Status:
COMPLETED
Efficacy and Safety of CNV2197944 Versus Placebo in Patients With Post-herpetic Neuralgia
Lead Sponsor:
Convergence Pharmaceuticals
Conditions:
Post-herpetic Neuralgia
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
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 compare...
Detailed Description
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 trea...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT01848730
Start Date
April 1 2013
End Date
May 1 2014
Last Update
October 30 2014
Active Locations (1)
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1
Christiaan Barnard Memorial Hospital
Cape Town, South Africa