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Clinical and pharmacological feasibility study with 2B3-101 in patients with breast cancer
and leptomeningeal metastases

Primary: To determine the response of 2B3-101 treatment as single agent or in combination with trastuzumab in patients with LM from breast cancer using the LM response scoreSecundary: - To determine the safety profile in patients with LM treated…

A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis

To make laquinimod 0.6 mg available for all subjects who completed the placebo-controlled MS-LAQ-301 study according to the protocol and to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in…

A Phase I/II, open-label, dose escalating with 48-week treatment study to assess the safety and tolerability, pharmacokinetics, pharmacodynamics and efficacy of BMN 053 (previously knoen as PRO053) in subjects with Duchenne muscular dystrophy

Primary objective: To assess the efficacy of BMN 053 at recommended dosing regimen after 48 weeks treatment in ambulant subjects with Duchenne muscular dystrophy.Secondary objectives: - To assess the safety and tolerability of BMN 053 after single…

A phase IIb, open-label study to assess the efficacy, safety, pharmacodynamics and pharmacokinetics of multiple subcutaneous doses of BMN 045 (previously known as PRO045) in subjects with Duchenne muscular dystrophy

Primary objective:To assess the efficacy of BMN 045 after 48 weeks treatment in ambulant subjects with Duchenne muscular dystrophy.Secondary objectives:To assess the safety and tolerability of BMN 045 after 48 weeks of treatment in all study…

The effects of internal and external attentional focus instructions on motor learning after stroke

The primary objective of this study is to assess whether motor learning using external attentional focus instructions results in superior single-task motor performance, movement automaticity, and dual-task performance in inpatient stroke patients…

A PHASE 1, OPEN-LABEL, PHARMACOKINETIC TRIAL TO INVESTIGATE POSSIBLE DRUG-DRUG INTERACTIONS BETWEEN CLOBAZAM, STIRIPENTOL OR VALPROATE AND CANNABIDIOL (GWP42003-P) IN HEALTHY SUBJECTS

During this study it will be investigated what the effect is of multiple doses of CBD on the absorption and elimination from the body (this is called pharmacokinetics) of clobazam, stiripentol or valproate. It will also be investigated what the…

Dorsal root ganglion stimulation and motor responses in patients, who have been implanted with a dorsal root ganglion stimulation device: a pilot study

The aim of this pilot study is to investigate if DRG stimulation can evoke motor reactions in the lower extremities in patients who have already been implanted with a DRG stimulator to treat neuropathic pain.

STOP NEUROMA
Surgical Treatment Of symPtomatic NEUROMA:
Open non-randomized clinical investigation to evaluate the safety and effectiveness of the nerve capping device to prevent neuroma formation after traumatic nerve section

Primary clinical investigation objectives[Safety]The primary safety objective of the clinical investigation is to provide data that demonstrates safety of the device, defined as < 8.3% serious adverse device effects, up to 6 weeks following…

2-STEP: A single-centre, phase II study to evaluate the safety, tolerability and pharmacokinetics of 2-Iminobiotin (2-IB) in neonates with gestational age of *36 weeks with moderate to severe perinatal asphyxia treated with therapeutic hypothermia

To explore the safety, tolerability and the pharmacokinetic profile of 2-IB when given on top of therapeutic hypothermia.

Robotic support in gait training for neurological patients

Primary objective: Determine for different control algorithms whether the algorithm is effective in providing the patient with the required support and bringing about the desired changes in the walking patternSecondary Objective(s): - Determine…

A comparative, open-label, randomized, 2-stage sequential design, 2 periods, crossover study to demonstrate the bioequivalence of 2 FT218 batches (single dose of 4.5 gram) in healthy volunteers

The purpose of the study is to investigate how quickly and to what extent 2 different production batches of FT218 (batch A and batch B) are absorbed and eliminated from the body (this is called pharmacokinetics). In this study it is investigated…

A Multi-Center, Open-Label Study Evaluating the Safety, Tolerability, and
Efficacy of Pridopidine in Patients with Huntington's Disease

Primary Objective: The primary objective of this study is to evaluate safety and tolerability of pridopidine in patients with HD.Secondary Objectives: The secondary objectives of the study are to assess the effects of long-term, open-label dosing…

The effects of providing asymmetrical guidance during Lokomat guided gait on muscle activity in persons with post-stroke hemiparesis

Primary Objective: To establish the effect of asymmetrical guidance provided by the Lokomat exoskeleton on levels of muscle activity in persons with post stroke hemiparesis. Secondary Objective(s): (i) To establish if the abovementioned effects (see…

The effect of forward arm extension on gait initiation in patients with Parkinson*s disease

To assess whether forward extension of both arms improves gait initiation in patients with PD, measured by faster coverage of the initial two meters of walking. Secondary objectives are to determine whether this change in performance can be measured…

Multicenter, open-label extension study to investigate the long-term safety and efficacy of IgPro20 in maintenance treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) in subjects completing study IgPro20_3003.

Primary objective: To evaluate the long-term safety of IgPro20.Secondary objectives: * To evaluate the long-term safety of IgPro20 by dose. * To evaluate the efficacy of IgPro20.Exploratory objectives:* To evaluate health-related quality of life (…

Long-Term Outcome of Split Laminectomy for Cervical Spondylotic Myelopathy

To determine long-term radiological and clinical outcome of a muscle-sparing surgical technique for posterior decompression of the cervical spinal cord (cervical split laminectomy).

The Effects of Transcutaneous Vagus Nerve Stimulation on the Pupil Diameter, Heart Rate and Heart Rate Variability in Epilepsy Patients and Healthy Subjects.

Primary objective: The main objective of this pilot study is to gain more insight into the effects of tVNS: to assess if the ABVN and consecutively the NTS are really stimulated by tVNS. Therefore this study investigates the effects of tVNS on the…

Excretion balance, pharmacokinetics and metabolism of S44819 after single administration of [14C]-S44819 in young healthy male volunteers. A phase 1 monocentre open-label study.

The purpose of the study is to investigate the pharmacokinetics of S 44819. S 44819 is labeled with 14-Carbon (14C) and is thus radioactive (also called radiolabeled). In this way, S 44819 and its metabolites can be traced in blood, urine and feces…

Thyroid hormone analog therapy of patients with severe psychomotor retardation caused by mutations in the MCT8 thyroid hormone transporter: The Triac Trial.

1. Normalization of the abnormal serum TH parameters and thereby improving the clinical condition of the AHDS patients2. Observation of changes in cognitive and motor function.

A single-center, open-label, single oral dose study to investigate the absorption, distribution, metabolism, and excretion (ADME) and pharmacokinetics of EMA401 after a single dose of [14C]EMA401 in healthy male subjects

The purpose of the study is to investigate how quickly and to what extent EMA401 is absorbed, distributed, metabolized (broken down) and eliminated from the body (this is called pharmacokinetics). EMA401 will be labeled with 14-Carbon (14C) and is…