A Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Painful Distal Diabetic Neuropathy - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00235443

Purpose

This phase 2/3 open-label trial is being conducted at approximately 100 sites in the US to assess the safety and tolerability of long-term treatment with lacosamide (SPM 927) in subjects with painful diabetic neuropathy. Approximately 525 subjects will be enrolled. To qualify for this trial, subjects with symptoms of painful distal diabetic neuropathy ranging in duration from 6 months to 5 years must have completed trial SP665, SP742, or SP768 and, in the investigator's opinion, may benefit from long-term administration of lacosamide. Subjects will be titrated to their optimal dose of lacosamide (up to 600mg/day).

The safety and tolerability of the different doses of lacosamide will be investigated throughout the trial. In addition, to determine what effect lacosamide has on diabetic neuropathic pain, subjects will use a diary to record their daily pain intensity and pain interference with sleep and activity. Subjects' quality of life will also be investigated.

Condition	Intervention	Phase
Diabetic Neuropathy	Drug: lacosamide	Phase II Phase III

MedlinePlus related topics: Diabetic Nerve Problems

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center, Open-Label, Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Subjects With Painful Distal Diabetic Neuropathy

Further study details as provided by UCB:

Primary Outcome Measures:

AEs reported spontaneously by the subject or observed by the investigator [ Time Frame: Throughout the study period ]
Changes in hematology, clinical chemistry, and urinalysis parameters [ Time Frame: Throughout the study period ]
Changes in vital sign measurements and physical (including neurological) examination findings [ Time Frame: Throughout the study period ]
Changes in 12-lead ECGs [ Time Frame: Throughout the study period ]
Subject withdrawals due to AEs [ Time Frame: Throughout the study period ]

Secondary Outcome Measures:

To evaluate the efficacy of long-term use of lacosamide in this indication. [ Time Frame: Throughout the study period ]
Average daily pain score at each designated week using an 11-point Likert scale (0-10) [ Time Frame: Throughout the study period ]
Average pain score at each visit as measured by a 100mm Visual Analogue Scale (VAS) [ Time Frame: Throughout the study period ]
Patient's Global Impression of Change in Pain (PGIC) assessed at Visit 7, Visits 8.x and the Termination Visit [ Time Frame: Throughout the study period ]
Within-subject change in different aspects of neuropathic pain from Baseline in the preceding trial (Visit 1 of SP665, Visit 2 of SP742 and SP768) to visit 7, Visits 8.x and the Termination Visit of SP745 using the Neuropathic Pain Scale (NPS) [ Time Frame: Throughout the study period ]
Average daily sleep and activity score at each designated week using an 11-point Likert scale (0-10). Sleep is assessed every morning and activity is assessed every evening during the assigned diary periods. [ Time Frame: Throughout the study period ]
Within subject change in quality of life from Baseline in the preceding trial (Visit 1 of SP665, Visit 2 of SP742 and SP768) to Visit 7, Visits 8.x and the Termination Visit of SP745 using SP-36 Health Survey QOL questionnaire. [ Time Frame: Throughout the study period ]

Enrollment:	452
Study Start Date:	September 2004
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Open label doses include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, and 600mg/day	Drug: lacosamide 50 mg tablets and 100 mg tablets of lacosamide taken BID for a protocol specified dose (100, 200, 300, 400, 500 or 600 mg daily dose); flex dosing for duration of trial

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Painful Distal Diabetic Neuropathy

Exclusion Criteria:

Must have experienced painful distal diabetic neuropathy for at least six months and no more than 5 years

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235443

Show 84 Study Locations

Sponsors and Collaborators

UCB

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	SP745
Study First Received:	October 6, 2005
Last Updated:	July 31, 2008
ClinicalTrials.gov Identifier:	NCT00235443
Health Authority:	United States: Food and Drug Administration

Keywords provided by UCB:

Painful Distal Diabetic Neuropathy

Study placed in the following topic categories:

Neuromuscular Diseases
Diabetic Neuropathies
Peripheral Nervous System Diseases
Diabetes Mellitus

Endocrine System Diseases
Pain
Endocrinopathy
Diabetes Complications

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009