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

UCB Pharma621 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

621

Conditions

Painful Diabetic Neuropathy

Interventions

LacosamideDRUG

50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (101)

Outcomes

Primary Outcomes

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).

Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

Time frame: 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).

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

Time frame: From entry Visit 1 through end of treatment (approximately 6.5 years)

Secondary Outcomes

Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Baseline Visit.

On the Likert Scale, 0 = no pain and 10 = worst possible pain.

Time frame: Baseline

Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Last Visit.

On the Likert Scale, 0 = no pain and 10 = worst possible pain.

Time frame: Last Visit (approximately 2 years)

Average Pain Score as Measured by a 100 mm Visual Analog Scale (VAS) at Baseline.

Visual Analog Scale (VAS) 0 mm = no pain and 100 mm = worst possible pain.

Data from ClinicalTrials.gov

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180

Vienna, Austria

183

Vienna, Austria

003

Antwerp, Belgium

006

Bonheiden, Belgium

002

Genk, Belgium

001

Leuven, Belgium

005

Merksem, Belgium

004

Roeselare, Belgium

011

Pleven, Bulgaria

014

Plovdiv, Bulgaria

...and 91 more locations

Time frame: Baseline

Average Pain Score as Measured by a 100 mm Visual Analogue Scale (VAS) at Last Visit.

On VAS 0 mm = no pain and 100 mm = worst possible pain.

Time frame: Last Visit (approximately 2 years)

Patient's Global Impression of Change (PGIC) at Last Visit.

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).

Time frame: Last Visit (approximately 2 years)

Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Intensity at Last Visit.

0 = no pain and 10 = most intense pain sensation imaginable.