Clinical Trials in the Spotlight

Clinical Trials in the Spotlight

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Benzodiazepine Refractory Status Epilepticus

The primary objective is to determine the most effective and/or the least effective treatment of benzodiazepine-refractory status epilepticus (SE) among patients older than 2 years. There are three active treatment arms being compared: fosphenytoin (FOS),levetiracetam (LEV), and valproic acid (VPA). The second objective is comparison of three drugs with respect to secondary outcomes. The final objective is to ensure that the trial is informative for treatment of established SE in children by describing the effectiveness, safety, and rate of adverse reactions of these drugs in children.

Brain and Spinal Tumors

The Evaluation and Treatment of Neurosurgical Disorders research study (03-N-0164) will evaluate people with a variety of neurosurgical disorders in order to provide standard expert care and physician training. In the study, doctors will assess and treat people who have disorders of the brain, spinal cord, peripheral nerves, or pituitary gland that may or may not require surgery. This study will not test new treatments. Participants will receive standard care.

The Tumor Related Epilepsy research study (16-N-0041) will evaluate and offer surgery to people with tumor-related epilepsy, and explore how surgery affects seizures. Some people who have brain tumors have seizures related to the tumor, which is a condition called tumor-related epilepsy. The standard treatment for people with brain tumors is surgery to remove as much of the tumor as possible without causing additional neurological problems. Researchers think this method of treatment may improve the outcome for people with brain tumors because it may completely relieve or greatly reduce the number of seizures they experience.

Brain Neoplasm

The Tumor Related Epilepsy research study (16-N-0041) will evaluate and offer surgery to people with tumor-related epilepsy, and explore how surgery affects seizures. Some people who have brain tumors have seizures related to the tumor, which is a condition called tumor-related epilepsy. The standard treatment for people with brain tumors is surgery to remove as much of the tumor as possible without causing additional neurological problems. Researchers think this method of treatment may improve the outcome for people with brain tumors because it may completely relieve or greatly reduce the number of seizures they experience.

Cancer

The Tumor Related Epilepsy research study (16-N-0041) will evaluate and offer surgery to people with tumor-related epilepsy, and explore how surgery affects seizures. Some people who have brain tumors have seizures related to the tumor, which is a condition called tumor-related epilepsy. The standard treatment for people with brain tumors is surgery to remove as much of the tumor as possible without causing additional neurological problems. Researchers think this method of treatment may improve the outcome for people with brain tumors because it may completely relieve or greatly reduce the number of seizures they experience.

Carotid Stenosis

Carotid revascularization for primary prevention of stroke (CREST-2) consists of 2 parallel, randomized clinical trials.  One trial will compare intensive medical management to carotid endarterectomy plus intensive medical management.  The parallel trial will compare intensive medical management to carotid artery stenting plus intensive medical management. Intensive medical management will involve a lifestyle intervention to monitor and manage risk factors such as blood pressure, cholesterol, smoking cessation, weight loss, and physical activity.

Cryptococcal Meningitis

This is a phase III trial to determine whether adjunctive sertraline will lead to improved survival 18-week survival. There was an initial phase I/II unmasked dose finding pharmacokinetic study of CSF concentrations in 172 persons conducted from August 2013 to August 2014..

Dystonia

The Deep Brain Stimulation Surgery for Movement Disorders study (11-N-0211) uses deep brain stimulation (DBS) to treat Parkinson’s disease, dystonia, and essential tremor. DBS is an approved surgical procedure for these neurological conditions which do not respond well to other treatments. The objective of this research is to study normal human biology and disease pathogenesis (natural history) and to collect physiology and efficacy data related to DBS therapy and motor and cognitive function in the study population.

Epilepsy

The Tumor Related Epilepsy research study (16-N-0041) will evaluate and offer surgery to people with tumor-related epilepsy, and explore how surgery affects seizures. Some people who have brain tumors have seizures related to the tumor, which is a condition called tumor-related epilepsy. The standard treatment for people with brain tumors is surgery to remove as much of the tumor as possible without causing additional neurological problems. Researchers think this method of treatment may improve the outcome for people with brain tumors because it may completely relieve or greatly reduce the number of seizures they experience.

Medically-intractable or uncontrolled epilepsy is a type of epilepsy that cannot be controlled with medication. Some people whose seizures do not respond to medication may respond to surgery. The purpose of the Surgery as a Treatment for Medically Intractable Epilepsy study (11-N-0051) is to learn more about medically-intractable or uncontrolled epilepsy and its treatment. Standard epilepsy treatment, including the possibility of surgery if needed, will be provided to participants.

The primary objective is to determine the most effective and/or the least effective treatment of benzodiazepine-refractory status epilepticus (SE) among patients older than 2 years. There are three active treatment arms being compared: fosphenytoin (FOS),levetiracetam (LEV), and valproic acid (VPA). The second objective is comparison of three drugs with respect to secondary outcomes. The final objective is to ensure that the trial is informative for treatment of established SE in children by describing the effectiveness, safety, and rate of adverse reactions of these drugs in children.

Fungal Meningitis

This is a phase III trial to determine whether adjunctive sertraline will lead to improved survival 18-week survival. There was an initial phase I/II unmasked dose finding pharmacokinetic study of CSF concentrations in 172 persons conducted from August 2013 to August 2014..

High Blood Pressure

ENCHANTED is an independent, investigator initiated, international collaborative, quasi-factorial randomised controlled trial involving a package of 2 linked comparative randomised treatment arms, which aims to address 4 key questions in patients eligible for thrombolysis in the acute phase of ischaemic stroke. (1) Does low-dose (0.6 mg/kg) intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) provide equivalent benefits compared to standard-dose (0.9 mg/kg) rtPA? (2) Does intensive blood pressure (BP) lowering (130-140 mmHg systolic target) improve outcomes compared to the current guideline recommended level of BP control (180 mmHg systolic target)? (3) Does low-dose (0.6 mg/kg) intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) reduce the risk of symptomatic intracerebral haemorrhage (sICH)? (4) Does the addition of intensive BP lowering to thrombolysis with rtPA reduce the risk of any intracerebral haemorrhage (ICH)? The rtPA dose arm of the study addressing questions (1) and (3) concluded with a publication of the results in May 2016. The BP intensity arm of the study is ongoing.

Intracranial Hemorrhages

Fibrinogen replacement could prevent haemorrhagic complications in ischemic stroke patients with secondary post-rtPA hypofibrinogenemia

Ischemic Stroke

The purpose of the ARCADIA trial is to compare two different blood-thinning drugs—apixaban and aspirin—to determine which is better for preventing recurrent stroke in people who have cryptogenic stroke (stroke of unknown cause) and atrial cardiopathy (abnormal changes in the atrial tissue and function of the heart).

ENCHANTED is an independent, investigator initiated, international collaborative, quasi-factorial randomised controlled trial involving a package of 2 linked comparative randomised treatment arms, which aims to address 4 key questions in patients eligible for thrombolysis in the acute phase of ischaemic stroke. (1) Does low-dose (0.6 mg/kg) intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) provide equivalent benefits compared to standard-dose (0.9 mg/kg) rtPA? (2) Does intensive blood pressure (BP) lowering (130-140 mmHg systolic target) improve outcomes compared to the current guideline recommended level of BP control (180 mmHg systolic target)? (3) Does low-dose (0.6 mg/kg) intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) reduce the risk of symptomatic intracerebral haemorrhage (sICH)? (4) Does the addition of intensive BP lowering to thrombolysis with rtPA reduce the risk of any intracerebral haemorrhage (ICH)? The rtPA dose arm of the study addressing questions (1) and (3) concluded with a publication of the results in May 2016. The BP intensity arm of the study is ongoing.
Study Population: Subjects with Mild Acute Ischemic Stroke in the anterior circulation within 24 hours from onset. Study objectives: 1. Identify the personal stimulation level for each patient based on physiological biomarkers 2. Identify improvement in stroke symptoms during ISS treatment at the personal stimulation level
Fibrinogen replacement could prevent haemorrhagic complications in ischemic stroke patients with secondary post-rtPA hypofibrinogenemia

Mild Acute Ischemic Stroke

Study Population: Subjects with Mild Acute Ischemic Stroke in the anterior circulation within 24 hours from onset. Study objectives: 1. Identify the personal stimulation level for each patient based on physiological biomarkers 2. Identify improvement in stroke symptoms during ISS treatment at the personal stimulation level

Myasthenia Gravis

The purpose of this trial is to determine if thymectomy combined with prednisone therapy is more beneficial in treating non-thymomatous myasthenia gravis than prednisone therapy alone.

Neurogenic Bladder

This is the first ever comparative effectiveness study of an antibiotic-sparing novel self-management intervention to prevent complicated urinary tract infection (UTI).

Parkinson's Disease

NINDS Announces Early Study Closure of SURE-PD3 Trial

The National Institute of Neurological Disorders and Stroke (NINDS) has accepted the Data and Safety Monitoring Board’s (DSMB) recommendation to stop SURE-PD3, the Study of URate Elevation in Parkinson’s disease (PD), after an interim analysis showed it would be unlikely to demonstrate benefit of long-term treatment with inosine in people with PD. The trial was testing whether a treatment that raises blood levels of the natural antioxidant urate for two years slows the rate of worsening in PD. The randomized, placebo-controlled, double-blinded trial, funded by the NINDS, was conducted nationwide at 57 clinical sites of the Parkinson Study Group (PSG). It was led by investigators at Massachusetts General Hospital (MGH) and the University of Rochester, with support from the Michael J. Fox Foundation.  

After two thirds of the patient data were collected, the study’s independent DSMB reviewed an unblinded analysis of the primary outcome, measurement of disease progression. Study statisticians determined that even if the trial were continued so that all participants were treated for the full two years, it would unlikely show benefit of inosine by the primary measurement.  Accordingly, the DSMB recommended that the study be ended early. The DSMB did not note any significant safety concerns though high levels of urate are known to cause gout. 

Site investigators and coordinators have informed SURE-PD3 participants of the study closure. Patients will be invited to continue as volunteers in the NINDS-funded AT-HOME-PD study which focuses on how telehealth assessments via video, smartphone tracking, and computer-based questionnaires can improve the way PD trials are performed.

The SURE-PD3 trial will be closed out over the next six months, and final results are expected by the end of 2019.  The NINDS is very appreciative of the efforts of patients, care givers and investigators in this important clinical trial.  

The Deep Brain Stimulation Surgery for Movement Disorders study (11-N-0211) uses deep brain stimulation (DBS) to treat Parkinson’s disease, dystonia, and essential tremor. DBS is an approved surgical procedure for these neurological conditions which do not respond well to other treatments. The objective of this research is to study normal human biology and disease pathogenesis (natural history) and to collect physiology and efficacy data related to DBS therapy and motor and cognitive function in the study population.

Spinal Cord Injuries

This is the first ever comparative effectiveness study of an antibiotic-sparing novel self-management intervention to prevent complicated urinary tract infection (UTI).

Stroke

The purpose of this study is to clarify efficacy and safety of MRI-based intravenous thrombolysis with alteplase for patients with acute wake-up ischemic stroke and those having acute ischemic stroke with unknown time of symptom onset.

The purpose of the ARCADIA trial is to compare two different blood-thinning drugs—apixaban and aspirin—to determine which is better for preventing recurrent stroke in people who have cryptogenic stroke (stroke of unknown cause) and atrial cardiopathy (abnormal changes in the atrial tissue and function of the heart).

Carotid revascularization for primary prevention of stroke (CREST-2) consists of 2 parallel, randomized clinical trials.  One trial will compare intensive medical management to carotid endarterectomy plus intensive medical management.  The parallel trial will compare intensive medical management to carotid artery stenting plus intensive medical management. Intensive medical management will involve a lifestyle intervention to monitor and manage risk factors such as blood pressure, cholesterol, smoking cessation, weight loss, and physical activity.

Tremor

The Deep Brain Stimulation Surgery for Movement Disorders study (11-N-0211) uses deep brain stimulation (DBS) to treat Parkinson’s disease, dystonia, and essential tremor. DBS is an approved surgical procedure for these neurological conditions which do not respond well to other treatments. The objective of this research is to study normal human biology and disease pathogenesis (natural history) and to collect physiology and efficacy data related to DBS therapy and motor and cognitive function in the study population.