AC105 in Patients With Acute Traumatic Spinal Cord Injury

Acute Spinal Cord Injury Clinical Trial

— AC105  

Official title:

A Phase 2 Double-blind, Randomized, Placebo-controlled Study to Determine the Safety, Tolerability and Potential Activity of AC105 Following a Regimen of 6 Doses Over 30 Hours in Patients With Acute Traumatic Spinal Cord Injury (SCI).

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01750684
• Other study ID #: ACPM-SI-1009
• Status: Terminated
• Phase: Phase 2
• Start date: July 2013
• Est. completion date: May 2015

Study information

• Verified date: October 2018
• Source: Acorda Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: May 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male or female between 18 and 65 years of age, inclusive

• Acute traumatic SCI, at a neurological level between C4 and T11

• No evidence of penetrating or transection injury (e.g. caused by projectile or stab wound)

• Neurological ASIA Impairment Scale A, B or C

• Patient is able to provide written or verbal witnessed consent. If unable to provide either, consent may be provided by legally authorized representative (LAR)

• Patient is able to initiate treatment within time window of injury

Exclusion Criteria:

• Known allergy or hypersensitivity to polyethylene glycol

• Mental impairment or other conditions that would preclude a reliable ASIA exam or adequate consent

• Positive urine pregnancy test result

• Serum creatinine level = 2 mg/dL

• History or active renal failure or dialysis

• Mean arterial blood pressure < 60 mmHg despite vasopressor treatment

• On a current regimen of digoxin

• Chronic use of magnesium salts prior to the SCI (within 1week of presentation) and/or the use of magnesium salts in the acute care setting prior to the administration of investigational product

• Any other medical condition that, in the judgment of the investigator, would preclude provision of informed consent, make participation in the study unsafe, or unreasonably complicate follow-up or the interpretation of study outcome data or may otherwise interfere with achieving the study objectives

• In the judgment of the Investigator, cannot adequately provide informed consent, is likely to be non-compliant, or may be unable to cooperate with study requirements

Related Conditions & MeSH terms

• Acute Spinal Cord Injury
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Drug:
• AC105

Other:
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Acorda Therapeutics	DP Clinical, Inc., United States Department of Defense

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	up to 6 months
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).	baseline, prior to and up to 5 hours following last infusion