13 results
Objective: Primary Aim (PHASE 1):To determine the prevalence of RLS in women with ALD.Secondary Aim (PHASE 2):To determine whether in a blinded crossover study a 8-week pramipexole treatment course will significantly reduce RLS symptoms compared to…
Primary: To determine the effect of withdrawing to placebo versus continuing treatment with levoketoconazole on the cortisol therapeutic response previously established during open-label levoketoconazole therapy.Secondary:1. To compare the effects…
The objective of this study is to assess long-term safety and efficacy durability of levoketoconazole as chronic treatment for endogenous Cushing*s Syndrome (CS).
This study is designed as an extension to other veliparib clinical studies. The primary objective of thisstudy is to evaluate the safety and tolerability of veliparib monotherapy, veliparib in combination withcarboplatin/paclitaxel, or veliparib in…
The objective of this study is to evaluate the effect of veliparib on QTcF.
The primary objective of the study is to assess the progression-free survival (PFS) of oralveliparib in combination with temozolomide (TMZ) or in combination with carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel.The…
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…
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…
To determine the relative bioavailability of pramipexole 4.5 mg tablets vs. 4.5 mg Sifrol in healthy subjects after up-titration.
The objective of this project is to study the role of dopaminergic mechanisms in apathy, mood and HDD in patients with PD. What is the involvement of the dopaminergic neurotransmitter system in motivation and reward processes in PD and the clinical…
The primary objective of the study is to assess the incidence of pathological complete response (pCR) in breast and ipsilateral axillary tissue after daily treatment with veliparib in combination with neoadjuvant carboplatin and paclitaxel followed…
The primary objective of the study is to assess if treatment with veliparib plus carboplatin and paclitaxel results in improved survival compared to Investigator's choice of standard chemotherapy in Lung Subtype Panel (LSP) positive subjects…