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NCT ID: NCT01285401 Completed - Clinical trials for Relapsing-Remitting Multiple Sclerosis

Supplementation of VigantOL® Oil Versus Placebo as Add-on in Patients With Relapsing Remitting Multiple Sclerosis Receiving Rebif® Treatment

SOLAR
Start date: March 2011
Phase: Phase 2
Study type: Interventional

The drug being tested is called VigantOL® oil - a very effective form of Vitamin D hormone supplement (cholecalciferol). Low levels of Vitamin D have been described to be associated with a higher risk of developing Multiple Sclerosis (MS), and it is known that up to 90% of patients with Multiple Sclerosis have Vitamin D deficiency. Rebif® is known to be an effective treatment for slowing down the progression of MS. The purpose of this research trial is to evaluate if VigantOL® oil on top of Rebif® has any benefit on the progression of MS compared to Rebif® and placebo. Disease activity will be assessed by clinical examination and Magnetic Resonance Imaging (MRI). The planned study treatment duration for each study participant is 48 weeks, and the study consists of a total of 8 visits. Study participants who are already passed Week 48 at the time of approval of Protocol Amendment 5 will have a study duration of 96 weeks and a total of 12 visits. During the study, the participant will undergo physical examination, neurological assessments, safety assessments, blood tests and urinalysis (including pregnancy tests).

NCT ID: NCT01284517 Completed - Bipolar Depression Clinical Trials

Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression

PREVAIL3
Start date: November 2010
Phase: Phase 3
Study type: Interventional

Lurasidone HCI is a compound that is a candidate for the treatment of bipolar I depression. This clinical study is designed to test the hypothesis that Lurasidone in combination with either Lithium or Divalproex is effective among patients with bipolar I depression.

NCT ID: NCT01281527 Completed - Schizophrenia Clinical Trials

Paliperidone Palmitate Flexible Dosing in Schizophrenia

PALMFlexS
Start date: November 2010
Phase: Phase 3
Study type: Interventional

This study explores the tolerability, safety and efficacy (i.e. how well the drug works) of flexibly dosed paliperidone palmitate in the treatment of schizophrenia in patients previously unsuccessfully treated with other oral or long-acting injectable (LAI) (i.e. with a long duration of action) antipsychotics.

NCT ID: NCT01265784 Completed - Clinical trials for Complicated Intra-abdominal Infection

Study to Compare TP-434 and Ertapenem in Community-acquired Complicated Intra-abdominal Infections

Start date: January 2011
Phase: Phase 2
Study type: Interventional

This is a Phase 2, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics of two dose regimens of TP-434 compared with ertapenem in the treatment of adult community-acquired complicated intra-abdominal infections (cIAIs).

NCT ID: NCT01262651 Completed - Pain Clinical Trials

Sativex® for Relieving Persistent Pain in Participants With Advanced Cancer

Start date: November 25, 2010
Phase: Phase 3
Study type: Interventional

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 advanced cancer. Eligible participants were not required to stop any of their current treatments or medications.

NCT ID: NCT01262365 Completed - Clinical trials for Systemic Lupus Erythematosus

Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus

EMBODY1
Start date: December 2010
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with Systemic Lupus Erythematosus (SLE)

NCT ID: NCT01261325 Completed - Epilepsy Clinical Trials

Brivaracetam Efficacy and Safety Study in Subjects With Partial Onset Seizures

BRITE
Start date: December 2010
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of brivaracetam at doses of 100 and 200mg/day compared to placebo as adjunctive treatment in adult focal epilepsy subjects with partial onset seizures not fully controlled despite current treatment with 1 or 2 concomitant antiepileptic drugs.

NCT ID: NCT01261273 Completed - Clinical trials for Coronary Artery Disease

e-NOBORI Observational Registry of Nobori DES

e-NOBORI
Start date: August 25, 2010
Phase:
Study type: Observational

Title Prospective, single-arm, multi-centre, observational registry to further validate safety and efficacy of the Nobori® DES in real-world patients. Objective Primary objective The primary objective of e-NOBORI registry is to further validate the safety and efficacy of Nobori® DES system in unselected patients representing everyday clinical practice. Primary Endpoint: Freedom from Target Lesion Failure (TLF) defined as a composite of cardiac death, target vessel related myocardial infarction (MI) and clinically driven target lesion revascularization (TLR) at 1 year

NCT ID: NCT01247324 Completed - Clinical trials for Relapsing Multiple Sclerosis

A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis

Start date: August 31, 2011
Phase: Phase 3
Study type: Interventional

This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy and safety of ocrelizumab in comparison with interferon beta-1a (Rebif) in participants with relapsing multiple sclerosis. Participants will be randomized to receive either ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week; or interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks). Planned duration of double-blind treatment is 96 weeks. Participants who complete the 96-week double-blind treatment will have an option to enter a single-group, active-treatment, open-label extension period, providing they fulfill the eligibility criteria.

NCT ID: NCT01243177 Completed - Epilepsy Clinical Trials

Trial Comparing the Efficacy and Safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR); Initial Monotherapy in Epilepsy; Subjects Aged 16 and Older

SP0993
Start date: April 2011
Phase: Phase 3
Study type: Interventional

Compare efficacy and safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR) as monotherapy in newly or recently newly diagnosed subjects with a primary efficacy endpoint of 6-month seizure freedom. Noninferiority design to show a similar risk/benefit balance between Lacosamide (LCM) and Carbamazepine-CR (CBZ-CR).