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Multicenter, randomised, double-blind Phase III trial to investigate the efficacy and safety of BIBF 1120 in combination with carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel in patients with advanced ovarian cancer

zie study protocol

The efficacy of the Inference Based Approach, a new cognitive therapy for patients with the Obsessive Compulsive Disorder with poor insight.

The objective of this study is to improve the prognosis of patients with the Obsessive Compulsive Disorder (OCD), with poor insight. A psychological treatment, the Inference Based Approach (IBA), which is developped and has been proven effective in…

Long-term single-arm open-label phase 3 study, to assess the safety and tolerability of selexipag (ACT-293987) in patients with pulmonary arterial hypertension

To assess the long-term safety and tolerability of selexipag (ACT-293987) in patients with pulmonary arterial hypertension (PAH).

A PHASE 3, MULTI-SITE, OPEN-LABEL STUDY OF THE LONG TERM SAFETY AND TOLERABILITY OF 2 ORAL DOSES OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS

Primary Objective- To evaluate the long term safety and tolerability of treatment with CP-690,550 (10 mg BID or variable dose 5 and 10 mg BID) in adult subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy…

A European randomised Phase 3 study to assess the efficacy and safety of TOOKAD® Soluble for localised prostate cancer compared to Active Surveillance

Primary Objective:To assess the impact of TOOKAD® Soluble VTP on the rate of absence of definite cancer using patients onactive surveillance as a comparison (co-primary objective A).To determine the difference in risk of treatment failure associated…

Basilar Artery International Cooperation Study Trial

Primary objective* To evaluate the efficacy of IAT in addition to BMM compaed to BMM alone in terms of favourable outcome at 90 days, defined as a modified Rankin score of 0-3, in patients with an acute ischemic stroke caused by basilar artery…

A Dose-Blind, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of Two Doses of BG00012 Monotherapy in Subjects with Relapsing-Remitting Multiple Sclerosis

Primary: To evaluate the long-term safety profile of BG00012.Additional: To evaluate the long-term efficacy of BG00012 using clinical endpoints (including relapse and annualized relapse rate [ARR]) and disability progression (Expanded Disability…

*An open randomized phase III study to compare 8 continuous cycles of chemotherapy with 8 cycles of intermittent (2 times 4 cycles) chemotherapy in first line treatment, in combination with bevacizumab, and second line treatment of patients with HER2/neu negative, incurable, metastatic or unresectable locally advanced breast cancer*

Primary:The primary objective of this study is to demonstrate that the overall progression-free survival (PFS) of 8 cycles of intermittent (2 times 4 cycles) chemotherapy (paclitaxel) is not inferior in efficacy, compared to 8 continuous cycles of…

An Open Label, Multicenter, randomized, phase III study to investigate the efficacy and safety of Bendamustine compared with Bendamustine + RO5072759 (GA101) in patients with Rituximab-refractory, indolent Non-Hodgkin's Lymphoma

The primary objective for this study is as follows:* To evaluate clinical benefit in terms of PFS, as assessed by an IRF, for GA101 when used incombination with bendamustine compared with bendamustine alone in patients with indolentNHL refractory to…

HD 16 for early stages, treatment optimization trial in the first-line treatment of early stage Hodkgin lymphoma; treatment stratification by means of FDG-PET.

The aim of the trial is to individualize treatment for each patient by adapting it to early response and to treat only those patients with addiotional radiotherapy who show an inadequate treatment response. The degree of treatment response is…

A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis (CFTY720D2399- LONGTERMS)

Primary: Safety and tolerability of fingolimod 0,5 mg.Secundairy: Long-term efficacy.Exploratory: Patient-Reported Outcomes Indices for Multiple Sclerosis (PRIMuS) and Short Form Health Survey*12 (SF-12), Treatment Satisfaction Questionnaire for…

Occipital nerve stimulation in medically intractable, chronic cluster headache

Primary: To demonstrate that high (100%) stimulation of ONS therapy reduces the mean attack frequency (MAF) in MICCH by at least 35% compared to low (30%) stimulation of ONS.Secondary: To evaluate • the rate of responders (>= 50% reduction in…

A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis

Primary:To investigate the efficacy of ocrelizumab compared with placebo in patients with primary progressive multiple sclerosis, as measured by thetime to onset of confirmed disability progression over the treatment period, defined as an increase…

A randomized phase III study to compare Bortezomib, Melphalan, Prednisone (VMP) with High Dose Melphalan followed by Bortezomib, Lenalidomide, Dexamethasone (VRD) consolidation and Lenalidomide maintenance in patients with newly diagnosed multiple myeloma

*To assess the efficacy of VMP versus high-dose therapy (HDT) and stem cell transplantation in patients with previously untreated multiple myeloma, as measured by the progression free survival.**To evaluate the effect of consolidation with VRD…