Clinical trials: Head Trauma
Chronic Troublesome Sialorrhea, Cerebral Palsy
Clinical Study to Investigate the Efficacy and Safety of NT 201 Compared to Placebo in the Treatment of Chronic Troublesome Drooling Associated With Neurological Disorders and/or Intellectual Disability
The objective of this study is to investigate the efficacy and safety of NT 201 compared with placebo for the treatment of chronic troublesome sialorrhea associated with neurological disorders (e.g.
- Conditions
- Chronic Troublesome Sialorrhea, Cerebral Palsy, Stroke, Traumatic Brain Injury
- Trial name
- SIPEXI (NCT02270736)
- Testing
- NT 201
- Where
- 31 sites in Georgia, Hungary and 4 more
- Volunteers
- 256 people
- Sponsor
- Merz Pharmaceuticals GmbH
Pseudobulbar Affect (PBA), Stroke
Safety, Tolerability and Effectiveness of Nuedexta in the Treatment of Pseudobulbar Affect (PBA)
The objectives of the study are to evaluate the safety, tolerability, and effectiveness of NUEDEXTA capsules containing 20 mg DM (Dextromethorphan)/10 mg Q (Quinidine) for treatment of Pseudobulbar Affect (PBA) in patients with…
- Conditions
- Pseudobulbar Affect (PBA), Stroke, Dementia, Traumatic Brain Injury (TBI)
- Trial name
- PRISM II (NCT01799941)
- Testing
- Nuedexta (DM 20 mg/Q 10 mg)
- Where
- United States
- Volunteers
- 367 people
- Sponsor
- Avanir Pharmaceuticals
Esophageal Fistula, Esophageal Neoplasms
Removal of the Evolution® Esophageal Stent - Fully Covered
The CLARITY study is a clinical trial approved by US FDA to study the removal of the Evolution® Esophageal Stent-Fully Covered in malignant and benign indications.
- Conditions
- Esophageal Fistula, Esophageal Neoplasms, Esophageal Perforation, Esophageal Stenosis
- Trial name
- CLARITY (NCT01900691)
- Testing
- Evolution® Esophageal Stent - Fully Covered
- Where
- 11 sites in United States
- Volunteers
- 130 people
- Sponsor
- Cook Group Incorporated
Traumatic Brain Injury
TBI MR Study 3 Houston Methodist
This hypothesis-generating feasibility study to determine potential associations between a broad range of clinical neurological symptoms and Magnetic Resonance Image (MRI), data, and clinical findings involved in mild traumatic…
- Trial name
- NCT02218216
- Testing
- MRI Diagnostic
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- GE Healthcare
Spasticity, Cerebrovascular Accident
Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Upper Limb Spasticity
Phase 2/3, randomized, double-blind, placebo-controlled, single-treatment, multicenter trial assessing the efficacy and safety of MYOBLOC for the treatment of upper limb spasticity in adults followed by an open-label extension…
- Conditions
- Spasticity, Cerebrovascular Accident, Multiple Sclerosis, Traumatic Brain Injury
- Trial name
- NCT04815967
- Testing
- Phase 2; Low Dose MYOBLOC (10,000 Units), Phase 2; High Dose MYOBLOC (20,000 Units), Phase 3; MYOBLOC
- Where
- 9 sites in United States, Hungary and 1 more
- Volunteers
- 32 people
- Sponsor
- Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC
Skull Fractures
PMCF Study on CranioFix®2 System Used for the Fixation of Craniotomized Bone Flaps and Fractures
The CranioFix®2 PMCF study has been set up as an action within the framework of a proactive post-market surveillance system of the manufacturer.
- Trial name
- CRANFLAP (NCT05119595)
- Where
- Germany
- Volunteers
- 25 people
- Sponsor
- Aesculap AG
Neurobehavioral Disinhibition
Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Neurobehavioral Disinhibition Including Aggression, Agitation, and Irritability in Participants With Traumatic Brain Injury
This is a multicenter, randomized, placebo-controlled study to evaluate AVP-786 for the treatment of neurobehavioral disinhibition including aggression, agitation, and irritability in participants with traumatic brain injury…
- Trial name
- NCT03095066
- Testing
- AVP-786-28, AVP-786-42.63
- Where
- 54 sites in United States
- Volunteers
- 168 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Chronic Traumatic Encephalopathy
18F-AV-1451 and Florbetapir F 18 PET (Positron Emission Tomography) Imaging in Subjects at Risk for Chronic Traumatic Encephalopathy
This study will explore the use of flortaucipir as a biomarker for chronic traumatic encephalopathy (CTE) and examine the relationship between clinical presentation and tau deposition.
- Trial name
- NCT02079766
- Testing
- florbetapir F 18, Flortaucipir F18
- Where
- 2 sites in United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Avid Radiopharmaceuticals
Chronic Troublesome Sialorrhea, Parkinson's Disease
Clinical Study to Investigate the Efficacy and Safety of Two Dose Levels of NT 201 Versus Placebo in Treating Chronic Troublesome Sialorrhea in Various Neurological Conditions
The objective of this study is to investigate the efficacy and safety of two different dose levels of NT 201 (75 U or 100 U per cycle), compared with placebo, in reducing the salivary flow rate, and the severity and frequency of…
- Conditions
- Chronic Troublesome Sialorrhea, Parkinson's Disease, Post-stroke, Traumatic Brain Injury
- Trial name
- SIAXI (NCT02091739)
- Testing
- IncobotulinumtoxinA (100 Units), IncobotulinumtoxinA (75 Units)
- Where
- 31 sites in Germany, Poland
- Volunteers
- 184 people
- Sponsor
- Merz Pharmaceuticals GmbH
Cerebrospinal Fluid Leaks
TASALL - TachoSil® Against Liquor Leak
The primary objective is to demonstrate superiority of TachoSil® compared to current practice as an adjunct in sealing the dura mater. The efficacy of the dura mater sealing must be evaluated post-operatively.
- Trial name
- NCT01355627
- Testing
- TachoSil®, Current Practice
- Where
- 39 sites in Austria, Belgium and 9 more
- Volunteers
- 726 people
- Sponsor
- Takeda
Concussion, Traumatic Brain Injury
Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2
This is an open-label, non-randomized, prospective, multi-site, parallel group (segment), hypothesis-generating study designed to collect data that will aid in future scientific and engineering exploration of correlations between…
- Trial name
- mTBI-phase2 (NCT02556177)
- Testing
- MRI
- Where
- 7 sites in United States
- Volunteers
- 477 people, healthy volunteers welcome
- Sponsor
- GE Healthcare
Ischemic Stroke, Acute
MEXIDOL® in the Rehabilitation Treatment of Patients With Acute Cerebral Failure
The use of metabolic modulators creates prospects for increasing the efficiency of the rehabilitation treatment of patients with acute cerebral failure
- Trial name
- NCT06221826
- Testing
- Mexidol
- Where
- Russia
- Volunteers
- 60 people
- Sponsor
- Pharmasoft
Brain Contusion
A Study to Evaluate the Efficacy and Safety of BIIB093 in Participants With Brain Contusion
The primary objective is to determine if BIIB093 reduces brain contusion expansion by Hour 96 when compared to placebo. The secondary objectives are to evaluate the effects of BIIB093 on acute neurologic status, functional…
- Trial name
- ASTRAL (NCT03954041)
- Testing
- BIIB093
- Where
- 63 sites in United States, France and 5 more
- Volunteers
- 92 people
- Sponsor
- Remedy Pharmaceuticals, Inc.
Head Injury
Effect of Intrathoracic Pressure Regulation on Traumatic Brain Injury
The purpose of this study is to demonstrate proof of clinical concept that application of the Intrathoracic Pressure Regulator (ITPR) will result in an increase in Cerebral Perfusion Pressure (CPP) and a decrease in Intracranial…
- Trial name
- NCT01824589
- Testing
- -7 cm H2O ITPR, -12cm H2O ITPR
- Volunteers
- 1 people
- Sponsor
- Advanced Circulatory Systems
Acute Concussion Syndrome
Pilot Clinical Investigation Evaluating the Safety and Performance of RGn550 in Treating Sportspeople Suffering From Acute Concussion Syndrome
This is a controlled investigation, with randomization of the patients, which aims at evaluating the safety and performance of device RGn550 in treating sportspeople suffering from acute concussion syndrome.
- Trial name
- RECOVERY (NCT05647304)
- Testing
- RGn550 5 Hz-PWM, RGn550 10 Hz-PWM
- Where
- France
- Volunteers
- 50 people
- Sponsor
- REGEnLIFE SAS
CSF Leak
The Paediatric EVICEL® Neuro Study
The purpose of this study is to evaluate the safety and efficacy of EVICEL® when used for suture-line sealing in dura-mater closure in elective or urgent paediatric cranial neurosurgery to provide intraoperative watertight…
- Trial name
- NCT02309645
- Testing
- EVICEL® Fibrin Sealant, Sutures Only
- Where
- 7 sites in United Kingdom
- Volunteers
- 40 people
- Sponsor
- Ethicon, Inc.
Non-arteritic Ischemic Optic Neuropathy, Optic Nerve Injuries
Safety and Efficacy Study of RPh201 Treatment of Ischemic Optic Neuropathy (ION).
The study objectives are to assess any changes in visual acuity and visual field observed following the administration of RPh201 during an overall treatment period of at least 13 consecutive weeks with an option to extended the…
- Trial name
- NCT02045212
- Testing
- RPh201
- Where
- Israel
- Volunteers
- 22 people
- Sponsor
- Regenera Pharma Ltd
Traumatic Brain Injury
Study to Evaluate the Safety, Tolerability, and Efficacy of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury
The primary objective of this study is to evaluate the safety and tolerability of long-term (12 months) armodafinil treatment in patients with excessive sleepiness associated with mild or moderate closed traumatic brain injury…
- Trial name
- NCT00983437
- Testing
- Armodafinil
- Where
- 61 sites in United States
- Volunteers
- 49 people
- Sponsor
- Cephalon, Inc.
Traumatic Brain Injury
Advanced MRI Applications for Mild Traumatic Brain Injury - UCSF
This hypothesis-generating feasibility study compares mTBI Patients and Controls using advanced MRI Applications.
- Trial name
- TBI-2 (NCT02141360)
- Testing
- MRI Diagnostic
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- GE Healthcare
Traumatic Brain Injury
Prospective, Interventional Study Evaluating the Feasibility and Safety of the Esophageal Cooling Device
The aim of this prospective, interventional study is to assess the feasibility and safety of the Esophageal Cooling Device in patients from suffering from traumatic brain injury who the treating physician is treating with…
- Trial name
- NCT02420639
- Testing
- Esophageal Cooling Device (ECD), manufactured by Advanced Cooling Therapy, Inc.
- Where
- Ukraine
- Volunteers
- 12 people
- Sponsor
- Advanced Cooling Therapy, Inc., d/b/a Attune Medical