Safety and Efficacy Study of KAI-1678 to Treat Pain in Su... | NCT01135108

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

NCT01135108

Sponsor

KAI Pharmaceuticals

Status

Completed

Last Update Posted

Sep 2, 2025Actual

Enrollment

5Actual

Phase

Phase 2

Conditions

Spinal Cord Injury

Interventions

Placebo
KAI-1678

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Mar 2010Actual

Completion Date

May 2010Actual

First Submitted Date

Apr 16, 2010

First Submission Date that Met QC Criteria

Jun 1, 2010

First Posted Date

Jun 2, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 28, 2025

Last Update Posted Date

Sep 2, 2025Actual

Name	Class
Trident Clinical Research Pty Ltd	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A1: Placebo	Placebo Comparator	Placebo	Drug: Placebo
A2: KAI-1678	Experimental	Experimental	Drug: KAI-1678

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Placebo IV Infusion	A1: Placebo
KAI-1678

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gregory Bell, MD	KAI Pharmaceuticals, Inc	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Sydney	New South Wales		Australia

Condition Browse Module

MeSH Terms

ID	Term
D013119	Spinal Cord Injuries
D010146	Pain
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C584124	KAI-1678

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided