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

This study has been completed.
Sponsor:
Information provided by:
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00220337
First received: September 1, 2005
Last updated: September 19, 2014
Last verified: September 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


Further study details as provided by UCB Pharma:

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
Experimental: 1
Open label active treatment
Drug: lacosamide
Lacosamide film-coated tablets; two times per day; up to 400 mg/day for 2.75 years
Other Name: SPM 927

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Schwarz
Monheim, Germany
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, UCB
ClinicalTrials.gov Identifier: NCT00220337     History of Changes
Other Study ID Numbers: SP0830, 2004-000960-28
Study First Received: September 1, 2005
Last Updated: September 19, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diabetic Neuropathies
Pain
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Peripheral Nervous System Diseases
Signs and Symptoms
Lacosamide
Anticonvulsants
Central Nervous System Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014