Spinal Cord InjuryPhase 2NCT01135108
Safety and Efficacy Study of KAI-1678 to Treat Pain in Subjects With Spinal Cord Injury
A Phase 2 study testing KAI-1678 in people with Spinal Cord Injury, run by KAI Pharmaceuticals at 1 site in Australia.
Trial summary
The purpose of this study is to determine whether KAI-1678 is effective in the treatment of pain associated with spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- KAI-1678
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2009to May 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- history of chronic alcoholism or chronic substance abuse
- tolerance to opioid analgesics
- clinically significant abnormality on laboratory tests or ECG
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
The purpose of this study is to determine whether KAI-1678 is effective in the treatment of pain associated with spinal cord injury.
- Conditions
- Spinal Cord Injury
- Being tested
- Placebo, KAI-1678
- Keywords
- Analgesics. Non-narcotic / therapeutic use, Spinal Cord Injuries, Pain, Pain measurement / drug effect, Pain postoperative / drug therapy
- Medical subject headings
- Spinal Cord Injuries, Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo IV Infusion
KAI-1678Drug
KAI-1678 IV Infusion
| Study group | Role | What they receive |
|---|---|---|
| A1: Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| A2: KAI-1678 | Experimental | Experimental Receives: Drug: KAI-1678 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of KAI-1678 on mean change from baseline in pain intensity at 6 hours (PID 6).
Measured: 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
Measured: 6 hours
The effect of KAI-1678 on patient global impression of change
Measured: 6 hours
The effect of KAI-1678 on symptoms of neuropathic pain assessed by the Neuropathic Pain Scale (NPS)
Measured: 6 hours
The number of participants with adverse events as a measure of safety and tolerability of KAI-1678
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startMar 2009
- Primary completionMar 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- KAI Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Trident Clinical Research Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Gregory Bell, MD, Study director, KAI Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135108
- Sponsor's protocol ID
- KAI-1678-004
- Status last verified
- Aug 2025
- First submitted
- 16 Apr 2010
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01135108
- Acronym / sponsor ID
- KAI-1678-004
- Conditions
- Spinal Cord Injury
- Keywords
- Analgesics. Non-narcotic / therapeutic use, Spinal Cord Injuries, Pain, Pain measurement / drug effect, Pain postoperative / drug therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- KAI PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Trident Clinical Research Pty Ltd
- Study start
- Mar 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 2 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether KAI-1678 is effective in the treatment of pain associated with spinal cord injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A1: Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| A2: KAI-1678 | Experimental | Drug: KAI-1678Experimental |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- history of chronic alcoholism or chronic substance abuse
- tolerance to opioid analgesics
- clinically significant abnormality on laboratory tests or ECG
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo IV Infusion | Drug | A1: Placebo |
| KAI-1678KAI-1678 IV Infusion | Drug | A2: KAI-1678 |
Primary outcome
The effect of KAI-1678 on mean change from baseline in pain intensity at 6 hours (PID 6).
Time frame: 6 hours
4 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Bell, MD study director
KAI Pharmaceuticals, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KAI-1678 in people with Spinal Cord Injury, run by KAI Pharmaceuticals at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of KAI-1678 on mean change from baseline in pain intensity at 6 hours (PID 6). (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.