Status and phase
Conditions
Treatments
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Primary purpose
Allocation
Interventional model
Masking
103 participants in 2 patient groups, including a placebo group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal