The Analgesic Efficacy and Safety of Crisugabalin in Patients With Herpes Zoster

Condition(s) studied

Investigational drug(s) / intervention(s)

Crisugabalin combined conventional therapy: In the crisugabalin combined conventional therapy group, crisugabalin will be initiated at 20 mg twice daily. In addition, the group will contain conventional treatment for HZ, except crisugabalin, including NSAIDs, opioids, antiviral drugs and so on.

Conventional therapy: In the conventional therapy group, treatments will include NSAIDs, opioids, antiviral drugs and so on.

Study summary

Herpes zoster (HZ) is characterized by a painful dermatomal rash and significantly affects quality of life, with acute pain increasing the risk of postherpetic neuralgia. Although early antiviral therapy limits viral replication, its analgesic effect is insufficient, and many patients experience inadequate relief despite stepwise use of non-opioids and opioids. Gabapentinoids such as gabapentin and pregabalin are recommended adjuncts, but their efficacy in acute HZ is inconsistent and often accompanied by adverse effects that limit tolerability. Crisugabalin, a newer gabapentinoid approved for peripheral neuropathic pain, has higher affinity and slower dissociation from the α2δ-1 subunit, suggesting stronger analgesia with fewer central side effects. However, its role in managing acute HZ pain remains unknown. We therefore hypothesize that adding crisugabalin to conventional therapy will provide superior pain relief compared with standard treatment alone, and propose a prospective, randomized, controlled, open-label, blinded-endpoint trial to evaluate this.

Eligibility

Primary outcome measure(s)

• the average numeric rating scale score over the past 24 hours, rated each morning upon awakening and average over 7 days at maximum tolerated dose. — At maximum tolerated dose
  The numeric rating scale (NRS) score is a way to quantify the degree of subjective feelings such as pain using numbers. Generally, 0 represents no pain, and 10 represents the most severe pain. A higher score indicates more severe pain.

Trial sites (1)

More Beijing Tiantan Hospital trials in China

Other trials for the same condition