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NCT ID: NCT01252355 Terminated - Clinical trials for Multiple Sclerosis Relapse

Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis and Treated With Interferon-beta

TERACLES
Start date: January 2011
Phase: Phase 3
Study type: Interventional

The primary objective was to demonstrate the effect of teriflunomide, in comparison to placebo, on frequency of Multiple Sclerosis (MS) relapses in patients with relapsing forms of MS who are treated with Interferon-beta (IFN-beta). The secondary objectives were: - Assess the effect of teriflunomide, in comparison to placebo, when added to IFN-beta on: - Disease activity as measured by brain Magnetic Resonance Imaging (MRI) - Disability progression - Burden of disease and disease progression as measured by brain MRI - Evaluate the safety and tolerability of teriflunomide when added to IFN-beta therapy - Assess the pharmacokinetics of teriflunomide in use in addition to baseline IFN-beta therapy - Assess associations between variations in genes and clinical outcomes (safety and efficacy) - Assess other measures of efficacy of teriflunomide such as fatigue and health-related quality of life - Assess measures of health economics (hospitalization due to relapse, including the length of stay and any admission to intensive care unit)

NCT ID: NCT01251354 Terminated - Endometrial Cancer Clinical Trials

Study of BN83495 in Post-menopausal Women With Endometrial Cancer Post-chemotherapy

Start date: November 2010
Phase: Phase 2
Study type: Interventional

The purpose of the protocol is to determine the effect of BN83495 on the progression of endometrial cancer with estrogen receptor in post menopausal women who had previously received chemotherapy.

NCT ID: NCT01249001 Terminated - Nausea Clinical Trials

Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Adolescents

Start date: October 2010
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to compare the absorption of a prepared aprepitant oral suspension with that of the aprepitant capsule in children being treated with chemotherapy agents that are likely to cause vomiting.

NCT ID: NCT01248858 Terminated - Cancer Clinical Trials

Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK2126458 and GSK1120212 Combination Therapy in Subjects With Advanced Solid Tumors.

Start date: December 3, 2010
Phase: Phase 1
Study type: Interventional

This is a Phase I, open-label, dose-escalation study to characterize the safety, tolerability, pharmacokinetic profile, pharmacodynamic profile, and clinical activity of the oral PI3K inhibitor GSK2126458 and the oral MEK inhibitor GSK1120212 dosed in combination in subjects with advanced solid tumors. The study will be conducted in 2 parts, a dose escalation phase and a tumor specific cohort expansion.

NCT ID: NCT01247922 Terminated - Ependymoma Clinical Trials

Single-agent Erlotinib in Patients Previously Treated With Oral Etoposide in Protocol OSI-774-205

Start date: May 23, 2011
Phase: Phase 2
Study type: Interventional

Participants that were assigned to the oral etoposide treatment arm in protocol OSI-774-205 and either progressed while on study or discontinued due to unacceptable toxicity related to etoposide were allowed to participate in this study to assess the safety profile of single-agent erlotinib in participants with recurrent or refractory pediatric ependymoma.

NCT ID: NCT01244269 Terminated - Parkinson's Disease Clinical Trials

The Effect of Methylphenidate on Non-motor Symptoms and Postural Control in Parkinson's Disease.

Start date: December 2010
Phase: Phase 4
Study type: Interventional

This project aims to determine if methylphenidate can improve deficits in attention and symptoms of orthostatic hypotension, two common non-motor symptoms, in patients with Parkinson's Disease. This project also seeks to evaluate the effect of methylphenidate on postural control in these patients, a debilitating motor symptom that places patients at an increased risk of falling. This study will build on existing data to support a new indication for the use of methylphenidate in Parkinson's Disease. Using standard and objective evaluations, this study will quantify the effect of methylphenidate at two doses on attention levels, orthostatic hypotension, and measures of postural control. Phase I of the study will compare methylphenidate 10mg three times daily to placebo and Phase II of the study, for those tolerating the lower dose in Phase I, will compare methylphenidate 20mg three times daily to placebo. By incorporating two different doses, the study also seeks to determine if any improvements are dose-related. Secondary endpoints will include safety assessments (adverse event monitoring and vital signs) performed every 30 minutes following supervised drug administration. Visual analog scales will be presented to each participant before treatment and following the final dose of each treatment to assess changes in fatigue. A secondary task will be added to postural tests to assess the influence of cognitive processes. It is hypothesized that methylphenidate will demonstrate a significant beneficial effect on all outcomes. It is projected that objective improvements will be observed following treatment with methylphenidate at both doses (10 and 20mg three time daily) when compared to placebo. It is further hypothesized that the effects will be dose-related and therefore more profound with higher doses.

NCT ID: NCT01244191 Terminated - Clinical trials for Non Squamous, Non-small-cell Lung Cancer

Tivantinib Plus Erlotinib Versus Placebo Plus Erlotinib for the Treatment of Non-squamous, Non-small-cell Lung Cancer

Start date: January 11, 2011
Phase: Phase 3
Study type: Interventional

This study is to determine if the combination regimen of tivantinib with erlotinib will improve overall survival relative to erlotinib alone in subjects with locally advanced or metastatic non-squamous, non-small cell lung cancer who have received 1 or 2 prior systemic anti-cancer therapies.

NCT ID: NCT01242748 Terminated - Prostate Cancer Clinical Trials

A Degarelix Trial in Patients With Prostate Cancer

Start date: October 2010
Phase: Phase 3
Study type: Interventional

A phase III extension trial comparing the efficacy and safety of degarelix 3 month depot with the established therapy Zoladex 3 month implant in patients with prostate cancer.

NCT ID: NCT01242514 Terminated - Clinical trials for Rheumatoid Arthritis

Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA)

OSKIRA-X
Start date: January 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long term safety and tolerability of fostamatinib in patients with rheumatoid arthritis (RA).

NCT ID: NCT01239758 Terminated - Clinical trials for Duchenne Muscular Dystrophy

Extension Study of ACE-031 in Subjects With Duchenne Muscular Dystrophy

Start date: October 2010
Phase: Phase 2
Study type: Interventional

To evaluate the long-term safety and tolerability of ACE-031 administration in subjects with Duchenne muscular dystrophy (DMD) who participated in Study A031-03. [Note: This study was terminated based on preliminary safety data. Pending further analysis of safety data and discussion with health authorities, a new ACE-031 trial will be planned.]