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).

April 18, 2024 updated by: UCB Pharma
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: 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
Placebo Comparator: 2
Other: Placebo
Placebo tablets two times a day for 10 weeks
Other Names:
  • Vimpat®
  • SPM927
  • Lacosamide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Daily Assessments via patient diary and during patient's visit at the site

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
Daily assessment during entire trial participation including visits at the site

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Investigators

  • Study Director: UCB Clinical Trial Call Center, +1 877 822 9493 (UCB)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2002

Primary Completion (Actual)

December 1, 2002

Study Completion (Actual)

January 1, 2003

Study Registration Dates

First Submitted

March 12, 2009

First Submitted That Met QC Criteria

March 12, 2009

First Posted (Estimated)

March 13, 2009

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP0655

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postherpetic Neuralgia

Clinical Trials on SPM927/Lacosamide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe