MarketScan®) that compared subjects subjects. period included 12 months prior index date (defined earliest diagnosis [International Classification...
To evaluate the efficacy and tolerability of naratriptan, a novel 5-HT1 agonist, in acute treatment migraine.Six hundred thirteen migraineurs, diagnosed according to International Headache Society criteria, treated single migraine attack with naratriptan tablets (2.5 mg, 1 0.25 or 0.1 mg) placebo randomized, double-blind, placebo-controlled, parallel-group study conducted at 54 United States centers. At dosing predetermined intervals beginning 30 minutes postdose, patients recorded pain...
This multicenter, double-blind, placebo-controlled study assessed the efficacy of rotigotine transdermal patch on apathy and motor symptoms in patients with Parkinson's disease (PD).Patients PD-associated (Unified Disease Rating Scale [UPDRS] I item 4 [motivation] ≥2 patient-rated Apathy [AS] ≥14) were randomized 1:1:1 to "low-dose" (≤6 mg/24 h for early PD [those not receiving levodopa] or ≤8 advanced levodopa]), "high-dose" (≤8 ≤16 PD), placebo, maintained at optimal/maximal dose 12 weeks....
To evaluate the safety, tolerability, and pharmacokinetics of soticlestat, a first-in-class cholesterol 24-hydroxylase inhibitor, in adults with developmental and/or epileptic encephalopathies (DEE). The study comprised 30-day, randomized, double-blind, placebo-controlled phase (Part A), followed by 55-day open-label B) (ClinicalTrials.gov ID: NCT03166215) . In Part A, patients DEE at least one bilateral motor seizure during 4-week prospective baseline period were randomized 4:1 to receive...
To evaluate the dopamine receptor agonist, rotigotine, for improving depressive symptoms in patients with Parkinson's disease (PD).Patients were randomized 1:1 to rotigotine or placebo, titrated ≤7 weeks, and maintained at optimal/maximum dose 8-weeks. Primary efficacy variable: 17- item Hamilton Depression Rating Scale (HAM-D 17) total score change from baseline end-of-maintenance. Secondary variables: changes Beck Inventory-II, Unified Disease (UPDRS) II (activities of daily living [ADL])...
Abstract Background Dravet syndrome (DS) and Lennox-Gastaut (LGS) are rare, severe, childhood-onset developmental epileptic encephalopathies characterized by treatment-resistant epilepsy varying intellectual disability levels. Clinical outcome assessments (COAs) describe how patients feel, function, or survive, thus providing valuable information on a therapy’s efficacy impact. Individuals with DS LGS heterogeneous, many have limited verbal abilities disability. Existing epilepsy-specific...
Soticlestat (TAK-935) is a first-in-class, selective inhibitor of cholesterol 24-hydroxylase (CH24H) under phase III development for the treatment developmental and epileptic encephalopathies (DEEs), Dravet syndrome (DS), Lennox-Gastaut (LGS). A previous model characterized pharmacokinetics (PKs), CH24H enzyme occupancy (EO), pharmacodynamics (PDs) soticlestat in healthy volunteers. The present study extended this original patients with DEEs investigated sources variability. Model-based...
The objective of the study was to describe treatment patterns in patients newly diagnosed with Parkinson's disease (PD) United States (US) and Kingdom (UK).This retrospective cohort used US IBM MarketScan database (2012-2017) UK Clinical Practice Research Datalink (CPRD) (2004-2015) incident PD cases. Patients fulfilling case definition PD, ≥30 years, a 2-year baseline period prior index date (date diagnosis), ≥90 days follow-up were included study. Treatment classified as monotherapy (one...
Abstract TAK-653 is a novel AMPA receptor positive allosteric modulator in clinical development for the treatment of major depressive disorder (MDD). This study aimed to measure functional pharmacodynamic central nervous system (CNS) effects TAK-653. A randomised, double-blind, placebo-controlled, three-way crossover (placebo, 0.5 mg and 6 mg) with 24 healthy volunteers was performed. NeuroCart tests consisting body sway (BS), saccadic peak velocity (SPV), smooth pursuit eye movements (SP),...