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

August 29, 2023 updated by: UCB Pharma

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
621

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria
        • 180
      • Wien, Austria
        • 183
  • Belgium
      • Antwerp, Belgium
        • 003
      • Bonheiden, Belgium
        • 006
      • Genk, Belgium
        • 002
      • Leuven, Belgium
        • 001
      • Merksem, Belgium
        • 005
      • Roeselare, Belgium
        • 004
  • Bulgaria
      • Pleven, Bulgaria
        • 011
      • Plovdiv, Bulgaria
        • 014
      • Plovdiv, Bulgaria
        • 017
      • Ruse, Bulgaria
        • 019
      • Sofia, Bulgaria
        • 012
      • Sofia, Bulgaria
        • 013
      • Sofia, Bulgaria
        • 015
      • Sofia, Bulgaria
        • 016
      • Stara Zagora, Bulgaria
        • 210
      • Varna, Bulgaria
        • 010
  • Czechia
      • Brno, Czechia
        • 028
      • Chomutov, Czechia
        • 220
      • Litomerice, Czechia
        • 026
      • Olomouc, Czechia
        • 027
      • Ostrava-Poruba, Czechia
        • 024
      • Pisek, Czechia
        • 029
      • Praha 1, Czechia
        • 021
      • Praha 5, Czechia
        • 022
  • Finland
      • Kuopio, Finland
        • 192
  • France
      • Lisieux, France
        • 034
      • Nevers, France
        • 031
  • Germany
      • Bad Saarow, Germany
        • 040
      • Beckum, Germany
        • 052
      • Berlin, Germany
        • 049
      • Berlin, Germany
        • 051
      • Berlin, Germany
        • 056
      • Berlin, Germany
        • 242
      • Berlin, Germany
        • 249
      • Bochum, Germany
        • 247
      • Hamburg, Germany
        • 041
      • Hamburg, Germany
        • 045
      • Hamburg, Germany
        • 054
      • Jena, Germany
        • 244
      • Köthen, Germany
        • 058
      • Künzing, Germany
        • 043
      • Leipzig, Germany
        • 050
      • Leipzig, Germany
        • 053
      • Leipzig, Germany
        • 250
      • Mittweida, Germany
        • 046
      • München, Germany
        • 243
      • Schwerin, Germany
        • 246
      • Stuhr-Brinkum, Germany
        • 044
      • Witten, Germany
        • 248
  • Hungary
      • Budapest, Hungary
        • 060
      • Budapest, Hungary
        • 062
      • Győr, Hungary
        • 061
      • Kecskemét, Hungary
        • 262
      • Makó, Hungary
        • 260
      • Nyíregyháza, Hungary
        • 266
      • Szeged, Hungary
        • 064
      • Szolnok, Hungary
        • 264
      • Székesfehérvár, Hungary
        • 265
      • Tatabánya, Hungary
        • 263
      • Veszprém, Hungary
        • 261
  • Italy
      • Pavia, Italy
        • 270
      • Pavia, Italy
        • 273
      • Pozzilli, Italy
        • 272
  • Poland
      • Bialystok, Poland
        • 092
      • Bialystok, Poland
        • 293
      • Bydgoszcz, Poland
        • 094
      • Częstochowa, Poland
        • 095
      • Gdansk, Poland
        • 091
      • Gdansk, Poland
        • 093
      • Kraków, Poland
        • 294
      • Kraków, Poland
        • 297
      • Lodz, Poland
        • 090
      • Lodz, Poland
        • 295
      • Radom, Poland
        • 291
      • Warszawa, Poland
        • 292
      • Warszawa, Poland
        • 296
      • Ząbkowicki, Poland
        • 290
  • Romania
      • Bucharest, Romania
        • 100
      • Bucharest, Romania
        • 102
      • Bucharest, Romania
        • 107
      • Bucharest, Romania
        • 108
      • Bucharest, Romania
        • 109
      • Cluj-Napoca, Romania
        • 101
      • Timisoara, Romania
        • 103
  • Russian Federation
      • Moscow, Russian Federation
        • 114
      • Moscow, Russian Federation
        • 115
      • Moscow, Russian Federation
        • 116
      • Samara, Russian Federation
        • 111
      • St. Petersburg, Russian Federation
        • 112
  • Serbia
      • Belgrade, Serbia
        • 140
      • Belgrade, Serbia
        • 143
      • Belgrade, Serbia
        • 144
      • Nis, Serbia
        • 142
  • Spain
      • Granada, Spain
        • 137
  • United Kingdom
      • Bath, United Kingdom
        • 159
      • Bristol, United Kingdom
        • 154
      • Leeds, United Kingdom
        • 152
      • Morriston, United Kingdom
        • 150
      • Newport, United Kingdom
        • 151

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Vimpat

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From entry Visit 1 through end of treatment (approximately 6.5 years)
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
From entry Visit 1 through end of treatment (approximately 6.5 years)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Last Visit (approximately 2 years)
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.
Baseline
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.
Last Visit (approximately 2 years)
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).
Last Visit (approximately 2 years)
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.
Baseline Visit; Last Visit (approximately 2 years)
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.
Baseline Visit; Last Visit (approximately 2 years)
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.
Baseline Visit; Last Visit (approximately 2 years)
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.
Baseline Visit; Last Visit (approximately 2 years)
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.
Baseline Visit; Last Visit (approximately 2 years)
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.
Baseline Visit; Last Visit (approximately 2 years)
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.
Baseline Visit; Last Visit (approximately 2 years)
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.
Baseline Visit; Last Visit (approximately 2 years)
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.
Baseline Visit; Last Visit (approximately 2 years)
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.
Baseline Visit; Last Visit (approximately 2 years)
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.
Baseline
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.
Last Visit
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.
Baseline
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.
Last Visit
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.
Baseline
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.
Last Visit
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.
Baseline
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.
Last Visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UCB Pharma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: UCB Clinical Trial Call Center, +1 877 822 9493 (UCB)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 16, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2007

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SP0746
  • 2004-000551-42 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Locations

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