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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: UCB Pharma

Current Primary Outcome: 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 ]

Number of subjects with adverse events (AEs) reported spontaneously by the subject or observed by the investigator (serious and non-serious).


Original Primary Outcome:

Current Secondary Outcome:

  • 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). ]
    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). ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    Change from Baseline in average pain interfe

    Original Secondary Outcome:

    Information By: UCB Pharma

    Dates:
    Date Received: October 6, 2005
    Date Started: September 2004
    Date Completion:
    Last Updated: September 19, 2014
    Last Verified: September 2011