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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00235443
First received: October 6, 2005
Last updated: September 19, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetic Neuropathy
 Drug: lacosamide
 Phase 2
Phase 3

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

Resource links provided by NLM:

Drug Information available for: Lacosamide
U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Number of Subjects With Adverse Events (AEs) Reported Spontaneously by the Subject or Observed by the Investigator. [ Time Frame: Throughout the study up to a maximum study period of 2.8 years ] [ Designated as safety issue: No ]
    Number of subjects with adverse events (AEs) reported spontaneously by the subject or observed by the investigator (serious and non-serious).


Secondary Outcome Measures:
  • Change From Baseline in Average Daily Pain Score Using an 11-point Likert Scale (0-10). [ Time Frame: Baseline to end of entire treatment phase (maximum study period of 2.8 years). ] [ Designated as safety issue: No ]
    Change from Baseline in average daily pain score using an 11-point Likert scale (0-10). On Likert scale, 0=no pain and 10=worst possible pain.

  • Change From Baseline in Average Pain Score as Measured by a 100mm Visual Analogue Scale (VAS). [ Time Frame: Baseline to end of entire treatment phase (maximum study period of 2.8 years). ] [ Designated as safety issue: No ]
    Change from Baseline in average pain score as measured by a 100mm Visual Analogue Scale (VAS). On VAS 0mm=no pain and 100mm=worst possible pain.

  • Patient's Global Impression of Change (PGIC) From Baseline in Pain. [ Time Frame: Baseline to Termination Visit ] [ Designated as safety issue: No ]
    Patient's Global Impression of Change (PGIC) from Baseline in Pain. Original categorical responses are much worse, moderately worse, mildly worst, no change, mildly better, moderately better, and much better. Reported results are presented as Better (sum of mildly, moderately, or much better), No Change, or Worse (sum of mildly, moderately, or much worse).

  • Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Intensity. [ Time Frame: Baseline to Termination Visit ] [ Designated as safety issue: No ]
    Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) for intensity of pain where 0=no pain and 10=most intense pain sensation imaginable.

  • Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sharpness [ Time Frame: Baseline to Termination Visit ] [ Designated as safety issue: No ]
    Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) for sharpness of pain where 0=not sharp and 10=most sharp sensation imaginable ("like a knife").

  • Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Heat [ Time Frame: Baseline to Termination Visit ] [ Designated as safety issue: No ]
    Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with heat sensation where 0=not hot and 10=the most hot sensation imaginable ("on fire").

  • Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Dullness [ Time Frame: Baseline to Termination Visit ] [ Designated as safety issue: No ]
    Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with dullness of pain where 0=not dull and 10=most dull sensation imaginable.

  • Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Cold [ Time Frame: Baseline to Termination Visit ] [ Designated as safety issue: No ]
    Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with cold sensation where 0=not cold and 10=most cold sensation imaginable ("freezing").

  • Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sensitivity [ Time Frame: Baseline to Termination Visit ] [ Designated as safety issue: No ]
    Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with sensitivity of pain where 0=not sensitive and 10=most sensitive sensation imaginable ("raw skin").

  • Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Itchiness [ Time Frame: Baseline to Termination Visit ] [ Designated as safety issue: No ]
    Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with itchiness where 0=not itchy and 10=most itchy sensation imaginable ("like poison oak").

  • Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Unpleasantness [ Time Frame: Baseline to Termination Visit ] [ Designated as safety issue: No ]
    Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with unpleasantness where 0=not pleasant and 10=most unpleasant sensation imaginable ("intolerable").

  • Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Deep Pain [ Time Frame: Baseline to Termination Visit ] [ Designated as safety issue: No ]
    Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with deep pain where 0=no deep pain and 10=most intense deep pain sensation imaginable.

  • Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Surface Pain [ Time Frame: Baseline to Termination Visit ] [ Designated as safety issue: No ]
    Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with surface pain where 0=no surface pain and 10=most intense surface pain imaginable.

  • Change From Baseline in Average Pain Interference With Sleep (11-point Likert Scale) [ Time Frame: Baseline to end of entire treatment phase visit ] [ Designated as safety issue: No ]
    Change from Baseline in average pain interference with sleep (11-point Likert scale) where 0=no interference with sleep and 10=worst possible interference with sleep.

  • Change From Baseline in Average Pain Interference With Activity (11-point Likert Scale) [ Time Frame: Baseline to end of entire treatment phase visit ] [ Designated as safety issue: No ]
    Change from Baseline in average pain interference with activity (11-point Likert scale) where 0=no interfence with activity and 10=worst possible interference with activity.

  • Change From Baseline in Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS) [ Time Frame: Baseline to Termination Visit ] [ Designated as safety issue: No ]
    Change from Baseline in quality of life using the SF-36 Health Survey - Physical Component Summary (PCS). Values range from 0 to 100 with high values indicating a good condition. Positive change in baseline values indicate improvement in quality of life.

  • Change From Baseline in Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS) [ Time Frame: Baseline to Termination Visit ] [ Designated as safety issue: No ]
    Change from Baseline in quality of life using the SF-36 Health Survey - Mental Component Summary (MCS). Values range from 0 to 100 with high values indicating a good condition. Positive change in baseline values indicate improvement in quality of life.


Enrollment: 451
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
Experimental: 1
Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
 Drug: lacosamide
Open-label treatment (two times per day) with film-coated tablets include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, and 600mg/day throughout individual study period.
Other Name: SPM927

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

Ages Eligible for Study:   32 Years to 81 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00235443

  Show 84 Study Locations
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
FDA Safety Alerts and Recalls  This link exits the ClinicalTrials.gov site
Product Information  This link exits the ClinicalTrials.gov site

No publications provided by UCB, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00235443     History of Changes
Other Study ID Numbers: SP745
Study First Received: October 6, 2005
Results First Received: August 31, 2009
Last Updated: September 19, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by UCB, Inc.:
Painful Distal Diabetic Neuropathy

Additional relevant MeSH terms:
Diabetic Neuropathies
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Peripheral Nervous System Diseases
Neuromuscular Diseases
 Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on May 19, 2013