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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
44
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
Placebo tablets two times a day for 10 weeks
Within-subject change in average daily pain score (Likert categorical scale) from the baseline week to the maintenance phase
Time frame: Daily Assessments via patient diary and during patient's visit at the site
Different qualities of pain due to PHN, sleep and activity (daily assessment during entire trial participation)
Time frame: Daily assessment during entire trial participation including visits at the site
Investigate the tolerability and safety of SPM927 (assessments and reporting during entire trial participation).
Time frame: 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)
Time frame: Daily assessment during entire trial participation including visits at the site
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