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

KAI Pharmaceuticals5 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Spinal Cord Injury

Interventions

PlaceboDRUG

Placebo IV Infusion

KAI-1678DRUG

KAI-1678 IV Infusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Sydney, New South Wales, Australia

Outcomes

Primary Outcomes

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

Time frame: 6 hours

Secondary Outcomes

The effect of KAI-1678 on the proportion of subjects achieving at least a 1 point improvement in pain intensity at 6 hours

Time frame: 6 hours

The effect of KAI-1678 on patient global impression of change

Time frame: 6 hours

The effect of KAI-1678 on symptoms of neuropathic pain assessed by the Neuropathic Pain Scale (NPS)

Time frame: 6 hours

The number of participants with adverse events as a measure of safety and tolerability of KAI-1678

Time frame: Two weeks

Data from ClinicalTrials.gov

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