Study Evaluating Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00546351
First received: October 16, 2007
Last updated: March 26, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Painful Diabetic Neuropathy
Drug: Lacosamide
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety 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 Lacosamide in Subjects With Painful Distal Diabetic Neuropathy Including a Double-blind, Randomized Time Point Withdrawal Subtrial.

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]

    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


Secondary Outcome Measures:
  • Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Baseline Visit. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    0 = not sensitive and 10 = most sensitive sensation imaginable.

  • Average Pain Interference With Sleep (11-point Likert Scale) at Baseline. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 621
Study Start Date: May 2004
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lacosamide
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
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

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00546351

  Show 101 Study Locations
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00546351     History of Changes
Other Study ID Numbers: SP746, 2004-000551-42
Study First Received: October 16, 2007
Results First Received: December 21, 2011
Last Updated: March 26, 2012
Health Authority: Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Bulgaria: Ministry of Health
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Hungary: National Institute of Pharmacy
Italy: Ministry of Health
Poland: Ministry of Health
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Spain: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by UCB, Inc.:
Lacosamide

Additional relevant MeSH terms:
Diabetic Neuropathies
Pain
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 July 28, 2014