Clinical trials: Optimization
Tourette Syndrome
Safety, Tolerability, and Efficacy of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome
This is a Phase 2b, randomized, double-blind, placebo-controlled, dose-optimization study to evaluate the efficacy, safety, and tolerability of NBI-98854 titrated to the subject's optimal dose administered once daily (qd) for a…
- Trial name
- NCT03325010
- Testing
- Valbenazine
- Where
- 35 sites in United States, Puerto Rico
- Volunteers
- 127 people
- Sponsor
- Neurocrine Biosciences
Body Fat Disorder
Tissue Optimization on Cryolipolysis Procedures for Fat Layer Reduction
Evaluate the effects of tissue optimization before and during cryolipolysis procedures on the outcome of non-invasive fat reduction using the ZELTIQ System.
- Trial name
- TOPS (NCT01728857)
- Testing
- The Zeltiq System
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Zeltiq Aesthetics
Seizures
Dose-Optimization, Adjunctive Treatment Study of Ezogabine/Retigabine Immediate Release in Partial-onset Seizures
This is a Phase IV adjunctive treatment dose-optimization study evaluating the efficacy, safety, and health outcomes of ezogabine/retigabine immediate release (IR) (GW582892) compared with placebo in adult subjects with…
- Trial name
- NCT01721317
- Testing
- Ezogabine/Retigabine IR
- Where
- 11 sites in United States, Greece
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Cancer, Neoplasm
Study of SAR444881 Administered Alone and in Combination With Other Therapeutics in Participants With Advanced Solid Tumors
The study enrolled advanced cancer participants with unresectable or metastatic disease who were refractory to or were not candidates for standard approved therapy.
- Trial name
- NCT04717375
- Testing
- SAR444881, Pembrolizumab, Cetuximab
- Where
- 18 sites in United States, Canada and 2 more
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- Sanofi
Binge Eating Disorder
SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder
The primary objective of the study is to demonstrate the efficacy of SPD489 compared with placebo in adults (18 55 years of age inclusive) with moderate to severe Binge Eating Disorder at Visit 8 (Weeks 11 and 12) as measured by…
- Trial name
- NCT01718509
- Testing
- SPD489 (Lisdexamfetamine dimesylate)
- Where
- 48 sites in United States, Germany
- Volunteers
- 390 people
- Sponsor
- Shire
Attention Deficit Hyperactivity Disorder (ADHD)
Safety and Efficacy Study of SHP465 in Children and Adolescents Aged 6-17 Years With Attention-Deficit Hyperactivity Disorder (ADHD)
The study is designed to evaluate the efficacy and safety of SHP465 in the treatment of ADHD in children and adolescents (aged 6-17 years).
- Trial name
- NCT02466425
- Testing
- SHP465
- Where
- 36 sites in United States
- Volunteers
- 264 people
- Sponsor
- Shire
Kidney Diseases
Enteric-coated Mycophenolate Sodium (EC-MPS) With Reduced-dose Tacrolimus Versus EC-MPS With Standard-dose Tacrolimus in Stable Kidney Transplant Recipients
This study introduces a new optimization immunosuppressive regimen associating tacrolimus at a reduced dose and enteric-coated mycophenolate sodium at an increased dose in order to slow down renal function worsening and to…
- Trial name
- OLYMPE (NCT00284934)
- Testing
- Enteric-coated mycophenolate sodium (EC-MPS), Tacrolimus, Corticosteroids
- Where
- Switzerland
- Volunteers
- 94 people
- Sponsor
- Novartis
Attention Deficit Hyperactivity Disorder
A Study of TAK-503 in Children and Teenagers With Attention Deficit Hyperactivity Disorder (ADHD)
The main aim of this study is learn more about long-term TAK-503 treatment in children and teenagers with ADHD for whom earlier stimulant treatment did not work. The study has two parts (A and B).
- Trial name
- NCT04085172
- Testing
- Guanfacine hydrochloride (TAK-503), Atomoxetine hydrochloride
- Where
- 50 sites in United States, Austria and 7 more
- Volunteers
- 396 people
- Sponsor
- Shire
Chronic Heart Failure
Optimization of the Ambulatory Monitoring for Patients With Heart Failure by Tele-cardiology
Targeted population: Patients with heart failure causing hospitalization during the last twelve months. Hypothesis: The number of all cause deaths and hospitalizations will be smaller for the Telecardiology group than for the…
- Trial name
- OSICAT (NCT02068118)
- Testing
- Telecardiology program
- Where
- 38 sites in France, Martinique
- Volunteers
- 990 people
- Sponsor
- CDM e-Health
Rheumatoid Arthritis
A Study to Evaluate the Safety and Efficacy of VIB4920 in Participants With Rheumatoid Arthritis
The purpose of the study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of VIB4920 (formerly MEDI4920) in adult participants with rheumatoid arthritis (RA).
- Trial name
- MIDORA (NCT04163991)
- Testing
- VIB4920
- Where
- 25 sites in United States, Poland
- Volunteers
- 78 people
- Sponsor
- Amgen
Neoplasms, Gastrointestinal Tract
LOGiC - Lapatinib Optimization Study in ErbB2 (HER2) Positive Gastric Cancer: A Phase III Global, Blinded Study Designed to Evaluate Clinical Endpoints and Safety of Chemotherapy Plus Lapatinib
This was an international multi-center trial that enrolled patients with locally advanced, unresectable, or metastatic gastric, esophageal, or gastro-esophageal junction cancer whose tumors had amplification of the ErbB2 (HER2)…
- Trial name
- NCT00680901
- Testing
- Lapatinib, Capecitabine, Oxaliplatin
- Where
- 183 sites in United States, Argentina and 21 more
- Volunteers
- 545 people
- Sponsor
- Novartis Pharmaceuticals
Attention Deficit Hyperactivity Disorder (ADHD)
Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) in Children Aged 6-12 Diagnosed With ADHD
Assess the efficacy \& tolerability of Vyvanse when children aged 6-12 years diagnosed with ADHD are dosed to optimal effect.
- Trial name
- NCT00500071
- Testing
- Vyvanse (lisdexamfetamine dimesylate)
- Where
- 46 sites in United States
- Volunteers
- 318 people
- Sponsor
- Shire
Heart Failure
Comparison of AV Optimization Methods Used in Cardiac Resynchronization Therapy (CRT)
The primary objective of SMART-AV is to assess the effect of SmartDelay for determining optimal AV delay timing during CRT compared to both a fixed AV delay and echocardiography-determined optimal AV timing chronically over a…
- Trial name
- SMART-AV (NCT00677014)
- Testing
- AV Delay programming through cardiac resynchronization therapy
- Where
- United States
- Volunteers
- 1,060 people
- Sponsor
- Boston Scientific Corporation
Glioblastoma Multiforme
A Dose-finding Study of Birabresib (MK-8628) in Participants With Recurrent Glioblastoma Multiforme (MK-8628-002)
A study of single-agent birabresib (MK-8628) (formerly known as OTX015) in recurrent GBM after standard front-line therapy failure. The first phase of the study (dose escalation) will determine the maximum tolerated dose (MTD).
- Trial name
- NCT02296476
- Testing
- Birabresib
- Volunteers
- 12 people
- Sponsor
- Oncoethix GmbH, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Binge Eating Disorder
SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder
The primary objective of the study is to demonstrate the efficacy of SPD489 compared with placebo in adults (18 55 years of age inclusive) with moderate to severe Binge Eating Disorder at Visit 8 (Weeks 11 and 12) as measured by…
- Trial name
- NCT01718483
- Testing
- SPD489 (Lisdexamfetamine dimesylate)
- Where
- 50 sites in United States, Germany and 2 more
- Volunteers
- 383 people
- Sponsor
- Shire
Healthy
A Study in Healthy Men to Find the Best Formulation of BI 894416 and to Test How This is Taken up in the Body
The main objective of this trial is to select a formulation principle (tablet vs. capsule) and to optimize the identified extended release formulation of BI 894416, if needed.
- Trial name
- NCT04232839
- Testing
- BI 894416 Reference Formulation, BI 894416 Formulation A2, BI 894416 Formulation C2
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Sinusitis
Optimization and Refinement of Technique in In-Office Sinus Dilation 2
A prospective, multi-arm, multi-center, observational post-market study of balloon sinus dilatation in the physician office setting under local anesthesia to treat patients with chronic rhinosinusitis (CRS).
- Trial name
- ORIOS 2 (NCT01107379)
- Testing
- Relieva Balloon Sinuplasty System
- Where
- 3 sites in United States
- Volunteers
- 203 people
- Sponsor
- Integra LifeSciences Corporation
Attention-Deficit/Hyperactivity Disorder
Dose-optimization in Adolescents Aged 13-17 Diagnosed With Attention-deficit/Hyperactivity Disorder (ADHD) Using Extended-release Guanfacine HCl
To assess the efficacy of optimized Extended-release Guanfacine Hydrochloride compared with placebo in the treatment of adolescents aged 13-17 years with a diagnosis of ADHD as measured by the ADHD-RS-IV
- Trial name
- NCT01081132
- Testing
- Extended-release Guanfacine Hydrochloride
- Where
- 54 sites in United States
- Volunteers
- 314 people
- Sponsor
- Shire
Colitis, Ulcerative
Vedolizumab Intravenous (IV) Dose Optimization in Ulcerative Colitis
The purpose of this study is to investigate the efficacy and safety of vedolizumab intravenous (IV) dose optimization on mucosal healing compared with the standard vedolizumab IV dosing regimen over a 30 week treatment period in…
- Trial name
- ENTERPRET (NCT03029143)
- Testing
- Vedolizumab IV
- Where
- 49 sites in United States, Canada
- Volunteers
- 278 people
- Sponsor
- Takeda
Pulmonary Arterial Hypertension
EXPEDITE: A Study of Remodulin Induction Followed by Orenitram Optimization to Treat Pulmonary Arterial Hypertension
This was a multicenter, open-label study to evaluate the dose of Orenitram® (treprostinil) Extended Release Tablets achieved at 16 weeks after a short-term course of Remodulin® (treprostinil) Injection in subjects with pulmonary…
- Trial name
- NCT03497689
- Testing
- Intravenous/Subcutaneous Treprostinil; Oral Treprostinil
- Where
- 11 sites in United States
- Volunteers
- 36 people
- Sponsor
- United Therapeutics