A Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Diabetic Neuropathy - Full Text View

Sponsor:	UCB, Inc.
Information provided by:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00220337

Purpose

The purpose of this study is to determine if lacosamide (SPM 927) is safe if taken for a longer period of time and whether it continues to work well to treat pain.

Subjects will receive lacosamide at a dose that will be individually determined to be the one that provides most pain relief with the least side effects. The maximum dose will be 600mg/day. Subjects may participate in this trial until October 2007. This time may be extended to allow them to participate until lacosamide is commercially available.

If a subject meet the requirements for the study at Visit 1 and after a two weeks phase without trial medication, s/he enters a Titration Phase to determine the personal optimal dose of lacosamide. When this dose is reached s/he will enter the Maintenance Phase and will be asked to return for visits every 4 weeks for the first 24 weeks and every 12 weeks thereafter.

Condition	Intervention	Phase
Painful Diabetic Neuropathy	Drug: lacosamide	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	A Multicenter, Open-label Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Diabetic Neuropathy

Resource links provided by NLM:

MedlinePlus related topics: Diabetic Nerve Problems

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

To assess the tolerability and safety of long-term lacosamide administration in subjects with painful diabetic neuropathy. Assessment of adverse events, changes in laboratory parameters, ECGs, and physical examinations.

Secondary Outcome Measures:

To evaluate the efficacy of long-term use of lacosamide in this indication. Efficacy will be determined by pain score ratings assessed in a patient's diary and with ratings at the clinic visits.

Enrollment:	371
Study Start Date:	December 2004
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Open label active treatment	Drug: lacosamide Lacosamide film-coated tablets; two times per day; up to 400 mg/day for 2.75 years

Eligibility

Genders Eligible for Study:

Both

Criteria

Inclusion Criteria:

Painful diabetic neuropathy

Exclusion Criteria:

no clinically relevant liver enzyme abnormalities and impaired renal function, no cardiac abnormalities, no pregnant or nursing females

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00220337

Locations

Germany
Schwarz
Monheim, Germany

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

Additional Information:

Study Summary on ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	SP830
Study First Received:	September 1, 2005
Last Updated:	September 9, 2009
ClinicalTrials.gov Identifier:	NCT00220337 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Signs and Symptoms
Neuromuscular Diseases
Diabetic Neuropathies
Peripheral Nervous System Diseases
Nervous System Diseases

Diabetes Mellitus
Neurologic Manifestations
Endocrine System Diseases
Pain
Diabetes Complications

ClinicalTrials.gov processed this record on February 08, 2010