NCT05965700终止1 期
A Randomized, Double-Blind, Placebo-Controlled Phase 1b/2a Study of NVG-291 in Spinal Cord Injury Subjects (CONNECT)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Electrophysiological
研究概览
简要总结
A Randomized, Double-Blind, Placebo-Controlled Phase 1b/2a Study of NVG-291 in Spinal Cord Injury Subjects
详细描述
To evaluate the effect of NVG-291 on descending connectivity in subjects with subacute and chronic SCI (20 subjects per Cohort and results will be analyzed separately) using objective electrophysiological measures, in addition to clinical assessments. To evaluate safety and tolerability of NVG-291 in a SCI population, as measured by clinical assessments (Physical Examination, Vital Signs, ECG, etc.) as well as clinical laboratory measures. NOTE: Enrollment of the chronic cohort has been completed; approximately 20 individuals will be enrolled in the subacute group. For more information about the trial please visit www.connectscistudy.com.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A subject must provide written informed consent in accordance with local regulations prior to initiation of any study-specific activities/procedures. A legally authorized representative (LAR) may be used to assist in signing the informed consent.
- •Cervical SCI resulting from acute physical trauma.
- •Males and females
- •Age 18 - 75 years, inclusive.
- •Cervical SCI, incomplete, with a neurological level of injury being at C7 or higher.
- •Had incomplete cervical SCI within the period from 1 year to 10 years inclusive (Chronic cohort 1) OR within 20 days to 90 days inclusive (Subacute cohort 2) at time of randomization.
- •Must be able to volitionally initiate at least one step on one leg (without body weight support). (Cohort 1 only)
- •Must have a Walking Index for Spinal Cord Injury II (WISCI II) score as follows:
- •For Chronic cohort 1: Less than or equal to Level
- •For Subacute cohort 2: Less than or equal to Level
- •GRASSP/hand grip strength Prehension Ability score
- •For Chronic cohort 1:
- •i. Must have a score of at least 2 on at least one of the Prehension Ability grasp patterns of the GRASSP assessment in at least one upper extremity. ii. Must have no more than one Prehension Ability grasp patterns score = 4 in the upper extremity satisfying criterion i
- •For Subacute cohort 2:
- •i. Must have some voluntary (nonzero) force measured by grip dynamometry in at least one upper extremity.
- •ii. Must have no more than one Prehension Ability grasp patterns score = 3 in at least one upper extremity.
- •iii. Must not have a Prehension Ability grasp patterns score = 4 in the upper extremity satisfying criterion.
- •Presence of Motor Evoked Potentials (MEPs):
- •In two specific target muscle groups (Cohort 1)
- •In one specific target muscle group (Cohort 2)
- •Must be fluent in English.
- •Subjects must be willing and able to comply with scheduled visits, all sample collections, and other trial procedures.
排除标准
- •Nontraumatic SCI (e.g., due to infection, ischemia, metabolic abnormality, congenital abnormality, malignancy, radiation injury, surgical complications, or other disease process).
- •Spinal cord injury due to gunshot wound or penetrating injury.
- •Two or more (noncontiguous) spinal cord lesions.
- •MRI or CT evidence of anatomically complete spinal cord transection.
- •Any form of ventilatory dependence.
- •Any condition that precludes adequate clinical assessment of all four extremities, such as contracture, peripheral nerve injury, amputation.
- •History of uncontrolled seizures or any seizure within the last 6 months (Cohort 1). History of uncontrolled seizures, or any seizure occurring 1 week or more after the SCI (Cohort 2)
- •Metal implant in the head that is likely to interfere with MRI analysis.
- •Pregnant or breast feeding.
- •Any neurological condition that is considered to interfere with performance or likly confound assessment, such as multiple sclerosis, stroke, or progressive syringomyelia.
- •History of substance abuse within 12 months prior to screening, based on medical records or self-report.
- •Evidence of spinal instability or persistent spinal stenosis and/or compression related to initial trauma.
- •Prior treatment with cell therapy delivered into the CNS (intrathecal or intraparenchymal).
- •Severe neuropathic pain inadequately controlled by medication.
- •Body mass index (BMI) > 40 (body weight in kilograms divided by height in meters squared).
- •Received botulinum toxin injection(s) in an upper or lower extremity muscle in the prior 6 months.
- •Received 4-aminopyridine within 7 days of first dose..
- •Prior treatment with a protein tyrosine phosphatase sigma (PTPσ) mimetic peptide.
- •Intrathecal opioid use.
- •Currently participating in an interventional clinical trial.
- •Received a non-permitted medication within 5.5 half-lives or 7 days, whichever is longer, prior to randomization
- •Receiving any treatment intended to enhance neuroplasticity (e.g., electrical stimulation, acute intermittent hypoxia) at the time of consent to participate in this study or within 4 weeks of randomization, whichever is longer.
- •Any implanted internal spinal cord stimulator.
- •Currently receiving neuromuscular stimulation.
- •Currently receiving vagal or phrenic nerve stimulation.
- •Chronic cohort 1 only: Any contraindication to undergo baseline and on study MRIs such as:
- •History of a cardiac pacemaker or pacemaker wires, OR
- •Ferromagnetic metallic particles in the body, OR
- •Baclofen pump, OR
- •Vascular clips in the head, OR
- •Prosthetic heart valves, OR
- •Severe claustrophobia impeding ability to participate in an imaging study.
- •Malignancy within 5 years prior to screening, except for non-melanoma skin cancers or cervical or breast ductal carcinoma in situ.
- •History of medically significant hepatic disease or evidence of impaired liver function based on initial laboratory testing
- •Severe renal insufficiency, as defined by eGFR < 30 mL/min/1.73m
- •Any disease, concomitant injury, such as significant traumatic brain injury, or other condition that could interfere with the performance or interpretation of the protocol specified assessments, in the opinion of the investigator.
- •Any other social or medical condition (e.g., uncontrolled diabetes, unstable hypertension) which, in the opinion of the investigator, would make the subject unsuitable for study participation.
研究组 & 干预措施
Placebo
Placebo Comparator
Injected under the skin (subcutaneous).
干预措施: NVG-291 (Drug)
NVG-291 for Injection
Experimental
Injected under the skin (subcutaneous).
干预措施: NVG-291 (Drug)
结局指标
主要结局
Electrophysiological
时间窗: 12 weeks
MEP amplitudes (corticospinal contribution) in key target muscle groups
次要结局
- 10mWT time(12 weeks)
- 9-HPT time(12 weeks)
- Dynamometry testing (pinch grip, Chronic cohort 1; hand grip, Subacute cohort 2)(12 weeks)
- Graded and Redefined Assessment of Strength, Sensibility, and Prehension Test(12 weeks)
- Lower extremity motor score (LEMS)(12 weeks)
- Upper extremity motor score (UEMS)(12 weeks)
- Incidences of Treatment Emergent Adverse Events (Safety and Tolerability)(16 Weeks)
- Plasma Concentration of Study Drug(12 Weeks)
研究者
研究点 (1)
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相关资讯
NervGen Pharma to Present Phase 1b/2a Trial of NVG-291 for Spinal Cord Injury at Upcoming Investor Event• NervGen Pharma will host a virtual investor event on April 9, 2025, featuring key opinion leaders to discuss the unmet medical needs and treatment landscape for spinal cord injury patients.
• The company will present details of its Phase 1b/2a clinical trial evaluating NVG-291, a first-in-class therapeutic peptide targeting nervous system repair in both chronic and subacute spinal cord injury patients.
• Clinical data from the double-blind, randomized, placebo-controlled trial is expected in the second quarter, with the study measuring corticospinal connectivity changes and motor function improvements as primary endpoints.last yearNervGen Completes Enrollment in Chronic Spinal Cord Injury Trial, Advances to Subacute Phase- NervGen Pharma has completed enrollment for the chronic cohort of its Phase 1b/2a clinical trial evaluating NVG-291 in spinal cord injury patients.
- The company has received IRB approval for trial amendments and initiated screening for the subacute cohort, expanding the study's scope.
- Topline results from the chronic cohort of the Phase 1b/2a trial are anticipated in the second quarter of 2025, marking a key milestone.
- NervGen's clinical trial is designed to assess the safety and efficacy of NVG-291 in both chronic and subacute spinal cord injury.last yearNervGen Nears Enrollment Completion in Spinal Cord Injury Trial of NVG-291- NervGen Pharma is approaching target enrollment in the chronic cohort of its Phase 1b/2a trial for NVG-291 in spinal cord injury (SCI).
- The trial evaluates NVG-291's efficacy in chronic and subacute cervical SCI patients using clinical, electrophysiological, and MRI measures.
- NVG-291, a first-in-class therapeutic peptide, aims to promote nervous system repair through enhanced plasticity, axonal regeneration, and remyelination.
- NervGen anticipates advising on enrollment completion and topline data availability for the SCI trial.last yearNervGen Pharma Highlights Clinical Trial Challenges in Spinal Cord Injury at U2FP Symposium• NervGen Pharma's CMO, Dr. Daniel Mikol, will present at the U2FP Symposium, addressing challenges in translating SCI animal model results to human clinical trials.
• NVG-291, NervGen's therapeutic peptide, targets nervous system repair mechanisms and has shown promise in preclinical models of spinal cord injury.
• A Phase 1b/2a trial (NCT05965700) is underway to evaluate NVG-291's efficacy in chronic and subacute cervical spinal cord injury, focusing on motor function improvements.
• The trial assesses corticospinal connectivity changes using electrophysiological and MRI imaging, with funding support from Wings for Life.last year