A Multi-Centre, Randomized, Double-Blind, Placebo Controlled Pilot Trial to Assess the Efficacy, Safety, and Tolerability of SPM 927 in Subjects With Postherpetic Neuralgia (PHN).

Launched by UCB PHARMA · Mar 12, 2009

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subject has clinically diagnosed painful postherpetic neuralgia present at least six months after healing of a herpes zoster skin rash and has at least one form of allodynia
• • Subject must have at least moderate pain (mean pain intensity ≥ 4 out of 10 during the baseline week on Likert scale).
• Exclusion Criteria:
• • Subject has other conditions that cause pain at least as severe as the postherpetic neuralgia.
• • Subject has had any surgical treatment or any neurolytic injections for PHN
• • Subject has clinically significant ECG and laboratory abnormalities.
• • Subject is receiving treatment with anti-epileptic drugs (AEDs), muscle relaxants, mexiletine, topical analgesics, antidepressants, opioids, non-steroidal anti-inflammatory drugs (NSAIDs), paracetamol, benzodiazepines, and antiviral agents.
• • Subject has liver function tests (AST, ALT, alkaline phosphatase, total bilirubin and GGT out of the reference range) \> 1,5 x ULN (upper limit of normal) at visit 1
• • Subject has serum creatinine ≥ 2 times the upper limit of reference range at Visit 1.

Trial Officials