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NCT00238511 Clinical Trial

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

Postherpetic Neuralgia Clinical Trial

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)

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, 

See also
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Terminated NCT01744522 - Leech Therapy for Postherpetic Neuralgia N/A
Completed NCT00478179 - Study of a Bupivacaine Patch (Eladur™) to Treat Post- Herpetic Neuralgia Phase 2
Completed NCT00566904 - New Topical Treatment for Continued Pain After Shingles Phase 1
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Terminated NCT01603394 - Pilot Study Of Pregabalin And Prediction Of Treatment Response In Patients With Postherpetic Neuralgia Phase 4
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Recruiting NCT05568186 - Correlation Between Thermal Patterns of Infrared Thermal Imaging and Clinical Phenotype in Patients With Postherpetic Neuralgia
Recruiting NCT04664530 - The Study on the Esketamine in the Treatment of Postherpetic Neuralgia Phase 4
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Completed NCT00885586 - Acupuncture in Herpes Zoster Neuralgia (ACUZoster) Phase 4
Completed NCT00981227 - Efficacy and Safety of Eslicarbazepine Acetate as Therapy for Patients With Post-Herpetic Neuralgia Phase 2
Completed NCT00576108 - A 2 Week Study of Topical KD7040 in the Treatment of Postherpetic Neuralgia (PHN) Phase 2
Completed NCT00007501 - Shingles Prevention Study Phase 3
Completed NCT04594226 - Electroacupuncture Therapy for Treating Postherpetic Neuralgia N/A
Completed NCT05140863 - To Evaluate the Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Postherpetic Neuralgia Phase 3

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