Trial Outcomes & Findings for AC105 in Patients With Acute Traumatic Spinal Cord Injury (NCT NCT01750684)

Last Updated: 2018-11-06

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

15 participants

Primary outcome timeframe

up to 6 months

Results posted on

2018-11-06

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	6	7
Overall Study COMPLETED	4	5
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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
Overall Study Death	1	0
Overall Study Non-compliance with Study Drug	0	1
Overall Study Withdrawn by Sponsor	0	1
Overall Study Protocol Violation	1	0

Baseline Characteristics

AC105 in Patients With Acute Traumatic Spinal Cord Injury

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=6 Participants 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	AC105 n=7 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	Total n=13 Participants Total of all reporting groups
Age, Continuous	37.0 years STANDARD_DEVIATION 7.12 • n=5 Participants	38.3 years STANDARD_DEVIATION 6.23 • n=7 Participants	37.7 years STANDARD_DEVIATION 4.50 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 6 months

Population: Safety Population

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants 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	AC105 n=7 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
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 Mild TEAEs	4 participants	6 participants
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 Moderate TEAEs	3 participants	5 participants
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 Severe TEAEs	2 participants	3 participants
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 Serious TEAEs	1 participants	2 participants
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 Drug-related TEAEs	0 participants	2 participants
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 TEAEs Leading to Death	1 participants	0 participants

SECONDARY outcome

Timeframe: baseline, prior to and up to 5 hours following last infusion

Population: 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.

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).

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 4 other events

Deaths: 1 deaths

AC105

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=6 participants at risk 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	AC105 n=7 participants at risk 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
Infections and infestations Pneumonia	0.00% 0/6 • 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.	28.6% 2/7 • 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.
Injury, poisoning and procedural complications Wound dehiscence	16.7% 1/6 • 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.	0.00% 0/7 • 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.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/6 • 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.	14.3% 1/7 • 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.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	16.7% 1/6 • 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.	0.00% 0/7 • 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.
Respiratory, thoracic and mediastinal disorders Respiratory failure	16.7% 1/6 • 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.	0.00% 0/7 • 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.

Other adverse events

Additional Information

Chief Scientific Officer

Acorda Therapeutics, Inc.

Phone: 914-347-4300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	Placebo n=6 participants at risk 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	AC105 n=7 participants at risk 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
Gastrointestinal disorders Nausea	33.3% 2/6 • 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.	57.1% 4/7 • 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.
Psychiatric disorders Anxiety	33.3% 2/6 • 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.	42.9% 3/7 • 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.
Infections and infestations Pneumonia	33.3% 2/6 • 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.	42.9% 3/7 • 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.
Psychiatric disorders Depression	50.0% 3/6 • 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.	28.6% 2/7 • 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.
Vascular disorders Hypotension	33.3% 2/6 • 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.	28.6% 2/7 • 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.
Nervous system disorders Neuralgia	33.3% 2/6 • 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.	28.6% 2/7 • 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.
Infections and infestations Urinary tract infection	16.7% 1/6 • 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.	28.6% 2/7 • 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.
Gastrointestinal disorders Ileus	0.00% 0/6 • 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.	28.6% 2/7 • 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.
Psychiatric disorders Insomnia	0.00% 0/6 • 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.	28.6% 2/7 • 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.
Investigations Oxygen saturation decreased	0.00% 0/6 • 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.	28.6% 2/7 • 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.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/6 • 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.	28.6% 2/7 • 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.
Gastrointestinal disorders Constipation	16.7% 1/6 • 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.	14.3% 1/7 • 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.
Gastrointestinal disorders Neurogenic bowel	16.7% 1/6 • 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.	14.3% 1/7 • 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.
General disorders Pyrexia	16.7% 1/6 • 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.	14.3% 1/7 • 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.
Skin and subcutaneous tissue disorders Rash	16.7% 1/6 • 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.	14.3% 1/7 • 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.
Musculoskeletal and connective tissue disorders Muscle spasms	33.3% 2/6 • 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.	0.00% 0/7 • 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.
Respiratory, thoracic and mediastinal disorders Respiratory failure	33.3% 2/6 • 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.	0.00% 0/7 • 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.