DS-5565 phase 3 study for post-herpetic neuralgia
- Conditions
- Post-herpetic neuralgia
- Registration Number
- JPRN-jRCT2080222691
- Lead Sponsor
- DAIICHISANKYO Co.,Ltd.
- Brief Summary
In this study, DS-5565 was administered at doses of 15 mg QD, 10 mg BID, or 15 mg BID for 14 weeks, including the titration period, to evaluate the efficacy and safety of DS-5565 in Asian patients with PHN. The mean changes from baseline in ADPS at Week 14 were greater as the daily dose of DS-5565 was increased, and the differences versus placebo were statistically significant in all DS-5565 treatment group. DS-5565 at a dose of 15 mg BID or below is considered safe and well tolerated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 765
Post-herpetic neuralgia defined as pain present for more than 3 months after herpes zoster skin rash
- Average daily pain score >= 4
- Previous use of neurolytic block (eg, chemical neurolytic block using phenol or ethyl alcohol, radiofrequency thermocoagulation) or neurosurgical therapy for current post-herpetic neuralgia
- Other severe pain at screening or randomization, unrelated to post-herpetic neuralgia, that may confound the assessment of post-herpetic neuralgia
- Neurologic disorders at screening or randomization, unrelated to post-herpetic neuralgia, that may confound the assessment of post-herpetic neuralgia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method