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The study was terminated by the Sponsor due to insufficient enrollment.
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
| DP Clinical, Inc. | INDUSTRY |
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The principal aim of this study was to establish the feasibility of rapid administration, safety, and tolerability of AC105 in patients with acute spinal cord injury.
To determine safety and tolerability of AC105 following a regimen of 6 intravenous doses over 30 hours in patients with acute non-penetrating traumatic spinal cord injury (SCI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saline | Placebo Comparator | Patients randomized (1:1) to the placebo arm will receive an initial intravenous infusion of saline for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals. |
|
| AC105 | Active Comparator | Patients randomized (1:1) to the active drug arm will receive an initial intravenous infusion of AC105 for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AC105 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Treatment-Emergent Adverse Events (TEAEs) are defined as AEs with date time of onset (or worsening) on or after the start date time of the first infusion and no more than 30 days after the end of the last infusion. | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) Parameters of AC105 Using Individual Patient Plasma Concentration-time Data | Measuring Maximum Measured Plasma Concentration (Cmax), Time to Maximum Measured Plasma Concentration (Tmax), Half-life calculated as In(2)/kel (T 1/2) and Area Under the Plasma Concentration versus time curve (AUC). | baseline, prior to and up to 5 hours following last infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Eisen, MD | Acorda Therapeutics | Study Director |
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A total of 15 subjects were enrolled. 2 subjects randomized to placebo were subsequently deemed ineligible and were not treated with the investigational product; they were excluded from the analysis. A total of 13 subjects received at least 1 infusion of the investigational product (AC105 and placebo) and were included in the Safety Population.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Patients randomized (1:1) to the placebo arm will receive an initial intravenous infusion of saline for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals. Placebo |
| FG001 | AC105 | Patients randomized (1:1) to the active drug arm will receive an initial intravenous infusion of AC105 for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals. AC105 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Population
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Patients randomized (1:1) to the placebo arm will receive an initial intravenous infusion of saline for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals. Placebo |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Treatment-Emergent Adverse Events (TEAEs) are defined as AEs with date time of onset (or worsening) on or after the start date time of the first infusion and no more than 30 days after the end of the last infusion. | Safety Population | Posted | Number | participants | up to 6 months |
|
Up to 6 months.
TEAEs are defined as adverse events (AEs) with date time of onset (or worsening) on or after the start date time of the first infusion and no more than 30 days after the end of the last infusion. Adverse events were classified according to Version 16.0 of the Medical Dictionary for Regulatory Activities (MedDRA) coding dictionary.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Patients randomized (1:1) to the placebo arm will receive an initial intravenous infusion of saline for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals. Placebo |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Scientific Officer | Acorda Therapeutics, Inc. | 914-347-4300 | acorda@acorda.com |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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|
| Withdrawn by Sponsor |
|
| Protocol Violation |
|
| AC105 |
Patients randomized (1:1) to the active drug arm will receive an initial intravenous infusion of AC105 for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals. AC105 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Patients randomized (1:1) to the active drug arm will receive an initial intravenous infusion of AC105 for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals. AC105 |
|
|
| Secondary | Pharmacokinetic (PK) Parameters of AC105 Using Individual Patient Plasma Concentration-time Data | Measuring Maximum Measured Plasma Concentration (Cmax), Time to Maximum Measured Plasma Concentration (Tmax), Half-life calculated as In(2)/kel (T 1/2) and Area Under the Plasma Concentration versus time curve (AUC). | No subjects were analyzed. No data was collected. There was a change in the planned analysis to not perform formal PK analysis for a terminated study and abbreviated Clinical Study Report. | Posted | baseline, prior to and up to 5 hours following last infusion |
|
|
| 1 |
| 6 |
| 1 |
| 6 |
| 4 |
| 6 |
| EG001 | AC105 | Patients randomized (1:1) to the active drug arm will receive an initial intravenous infusion of AC105 for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals. AC105 | 0 | 7 | 2 | 7 | 6 | 7 |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA (16.0) | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA (16.0) | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Neurogenic bowel | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
|
Sponsor (Acorda) has right to review and comment on proposed publications within a specified time frame, up to 60 days; multi-center trials require joint publication unless specifically permitted otherwise.
| D014947 | Wounds and Injuries |