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AXER-204 in Participants With Chronic Spinal Cord Injury

Source: ClinicalTrials.gov · Trial registry · Not peer reviewed · real data

Published: 2019-07-16

The injury this work is about

The phase, the band and the outcomes this paper's studies were recorded under, explained in plain words.

Open this plate

The whole vertebral column in profile along the curves it actually has, every bone drawn with its body, its arch around the canal and its spinous process, labelled C1 to the coccyx, with thirty-one pairs of nerve roots leaving it, the cord ending in a cone and the cauda equina below. Beside it, a ring of the three coverings — dura, arachnoid and pia — with the fluid space between them.
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Plate 2Atlas of a spinal cord injury2of 19The column, andits five regionsThe whole vertebral column in profile along the curves it actually has, every bone drawn with its body, its arch around the canal and its spinous process, labelled C1 to the coccyx, with thirty-one pairs of nerve roots leaving it, the cord ending in a cone and the cauda equina below. Beside it, a ring of the three coverings — dura, arachnoid and pia — with the fluid space between them.Cervical regionCervical regionThoracic regionThoracic regionLumbar regionLumbar regionSacral regionSacral regionThe coccygeal regionThe coccygeal regionWhat the spinal cord is — The whole vertebral column in profile along the curves it actually has, every bone drawn with its body, its arch around the canal and its spinous process, labelled C1 to the coccyx, with thirty-one pairs of nerve roots leaving it, the cord ending in a cone and the cauda equina below. Beside it, a ring of the three coverings — dura, arachnoid and pia — with the fluid space between them.Thirty-one pairs of spinal nervesThirty-one pairs of spinal nervesConus medullarisConus medullarisCauda equinaCauda equinaThe meninges — The whole vertebral column in profile along the curves it actually has, every bone drawn with its body, its arch around the canal and its spinous process, labelled C1 to the coccyx, with thirty-one pairs of nerve roots leaving it, the cord ending in a cone and the cauda equina below. Beside it, a ring of the three coverings — dura, arachnoid and pia — with the fluid space between them.The meningesThe meningesThe vertebral canalThe vertebral canalDura materDura materArachnoid materArachnoid materCerebrospinal fluidCerebrospinal fluidPia materPia materHow many bones, how many pieces of cordCervical regionThoracic regionLumbar regionSacral regionThe coccygeal region

What is being changed here, drawn

The column, and its five regions

Eight segments, C1–C8. The nerves to the diaphragm, the shoulders and the arms leave from here.

Open this plate · 2 of 19 →

  • Cervical regionEight segments, C1–C8. The nerves to the diaphragm, the shoulders and the arms leave from here.
  • Lumbar regionFive segments, L1–L5. The nerves to the hips and legs leave from here.
  • Ventral hornThe front part of the butterfly. The motor neurons that drive muscles directly sit here.
  • Ventral rootThe bundle of fibres leaving the cord in front, carrying motor commands out to the muscles.
  • Corticospinal tractA descending path from the motor cortex to the motor neurons. It carries voluntary movement and crosses to the other side in the brainstem.
  • Motor signsWeakness, loss of voluntary movement, a change in tone. What exactly, and where, depends on the level and the completeness.
  • Signs that need urgent helpSudden loss of movement or sensation, severe neck or back pain after an injury, difficulty breathing, sudden loss of bladder or bowel control, a sudden severe headache with rising blood pressure. This is not a checklist to score yourself against: with any of these, seek urgent professional help.
  • Neurogenic shockA state of the circulation: loss of sympathetic tone, dilated vessels, low blood pressure and a slow pulse. More common at high levels. It is dangerous, and it is constantly confused with spinal shock, which is a different thing.

Identifiers

  • NCT number: NCT03989440

Claims this paper bears on

  • Contradicts — Intrathecal administration of a soluble Nogo receptor decoy protein does not improve self-reported global impression of change or independence in self-care after spinal cord injury.
  • Contradicts — Intrathecal administration of a soluble Nogo receptor decoy protein does not improve upper extremity motor strength or hand prehension function after spinal cord injury.
  • Partially supports — Intrathecal administration of a soluble Nogo receptor decoy protein is well tolerated after spinal cord injury and does not increase the incidence of serious adverse events.

Results extracted

ResultLocation in the sourceQuotation
Safety · Primary, pre-specifiedresultsPRIMARY · Incidence of Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) · unit: Participants · measured at: Up to Day 29 for Part 1 and Day 253 for Part 2 Part 1 - AXER-204 - 3 mg: 5
Safety · Primary, pre-specifiedresultsPRIMARY · Incidence of Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) · unit: Participants · measured at: Up to Day 29 for Part 1 and Day 253 for Part 2 Part 1 - AXER-204 - 3 mg: 5 Part 1 - AXER-204 - 30 mg: 4
Safety · Primary, pre-specifiedresults Part 1 - AXER-204 - 90 mg: 5
Safety · Primary, pre-specifiedresults Part 1 - AXER-204 - 200 mg: 6
Safety · Primary, pre-specifiedresults Part 2 - AXER-204 - 200 mg: 14
Safety · Primary, pre-specifiedresults Part 2 - Placebo: 10
Outside our vocabulary · Primary, pre-specifiedresultsPRIMARY · Area Under the Concentration-Time Curve From Time 0 to Time of the Last Measurable Concentration (AUClast) of AXER-204 in Serum · unit: h*ng/mL · measured at: Part 1: pre-dose and 1 h, 6 h, 12 h, and 24 h post-dose, Day 4, 8, 15, and 29, Part 2: pre-dose and 4 h post-dose on days 1, 21, 42, 63, and 104; and on Study Days 169 and 253. Part 1 - AXER-204 - 3 mg: NA (spread NA)
Outside our vocabulary · Primary, pre-specifiedresults Part 1 - AXER-204 - 90 mg: 3670 (spread 1520)
Outside our vocabulary · Primary, pre-specifiedresults Part 1 - AXER-204 - 200 mg: 20900 (spread 7540)
Outside our vocabulary · Primary, pre-specifiedresultsPRIMARY · Cmax in Serum · unit: ng/mL · measured at: Part 1: pre-dose and 1 h, 6 h, 12 h, and 24 h post-dose, Day 4, 8, 15, and 29, Part 2: pre-dose and 4 h post-dose on days 1, 21, 42, 63, and 104; and on Study Days 169 and 253. Part 1 - AXER-204 - 3 mg: NA (spread NA)
Outside our vocabulary · Primary, pre-specifiedresults Part 1 - AXER-204 - 90 mg: 277 (spread 79.1)
Outside our vocabulary · Primary, pre-specifiedresults Part 1 - AXER-204 - 200 mg: 641 (spread 173)
Outside our vocabulary · Primary, pre-specifiedresults Part 2 - AXER-204 - 200 mg: NA (spread NA)
Outside our vocabulary · Primary, pre-specifiedresultsPart 1 - AXER-204 - 90 mg: 16.8 (spread 6.5)
Outside our vocabulary · Primary, pre-specifiedresultsPart 1 - AXER-204 - 200 mg: 12.8 (spread 5.06)
Outside our vocabulary · Primary, pre-specifiedresultsPart 1 - AXER-204 - 200 mg: 53.9 (spread 24.8)
Outside our vocabulary · Primary, pre-specifiedresultsPart 1 - AXER-204 - 200 mg: 4.84 (spread 1.41)
Outside our vocabulary · Primary, pre-specifiedresultsPart 2 - AXER-204 - 200 mg: NA (spread NA)
Outside our vocabulary · Primary, pre-specifiedresultsPRIMARY · Volume of Distribution · unit: L · measured at: Part 1: pre-dose and 1 h, 6 h, 12 h, and 24 h post-dose, Day 4, 8, 15, and 29, Part 2: pre-dose and 4 h post-dose on days 1, 21, 42, 63, and 104; and on Study Days 169 and 253.
Outside our vocabulary · Primary, pre-specifiedresultsPRIMARY · Volume of Distribution · unit: L · measured at: Part 1: pre-dose and 1 h, 6 h, 12 h, and 24 h post-dose, Day 4, 8, 15, and 29, Part 2: pre-dose and 4 h post-dose on days 1, 21, 42, 63, and 104; and on Study Days 169 and 253.
Outside our vocabulary · Primary, pre-specifiedresultsPRIMARY · Volume of Distribution · unit: L · measured at: Part 1: pre-dose and 1 h, 6 h, 12 h, and 24 h post-dose, Day 4, 8, 15, and 29, Part 2: pre-dose and 4 h post-dose on days 1, 21, 42, 63, and 104; and on Study Days 169 and 253.
Outside our vocabulary · Primary, pre-specifiedresultsPRIMARY · Volume of Distribution · unit: L · measured at: Part 1: pre-dose and 1 h, 6 h, 12 h, and 24 h post-dose, Day 4, 8, 15, and 29, Part 2: pre-dose and 4 h post-dose on days 1, 21, 42, 63, and 104; and on Study Days 169 and 253.
Outside our vocabulary · Primary, pre-specifiedresultsPRIMARY · Volume of Distribution · unit: L · measured at: Part 1: pre-dose and 1 h, 6 h, 12 h, and 24 h post-dose, Day 4, 8, 15, and 29, Part 2: pre-dose and 4 h post-dose on days 1, 21, 42, 63, and 104; and on Study Days 169 and 253.
Outside our vocabulary · Primary, pre-specifiedresultsPRIMARY · Area Under the Concentration-Time Curve From Time 0 to Time of the Last Measurable Concentration (AUClast) of AXER-204 in CSF · unit: h*ng/mL · measured at: Part 1: pre-dose, post-dose at 24 h, 72 h, Days 8 and 29, Part 2: pre-dose on Days 1, 21, 42, 63, and 104, and on Day 253.
Outside our vocabulary · Primary, pre-specifiedresultsPRIMARY · Area Under the Concentration-Time Curve From Time 0 to Time of the Last Measurable Concentration (AUClast) of AXER-204 in CSF · unit: h*ng/mL · measured at: Part 1: pre-dose, post-dose at 24 h, 72 h, Days 8 and 29, Part 2: pre-dose on Days 1, 21, 42, 63, and 104, and on Day 253.
Outside our vocabulary · Primary, pre-specifiedresultsPRIMARY · Area Under the Concentration-Time Curve From Time 0 to Time of the Last Measurable Concentration (AUClast) of AXER-204 in CSF · unit: h*ng/mL · measured at: Part 1: pre-dose, post-dose at 24 h, 72 h, Days 8 and 29, Part 2: pre-dose on Days 1, 21, 42, 63, and 104, and on Day 253.
Outside our vocabulary · Primary, pre-specifiedresultsPRIMARY · Area Under the Concentration-Time Curve From Time 0 to Time of the Last Measurable Concentration (AUClast) of AXER-204 in CSF · unit: h*ng/mL · measured at: Part 1: pre-dose, post-dose at 24 h, 72 h, Days 8 and 29, Part 2: pre-dose on Days 1, 21, 42, 63, and 104, and on Day 253.
Outside our vocabulary · Primary, pre-specifiedresultsPRIMARY · Area Under the Concentration-Time Curve From Time 0 to Time of the Last Measurable Concentration (AUClast) of AXER-204 in CSF · unit: h*ng/mL · measured at: Part 1: pre-dose, post-dose at 24 h, 72 h, Days 8 and 29, Part 2: pre-dose on Days 1, 21, 42, 63, and 104, and on Day 253.
Outside our vocabulary · Primary, pre-specifiedresultsPRIMARY · Tmax of AXER-204 in CSF · unit: h · measured at: Part 1: pre-dose, post-dose at 24 h, 72 h, Days 8 and 29, Part 2: pre-dose on Days 1, 21, 42, 63, and 104, and on Day 253.
Outside our vocabulary · Primary, pre-specifiedresultsPRIMARY · Tmax of AXER-204 in CSF · unit: h · measured at: Part 1: pre-dose, post-dose at 24 h, 72 h, Days 8 and 29, Part 2: pre-dose on Days 1, 21, 42, 63, and 104, and on Day 253.
Outside our vocabulary · Primary, pre-specifiedresultsPRIMARY · Tmax of AXER-204 in CSF · unit: h · measured at: Part 1: pre-dose, post-dose at 24 h, 72 h, Days 8 and 29, Part 2: pre-dose on Days 1, 21, 42, 63, and 104, and on Day 253.
Outside our vocabulary · Primary, pre-specifiedresultsPRIMARY · Tmax of AXER-204 in CSF · unit: h · measured at: Part 1: pre-dose, post-dose at 24 h, 72 h, Days 8 and 29, Part 2: pre-dose on Days 1, 21, 42, 63, and 104, and on Day 253.
Outside our vocabulary · Primary, pre-specifiedresultsPRIMARY · Tmax of AXER-204 in CSF · unit: h · measured at: Part 1: pre-dose, post-dose at 24 h, 72 h, Days 8 and 29, Part 2: pre-dose on Days 1, 21, 42, 63, and 104, and on Day 253.
Motor function · Secondary, pre-specifiedresultsSECONDARY · Change in International Standards for Neurological Classification of SCI (ISNCSCI) Bilateral Upper Extremity Motor Score (UEMS) · unit: score on a scale · measured at: Baseline to Day 169
Motor function · Secondary, pre-specifiedresultsSECONDARY · Change in International Standards for Neurological Classification of SCI (ISNCSCI) Bilateral Upper Extremity Motor Score (UEMS) · unit: score on a scale · measured at: Baseline to Day 169
Motor function · Secondary, pre-specifiedresultsPart 2 - AXER-204 - 200 mg: 0.42 (95% CI -1.07 to 1.91)
Motor function · Secondary, pre-specifiedresultsPart 2 - Placebo: 1.97 (95% CI 0.41 to 3.54)
Motor function · Secondary, pre-specifiedresultsPart 2 - AXER-204 - 200 mg: -0.25 (95% CI -1.50 to 1.00)
Motor function · Secondary, pre-specifiedresultsPart 2 - Placebo: 0.91 (95% CI -0.38 to 2.20)
Patient reported · Secondary, pre-specifiedresultsPart 2 - AXER-204 - 200 mg: 3
Patient reported · Secondary, pre-specifiedresultsPart 2 - Placebo: 4
Patient reported · Secondary, pre-specifiedresultsPart 1 - AXER-204 - 3 mg: NA
Patient reported · Secondary, pre-specifiedresultsPart 1 - AXER-204 - 30 mg: NA
Patient reported · Secondary, pre-specifiedresultsPart 1 - AXER-204 - 90 mg: NA
Patient reported · Secondary, pre-specifiedresultsPart 1 - AXER-204 - 200 mg: NA

Study

  • NCT03989440/brief_summary human

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