Clinical trial NCT00235443: A Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Painful Distal Diabetic Neuropathy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Diabetic Neuropathy
Keywords: Painful Distal Diabetic Neuropathy
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-10-10
Enrollment: 451
Sex: ALL
Minimum age (years): 32
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase 2/3 open-label trial to assess the safety and tolerability of long-term treatment with lacosamide (SPM 927) in subjects with painful diabetic neuropathy. The safety and tolerability of the different doses of lacosamide will be investigated.

Detailed description: 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 trials 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.

Eligibility criteria: Inclusion Criteria:

* Subjects who completed Study SP665, SP742, or SP768 and, in the investigators opinion, might benefit from long-term administration of SPM 927. Exception: subjects who prematurely discontinued Study SP742 or SP768 due to lack of efficacy or due to intolerability to trial medication may be eligible to participate in Study SP745, after consultation with the medical monitor.

Exclusion Criteria:

* Subject has clinically relevant electrocardiogram (ECG) abnormalities, or QT-corrected (QTc) interval \>=500 milliseconds (ms), and/or a QTc interval increase of \>=60ms from the mean pre-dose QTc value at Visit 2 of Studies SP665, SP742 or SP768.
* Subject has aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>=3 times the upper limit of the normal range (ULN) with total bilirubin \>=2 times ULN or transaminases (AST and/or ALT) \>=5 times ULN.
* Subject has a clinically relevant medical condition that, in the opinion of the investigator, jeopardizes or compromises the subject's ability to participate in this trial.

Primary outcomes:
measure: Number of Subjects With Adverse Events (AEs) Reported Spontaneously by the Subject or Observed by the Investigator.
timeFrame: Throughout the study up to a maximum study period of 2.8 years
Secondary outcomes:
measure: Change From Baseline in Average Daily Pain Score Using an 11-point Likert Scale (0-10).
timeFrame: Baseline to end of entire treatment phase (maximum study period of 2.8 years).
measure: Change From Baseline in Average Pain Score as Measured by a 100mm Visual Analogue Scale (VAS).
timeFrame: Baseline to end of entire treatment phase (maximum study period of 2.8 years).
measure: Patient's Global Impression of Change (PGIC) From Baseline in Pain.
timeFrame: Baseline to Termination Visit
measure: Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Intensity.
timeFrame: Baseline to Termination Visit
measure: Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sharpness
timeFrame: Baseline to Termination Visit
measure: Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Heat
timeFrame: Baseline to Termination Visit
measure: Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Dullness
timeFrame: Baseline to Termination Visit
measure: Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Cold
timeFrame: Baseline to Termination Visit
measure: Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sensitivity
timeFrame: Baseline to Termination Visit
measure: Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Itchiness
timeFrame: Baseline to Termination Visit
measure: Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Unpleasantness
timeFrame: Baseline to Termination Visit
measure: Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Deep Pain
timeFrame: Baseline to Termination Visit
measure: Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Surface Pain
timeFrame: Baseline to Termination Visit
measure: Change From Baseline in Average Pain Interference With Sleep (11-point Likert Scale)
timeFrame: Baseline to end of entire treatment phase visit
measure: Change From Baseline in Average Pain Interference With Activity (11-point Likert Scale)
timeFrame: Baseline to end of entire treatment phase visit
measure: Change From Baseline in Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS)
timeFrame: Baseline to Termination Visit
measure: Change From Baseline in Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS)
timeFrame: Baseline to Termination Visit
Other outcomes:
Locations:
city: Anniston
country: United States
state: Alabama
city: Hoover
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Northport
country: United States
state: Alabama
city: Tuscaloosa
country: United States
state: Alabama
city: Peoria
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Hot Springs
country: United States
state: Arkansas
city: Jonesboro
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Irvine
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: Santa Monica
country: United States
state: California
city: Spring Valley
country: United States
state: California
city: Tustin
country: United States
state: California
city: Walnut Creek
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Stratford
country: United States
state: Connecticut
city: Newark
country: United States
state: Delaware
city: Wilmington
country: United States
state: Delaware
city: Bradenton
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: New Port Richey
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Pinellas Park
country: United States
state: Florida
city: Saint Petersburg
country: United States
state: Florida
city: South Miami
country: United States
state: Florida
city: Sunrise
country: United States
state: Florida
city: Tallahassee
country: United States
state: Florida
city: Marietta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Elk Grove Village
country: United States
state: Illinois
city: North Chicago
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: West Des Moines
country: United States
state: Iowa
city: Crestview Hills
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Madisonville
country: United States
state: Kentucky
city: Paducah
country: United States
state: Kentucky
city: Owings Mills
country: United States
state: Maryland
city: Towson
country: United States
state: Maryland
city: Brockton
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Saint Louis
country: United States
state: Missouri
city: Great Falls
country: United States
state: Montana
city: Omaha
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Lawrenceville
country: United States
state: New Jersey
city: Voorhees
country: United States
state: New Jersey
city: Albany
country: United States
state: New York
city: Mineola
country: United States
state: New York
city: White Plains
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Greensboro
country: United States
state: North Carolina
city: Greenville
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Medford
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Upland
country: United States
state: Pennsylvania
city: Greer
country: United States
state: South Carolina
city: Bristol
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Amarillo
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Richardson
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Bennington
country: United States
state: Vermont
city: Richmond
country: United States
state: Virginia
city: Salem
country: United States
state: Virginia
city: Virginia Beach
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
city: Wenatchee
country: United States
state: Washington
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Shaibani A, Biton V, Rauck R, Koch B, Simpson J. Long-term oral lacosamide in painful diabetic neuropathy: a two-year open-label extension trial. Eur J Pain. 2009 May;13(5):458-63. doi: 10.1016/j.ejpain.2008.05.016. Epub 2008 Jul 10.