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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00238511
Other study ID # SP0690
Secondary ID
Status Completed
Phase Phase 2
First received October 11, 2005
Last updated September 19, 2014
Start date November 2002
Est. completion date January 2005

Study information

Verified date September 2009
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date January 2005
Est. primary completion date January 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Postherpetic Neuralgia

Exclusion Criteria:

- Does not benefit from long term treatment

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
SPM 927


Locations

Country Name City State
Germany Schwarz Monheim

Sponsors (1)

Lead Sponsor Collaborator
UCB Pharma

Country where clinical trial is conducted

Germany, 

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