Efficacy and Safety of CNV2197944 Versus Placebo in Patients With Post-herpetic Neuralgia
- Registration Number
- NCT01848730
- Lead Sponsor
- Convergence Pharmaceuticals
- 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 compared to the baseline period.
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 103
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.
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo tid 21 days CNV2197944 CNV2197944 CNV2197944 75mg tid 21 days
- Primary Outcome Measures
Name Time Method Pain Intensity Numerical Rating Scale 21 days
- Secondary Outcome Measures
Name Time Method Neuropathic Pain Symptom Inventory 21 days Pain responder rates 21 days
Trial Locations
- Locations (1)
Christiaan Barnard Memorial Hospital
🇿🇦Cape Town, South Africa