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A novel neurophysiological measurement (MUNIX) in neuromuscular disorders; test-retest reliability and longitudinal follow up measurements in ALS patients

PrimaryTo investigate the inter-rater and intra-rater variability of a novel neurophysiological measurement (Motor Unit Number Index, MUNIX) for estimation of functioning motor units, in healthy controls and ALS patientsSecondaryTo evaluate the…

INTERVENTIONAL MANAGEMENT OF STROKE TRIAL CLINICAL PROTOCOL - IMS III
A phase III, randomized, multi-center, open label, 900 subject clinical trial that will examine whether a combined intravenous (IV) and intra-arterial (IA) approach to recanalization is superior to standard IV rt-PA (Activase®/Actilyse®) alone when initiated within three hours of acute ischemic stroke onset.

The primary objective of the trial is to determine if ischemic stroke subjects with a baseline NIH Stroke Scale Score (NIHSSS] >= 10 (8-9 with positive CTA) treated with recombinant tissue plasminogen activator (rt-PA; [Alteplase recombinant…

An outpatient phase 3 efficacy study of Ecopipam (PSYRX 101) in the symptomatic treatment of self-injurious behavior in subjects with Lesch-Nyhan disease.

The primary objective of this study is to assess the efficacy of Ecopipam to reduce self-injurious behaviors (SIB) in adults and children with Lesch-Nyhan Disease (LND) in an outpatient setting. The secondary objectives of this study are to assess…

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 Double-blind, Placebo-Controlled, Randomized, 4-Week, Multiple-Dose, Proof-of-Mechanism Study in Subjects with Early Alzheimer*s Disease Investigating the Effects of JNJ-54861911 on Aß Processing in CSF and Plasma

This proof-of-mechanism (POM) study in subjects with early AD, being subjects asymptomatic at risk for AD and subjects with pAD, is performed to confirm a drug interaction with the intended enzyme (BACE) at the intended target location (brain) by…

Transcranial Direct Current Stmulation in Children with Unilateral Motor Deficits: A New Approach for Pediatric Rehabilitation.

The main objective of this study is to investigate the effect of a single tDCS session in children with mild CP on different motor tasks. The second objective is to identify the optimal site of stimulation. In tDCS research the electrodes can be…

Study of Safety, Tolerability, and Pharmacokinetics of BG00010 (Neublastin) Intravenous and Subcutaneous Single Ascending Doses in Healthy Volunteers, and Subcutaneous Multiple Ascending Doses in Subjects with Painful Lumbar Radiculopathy

The primary objective of the study is to evaluate the safety and tolerability of a range of single IV and SC doses of BG00010 in healthy volunteers, and a range of multiple SC doses of BG00010 in subjects with painful lumbar radiculopathy.Secondary…

Exploratory open label study to investigate the effect of teriflunomide on immune cell subsets in the blood of patients with relapsing forms of multiple sclerosis

Primary:- To measure the effect of Teriflunomide on lymphocytes subsets in patients with relapsing forms of multiple sclerosis as compared with baseline values and those of a reference population of untreated healthy subjects.Secondary:- To assess…

A phase 1, double blind (3rd party open), randomized, placebo controlled, crossover single dose escalation study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-06372865 in healthy subjects

The objective of the first two cohorts of this study is to explore the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06372865 after a single dose across a wide exposure range up to the maximum tolerated dose or the maximum…

Efficacy, safety and tolerability of multiple doses of oral cebranopadol in subjects with moderate to severe chronic pain due to diabetic peripheral neuropathy

To assess the analgesic efficacy, safety, and tolerability of once daily orally administered cebranopadol in a total of 3 fixed doses (100 µg, 300 µg, and 600 µg cebranopadol) compared to placebo in subjects with moderate to severe chronic pain due…

Body awareness training in the trEatment of Wearing-off related Anxiety in patients with paRkinson*s diseasE.

The current proposal aims at investigating the effect of a multidisciplinary non-verbal intervention on the awareness and modulation of WRA to improve self-efficacy, mobility, mood, and quality of life as compared to usual care.

A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallelgroup, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2- amino-3-phenylpropylcarbamate hydrochloride] in the Treatment of Excessive Sleepiness in Subjects with Narcolepsy

To evaluate the efficacy of JZP-110 administered once daily for up to 12 weeks in doses of 75, 150, and 300 mg compared to placebo in the treatment of excessive sleepiness in adult subjects with narcolepsy.

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…

Interbody fusion in the treatment of cervicobrachial syndrome; a prospective trial of porous titanium cervical cages.

Documentation of the patients' functional recovery and quantification of fusion after implantation of 3-D trabecular titanium cages on the short and long term. These data will be compared with the recently performed randomized CASCADE trial on…

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…

A comparative phase2 study assessing the efficacy of triheptanoin, an anaplerotic therapy in Huntington's Disease (HD)

The primary objective of TRIHEP 3 is to evaluate the efficacy of triheptanoin in (i) increasing the short term energy response in the metabolic profile of the brain of early affected HD patients, as captured by 31P-MRS, and (ii) slowing atrophy in…

Trigeminovascular effects of propranolol in migraine treatment

To determine the mechanism of action of propranolol in the prophylactic treatment of migraine.