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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01135108
Enrollment
5
Registered
2010-06-02
Start date
2009-03-31
Completion date
2010-05-31
Last updated
2025-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injury

Keywords

Analgesics. Non-narcotic / therapeutic use, Spinal Cord Injuries, Pain, Pain measurement / drug effect, Pain postoperative / drug therapy

Brief summary

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

Interventions

DRUGPlacebo

Placebo IV Infusion

DRUGKAI-1678

KAI-1678 IV Infusion

Sponsors

Trident Clinical Research Pty Ltd
CollaboratorINDUSTRY
KAI Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The effect of KAI-1678 on mean change from baseline in pain intensity at 6 hours (PID 6).6 hours

Secondary

MeasureTime frame
The number of participants with adverse events as a measure of safety and tolerability of KAI-1678Two weeks
The effect of KAI-1678 on patient global impression of change6 hours
The effect of KAI-1678 on symptoms of neuropathic pain assessed by the Neuropathic Pain Scale (NPS)6 hours
The effect of KAI-1678 on the proportion of subjects achieving at least a 1 point improvement in pain intensity at 6 hours6 hours

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026