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CompletedNCT01106716Updated Sep 2, 2025

Safety and Efficacy Study of KAI-1678 to Treat Pain in Subjects With Postherpetic Neuralgia

A Phase 2 interventional study of Placebo and KAI-1678 in Postherpetic Neuralgia, sponsored by KAI Pharmaceuticals. Completed at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-02.

Sponsored by KAI Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine whether KAI-1678 is effective in the treatment of postherpetic neuralgia pain

02

Conditions studied

  • Postherpetic Neuralgia

Keywords

  • Lidocaine
  • Lignocaine
  • Analgesics. Non-narcotic / therapeutic use
  • Neuralgia, Postherpetic
  • Pain
  • Pain measurement / drug effect
  • Pain postoperative / drug therapy
  • PHN
03

In context

Neuralgia, Postherpetic

195 studies on the registry are indexed under Neuralgia, Postherpetic; 31 are open to participants now.

This study's enrollment of 23 is below the median of 100 across 160 interventional studies indexed under Neuralgia, Postherpetic.

Browse Neuralgia, Postherpetic studies →

Lead sponsor

KAI Pharmaceuticals is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • diagnosis of PHN with pain for at least 3 months after segmental herpes zoster eruption
  • 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

Exclusion Criteria:

  • diagnosis of PHN with pain for at least 3 months after segmental herpes zoster eruption
  • pain score at least 4 on 11-point numerical rating scale (0-10)
  • stable doses of analgesic medications for at least 1 month"
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
23 participants (actual)

Study arms

  • Placebo comparator
    A1: Placebo

    Placebo

    Drug: Placebo

  • Experimental
    A2: KAI-1678

    Experimental

    Drug: KAI-1678

  • Active comparator
    A3: Lidocaine

    Lidocaine

    Drug: Lidocaine

Interventions

  • DrugPlacebo

    Placebo IV Infusion

  • DrugKAI-1678

    KAI-1678 IV Infusion

  • DrugLidocaine

    Lidocaine

06

What researchers measure

Primary outcomes

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

    Measurements are made using a qualified pain scale and the change from basline is calculated at 6 hours.

    Time frame: Day 1

Secondary outcomes

  1. 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: Day 1

  2. The effect of KAI-1678 on patient global response to treatment

    Time frame: Day 1

  3. The effect of KAI-1678 on symptoms associated with PHN assessed by the Neuropathic Pain Scale (NPS)

    Time frame: Day 1

  4. The number of adverse events as a measure of safety and tolerability of KAI-1678

    Frequency of adverse events on each study treatment

    Time frame: Two weeks

07

Study locations

1 site
  • Sydney, New South Wales, Australia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01106716
Lead sponsor
KAI Pharmaceuticals
Collaborators
Trident Clinical Research Pty Ltd
Responsible party
Sponsor
First posted
Apr 20, 2010
Start date
Mar 2009
Primary completion
Mar 2010
Completion
Apr 2010
Last update
Sep 2, 2025

Study contacts

Gregory Bell, MD
study director · KAI Pharmaceuticals, Inc

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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