NCT01135108

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2010

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 2, 2010

Completed
Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

April 16, 2010

Last Update Submit

August 28, 2025

Conditions

Spinal Cord Injury

Keywords

Analgesics. Non-narcotic / therapeutic useSpinal Cord InjuriesPainPain measurement / drug effectPain postoperative / drug therapy

Outcome Measures

Primary Outcomes (1)

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

    6 hours

Secondary Outcomes (4)

  • 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

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

    6 hours

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

    6 hours

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

    Two weeks

Study Arms (2)

A1: Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

A2: KAI-1678

EXPERIMENTAL

Experimental

Drug: KAI-1678

Interventions

PlaceboDRUG

Placebo IV Infusion

A1: Placebo
KAI-1678DRUG

KAI-1678 IV Infusion

A2: KAI-1678

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • history of chronic alcoholism or chronic substance abuse
  • tolerance to opioid analgesics
  • clinically significant abnormality on laboratory tests or ECG

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Sydney, New South Wales, Australia

Location

MeSH Terms

Conditions

Spinal Cord InjuriesPainPain, Postoperative

Interventions

KAI-1678

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Officials

  • Gregory Bell, MD

    KAI Pharmaceuticals, Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2010

First Posted

June 2, 2010

Study Start

March 1, 2009

Primary Completion

March 1, 2010

Study Completion

May 1, 2010

Last Updated

September 2, 2025

Record last verified: 2025-08

Locations

AU(1)