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Sponsored by: |
UCB |
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Information provided by: | UCB |
ClinicalTrials.gov Identifier: | NCT00861445 |
The primary purpose is to investigate the safety and efficacy of SPM927 in patients with Painful Diabetic Neuropathy
Condition | Intervention | Phase |
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Painful Diabetic Neuropathy |
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 Randomized, Double-Blind Placebo Controlled Trial to Investigate Safety and Efficacy of SPM927 in Painful Diabetic Neuropathy |
Enrollment: | 119 |
Study Start Date: | June 2001 |
Study Completion Date: | February 2003 |
Primary Completion Date: | January 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: SPM927/Lacosamide
SPM927 (film-coated tablets, 25/50/100mg per tablet), dosage 400mg/day, intake in the morning and in the evening, intake for 10 weeks
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2: Placebo Comparator |
Other: Placebo
Placebo tablets two times a day for 10 weeks
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | UCB ( Study Director ) |
Study ID Numbers: | SP614 |
Study First Received: | March 12, 2009 |
Last Updated: | March 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00861445 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Lacosamide, Vimpat® |
Signs and Symptoms Neuromuscular Diseases Diabetic Neuropathies Peripheral Nervous System Diseases Diabetes Mellitus |
Neurologic Manifestations Endocrine System Diseases Pain Endocrinopathy Diabetes Complications |
Signs and Symptoms Neuromuscular Diseases Diabetic Neuropathies Peripheral Nervous System Diseases Nervous System Diseases |
Diabetes Mellitus Neurologic Manifestations Endocrine System Diseases Pain Diabetes Complications |