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Trial record 1 of 1 for:    NCT00238511
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An Open-Label Follow-on Trial to Assess the Long-Term Safety and Efficacy of Oral SPM 927 in Subjects With Postherpetic Neuralgia (PHN)

This study has been completed.
Information provided by:
UCB Pharma Identifier:
First received: October 11, 2005
Last updated: September 19, 2014
Last verified: September 2009
This trial was the follow-on trial to a preceeding double-blind, placebo controlled trial which included patients with at least moderate pain due to postherpetic neuralgia. It was conducted at six sites in Germany and has been clinically finalized. The patients had successfully completed the above mentioned trial in postherpetic neuralgia and, in the investigator's opinion, would benefit from long-term administration of Lacosamide. After a 1-week run-in phase the patients were uptitrated to their optimal dose and then continued into the maintenance phase. Dose adjustments were allowed throughout the trial.The change in pain was measured daily as well as interference of pain with sleep and general activity. As per protocol this trial was terminated after two years of treatment.

Condition Intervention Phase
Postherpetic Neuralgia
Drug: SPM 927
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Follow-on Trial to Assess the Long-Term Safety and Efficacy of Oral SPM 927 in Subjects With Postherpetic Neuralgia (PHN)

Resource links provided by NLM:

Further study details as provided by UCB Pharma:

Study Start Date: November 2002
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Postherpetic Neuralgia

Exclusion Criteria:

  • Does not benefit from long term treatment
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Please refer to this study by its identifier: NCT00238511

Monheim, Germany
Sponsors and Collaborators
UCB Pharma
Study Director: UCB Clinical Trial Call Center UCB Pharma
  More Information

Additional Information: Identifier: NCT00238511     History of Changes
Other Study ID Numbers: SP0690
Study First Received: October 11, 2005
Last Updated: September 19, 2014

Additional relevant MeSH terms:
Neuralgia, Postherpetic
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms processed this record on May 25, 2017