Efficacy and Safety of CNV2197944 Versus Placebo in Patients With Post-herpetic Neuralgia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-05-31

Brief Summary

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To investigate the effect of repeat oral dosing of CNV2197944 75 mg tid on the pain experienced in post-herpetic neuralgia (PHN) as measured by changes in PI-NRS after three weeks of treatment compared to the baseline period.

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Detailed Description

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A 3 week randomised crossover study to investigate the effect of repeat oral dosing of CNV2197944 75 mg tid versus placebo for on the pain experienced in post-herpetic neuralgia (PHN. Each 3 week treatment period is seperated by a 2 week washout period. The primary outcome measure is the change from baseline in the PI-NRS after three weeks of treatment. Secondary outcome measures include pain responder rates, clinical and patient global impressions of pain, and the Neuropathic Pain Symptom Inventory.

Conditions

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Post-herpetic Neuralgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CNV2197944

CNV2197944 75mg tid 21 days

Group Type EXPERIMENTAL

CNV2197944

Intervention Type DRUG

Placebo

Placebo tid 21 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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CNV2197944

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Male or female between 18 and 85 years of age inclusive, at the time of signing the informed consent.

Patients with post-herpetic neuralgia (PHN) with pain at screening present for more than 3 months after healing of the herpes zoster skin rash. The maximum duration of PHN will be no longer than 5 years.

Exclusion Criteria

Patients having other severe pain, which may impair the self-assessment of the pain due to PHN.

Patients who have received nerve blocks for neuropathic pain within 4 weeks prior to the start of the single-blind placebo run-in Certain medications used to relieve the pain of PHN, specifically gabapentinoids (gabapentin and pregabalin), carbamazepine and topical agents (eg capsaicin, lidocaine) Patients with a documented failure to respond to a maximally tolerated dose regimen of gabapentin or pregabalin.

Patients taking more than one medication to treat the PHN pain

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No