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Completed

NCT Number: NCT00861068

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).

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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Key information

Conditions

Postherpetic Neuralgia Nervous System Diseases Neuralgia Neuralgia, Postherpetic Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SPM927/Lacosamide

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

Placebo

Other

Placebo tablets two times a day for 10 weeks

Other names: SPM927, Lacosamide, Vimpat®

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Important dates

Study start
2002
Primary completion
2002
Study completion
2003
First posted
Mar 13, 2009
Registry last updated
Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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