Safety and Efficacy Study of KAI-1678 to Treat Pain in Subjects With Spinal Cord Injury

Spinal Cord Injury Clinical Trial

Official title:

A Double-Blind, Randomized, Placebo-Controlled, Single-Dose Two-Period Crossover Study to Assess the Efficacy of KAI-1678 Administered by Subcutaneous Infusion in Subjects With Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01135108
• Other study ID #: KAI-1678-004
• Status: Completed
• Phase: Phase 2
• First received: April 16, 2010
• Last updated: August 30, 2011
• Start date: March 2009
• Est. completion date: May 2010

Study information

• Verified date: August 2011
• Source: KAI Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether KAI-1678 is effective in the treatment of pain associated with spinal cord injury.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: May 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• spinal cord injury at least 1 year prior and nonprogressive ofr at least 6 months

• central neuropathic pain for at least 3 months or with relapses and remissions for at least 6 months

• pain score at least 4 on 11-point numerical rating scale (0-10)

• stable doses of analgesic medications for at least 1 month

Exclusion Criteria:

• history of chronic alcoholism or chronic substance abuse

• tolerance to opioid analgesics

• clinically significant abnormality on laboratory tests or ECG

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Drug:
• Placebo
Placebo IV Infusion
• KAI-1678
KAI-1678 IV Infusion

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
KAI Pharmaceuticals	Trident Clinical Research Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of KAI-1678 on mean change from baseline in pain intensity at 6 hours (PID 6).		6 hours	No
Secondary	The effect of KAI-1678 on the proportion of subjects achieving at least a 1 point improvement in pain intensity at 6 hours		6 hours	No
Secondary	The effect of KAI-1678 on patient global impression of change		6 hours	No
Secondary	The effect of KAI-1678 on symptoms of neuropathic pain assessed by the Neuropathic Pain Scale (NPS)		6 hours	No
Secondary	The number of participants with adverse events as a measure of safety and tolerability of KAI-1678		Two weeks	Yes