Clinical trials: Neurological Injury
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
Acute Pain
A Multi-Center Study of the Efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) of IV Acetaminophen for the Treatment of Acute Pain in Pediatric Patients
The purpose of this study is to demonstrate the efficacy and safety of Intravenous (IV) acetaminophen plus rescue opioids for the relief of moderate to severe acute pain in neonates and infants (age < 2 years) compared to placebo…
- Trial name
- NCT01635101
- Testing
- IV Acetaminophen, IV Control
- Where
- 22 sites in United States
- Volunteers
- 197 people
- Sponsor
- Mallinckrodt
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
Spinal Fractures, Fractures, Compression
The Kiva® System as a Vertebral Augmentation Treatment
The purpose of this study is to evaluate the safety and effectiveness of the Kiva VCF Treatment system in comparison to balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures of the thoracic or…
- Conditions
- Spinal Fractures, Fractures, Compression, Back Injuries
- Trial name
- KAST (NCT01123512)
- Testing
- Vertebral augmentation
- Where
- 21 sites in United States, Belgium and 3 more
- Volunteers
- 300 people
- Sponsor
- Benvenue Medical, Inc.
Pain
A Pilot Study of TRV130 for the Treatment of Fracture Pain
The primary objective is to evaluate the analgesic efficacy of TRV130 for moderate to severe acute pain in patients presenting to the emergency department (ED) with a suspected/known, unilateral, closed long bone fracture.
- Trial name
- NCT02520297
- Testing
- TRV130
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Trevena Inc.
Pain
Prospective, Randomized, Non-inferiority Investigation to Compare Effects of Mepitel® One and UrgoTul® Dressings in Acute Wound Management (Only)"
To compare the effects of pain of the two dressings, Mepitel® One and UrgoTul® in acute wound management.
- Trial name
- Only (NCT02237118)
- Testing
- Mepitel One, UrgoTul
- Where
- France
- Volunteers
- 123 people
- Sponsor
- Molnlycke Health Care AB
Sternal Wound Infection, Sternal Non-union
Evaluation of Primary Plating in Sternotomy Patients for Osteosynthesis and Pain
The goal of this study is to evaluate sternal osteosynthesis, chest wall pain and return to normal activity in open heart surgery patients who had their breast bone closed either with wires or plates.
- Conditions
- Sternal Wound Infection, Sternal Non-union, Pain, Mediastinitis
- Trial name
- RESTORE (NCT00819286)
- Testing
- SternaLock Rigid Fixation Plates, wire (control)
- Where
- 6 sites in United States, Germany
- Volunteers
- 140 people
- Sponsor
- Zimmer Biomet
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 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
Traumatic Thoracic Acute Spinal Cord Injury
The INSPIRE Study: Probable Benefit of the Neuro-Spinal Scaffold for Treatment of AIS A Thoracic Acute Spinal Cord Injury
This is an HDE probable benefit, open-label, non- randomized, single-arm, multicenter study to evaluate the safety and probable benefit of the poly(lactic-co-glycolic acid)-b-poly(L-lysine) Scaffold ("Scaffold") in subjects with…
- Trial name
- NCT02138110
- Testing
- Neuro-Spinal Scaffold
- Where
- 8 sites in United States
- Volunteers
- 20 people
- Sponsor
- InVivo Therapeutics
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
Spinal Cord Injury, Quadriplegia
Electrical Activation of The Diaphragm for Ventilatory Assist
OBJECTIVES: The objectives of this study are to test the Diaphragm Pacing Stimulation (DPS) System for treating chronic ventilatory insufficiency in persons with respiratory muscle paralysis.
- Trial name
- NCT00010374
- Testing
- NeuRx DPS
- Where
- 5 sites in United States, Canada
- Volunteers
- 54 people
- Sponsor
- Synapse Biomedical
Spondylolisthesis, Neurologic Deficits
A Postmarket Surveillance Study of the Paradigm Spine Dynamic Stabilization System (DSS)
The purpose of the Post-Market Surveillance study is to evaluate safety.
- Conditions
- Spondylolisthesis, Neurologic Deficits, Kyphosis, Pseudarthrosis
- Trial name
- DSS (NCT01461005)
- Testing
- Dynamic Stabilization System (DSS)
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Paradigm Spine
Delirium, Fall Injury
Care.Coach Avatars for Improvement of Outcomes in Hospitalized Elders, Including Mitigation of Falls and Delirium: a Multi-Site Clinical Study
Through NINR project 1R44NR017842-01 which preceded the present study, the investigators enhanced the care.coach avatar platform to incorporate a robust suite of evidence-based protocols based on the Hospital Elder Life Program…
- Trial name
- AvatarHELP (NCT03832192)
- Testing
- care.coach Avatar (HELP-Protocolized)
- Where
- United States
- Volunteers
- 301 people, healthy volunteers welcome
- Sponsor
- Victor Wang
Pain
A Study of Cannabis Based Medicine Extracts and Placebo in Patients With Pain Due to Spinal Cord Injury
A study to investigate the effects of sublingual cannabis based medicine extracts on neuropathic pain associated with spinal cord injury.
- Trial name
- NCT01606202
- Testing
- GW-1000-02
- Where
- United Kingdom
- Volunteers
- 116 people
- Sponsor
- Jazz Pharmaceuticals
Degenerative Spondylolisthesis, Pseudoarthrosis
Dynesys Spinal System Post Market 522 Study
The purpose of this study is to assess the safety and fusion rates following posterior lateral fusion with the Dynesys Spinal System used as an adjunct to fusion and compare to literature control.
- Trial name
- NCT01528072
- Testing
- Dynesys Spinal System
- Where
- 9 sites in United States
- Volunteers
- 153 people
- Sponsor
- Zimmer Biomet
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.
Ototoxicity
SPI-1005 for Prevention and Treatment of Tobramycin Induced Ototoxicity
The primary objective of this study is to determine the safety and efficacy of SPI-1005 treatment in CF patients with active pulmonary exacerbation that are receiving an IV course of tobramycin, determined by comparing hearing…
- Trial name
- NCT02819856
- Testing
- SPI-1005 Ebselen 200mg Capsule x1, SPI-1005 Ebselen 200mg Capsule x2, SPI-1005 Ebselen 200mg Capsule x3
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Sound Pharmaceuticals, Incorporated
Lesch-Nyhan Disease, Self-injurious Behavior
Ecopipam Treatment of Self-Injurious Behavior in Subjects With Lesch-Nyhan Disease
The purpose of this research study is to gather scientific information about the effectiveness and safety of the study drug, Ecopipam (PSYRX 101), for the treatment of self-injurious behaviors when compared with the effectiveness…
- Trial name
- NCT01751802
- Testing
- Ecopipam
- Where
- 2 sites in United States, Spain
- Volunteers
- 9 people
- Sponsor
- Emalex Biosciences Inc.
Cervical Spinal Cord Injury, Spine Injury
Dose Escalation Study of AST-OPC1 in Spinal Cord Injury
The purpose of this study is to evaluate the safety of cross sequential escalating doses of AST-OPC1 administered among 5 cohorts at a single time-point between 21 and 42 days post injury, inclusively, to subjects with subacute…
- Conditions
- Cervical Spinal Cord Injury, Spine Injury, Spinal Cord Trauma
- Trial name
- NCT02302157
- Testing
- AST-OPC1
- Where
- 9 sites in United States
- Volunteers
- 25 people
- Sponsor
- Lineage Cell Therapeutics, Inc.