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).

UCB Pharma0 sites44 target enrollmentFebruary 2002

ConditionsPostherpetic Neuralgia

InterventionsSPM927/Lacosamide Placebo

DrugsSPM927/Lacosamide

Overview

Phase: Phase 2
Intervention: SPM927/Lacosamide
Conditions: Postherpetic Neuralgia
Sponsor: UCB Pharma
Enrollment: 44
Primary Endpoint: Within-subject change in average daily pain score (Likert categorical scale) from the baseline week to the maintenance phase
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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)

Registry

clinicaltrials.gov

Start Date

February 2002

End Date

January 2003

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

UCB Pharma

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.

Arms & Interventions

1

Intervention: SPM927/Lacosamide

2

Intervention: Placebo

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)