This Phase 1 study is part of the global development plan, which includes plans to seek marketing approval of IPN60170 in Japan and China. The Japan Pharmaceuticals and Medical Devices Agency (PMDA) and the National Medical Products Administration (NMPA) in China request that the full pharmacokinetic (PK) profile of a new drug entity be assessed
The test treatment, IPN60170 (Mesdopetam), is in development for the treatment of levodopa -induced dyskinesia in Parkinson’s Disease. Parkinson’s Disease is a progressive nervous system condition that affects movement, caused by nerve cells in a specific area of the brain called the substantia nigra deteriorating or dying. Dyskinesia is uncontrolled or involuntary muscle movements that
The aim of this study was to learn how the highest and the total amount of fidrisertib in the blood change when taken with phenytoin or itraconazole, compared with when taken alone.
The main aim of this study is to understand how moderate and severe liver impairment (based on the Child-Pugh classification) affects the body’s processing of a single dose of 10 mg maximum of palovarotene, compared to healthy participants with normal liver function. The study will also assess the safety and tolerability of the single dose
The main objective of this study is to further evaluate the safety and efficacy of palovarotene in adult and paediatric participants with FOP. The aim of the study is also to ensure treatment continuity to participants who have completed one of the parent studies (Study PVO-1A-301, Study PVO-1A-202 and Study PVO-1A-204) and who, in the
This study is aiming to demonstrate the non-inferiority of AbobotulinumtoxinA (aboBoNT-A) versus OnabotulinumtoxinA (onaBoNT-A) as the primary safety endpoint, and the superiority of aboBoNT-A over onaBoNT-A with respect to duration of response as the key secondary efficacy endpoint when used at optimal doses according to approved prescribing information of each product.
The purpose of the protocol is to evaluate the efficacy and safety of Dysport® using 2 mL dilution compared with placebo for the treatment of Cervical Dystonia.
The purpose of the protocol is to assess the long term safety of repeat treatment cycles of Dysport® 500 U using 2 mL dilution scheme for the treatment of Cervical Dystonia. This is an extension study to study A-TL-52120-169 (hereafter referred to as Study 169).
The primary aim of this study is to assess which method of lanreotide Autogel administration patients with neuroendocrine tumours prefer – self/partner administrations or healthcare provided administrations. The study will also assess if self/partner administration can be performed without loss of efficacy and with a preserved safety profile. The impact of self/partner administration on resource
Circulating tumour cells (CTCs) are detectable in the blood in around 50% of patients with functioning NeuroEndocrine Tumours (NET) arising in the midgut area (tumours which are secreting hormones and are located in the area in the middle of the digestive system) and their presence usually means that the prognosis for the patient is poor.