![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
Sponsored by: |
UCB |
---|---|
Information provided by: | UCB |
ClinicalTrials.gov Identifier: | NCT00861068 |
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)
Condition | Intervention | Phase |
---|---|---|
Postherpetic Neuralgia |
Drug: SPM927/Lacosamide Other: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | 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). |
Enrollment: | 44 |
Study Start Date: | February 2002 |
Study Completion Date: | January 2003 |
Primary Completion Date: | December 2002 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
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
|
2: Placebo Comparator |
Other: Placebo
Placebo tablets two times a day for 10 weeks
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | UCB ( Study Director ) |
Study ID Numbers: | SP655 |
Study First Received: | March 12, 2009 |
Last Updated: | March 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00861068 History of Changes |
Health Authority: | Belgium: Directorate general for the protection of Public health: Medicines; Denmark: Danish Medicines Agency; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; United Kingdom: Department of Health |
Lacosamide, Vimpat® |
Neuralgia, Postherpetic Signs and Symptoms Neuromuscular Diseases Neuralgia |
Peripheral Nervous System Diseases Neurologic Manifestations Pain |
Neuralgia, Postherpetic Signs and Symptoms Neuromuscular Diseases Neuralgia |
Peripheral Nervous System Diseases Nervous System Diseases Neurologic Manifestations Pain |