A Placebo-Controlled, Randomized, Two-Way Cross-Over, Double-Blind, Flexible Dose, Multicenter Study to Evaluate the Efficacy and Safety of Viagra in Male Patients With Traumatic Spinal Cord Injury and Erectile Dysfunction
To demonstrate the efficacy, safety and tolerability of sildenafil administered orally, as required, approximately 1 hour prior to sexual activity to men with erectile dysfunction (ED) associated with spinal cord injury (SCI), as well as its effects on the quality of life (QoL) of these patients.
NCT00654082 — Spinal Cord Injury
Status: Completed
http://inclinicaltrials.com/spinal-cord-injury/NCT00654082/
Prevalence and Risk of Coronary Heart Disease as Measured by Coronary Calcium Score Among Individuals With Chronic Traumatic Spinal Cord Injury(SCI): A Pilot Study
This study includes male subjects age 45 to 70, who have sustained a traumatic Spinal Cord Injury (SCI) at least 10 years prior. Subjects will be interviewed for demographic data, including heart disease risk factors. A blood test for cholesterol levels will be drawn. A CT scan of arteries of the heart will be performed to determine the presence of coronary calcium, a marker of subclinical Coronary Heart Disease. Scoring of Coronary Calcium or Coronary Calcium Score (CCS) is automated by the CT scanner. Each subject's Framingham Risk Score will be calculated; This is an individuals 10 year risk of having a Coronary Heart Disease event (significant symptoms). In addition, it will be determined if subjects are being treated for diagnosed dyslipidemia (high cholesterol) according to the National Cholesterol Educational Program (NCEP) guidelines. The proposed pilot study aims to better understand the problem of Coronary Heart Disease in individuals with Spinal Cord Injury, specifically CCS in SCI, when compared to the general population.
NCT00628446 — Heart Diseases
Status: Completed
http://inclinicaltrials.com/heart-diseases/NCT00628446/
Treatment With Erythropoetin in Patients With Spinal Trauma With Neurological Deficit, Maximum Tolerated Dose Study. TETRAM2
The social, psychological, economic burden of Spinal trauma with deficit is great, and there is no curative treatment. Erythropoetin (EPO) is promising, due to its neuroprotective effects demonstrated in vitro, in vivo in animal models and in a preliminary study including patients with stroke. The study primary end point is to find out the maximum tolerated dose of EPO. This is based on the occurrence of pulmonary embolism during a 14 day delay following EPO injection. Secondary end points include comparisons of EPO kinetics in blood and cerebrospinal fluid (CSF), study of EPO effects on several inflammatory and apoptotic bio markers and blood cell counts. The experimental design is a dose scale study (600 to 2400 UI/Kg), using a single dose of rHuEPO, (EPREX®). The EPO dose is defined using a Bayesian continuous reassessment Method (CRM). The sample size is expected for less than 20 patients. Eligible patients are patients aged 15 to 65 years, able to receive the EPO injection within 12 hours of a spinal trauma, without vital blood loss or associated diseases. The follow-up lasts 6 months.
NCT00478517 — Spinal Trauma With Neurological Deficit
Status: Withdrawn
http://inclinicaltrials.com/spinal-trauma-with-neurological-deficit/NCT00478517/
Pilot Study of Clinical Safety and Feasibility of the Neuro-Spinal Scaffold for the Treatment of Complete (AIS A) Traumatic Acute Spinal Cord Injury at the C5 - T1 Neurological Levels
Pilot Study of Clinical Safety and Feasibility of the Neuro-Spinal ScaffoldTM for the Treatment of Complete (AIS A) Traumatic Acute Spinal Cord Injury at the C5-T1 Neurological Levels The purpose of this study is to support an expansion to support marketing applications as well as future studies.
NCT03105882 — Traumatic Cervical Acute Spinal Cord Injury
Status: Withdrawn
http://inclinicaltrials.com/traumatic-cervical-acute-spinal-cord-injury/NCT03105882/
A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of MT-3921 in Subjects With Acute Traumatic Cervical Spinal Cord Injury
The purpose of this study is to compare the efficacy and safety of intravenous (IV) infusions of MT-3921 to placebo in subjects with acute traumatic cervical spinal cord injury. Subjects meeting eligibility criteria will enter the 6-month double-blind period. Subjects will be randomized in a 2:1 ratio to receive MT-3921 or placebo in a double blind manner.
NCT04683848 — Spinal Cord Injury
Status: Recruiting
http://inclinicaltrials.com/spinal-cord-injury/NCT04683848/
A Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Assess the Safety and Efficacy of Elezanumab in Acute Traumatic Cervical Spinal Cord Injury
Acute Spinal Cord Injury (SCI) is a rare injury that leads to permanent neuromotor impairment and sudden disability. Approximately 25,000 people experience cervical SCI in the United States, Europe, and Japan every year. The purpose of this study is to see if elezanumab is safe and assess change in Upper Extremity Motor Score (UEMS) in participants with acute traumatic cervical SCI. Elezanumab is an investigational drug being developed for the treatment of SCI. Elezanumab is a monoclonal antibody, that binds to an inhibitor of neuronal regeneration and neutralizes the inhibitor, thus potentially promoting neuroregeneration. This study is "double-blinded", which means that neither trial participants nor the study doctors will know who will be given which study drug. Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. Participants 18-75 years of age with a SCI will be enrolled. Approximately 54 participants will be enrolled in the study in approximately 49 sites worldwide. Participants will receive intravenous (IV) doses of elezanumab or placebo within 24 hours of injury and every 4 weeks thereafter through Week 48 for a total of 13 doses. There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
NCT04295538 — Spinal Cord Injury (SCI)
Status: Active, not recruiting
http://inclinicaltrials.com/spinal-cord-injury-sci/NCT04295538/
Incidence of Neurogenic Paraosteoarthropathies (NPOA) in a Population of Brain Traumatized and Spinal Cord Injured Patients and Specific Markers of Early Neurogenic Paraosteoarthropathies Development"
Neurogenic paraosteoarthropathies are peri-articular bone formations that may occur as a result of central neurological injury. Their occurrence limits reeducation and recovery capacities. Neurogenic paraosteoarthropathies sometimes cause complications (pain, joint stiffness, vascular and nerve compression, pressure sores) in patients already suffering from severe neurological sequelae affecting functional prognosis. A lot of clinical research work has been carried out within Dr Salga team. Subsequently, a collaboration was born with fundamental research teams (Pr Levesque, Pr Le Bousse Kerdilès, Pr Banzet, Pr Genêt) allowing translational work between humans and animals. The clinical application of recent research findings now makes it possible to launch the very first prospective study on neurogenic paraosteoarthropathies.
NCT04273347 — Spinal Cord Injuries
Status: Not yet recruiting
http://inclinicaltrials.com/spinal-cord-injuries/NCT04273347/
The Effect of Gabapentin Used as a Preemptive to the Emergence and Development Chronic Neuropathic Pain in Patients After Spinal Cord Trauma
Study of the effect of gabapentin used as a preemptive to the emergence and development chronic neuropathic pain in patients after spinal cord trauma
NCT03255330 — Spinal Cord Injuries
Status: Withdrawn
http://inclinicaltrials.com/spinal-cord-injuries/NCT03255330/
A Phase 2b/3, Double-blind, Randomized, Placebo Controlled, Multicenter Study to Assess the Efficacy and Safety of VX-210 in Subjects With Acute Traumatic Cervical Spinal Cord Injury
The purpose of this study is to determine the efficacy and safety of VX-210 in subjects with Acute Traumatic Cervical Spinal Cord Injury. Secondary objectives include the specific evaluation of the effects of VX-210 on neurological recovery and daily function after spinal cord injury.
NCT02669849 — Cervical Spinal Cord Injury
Status: Terminated
http://inclinicaltrials.com/cervical-spinal-cord-injury/NCT02669849/
Spinal cord trauma and the consequent paraplegia are possibly among the most devastating injuries in soldiers and during spine surgery, and are significant in the medical, social and financial aspects. Limited mobility, the need for assistance in all human activities, shame, and many medical complications related directly to the neural deficits make paraplegia an important target for prevention. Our study will evaluate the efficacy of Minocycline in two different groups: 1. Minimizing the neurological damage among trauma patients. 2. Preventing neurological damage through operation in spinal tumors patients. 2.OBJECTIVES The primary objectives of the trial are to determine: 1. Efficacy of administrating minocycline in minimizing the neurological damage among acute spinal cord injury patients and spinal cord tumors (primary and metastases) patients? 2. Efficacy of administrating minocycline at changing the natural history and rehabilitation of spinal cord trauma patients. 3. Safety of applying minocycline in spinal cord injuries patients and spinal cord tumors?
NCT01813240 — Spinal Tumors, Trauma Patients, Minocycline.
Status: Not yet recruiting
http://inclinicaltrials.com/spinal-tumors-trauma-patients-minocycline/NCT01813240/