Clinical trials: Optimized Treatment
Bipolar Disorder
Effectiveness of Lithium Plus Optimized Medication in Treating People With Bipolar Disorder
This study evaluated whether lithium included as part of optimized medication treatment improved overall level of illness, symptoms of mania and depression, and quality of life in people with bipolar disorder.
- Trial name
- LiTMUS (NCT00667745)
- Testing
- Lithium Carbonate, Optimized Treatment (OPT)
- Where
- 6 sites in United States
- Volunteers
- 283 people
- Sponsor
- National Institute of Mental Health (NIMH)
HIV, Pediatric
Safety Sudy of Atazanavir Boosted With Ritonavir in the Treatment of HIV Infection in Pediatric Patients
The purpose of this study is to collect safety clinical data in HIV-infected pediatric patients aged 6 and older to younger than18 years and weighing 15 kg or more, who are receiving atazanavir capsule boosted with ritonavir and…
- Trial name
- NCT01691794
- Testing
- Atazanavir, Ritonavir
- Where
- 27 sites in United States, Argentina and 6 more
- Volunteers
- 108 people
- Sponsor
- Bristol-Myers Squibb
HIV Infections
Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of HIV-1 Infected Subjects
Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown to be active in vitro against a wide range of clinical isolates (including those resistant to existing classes).
- Trial name
- MOTIVATE 2 (NCT00098722)
- Testing
- Maraviroc (UK-427,857), optimized background therapy
- Where
- 172 sites in United States, Australia and 11 more
- Volunteers
- 474 people
- Sponsor
- ViiV Healthcare
HIV Infections
A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (MK0518-018 EXT2)
This study will investigate the safety and efficacy of raltegravir as a therapy for HIV-infected patients failing current therapy with 3-class antiviral resistance.
- Trial name
- NCT00293267
- Testing
- raltegravir potassium
- Volunteers
- 352 people
- Sponsor
- Merck Sharp & Dohme LLC
Hemophilia B
HOPE-B: Trial of AMT-061 in Severe or Moderately Severe Hemophilia B Patients
This is an open-label, single-dose, multi-center, multinational trial to demonstrate the efficacy of AMT-061 and to further describe its safety profile. The study drug is identified as AAV5-hFIXco-Padua (AMT- 061).
- Trial name
- NCT03569891
- Testing
- AAV5-hFIXco-Padua, Factor IX (FIX)
- Where
- 33 sites in United States, Belgium and 6 more
- Volunteers
- 67 people
- Sponsor
- CSL Behring
Low Back Pain, Chronic Pain
Optimize Low Back Pain
The objective of this study is to improve health care for patients with chronic LBP and increase the likelihood that patients obtain outcomes that matter most to them.
- Trial name
- OPTIMIZE (NCT03859713)
- Testing
- Physical Therapy, Cognitive Behavioral Therapy, Mindfulness
- Where
- 3 sites in United States
- Volunteers
- 749 people
- Sponsor
- University of Utah
Tourette Syndrome
Open-Label Safety and Tolerability Study of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome
This is a Phase 2b, multicenter, open-label study to evaluate the safety and tolerability of optimized doses of NBI-98854 administered once daily for 24 weeks in pediatric subjects with Tourette Syndrome.
- Trial name
- NCT03444038
- Testing
- Valbenazine
- Where
- 37 sites in United States, Puerto Rico
- Volunteers
- 85 people
- Sponsor
- Neurocrine Biosciences
Advanced Parkinson's Disease
A Study to Examine the Effect of Levodopa-Carbidopa Intestinal Gel (LCIG) Therapy Relative to That of Optimized Medical Treatment (OMT) on Non-motor Symptoms (NMS) Associated With Advanced Parkinson's Disease (PD)
The primary objective of this study is to examine the effect of LCIG relative to that of OMT on NMS associated with PD.
- Trial name
- NCT02549092
- Testing
- Optimized Medical Treatment, Levodopa-Carbidopa Intestinal Gel, Nasojejunal (NJ) tube
- Where
- 38 sites in United States, Australia and 7 more
- Volunteers
- 89 people
- Sponsor
- AbbVie
HIV Infections
Vicriviroc (SCH 417690) in Combination Treatment With Optimized ART Regimen in Experienced Participants (VICTOR-E1) (MK-7690-020/P03672)
Vicriviroc (vye-kri-VYE-rock) is an investigational drug that belongs to a new class of drugs, called C-C chemokine receptor type 5 (CCR5) receptor blockers.
- Trial name
- VICTOR-E1 (NCT00243230)
- Testing
- Vicriviroc 30 mg, Vicriviroc 20 mg, Background ART Regimen
- Volunteers
- 116 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV
Ibalizumab Plus Optimized Background Regimen in Patient With Multi-Drug Resistant HIV
This Phase 3, single arm, multicenter study will evaluate the safety and effectiveness of ibalizumab in treatment-experienced patients infected with multi-drug resistant HIV-1.
- Trial name
- NCT02475629
- Testing
- ibalizumab, Optimized Background Regimen (OBR)
- Where
- 30 sites in United States, Puerto Rico and 1 more
- Volunteers
- 40 people
- Sponsor
- TaiMed Biologics Inc.
HIV Infections
PRINCE: Study of Atazanavir (ATV)/Ritonavir (RTV)
The purpose of this study is to determine whether atazanavir powder combined with ritonavir is safe and well tolerated and produces appropriate drug exposure in children ≥3 months to <6 years of age.
- Trial name
- PRINCE1 (NCT01099579)
- Testing
- Atazanavir powder, Ritonavir oral solution, Atazanavir capsules
- Where
- 18 sites in Brazil, Chile and 4 more
- Volunteers
- 82 people
- Sponsor
- Bristol-Myers Squibb
Tuberculosis, Multidrug-Resistant
Efficacy and Safety of Levofloxacin for the Treatment of MDR-TB
Multi-drug-resistant tuberculosis (MDR-TB) affects nearly 600,000 persons each year around the world. This type of tuberculosis is very difficult to treat, and many patients die from it.
- Trial name
- Opti-Q (NCT01918397)
- Testing
- Levofloxacin, Optimized background regimen (OBR)
- Where
- 3 sites in Peru, South Africa
- Volunteers
- 111 people
- Sponsor
- Boston University
Heart Failure
Conduction System Pacing Optimized Therapy
The purpose of the CSPOT study is to determine the best mode of cardiac resynchronization therapy (CRT) pacing for different populations of CRT patients, comparing traditional biventricular or left ventricular pacing (BiV)…
- Trial name
- CSPOT (NCT04905290)
- Testing
- Left ventricular coronary sinus (BiV) configuration, Conduction system pacing-only configuration, Conduction System Pacing Optimized Therapy (CSPOT) configuration
- Where
- 12 sites in United States, Ireland and 2 more
- Volunteers
- 60 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Anal Canal Squamous Cell Carcinoma, Stage I Anal Cancer AJCC v8
Linear Energy Transfer (LET)-Optimized Intensity Modulated Proton Therapy (IMPT) as a Component of Definitive Chemoradiation for Newly Diagnosed Squamous Cell Carcinoma of the Anal Canal: a Feasibility Trial
This phase II trial studies the side effects of LET-IMPT and standard chemotherapy, and how well they work in treating patients with newly diagnosed stage I-III anal canal squamous cell cancer.
- Conditions
- Anal Canal Squamous Cell Carcinoma, Stage I Anal Cancer AJCC v8, Stage II Anal Cancer AJCC v8, Stage IIA Anal Cancer AJCC v8
- Trial name
- NCT03690921
- Testing
- Cisplatin, Fluorouracil, Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- M.D. Anderson Cancer Center
Palliative Care, Pain
A Study of Sativex® for Pain Relief in Patients With Advanced Malignancy.
The purpose of this study is to determine the effective dose range and to demonstrate a non-effective dose range of Sativex in patients with advanced cancer, who experience inadequate pain relief even though they are on optimized…
- Conditions
- Palliative Care, Pain, Cancer
- Trial name
- SPRAY (NCT00530764)
- Testing
- Sativex Low Dose, Sativex Medium Dose, Sativex High Dose
- Where
- 110 sites in United States, Belgium and 14 more
- Volunteers
- 360 people
- Sponsor
- GW Pharmaceuticals Ltd
HIV
Phase IIIB Study Evaluating the Effects of Atazanavir Powder With Ritonavir in HIV-infected Pediatric Patients
The purpose of this study is to describe the safety, efficacy, and pharmacokinetics of a regimen of atazanavir powder boosted with ritonavir and an optimized dual nucleoside reverse transcriptase inhibitor in pediatric patients…
- Trial name
- PRINCE2 (NCT01335698)
- Testing
- Atazanavir Sulphate, Ritonavir
- Where
- 32 sites in United States, Argentina and 9 more
- Volunteers
- 160 people
- Sponsor
- Bristol-Myers Squibb
HIV Infections
Raltegravir With Optimized Background Therapy (OBT) in Multiple Experienced HIV-infected Patients
The purpose of this study is to evaluate the efficacy of raltegravir with optimized background therapy (OBT) in multiple-experienced HIV infected patients, measured by the proportion of patients with undetectable viral load and…
- Trial name
- NCT01190124
- Volunteers
- 151 people
- Sponsor
- Doroana, Maria Manuela, M.D.
Myocardial Infarction
Safety and Efficacy of Aliskiren in Post Myocardial Infarction Patients (ASPIRE)
The core and extension studies assessed the safety and efficacy of aliskiren when added to optimized standard therapy in patients that have had a high risk acute myocardial infarction (heart attack).
- Trial name
- NCT00414609
- Testing
- Aliskiren
- Where
- 23 sites in United States, Argentina and 21 more
- Volunteers
- 820 people
- Sponsor
- Novartis
HIV Infections
Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of HIV-1 Infected Subjects
Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown to be active in vitro against a wide range of clinical isolates (including those resistant to existing classes).
- Trial name
- MOTIVATE 1 (NCT00098306)
- Testing
- Maraviroc (UK-427,857), Optimized Background Therapy
- Where
- 22 sites in United States, Canada
- Volunteers
- 601 people
- Sponsor
- ViiV Healthcare
Advanced Parkinson's Disease
Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson's Disease
The primary objective of this study will be to provide further evidence of the long-term safety and tolerability of levodopa-carbidopa intestinal gel (Duodopa®) over 12-months in participants with advanced Parkinson's disease…
- Trial name
- NCT00335153
- Testing
- Levodopa-carbidopa intestinal gel, CADD-Legacy® 1400 ambulatory infusion pump, PEG tube
- Where
- 83 sites in United States, Australia and 14 more
- Volunteers
- 354 people
- Sponsor
- AbbVie (prior sponsor, Abbott)