Postherpetic Neuralgia
Conditions
Keywords
Lacosamide, Vimpat®
Brief summary
The objective of the trial is to investigate the analgesic efficacy of SPM 927 in subjects with moderate to severe neuropathic pain due to Postherpetic Neuralgia (PHN)
Interventions
SPM927 (film-coated tablets, 25/50/100mg per tablet), dosage up to 600mg/day, intake in the morning and in the evening, intake for 11 weeks
OTHERPlacebo
Placebo tablets two times a day for 10 weeks
Sponsors
UCB Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Within-subject change in average daily pain score (Likert categorical scale) from the baseline week to the maintenance phase | Daily Assessments via patient diary and during patient's visit at the site |
Secondary
| Measure | Time frame |
|---|---|
| Investigate the tolerability and safety of SPM927 (assessments and reporting during entire trial participation). | Daily assessment during entire trial participation including visits at the site |
| To examine the pharmacokinetics of SPM927 (assessment at all site visits during entire trial participation) | Daily assessment during entire trial participation including visits at the site |
| Different qualities of pain due to PHN, sleep and activity (daily assessment during entire trial participation) | Daily assessment during entire trial participation including visits at the site |
Outcome results
None listed