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New drug KAI-1678 tested for spinal cord injury pain

NCT ID NCT01135108

Symptom relief Sponsor: KAI Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This Phase 2 trial tested whether KAI-1678, given as a single injection under the skin, can reduce pain in people with spinal cord injury. Only 5 adults with long-term spinal cord injury and chronic pain took part. The study compared KAI-1678 to a placebo to see if it improved pain scores.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
KAI-1678
What this could lead to
If it works, this could point toward a new pain treatment for people with spinal cord injury.
What could go wrong
This is a very small, early Phase 2 trial with only 5 participants, so results may not apply broadly. The drug may not reduce pain better than placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

5 people

The number who actually took part.

Start date

Mar 2009

Finished

May 2010

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Pain Pain, Postoperative spinal cord injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Spinal cord injury

Contacts and locations

Locations

  • Study site

    Sydney, New South Wales, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.