Clinical trials: Optimized Treatment
Non-Hodgkin Lymphoma
Study of Fc-Optimized Anti-CD19 Antibody (MOR00208) to Treat Non-Hodgkin's Lymphoma (NHL)
This is an open-label, multicenter study to characterize the safety and efficacy of the human anti-CD19 antibody MOR00208 in adult patients with relapsed/refractory non-Hodgkin's lymphoma (NHL) who have received at least 1 prior…
- Trial name
- NCT01685008
- Testing
- MOR00208 (formerly Xmab 5574)
- Where
- 22 sites in United States, Belgium and 5 more
- Volunteers
- 92 people
- Sponsor
- MorphoSys AG
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
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
Partial Epilepsies
Trial to Assess Optimized Dosage of Lacosamide as add-on Therapy in Patients With Partial Onset Seizure
To evaluate if a flexible dose escalation of lacosamide, up to the maximum approved dose of 400 mg/day, or to a clinically effective lower dose for an individual patient, improves the tolerability and safety of lacosamide (200 mg…
- Trial name
- SELF (NCT01235403)
- Testing
- Lacosamide
- Where
- 32 sites in France
- Volunteers
- 100 people
- Sponsor
- UCB Pharma
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
Asthma
Omalizumab in Adult and Adolescent Patients With Severe Persistent Allergic Asthma
Omalizumab will be given as add-on treatment to optimized asthma therapy in patients with severe persistent asthma, who demonstrate inadequate asthma symptom control.
- Trial name
- NCT00264849
- Testing
- Omalizumab, Optimized asthma therapy
- Where
- 17 sites in Belgium, Canada and 15 more
- Volunteers
- 406 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 Antiretroviral-Experienced NonCCR5-Tropic HIV-1 Infected Subjects
Maraviroc (UK-427,857), a selective and reversible CCR5 co-receptor antagonist, has been shown to be active in vitro against a wide range of clinical isolates (including those resistant to existing classes).
- Trial name
- NCT00098748
- Testing
- Optimized Background Therapy (OBT), maraviroc (UK-427,857)
- Where
- 77 sites in United States, Australia and 7 more
- Volunteers
- 190 people
- Sponsor
- ViiV Healthcare
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
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 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
Hemophilia B
Trial of AAV5-hFIX in Severe or Moderately Severe Hemophilia B
This study evaluates how safe gene therapy treatment with AAV5-hFIX is in adult patients with severe or moderately severe hemophilia B and severe bleeding type.
- Trial name
- NCT02396342
- Testing
- AAV5-hFIX
- Where
- 7 sites in Denmark, Germany and 1 more
- Volunteers
- 10 people
- Sponsor
- CSL Behring
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.
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, Infectious
GRACE: A Study to Compare the Effectiveness, Safety and Tolerability of PREZISTA (Darunavir)/Ritonavir by Gender and Race When Administered With Other Antiretroviral Medications in Human Immunodeficiency Virus (HIV) Positive Women and Men.
The purpose of this study is to evaluate any differences in the effectiveness, safety, and tolerability of PREZISTA (darunavir; DRV) 600 mg, administered with ritonavir (RTV) 100 mg twice a day on virologic response (defined as a…
- Trial name
- NCT00381303
- Testing
- darunavir, ritonavir
- Where
- 46 sites in United States, Canada and 1 more
- Volunteers
- 429 people
- Sponsor
- Tibotec, 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
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
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)
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 Infections
A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (0518-019)
This study will investigate the safety and efficacy of raltegravir as a therapy for Human Immunodeficiency Virus (HIV)-infected patients failing current therapy with 3-class antiviral resistance.
- Trial name
- NCT00293254
- Testing
- raltegravir potassium
- Volunteers
- 351 people
- Sponsor
- Merck Sharp & Dohme LLC
Restless Legs Syndrome
Study to Investigate Pharmacokinetics (PK) of Pramipexole in Pediatric Patients Who Are Individually Optimized to Stable Pramipexole Doses for the Treatment of Idiopathic Restless Legs Syndrome (RLS)
Study to determine the pharmacokinetics (PK) of pramipexole (PPX) after administration of a single dose orally (p.o.) in pediatric patients with the diagnosis of RLS
- Trial name
- NCT02231918
- Testing
- MIRAPEX® - low, MIRAPEX® - medium, MIRAPEX® - high
- Volunteers
- 26 people
- Sponsor
- Boehringer Ingelheim