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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…

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…

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…

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 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…

Dietary treatment of children with Angelman Syndrome and refractory epilepsy

Primary objective: - 50% seizure reduction or more at 3 months of dietary treatment .Secondary objectives: -level of ketosis on KD and MAD.-number of patients maintaining >50% seizure reduction on MAD.-number of withdrawals (not able to…

A multi-centre, double-blind, parallel-group, randomised controlled study to investigate efficacy, safety and tolerability of orally administered BI 409306 during a 12-week treatment period compared to placebo in patients with cognitive impairment due to Alzheimer's Disease.

The primary objective of this study is to assess efficacy and safety of BI 409306 at doses of 10 mg, 25 mg and 50 mg once daily, 25 mg twice daily compared to placebo over a 12-week treatment period in patients with the following criteria: mild…

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SAGE-547 INJECTION IN THE TREATMENT OF SUBJECTS WITH SUPER-REFRACTORY STATUS EPILEPTICUS

Primary objective:To determine the response to a 144-hour (6 day) continuous intravenous infusion of SAGE-547 compared to placebo administered to support the weaning of all third-line agents in subjects with SRSE, and for the response to endure at…

Cervical radicular pain: A randomised controlled trial comparing percutaneous plasma discectomy and anterior cervical discectomy.

The aim of this study is to compare the effects of anterior cervical discectomy versus percutaneous plasma discectomy on pain, on global perceived effect, functional status and health-related quality of life in a group of patients with cervical…

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 Obstructive Sleep Apnea (OSA)

To evaluate the efficacy of JZP-110 administered once daily for up to 12 weeks in doses of 37.5, 75, 150, and 300 mg compared to placebo in the treatment of excessive sleepiness in adult subjects with OSA.

Neuralgic amyotrophy: Central reorganization and rehabilitation after peripheral dysfunction

Primary Objectives: * To determine if NA patients have altered cerebral activity related to motor planning of their affected arm compared to healthy controls and compared to their non-affected arm.* To determine if specific rehabilitation focused on…

A Phase 1 Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of ALKS 7119 in Healthy Male Adults

To evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ALKS 7119 following oral administration of single ascending doses of ALKS 7119 in healthy male adults

BLUE LIGHT THERAPY FOR SLEEP IMPAIRMENT IN PARKINSON*S DISEASE - Pilot Study -

1. Primary Objective:The primary objective is to evaluate the efficacy of Propeaq light therapy glasses with integrated blue LED lights on sleep disorders in patients with PD using the PSQI. 2. Secondary Objectives: The secondary objective of the…

The Park-in-Shape study: a randomized controlled trial evaluating the effects of exercise on motor and non-motor symptoms in Parkinson*s disease.

Objectives: To evaluate whether aerobic exercise leads to clinically relevant improvements in 1) motor and 2) non-motor symptoms as well as quality of life and physical fitness.

Efficacy and safety of MRI-based thrombolysis in wake-up
stroke: a randomised, double-blind, placebo-controlled trial

The ,aim of Wake-Up is to provide a new safe and effective treatment option for acute stroke patients waking up with stroke symptoms or patients with unknown symptom onset. Every year about 2milion patients suffer a stroke in the EU and up to 20% of…

A Randomized, Placebo-Controlled, Double-Blind, Parallel Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of LTI-291 in Patients with Parkinson*s Disease and a GBA1 Mutation

The main objectives of this study are:To evaluate the safety and tolerability of three oral dose levels of LTI-291 following 28 days of LTI-291 treatment in patients with GBA-PDTo characterize the plasma and CSF pharmacokinetics (PK) of LTI-291…

TimeToStop (TTS) Trial, A randomized controlled trial of cognitive consequences of early versus late antiepileptic drug withdrawal after pediatric epilepsy surgery

Primary Objective: To assess whether early postoperative AED withdrawal improves cognitive function compared to late withdrawal.Secondary objectives: * To confirm safety of earlier AED withdrawal; we will assess eventual seizure freedom, seizure…

A double-blind, randomized, placebo-controlled study of the efficacy, safety/tolerability, and pharmacokinetic profile of UCB0942 in adult patients with highly drug-resistant focal epilepsy

To assess the efficacy as well as the safety and tolerability of an investigational drug called UCB0942 that will be given in addition to the current epilepsy treatment of the patient.