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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Study Completion Date

2003-01-31

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)

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Detailed Description

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Conditions

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Postherpetic Neuralgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

SPM927/Lacosamide

Intervention Type DRUG

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

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo tablets two times a day for 10 weeks

Interventions

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SPM927/Lacosamide

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

Intervention Type DRUG

Placebo

Placebo tablets two times a day for 10 weeks

Intervention Type OTHER

Other Intervention Names

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SPM927 Lacosamide Vimpat®

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No