60 results
Primary:To establish the safety and tolerability of rivastigmine when given with concomitant glycopyrrolate at an accelerated dose escalation schedule up to 12 mg BID.To establish the safety and tolerability of rivastigmine when given with…
Primary* To determine the safety and tolerability of multiple oral ascending doses of FP 025 in healthy subjects.Secondary* To determine the pharmacokinetics (PK) of FP 025 after multiple oral ascending doses of FP 025 in healthy subjects.* To…
The primary objective of the study is to assess whether the addition of oral veliparib to carboplatin and paclitaxel will improve overall survival (OS) in current smokers when compared to the addition of placebo to carboplatin and paclitaxel, in…
The objectives of the Phase 1 dose escalation are:Primary Objectives:* To establish the Maximum Tolerated Dose (MTD) and to establish the Recommended Phase 2 Dose (RPTD) for veliparib in combination withcarboplatin and etoposide.* To evaluate the…
Primary ObjectiveTo assess the effect of ABT-981 on OA knee pain using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Week 16 and synovitis/effusion volume of the index knee using quantitative measures and semi-…
The purpose of this study is to assess the safety and effectiveness of the Freedom SCS (spinal cord stimulation) System for the treatment of chronic back and leg pain secondary to failed back surgery syndrome (FBSS) over a follow-up period of one…
The primary endpoint is to assess the progression-free survival (PFS) of veliparib in combination with carboplatin (C) and paclitaxel (P) compared to placebo with C/P in subjects with a BRCA1 and/or BRCA2 Mutation and HER2-Negative Metastatic or…
The objectives of the study are as follows:*1. To assess the effectiveness of inhaled PA101 delivered via eFlow high efficiency nebulizer for treating chronic cough. Improvements in chronic cough will be assessed by measuring the change from…
Primary objectiveTo assess safety and tolerability of Neu-P12 in four different single doses of the drug. Secondary objectiveTo compare the pharmacokinetics, pharmacodynamics, safety, and tolerability of different single doses of Neu-P12.
PrimaryThe primary objective is to evaluate the effect of ABT-981 on pain using the Australian/Canadian Osteoarthritis Hand Index (AUSCAN NR3.1) pain subdomain score, in subjects with erosive hand OA at Week 16.Secundary* Evaluate the safety and…
The primary objective of the study is to evaluate the percentage of subjects who do not experience a flare on CZP 200mg Q2W (full-dose) or 200mg Q4W (half-dose) during Part B. The secondary objectives are: 1) to evaluate the percentage of subjects…
The primary objective is to demonstrate the efficacy of AR101, a pharmaceutical-grade peanut allergen formulation, through reduction in clinical reactivity to limited amounts of peanut allergen in peanut-allergic children (ages 4-17 years, inclusive…
Patients with hyperlipidemie and an elevated Lp(a) will be asked to partipate in this study. This part potentially increases the risk of cardiovascular diseases. One of the reasons why Lp(a) is expected to increases this risk is that Lp(a)…
To demonstrate that SCS is capable of treating otherwise refractory neuropathic pain after chemotherapy / radiotherapy.
To validate the results from two RCTs that SCS is indeed capable of treating otherwise refractory diabetic neuropathic pain, and to evaluate the effects of burst stimulation settings in this patient group.
Secondary objectives:The secondary objectives include demonstration of clinical efficacy of SCIT with BM41 alone, with BM41 plus VD3 and with VD3 alone, all three compared to placebo. Efficacy will be analysed for the upper airways by titrated nasal…
1. Primary Objectives• To evaluate the safety and tolerability of VX 440 monotherapy and VX 440 in dual and triple combination with VX-661 and IVA• To evaluate the efficacy of VX 440 monotherapy and VX 440 in dual and triple combination with VX 661…
Primary Objective:To evaluate the efficacy of VX-150 for the treatment of pain caused by small fiber neuropathy.Secondary Objectives:* To evaluate the safety and tolerability of VX-150* To evaluate the pharmacokinetics (PK) of VRT-1207355 and the…
Primary Objective: The main objective of this study is to identify a new treatment to alleviate pain and diminish inflammation in patients with hand osteoarthritis with symptoms and signs of inflammation.Secondary Objectives: The secondary…
The aim of this clinical phase IIa randomized, double-blind, placebo-controlled study is to investigate tolerability/ safety and clinical and immunological effects of the addition of a subcuteaneous injection of a VD3 analogue in the vicinity of the…