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Trial record 1 of 1 for:    NCT00546351
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Study Evaluating Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy.

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ClinicalTrials.gov Identifier: NCT00546351
Recruitment Status : Completed
First Posted : October 18, 2007
Results First Posted : April 19, 2012
Last Update Posted : August 28, 2017
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Tracking Information
First Submitted Date  ICMJE October 16, 2007
First Posted Date  ICMJE October 18, 2007
Results First Submitted Date  ICMJE December 21, 2011
Results First Posted Date  ICMJE April 19, 2012
Last Update Posted Date August 28, 2017
Study Start Date  ICMJE May 2004
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2012)
  • Number of Participants Experiencing the Occurrence of at Least One Treatment-emergent Adverse Event (TEAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (Approximately 6.5 Years). [ Time Frame: From entry Visit 1 through end of treatment (approximately 6.5 years) ]
    Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
  • Number of Participants Experiencing the Occurrence of at Least One Serious Adverse Event (SAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (Approximately 6.5 Years). [ Time Frame: From entry Visit 1 through end of treatment (approximately 6.5 years) ]
    A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:
    • Is fatal
    • Is life-threatening
    • Results in persistent or significant disability/incapacity
    • Requires inpatient hospitalization
    • Prolongs existing inpatient hospitalization
    • Is a congenital anomaly/birth defect
    • Is considered to be an important medical event. Such an event may not be immediately life threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent one of the other outcomes listed in the definitions above
Original Primary Outcome Measures  ICMJE
 (submitted: October 17, 2007)
To assess the tolerability and safety of long-term lacosamide administration in subjects with painful distal diabetic neuropathy. Assessment of adverse events, changes in laboratory parameters, ECGs, and physical examinations. [ Time Frame: Assessments are made at all clinic visits. ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2012)
  • Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Baseline Visit. [ Time Frame: Baseline ]
    On the Likert Scale, 0 = no pain and 10 = worst possible pain.
  • Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Last Visit. [ Time Frame: Last Visit (approximately 2 years) ]
    On the Likert Scale, 0 = no pain and 10 = worst possible pain.
  • Average Pain Score as Measured by a 100 mm Visual Analog Scale (VAS) at Baseline. [ Time Frame: Baseline ]
    Visual Analog Scale (VAS) 0 mm = no pain and 100 mm = worst possible pain.
  • Average Pain Score as Measured by a 100 mm Visual Analogue Scale (VAS) at Last Visit. [ Time Frame: Last Visit (approximately 2 years) ]
    On VAS 0 mm = no pain and 100 mm = worst possible pain.
  • Patient's Global Impression of Change (PGIC) at Last Visit. [ Time Frame: Last Visit (approximately 2 years) ]
    The PGIC is a 7-point self-administered categorical rating scale in which the subject rated the change in pain since starting trial medication (from much worse [score of 1] to much better [score of 7]). 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 at Last Visit. [ Time Frame: Baseline Visit; Last Visit (approximately 2 years) ]
    0 = no pain and 10 = most intense pain sensation imaginable.
  • Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sharpness at Last Visit. [ Time Frame: Baseline Visit; Last Visit (approximately 2 years) ]
    0 = not sharp and 10 = most sharp sensation imaginable.
  • Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Heat at Last Visit. [ Time Frame: Baseline Visit; Last Visit (approximately 2 years) ]
    0 = not hot and 10 = the most hot sensation imaginable.
  • Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Cold at Last Visit. [ Time Frame: Baseline Visit; Last Visit (approximately 2 years) ]
    0 = not cold and 10 = the coldest sensation imaginable.
  • Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Dullness at Last Visit. [ Time Frame: Baseline Visit; Last Visit (approximately 2 years) ]
    0 = not dull and 10 = most dull sensation imaginable.
  • Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Unpleasantness at Final Visit. [ Time Frame: Baseline Visit; Last Visit (approximately 2 years) ]
    0 = not unpleasant and 10 = most unpleasant sensation imaginable.
  • Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Surface Pain at Last Visit. [ Time Frame: Baseline Visit; Last Visit (approximately 2 years) ]
    0 = no surface pain and 10 = most intense surface pain imaginable.
  • Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Deep Pain at Last Visit. [ Time Frame: Baseline Visit; Last Visit (approximately 2 years) ]
    0 = no deep pain and 10 = most intense deep pain imaginable.
  • Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Itchiness at Final Visit. [ Time Frame: Baseline Visit; Last Visit (approximately 2 years) ]
    0 = not itchy and 10 = most itchy sensation imaginable.
  • Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sensitivity at Last Visit. [ Time Frame: Baseline Visit; Last Visit (approximately 2 years) ]
    0 = not sensitive and 10 = most sensitive sensation imaginable.
  • Average Pain Interference With Sleep (11-point Likert Scale) at Baseline. [ Time Frame: Baseline ]
    0 = no interference with sleep and 10 = worst possible interference with sleep.
  • Average Pain Interference With Sleep (11-point Likert Scale) at Last Visit. [ Time Frame: Last Visit ]
    0 = no interference with sleep and 10 = worst possible interference with sleep.
  • Average Pain Interference With Activity (11-point Likert Scale) at Baseline. [ Time Frame: Baseline ]
    0 = no interference with activity and 10 = worst possible interference with activity.
  • Average Pain Interference With Activity (11-point Likert Scale) at Last Visit. [ Time Frame: Last Visit ]
    0 = no interference with activity and 10 = worst possible interference with activity.
  • Average Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS) at Baseline. [ Time Frame: Baseline ]
    The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.
  • Average Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS) at Last Visit. [ Time Frame: Last Visit ]
    The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.
  • Average Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS) at Baseline. [ Time Frame: Baseline ]
    The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.
  • Average Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS) at Last Visit. [ Time Frame: Last Visit ]
    The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2007)
The secondary objective is 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. [ Time Frame: Efficacy will be determined by pain score ratings assessed in a patient's diary for daily entries and with ratings at the clinic visits. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy.
Official Title  ICMJE A Multi-center, Open-label, follow-on Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy Including a Double-blind, Randomized Time Point Withdrawal Subtrial.
Brief Summary SP746 (NCT00546351) is a multi-center, open-label, follow-on trial. The purpose of this trial is to assess safety and tolerability of long-term exposure of lacosamide (previously referred to as SPM 927) in subjects with painful distal diabetic neuropathy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Painful Diabetic Neuropathy
Intervention  ICMJE Drug: Lacosamide
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years
Other Name: Vimpat
Study Arms  ICMJE Experimental: Lacosamide
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
Intervention: Drug: Lacosamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 11, 2010)
621
Original Actual Enrollment  ICMJE
 (submitted: October 17, 2007)
614
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects who completed Study SP743 (NCT00238524) or SP874 (NCT00350103) and, in the investigator's opinion, might benefit from long-term administration of SP746 (NCT00546351). Exception: subjects who prematurely discontinued
  • SP743 (NCT00238524) or SP874 (NCT00350103) due to lack of efficacy or due to intolerability to trial medication (after Visit 5but prior to entering the Maintenance Phase) may be eligible to participate in SP746 (NCT00546351), after consultation with the medical monitor

Exclusion Criteria:

  • Subject has clinically relevant ECG abnormalities, or a QTc interval ≥500 ms, and/or a QTc interval increase of ≥60 ms from the mean pre-dose QTc value at Visit 2 of SP743 (NCT00238524) or SP874 (NCT00350103)
  • 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
  • Subject is a pregnant or nursing female, or is of childbearing potential and is not surgically sterile, 2 years postmenopausal, or does not practice 2 combined methods of contraception
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Bulgaria,   Czechia,   Finland,   France,   Germany,   Hungary,   Italy,   Poland,   Romania,   Russian Federation,   Serbia,   Spain,   United Kingdom
Removed Location Countries Czech Republic,   Former Serbia and Montenegro
 
Administrative Information
NCT Number  ICMJE NCT00546351
Other Study ID Numbers  ICMJE SP0746
2004-000551-42 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma
Study Sponsor  ICMJE UCB Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
PRS Account UCB Pharma
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP