A 12-week Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment...
Alzheimer's DiseaseActive treatment extension study of the 331-14-213 trial, to assess the long-term safety and tolerability of oral brexpiprazole as treatment in adult subjects with agitation associated with dementia of the Alzheimer's type (AAD).
Gabapentin as Preanesthetic Medication to Fast Procedures in Pediatric´s Oncology
PainPostoperative3 moreThis study is a clinical trial, prospective, randomized and double-blinded. Placebo, Gabapentin syrup at 15 mg/kg, and Gabapentin syrup at 30 mg/kg were administered to reduce agitation before and after in children submitted procedures (myelogram or lumbar puncture) among 1 and 6 years.
Long-term Efficacy and Safety of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients...
Restless Legs SyndromeThe objective of this study is to evaluate the efficacy and safety of ASP8825 (gabapentin enacarbil) for long-term treatment of restless legs syndrome patients.
The Effect of Horizant (Gabapentin Enacarbil) on Augmentation
Restless Legs SyndromeRestless Legs Syndrome (RLS) is a common neurological disorder. Augmentation is the main complication during long-term DA treatment of RLS. This study aims to examine effect of Horizant (Gabapentin Enacarbil) on Augmentation in RLS patients.
Sub-Lingual Dexmedetomidine in Agitation Associated With Dementia
Agitation,PsychomotorDementiaThis is an adaptive Phase 1b/2 trial design. It is randomized, double-blind, placebo-controlled, multiple ascending dose study assessing efficacy, pharmacokinetics, safety and tolerability of BXCL-501 dosing in adult (65 years and older) males and females with acute agitation associated with dementia. Evaluation of 3 doses are planned.
Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder
Agitation Associated With Bipolar DisorderAgitation,Psychomotor1 moreThis is a definitive study to support the safety and efficacy evaluation of BXCL501 for the acute treatment of agitation in bipolar disorder. The BXCL501-302 study is designed to characterize the efficacy, safety and tolerability of BXCL501 (sublingual film formulation of DEX, HCl) in agitation associated with bipolar disorder.
Mother's Recorded Voice Versus Dexmedetomidine on Postoperative Agitation
AgitationEmergenceThe aim of this study is to compare the efficacy of mother's recorded voice versus dexmedetomidine injection on postoperative agitation in children undergoing elective surgery.
Long-Term Follow-Up Study for Safety, Efficacy and Tolerability of Rotigotine in Adolescents With...
Restless Legs SyndromeThis is a Phase 2, multicenter, open-label, single-arm, optimal dose, long-term follow-up study of monotherapy administration of rotigotine transdermal patch in adolescents with Restless Legs Syndrome (RLS). This study will assess the long-term safety and tolerability of Rotigotine treatment in adolescents with RLS.
Study of SPM 962 in Patients With Restless Legs Syndrome (RLS)
Idiopathic Restless Legs SyndromeThe objective of this study is to evaluate the clinical efficacy and safety of SPM962 in patients with restless legs syndrome (RLS) with once-daily repeated doses of 4.5mg and 6.75mg during a 13-week dose-titration and maintenance period. This is a multi-center, randomized, placebo-controlled, double-blind, 3-armed parallel group comparison study. Efficacy will be determined by investigating the superiority of SPM962 to placebo in terms of the primary efficacy variable, change in International Restless Legs Syndrome Rating Scale (IRLS) total score from baseline to the end of the dose-maintenance period.
Intravenous Iron Metabolism in Restless Legs Syndrome
Restless LegsTo determine the effects of high-dose infusions of iron on Restless Legs Syndrome (RLS) symptoms and brain concentrations of iron.