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

NCT01106716 — Phase 2, Completed, 23 participants, KAI Pharmaceuticals

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A Double-Blind, Randomized, Placebo- and Active-Comparator-Controlled, Single-Dose Study to Assess the Efficacy of KAI-1678 Administered by Subcutaneous Infusion in Subjects With Postherpetic Neuralgia

Registry	NCT01106716
Status	Completed
Phase	Phase 2
Study type	Interventional; randomized, crossover, masking: double, treatment
Enrollment	23 (Actual)
Sponsor	KAI Pharmaceuticals (Industry); collaborators: Trident Clinical Research Pty Ltd
Conditions	Postherpetic Neuralgia
Interventions	Placebo, KAI-1678, Lidocaine (Drug)
Dates	start 2009-03-01, primary completion 2010-03-01, completion 2010-04-01, first posted 2010-04-20, last updated 2025-09-02
Locations	1 site in Australia

-Summary

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

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+Arms and interventions

Arm	Type	Interventions	Description
A1: Placebo	Placebo comparator	Drug: Placebo	Placebo
A2: KAI-1678	Experimental	Drug: KAI-1678	Experimental
A3: Lidocaine	Active comparator	Drug: Lidocaine	Lidocaine

Placebo (Drug): Placebo IV Infusion
KAI-1678 (Drug): KAI-1678 IV Infusion
Lidocaine (Drug): Lidocaine

+Outcome measures

Primary outcomes

The effect of KAI-1678 on mean change from baseline in pain intensity at 6 hours (PID 6). [Day 1]: Measurements are made using a qualified pain scale and the change from basline is calculated at 6 hours.

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 [Day 1]
The effect of KAI-1678 on patient global response to treatment [Day 1]
The effect of KAI-1678 on symptoms associated with PHN assessed by the Neuropathic Pain Scale (NPS) [Day 1]
The number of adverse events as a measure of safety and tolerability of KAI-1678 [Two weeks]: Frequency of adverse events on each study treatment

+Eligibility

Sex: All, ages: 18 Years to any

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:

* 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"

+Locations (1)

Facility	City	Country	Status
	Sydney, New South Wales	Australia

+Investigators

Gregory Bell, MD, Study director, KAI Pharmaceuticals, Inc