Clinical trials: Optimized Treatment
Hemophilia B
Dose Confirmation Trial of AAV5-hFIXco-Padua
This is an open-label, single-dose, single-arm, multi-center trial, with a screening, a treatment + post-treatment follow-up phase, and a long-term follow-up phase.
- Trial name
- NCT03489291
- Testing
- AAV5-hFIXco-Padua (AMT-061)
- Where
- 4 sites in United States
- Volunteers
- 3 people
- Sponsor
- CSL Behring
Pyruvate Kinase Deficiency
Gene Therapy for Pyruvate Kinase Deficiency (PKD)
This is an open-label Phase I trial to evaluate the safety of a hematopoietic cell-based gene therapy for patients with Pyruvate Kinase Deficiency (PKD).
- Trial name
- NCT04105166
- Testing
- RP-L301
- Where
- 3 sites in United States, Spain
- Volunteers
- 4 people
- Sponsor
- Rocket Pharmaceuticals Inc.
Coronary Heart Disease
Optimized Antiplatelet Therapy in Patients With CHD After Implantation of NeoVas™ BRS System
This study is designed to verify the safety and efficacy of Lepu® NeoVas™ Bioabsorbable Coronary Artery Rapamycin-eluting Stent System combined with different antiplatelet therapies in the treatment of coronary heart disease.
- Trial name
- NCT04995159
- Testing
- Single anti-platelet therapy, Dual anti-platelet therapy
- Where
- 114 sites in China
- Volunteers
- 2,150 people
- Sponsor
- Lepu Medical Technology (Beijing) Co., Ltd.
HIV
Randomized, Double-Blind, Placebo-Controlled Trial, Followed by Single-Arm Treatment of PRO 140
This is a Phase 2b/3, multi-center, two part study, designed to evaluate the efficacy, safety, and tolerability of PRO 140 in conjunction with existing ART (failing regimen) for one week and Optimized Background Therapy (OBT) for…
- Trial name
- PRO140 (NCT02483078)
- Testing
- PRO 140, Optimized Background Regimen
- Where
- 36 sites in United States, Puerto Rico
- Volunteers
- 52 people
- Sponsor
- CytoDyn, Inc.
Advanced Parkinson's Disease
Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects
The primary objective of this study was to demonstrate the superiority of levodopa - carbidopa intestinal gel over treatment with optimized oral levodopa/carbidopa during 12 weeks.
- Trial name
- NCT00660387
- Testing
- Levodopa carbidopa intestinal gel (LCIG), Levodopa-carbidopa (LC) oral encapsulated immediate release (IR) tablets, CADD-Legacy® 1400 ambulatory infusion pump
- Where
- 14 sites in United States, New Zealand
- Volunteers
- 35 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Pain, Advanced Cancer
A Two-Part Study of Sativex® Oromucosal Spray for Relieving Uncontrolled Persistent Pain in Patients With Advanced Cancer
The primary objective of this study was to evaluate the efficacy of nabiximols (Sativex®), compared with placebo, when used as an adjunctive measure in relieving uncontrolled persistent chronic pain (not breakthrough pain) in…
- Trial name
- NCT01424566
- Testing
- Nabiximols
- Where
- 65 sites in Australia, Bulgaria and 11 more
- Volunteers
- 406 people
- Sponsor
- Jazz Pharmaceuticals
Frown Lines, Glabellar Frown Lines
Study Evaluating the Treatment of Forehead and/or Glabellar Lines With the CRYO-TOUCH III Device
myoscience Inc. (Redwood City, CA) has developed a device for a novel, minimally invasive facial rejuvenation procedure designed to soften hyperdynamic facial lines.
- Trial name
- NCT01808742
- Testing
- Treatment with CryoTouch III Device
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Pacira Pharmaceuticals, Inc
HIV Infections
A Study of Fuzeon (Enfuvirtide) With an Integrase Inhibitor Plus Optimized Background in Treatment-Experienced HIV-1 Infected Patients
This 2-arm study evaluated the efficacy and safety of Fuzeon with an integrase inhibitor in an expanded access program plus an optimized background antiviral regimen (AVR) in HIV-1 infected patients naive to Fuzeon and an…
- Trial name
- AMICI (NCT00488059)
- Testing
- enfuvirtide [Fuzeon], Optimized background ARV, Integrase inhibitor
- Where
- 43 sites in United States, Puerto Rico
- Volunteers
- 29 people
- Sponsor
- Hoffmann-La Roche
Acute Myeloid Leukemia
FLYSYN in MRD Positive AML
This is a first in human, prospective, multicentric, nonrandomized, open-label study to investigate the safety, tolerability, preliminary efficacy, pharmacokinetics, pharmacodynamics and immunogenicity of the Fc-optimized…
- Trial name
- FLYSYN-101 (NCT02789254)
- Testing
- FLYSYN
- Where
- 5 sites in Germany
- Volunteers
- 31 people
- Sponsor
- Synimmune GmbH
Advanced Parkinson's Disease
A Study to Assess the Efficacy, Safety and Tolerability of ABT-SLV187 Monotherapy in Subjects With Advanced Parkinson's Disease (PD) and Persistent Motor Complications, Despite Optimized Treatment With Available Anti-Parkinsonian Medications
The primary objective of this study is to measure the efficacy of ABT-SLV187 in subjects with advanced Parkinson's disease.
- Trial name
- NCT01960842
- Testing
- Levodopa-carbidopa intestinal gel, CADD-Legacy® 1400 ambulatory infusion pump, PEG tube
- Volunteers
- 31 people
- Sponsor
- AbbVie
Multiple Myeloma
Study to Evaluate Optimized Retreatment and Prolonged Therapy With Bortezomib
The objective of this study is to describe the effect of optimized retreatment with bortezomib in combination with dexamethasone followed by prolonged therapy with bortezomib, versus standard retreatment with bortezomib in…
- Trial name
- OPTIMRETREAT (NCT01910987)
- Testing
- bortezomib (optimized retreatment), dexamethasone (optimized retreatment), bortezomib (standard retreatment)
- Where
- 54 sites in Belgium, Finland and 9 more
- Volunteers
- 80 people
- Sponsor
- Janssen-Cilag International NV
Parkinson Disease
Temporally Optimized Patterned Stimulation (TOPS®) Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease
This study will test newly developed stimulation settings called Temporally Optimized Patterned Stimulation or TOPS, which can be used with an already implanted deep brain stimulation system.
- Trial name
- TOPS (NCT04390867)
- Testing
- TOPS1 DBS, TOPS2 DBS, TOPS3 DBS
- Where
- 3 sites in United States
- Volunteers
- 6 people
- Sponsor
- Deep Brain Innovations LLC
Pain, Advanced Cancer
Sativex® for Relieving Persistent Pain in Patients With Advanced Cancer
This 9-week study aimed to determine the efficacy, safety, and tolerability of nabiximols (Sativex®) as an adjunctive treatment, compared with placebo in relieving uncontrolled persistent chronic pain in participants with…
- Trial name
- SPRAY III (NCT01361607)
- Testing
- Nabiximols
- Where
- 68 sites in United States, Bulgaria and 8 more
- Volunteers
- 399 people
- Sponsor
- Jazz Pharmaceuticals
Primary Hypercholesterolemia or Mixed Hyperlipidemia
QLC7401 in the Treatment of Primary Hypercholesterolemia or Mixed Hyperlipidemia With Elevated Low Density Lipoprotein Cholesterol (LDL-C)
To evaluate the efficacy, safety and immunogenicity of QCL7401 subcutaneous administration in patients with primary hypercholesterolemia or mixed hyperlipidemia with poorly controlled LDL-C elevated on optimized lipid-lowering…
- Trial name
- NCT07441317
- Testing
- QLC7401
- Volunteers
- 780 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
HIV Infections
T-20 Plus a Selected Anti-HIV Treatment in HIV-Infected Children and Adolescents
This study will evaluate T-20 in children.
- Trial name
- NCT00022763
- Testing
- Enfuvirtide
- Where
- 7 sites in United States
- Volunteers
- 52 people
- Sponsor
- Hoffmann-La Roche
Major Depressive Disorder (MDD)
Regulated Stimulation for Optimized Network Activity and Therapeutic Equilibrium - Maintenance
The objective of this study is to evaluate the safety, tolerability, and preliminary efficacy of the Motif XCS System when used as indicated for treatment-resistant depression (TRD).
- Trial name
- RESONATE-M (NCT07684794)
- Testing
- Motif XCS System
- Volunteers
- 10 people
- Sponsor
- Motif Neurotech, Inc.
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
Major Depressive Disorder
Regulated Stimulation for Optimized Network Activity and Therapeutic Equilibrium
The objective of this study is to evaluate the safety, tolerability, and preliminary efficacy of the Motif eXternally powered Cortical Stimulation (XCS) System when used as indicated for treatment-resistant depression (TRD).
- Trial name
- RESONATE (NCT07594483)
- Testing
- Motif XCS System
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- Motif Neurotech, Inc.
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
Chronic Spontaneous Urticaria
OPTIMA: Efficacy of Optimized Re-treatment and Step-up Therapy With Omalizumab in Chronic Spontaneous Urticaria (CSU) Patients
This trial assessed the efficacy of optimized re-treatment therapy with omalizumab (150mg or 300mg) after relapse, in participants with Chronic Spontaneous Urticaria who were clinically well-controlled following their first…
- Trial name
- OPTIMA (NCT02161562)
- Testing
- omalizumab
- Where
- 35 sites in Argentina, Brazil and 6 more
- Volunteers
- 314 people
- Sponsor
- Novartis Pharmaceuticals