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).

Study Overview
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Brief Summary
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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)

Official Title
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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).

Conditions
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Postherpetic Neuralgia

Intervention / Treatment
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* Drug: SPM927/Lacosamide
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: SPM927/Lacosamide<br>* 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<br>|
| Placebo Comparator: 2<br> | Other: Placebo<br>* Placebo tablets two times a day for 10 weeks<br>* Other names: Vimpat®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lacosamide, Vimpat®