Clinical and Research Trials

Hydrocephalus
Neurosurgery Trials
Active
Principal Investigator: Daniel Barrow
NCTID: NCT05081128

The Placebo-Controlled Efficacy in Idiopathic Normal Pressure Hydrocephalus (iNPH) Shunting (PENS) trial is a multi-center blinded, randomized, placebo-controlled design investigation of cerebrospinal fluid (CSF) shunt surgery to study the shunt efficacy in iNPH patients. Learn more. 

Cushing Disease
Neurology and Psychiatry Trials
Active
Principal Investigator: Adriana Ioachimescu
NCTID: NCT03621280

This is a long-term, open-label extension study of levoketoconazole in subjects with endogenous Cushing's Syndrome. Learn more. 

Cushing's Syndrome
Active
Principal Investigator: Adriana Ioachimescu
NCTID: NCT03606408

The purpose of this study is the evaluation of long-term safety of osilodrostat in patients who have already received osilodrostat treatment in a previous Global Novartis-sponsored trial and who, based on investigators' judgment, will continue benefiting with its administration. Learn more.

Metastatic Malignant Neoplasm in the Brain, Neurology and Psychiatry Trials
Active
Principal Investigator: Kimberly Hoang
NCTID: NCT04114981

This phase III trial studies how well single-fraction stereotactic radiosurgery works compared with fractionated stereotactic radiosurgery in treating patients with cancer that has spread to the brain from other parts of the body and has been removed by surgery. Single fraction stereotactic radiosurgery is a specialized. Learn more. 

Glioblastoma, Neurology and Psychiatry Trials
Active
Principal Investigator: Jeffrey James Olson
NCTID: NCT03970447

Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II/III response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM. Learn more.

Injury, Spinal Cord, Neurology and Psychiatry Trials
Active
Principal Investigator: Faiz Ahmad
NCTID: NCT03762655

This is a randomized, controlled, single-blind, multicenter, two Arm (Treatment or "Scaffold" Arm; Standard of Care or "Comparator" Arm) of a Neuro-Spinal Scaffold to evaluate whether the Scaffold is safe and demonstrates probable benefit for the treatment of complete T2-T12 spinal cord injury as compared to standard of care open spine surgery. Learn more.

Recurrent Glioblastoma, Neurology and Psychiatry Trials
Active
Principal Investigator: Jeffrey James Olson
NCTID: NCT03115333

This phase II trial studies how well dynamic susceptibility contrast-enhanced magnetic resonance imaging (DSC-MRI) works in measuring relative cerebral blood volume (rCBV) for early response to bevacizumab in patients with glioblastoma that has come back. DSC-MRI may help evaluate changes in the blood vessels within the cancer to determine a patient's response to treatment. Learn more.

Spinal Cord Injury, Acute, Neurology and Psychiatry Trials
Active
Principal Investigator: Faiz Ahmad
NCTID: NCT02991690

This study is a prospective multi-center trial designed to determine the safety profile and efficacy of modest (33ºC) intravascular hypothermia following acute cervical (C1 to C8) Spinal Cord Injury (SCI). Learn more.

CNS Tumor, Neurology and Psychiatry Trials
Active
Principal Investigator: Jeffrey James Olson
NCTID: NCT02684838

This is a prospective, observational registry in patients who have been prescribed Gliadel Wafer by the physician as part of usual care. Learn more.

Sponsor: Novartis
PI: Adriana G. Ioachimescu, MD, PhD
Condition: Cushing Disease

Status: COMPLETED/CLOSED

The study aimed to confirm long-term efficacy and safety of osilodrostat (LCI699), a drug for the treatment of patients with Cushing's disease. Cushing’s disease is a condition where the body produces too much of a substance or hormone called cortisol. Efficacy means that the study assessed how well the study drug was effective in reducing the cortisol level in all of them. Safety means that the study records and checks for any side effects in people treated with Osilodrostat.

Patient enrolled in the study were treated with the investigational drug LCI699 (osilodrostat) at doses up to 60 mg a day. For a short period of time to the study (up to 8 weeks), patients were randomly (1 chance out of 2) assigned to receive either osilodrostat or a placebo pill. A placebo is a pill or tablet with no active medicine inside and is used to ensure that the study medication was the factor that is impacting the subject rather than external factors

Osilodrostat is currently FDA-approved and is marketed under the name Isturisa®.

Sponsor: Strongbridge/Cortendo
PI: Adriana G. Ioachimescu, MD, PhD
Condition: Endogenous Cushing Syndrome

Status: COMPLETED/CLOSED

Endogenous Cushing’s syndrome’ is a condition where the body produces too much of a substance or hormone called cortisol. An investigational drug, levoketoconazole, has been studied in people without excess cortisol (healthy volunteers) and was shown to lower cortisol levels in these volunteers. The purpose of this research study was to find out if levoketoconazole, compared to placebo (a pill with inactive ingredients) is safe, tolerable, and helps improve signs and symptoms of Cushing’s syndrome by decreasing the amount of cortisol. A placebo was used to ensure that the study medication was the factor that is impacting the subject rather than external factors (i.e. other diseases, lifestyles, significant life events). In addition, the study checked for any side effects in people with endogenous Cushing’s syndrome.

Sponsor: Chiasma, Inc.
PI: Adriana G. Ioachimescu, MD, PhD
Condition: Acromegaly

Status: NO LONGER ENROLLING

This clinical study was being conducted for research purposes with octreotide capsules for the treatment of acromegaly. Octreotide capsule is a new preparation that can be taken by mouth, of an already approved drug for acromegaly called octreotide. Until now, octreotide was only available as injection (insertion of liquid into the body with a syringe). The octreotide capsule contains octreotide and a mix of food ingredients that are considered safe.  These additional ingredients allow the medication to be given by mouth. The capsule and the mix of ingredients inside it protect octreotide from breakdown in the digestive system and help it be taken into the bloodstream. Octreotide capsule is an experimental drug which means that health authorities have not approved octreotide capsules for the treatment of acromegaly.

The purpose of this study was to assess the effectiveness (disease control), side effects and overall satisfaction with octreotide capsules in comparison to injections of octreotide or lanreotide.  Participants in this study were enrolled because they had acromegaly and were currently treated with injections of octreotide or lanreotide for the last six months prior to study enrollment, and responded to these injections (i.e. their acromegaly was adequately controlled and managed with these approved medications).

Octreotide capsules is currently FDA-approved and is marketed under the name Mycapssa®.