Clinical trial NCT00220337: A Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Diabetic Neuropathy
Official title: A Multicenter, Open-label Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Painful Diabetic Neuropathy
Keywords: Painful diabetic neuropathy
Lacosamide
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
Collaborators: name: SCHWARZ BIOSCIENCES GmbH - Part of UCB Group
First posted: 2005-09-22
Enrollment: 371
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if lacosamide (SPM 927) is safe if taken for a longer period of time and whether it continues to work well to treat pain.

Subjects will receive lacosamide at a dose that will be individually determined to be the one that provides most pain relief with the least side effects. The maximum dose will be 600mg/day. Subjects may participate in this trial until October 2007. This time may be extended to allow them to participate until lacosamide is commercially available.

If a subject meet the requirements for the study at Visit 1 and after a two weeks phase without trial medication, s/he enters a Titration Phase to determine the personal optimal dose of lacosamide. When this dose is reached s/he will enter the Maintenance Phase and will be asked to return for visits every 4 weeks for the first 24 weeks and every 12 weeks thereafter.


Eligibility criteria: Inclusion Criteria:

Inclusion Criteria:

* Painful diabetic neuropathy

Exclusion Criteria:

* no clinically relevant liver enzyme abnormalities and impaired renal function, no cardiac abnormalities, no pregnant or nursing females

Exclusion Criteria:

Primary outcomes:
measure: Percentage of Subjects With Adverse Events (AE) Reported Spontaneously by the Subject or Observed by the Investigator
timeFrame: From Screening until Safety Follow up Visit (up to 140 weeks)
measure: Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Titration Period
timeFrame: During the titration period (up to Week 8)
measure: Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Maintenance Period
timeFrame: During the maintenance period (up to 136 weeks)
measure: Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Titration Period
timeFrame: During the titration period (up to Week 8)
measure: Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Maintenance Period
timeFrame: During the maintenance period (up to 136 weeks)
measure: Number of Subjects With Urine pH= 5.0 at Baseline, Categorized by Urine pH at Last Visit
timeFrame: Baseline, Last Visit (up to 140 weeks)
measure: Number of Subjects With Urine pH= 6.0 at Baseline, Categorized by Urine pH at Last Visit
timeFrame: Baseline, Last Visit (up to 140 weeks)
measure: Number of Subjects With Urine pH= 6.5 at Baseline, Categorized by Urine pH at Last Visit
timeFrame: Baseline, Last Visit (up to 140 weeks)
measure: Number of Subjects With Urine pH= 7.0 at Baseline, Categorized by Urine pH at Last Visit
timeFrame: Baseline, Last Visit (up to 140 weeks)
measure: Number of Subjects With Urine pH= 7.5 at Baseline, Categorized by Urine pH at Last Visit
timeFrame: Baseline, Last Visit (up to 140 weeks)
measure: Number of Subjects With Urine pH= 8.0 at Baseline, Categorized by Urine pH at Last Visit
timeFrame: Baseline, Last Visit (up to 140 weeks)
measure: Number of Subjects With Urine White Blood Cell Count 'Negative' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit
timeFrame: Baseline, Last Visit (up to 140 weeks)
measure: Number of Subjects With Urine White Blood Cell Count 'Trace' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit
timeFrame: Baseline, Last Visit (up to 140 weeks)
measure: Number of Subjects With Urine White Blood Cell Count 'Positive +' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit
timeFrame: Baseline, Last Visit (up to 140 weeks)
measure: Number of Subjects With Urine White Blood Cell Count 'Positive ++' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit
timeFrame: Baseline, Last Visit (up to 140 weeks)
measure: Number of Subjects With Urine Nitrite Status 'Negative' at Baseline, Categorized by Urine Nitrite Status at Last Visit
timeFrame: Baseline, Last Visit (up to 140 weeks)
measure: Number of Subjects With Urine Nitrite Status 'Positive' at Baseline, Categorized by Urine Nitrite Status at Last Visit
timeFrame: Baseline, Last Visit (up to 140 weeks)
measure: Number of Subjects With Urine Urobilinogen Value 3 µmol/l at Baseline, Categorized by Urine Urobilinogen Value at Last Visit
timeFrame: Baseline, Last Visit (up to 140 weeks)
measure: Number of Subjects With Urine Urobilinogen Value 16 µmol/l at Baseline, Categorized by Urine Urobilinogen Value at Last Visit
timeFrame: Baseline, Last Visit (up to 140 weeks)
measure: Number of Subjects With Urine Urobilinogen Value 66 µmol/l at Baseline, Categorized by Urine Urobilinogen Value at Last Visit
timeFrame: Baseline, Last Visit (up to 140 weeks)
measure: Number of Subjects With Urine Protein Status 'Negative' at Baseline, Categorized by Urine Protein Status at Last Visit
timeFrame: Baseline, Last Visit (up to 140 weeks)
measure: Number of Subjects With Urine Protein Status 'Trace' at Baseline, Categorized by Urine Protein Status at Last Visit
timeFrame: Baseline, Last Visit (up to 140 weeks)
measure: Number of Subjects With Urine Protein Status 'Positive +' at Baseline, Categorized by Urine Protein Status at Last Visit
timeFrame: Baseline, Last Visit (up to 140 weeks)
measure: Number of Subjects With Urine Protein Status 'Positive ++' at Baseline, Categorized by Urine Protein Status at Last Visit
timeFrame: Baseline, Last Visit (up to 140 weeks)
measure: Number of Subjects With Urine Blood Status 'Negative' at Baseline, Categorized by Urine Blood Status at Last Visit
timeFrame: Baseline, Last Visit (up to 140 weeks)
measure: Number of Subjects With Urine Blood Status 'Trace (N)' at Baseline, Categorized by Urine Blood Status at Last Visit
timeFrame: Baseline, Last Visit (up to 140 weeks)
measure: Number of Subjects With Urine Blood Status 'Trace (H)' at Baseline, Categorized by Urine Blood Status at Last Visit
timeFrame: Baseline, Last Visit (up to 140 weeks)
measure: Number of Subjects With Urine Blood Status 'Positive +' at Baseline, Categorized by Urine Blood Status at Last Visit
timeFrame: Baseline, Last Visit (up to 140 weeks)
measure: Number of Subjects With Urine Blood Status 'Positive ++' at Baseline, Categorized by Urine Blood Status at Last Visit
timeFrame: Baseline, Last Visit (up to 140 weeks)
measure: Number of Subjects With Urine Ketone Status 'Negative' at Baseline, Categorized by Urine Ketone Status at Last Visit
timeFrame: Baseline, Last Visit (up to 140 weeks)
measure: Number of Subjects With Urine Ketone Status 'Trace' at Baseline, Categorized by Urine Ketone Status at Last Visit
timeFrame: Baseline, Last Visit (up to 140 weeks)
measure: Number of Subjects With Urine Ketone Status 'Small' at Baseline, Categorized by Urine Ketone Status at Last Visit
timeFrame: Baseline, Last Visit (up to 140 weeks)
measure: Number of Subjects With Urine Ketone Status 'Moderate' at Baseline, Categorized by Urine Ketone Status at Last Visit
timeFrame: Baseline, Last Visit (up to 140 weeks)
measure: Number of Subjects With Urine Bilirubin Status 'Negative' at Baseline, Categorized by Urine Bilirubin Status at Last Visit
timeFrame: Baseline, Last Visit (up to 140 weeks)
measure: Number of Subjects With Urine Bilirubin Status 'Positive +' at Baseline, Categorized by Urine Bilirubin Status at Last Visit
timeFrame: Baseline, Last Visit (up to 140 weeks)
measure: Number of Subjects With Urine Bilirubin Status 'Positive ++' at Baseline, Categorized by Urine Bilirubin Status at Last Visit
timeFrame: Baseline, Last Visit (up to 140 weeks)
measure: Number of Subjects With Urine Glucose Value 'Negative' at Baseline, Categorized by Urine Glucose Value at Last Visit
timeFrame: Baseline, Last Visit (up to 140 weeks)
measure: Number of Subjects With Urine Glucose Value 5.5 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit
timeFrame: Baseline, Last Visit (up to 140 weeks)
measure: Number of Subjects With Urine Glucose Value 14 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit
timeFrame: Baseline, Last Visit (up to 140 weeks)
measure: Number of Subjects With Urine Glucose Value 28 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit
timeFrame: Baseline, Last Visit (up to 140 weeks)
measure: Number of Subjects With Urine Glucose Value 55 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit
timeFrame: Baseline, Last Visit (up to 140 weeks)
measure: Number of Subjects With Urine Glucose Value >=111 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit
timeFrame: Baseline, Last Visit (up to 140 weeks)
measure: Percentage of Subjects With Marked Abnormalities in Vital Signs After Start of Treatment
timeFrame: During study period (up to 140 weeks)
measure: Percentage of Subjects With Marked Abnormalities in Physical Examination Findings After Start of Treatment.
timeFrame: Last Visit (up to 140 weeks)
measure: Percentage of Subjects With Marked Abnormalities in Neurological Examination Findings After Start of Treatment
timeFrame: Last Visit (up to 140 weeks)
measure: Percentage of Subjects With Abnormal Electrocardiogram (ECG) Findings
timeFrame: Last Visit (up to 140 weeks)
measure: Percentage of Subjects Who Withdrew Due to Adverse Events (AEs)
timeFrame: During the study period (up to 140 weeks)
measure: Number of Subjects With Urine Protein Status 'Positive +++' at Baseline, Categorized by Urine Protein Status at Last Visit
timeFrame: Last Visit (up to 140 weeks)
Secondary outcomes:
measure: Change in Average Pain Interference With Sleep From the Baseline Week to the 7 Days Prior to Each Visit
timeFrame: Baseline, Visit 2.1, Visit 2.2, Visit 2.4, Visit 2.5, Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, Visit 8, Visit 9.0, Visit 9.1, Visit 9.2, Visit 9.3, Visit 9.4, Visit 9.5, Visit 9.6, Visit 9.7, Visit 9.8, Visit 9.9
measure: Change in Average Pain Interference With General Activity From the Baseline Week to the 7 Days Prior to Each Visit
timeFrame: Baseline, Visit 2.1, Visit 2.2, Visit 2.4, Visit 2.5, Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, Visit 8, Visit 9.0, Visit 9.1, Visit 9.2, Visit 9.3, Visit 9.4, Visit 9.5, Visit 9.6, Visit 9.7, Visit 9.8, Visit 9.9
measure: Change in Current Pain From Visit 2 (Baseline) to Each Subsequent Visit as Measured by a 100 mm Visual Analogue Scale (VAS)
timeFrame: Baseline, Visit 2.1, Visit 2.2, Visit 2.4, Visit 2.5, Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, Visit 8, Visit 9.0, Visit 9.1, Visit 9.2, Visit 9.3, Visit 9.4, Visit 9.5, Visit 9.6, Visit 9.7, Visit 9.8, Visit 9.9
measure: Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 4
timeFrame: Visit 4
measure: Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 6
timeFrame: Visit 6
measure: Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.0
timeFrame: Visit 9.0
measure: Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.1
timeFrame: Visit 9.1
measure: Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.2
timeFrame: Visit 9.2
measure: Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.3
timeFrame: Visit 9.3
measure: Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.4
timeFrame: Visit 9.4
measure: Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.5
timeFrame: Visit 9.5
measure: Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.6
timeFrame: Visit 9.6
measure: Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.7
timeFrame: Visit 9.7
measure: Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.8
timeFrame: Visit 9.8
measure: Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Termination Visit
timeFrame: Termination Visit (last treatment visit)
measure: Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 4
timeFrame: Baseline, Visit 4
measure: Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 6
timeFrame: Baseline, Visit 6
measure: Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.0
timeFrame: Baseline, Visit 9.0
measure: Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.1
timeFrame: Baseline, Visit 9.1
measure: Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.2
timeFrame: Baseline, Visit 9.2
measure: Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.3
timeFrame: Baseline, Visit 9.3
measure: Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.4
timeFrame: Baseline, Visit 9.4
measure: Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.5
timeFrame: Baseline, Visit 9.5
measure: Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.6
timeFrame: Baseline, Visit 9.6
measure: Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.7
timeFrame: Baseline, Visit 9.7
measure: Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.8
timeFrame: Baseline, Visit 9.8
measure: Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Termination Visit
timeFrame: Baseline, Termination Visit (last treatment visit)
measure: Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 2 (Baseline)
timeFrame: Visit 2 (Baseline)
measure: Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 4
timeFrame: Visit 4
measure: Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 6
timeFrame: Visit 6
measure: Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.0
timeFrame: Visit 9.0
measure: Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.1
timeFrame: Visit 9.1
measure: Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.2
timeFrame: Visit 9.2
measure: Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.3
timeFrame: Visit 9.3
measure: Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.4
timeFrame: Visit 9.4
measure: Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.5
timeFrame: Visit 9.5
measure: Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.6
timeFrame: Visit 9.6
measure: Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.7
timeFrame: Visit 9.7
measure: Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.8
timeFrame: Visit 9.8
measure: Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Termination Visit
timeFrame: Termination Visit (last treatment visit)
measure: Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 2 (Baseline)
timeFrame: Visit 2 (Baseline)
measure: Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 4
timeFrame: Visit 4
measure: Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 6
timeFrame: Visit 6
measure: Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.0
timeFrame: Visit 9.0
measure: Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.1
timeFrame: Visit 9.1
measure: Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.2
timeFrame: Visit 9.2
measure: Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.3
timeFrame: Visit 9.3
measure: Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.4
timeFrame: Visit 9.4
measure: Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.5
timeFrame: Visit 9.5
measure: Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.6
timeFrame: Visit 9.6
measure: Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.7
timeFrame: Visit 9.7
measure: Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.8
timeFrame: Visit 9.8
measure: Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Termination Visit
timeFrame: Termination Visit (last treatment visit)
measure: Change in Quality of Life From Visit 2 (Baseline) to Visit 4
timeFrame: Baseline, Visit 4
measure: Change in Quality of Life From Visit 2 (Baseline) to Visit 6
timeFrame: Baseline, Visit 6
measure: Change in Quality of Life From Visit 2 (Baseline) to Visit 9.0
timeFrame: Baseline, Visit 9.0
measure: Change in Quality of Life From Visit 2 (Baseline) to Visit 9.1
timeFrame: Baseline, Visit 9.1
measure: Change in Quality of Life From Visit 2 (Baseline) to Visit 9.2
timeFrame: Baseline, Visit 9.2
measure: Change in Quality of Life From Visit 2 (Baseline) to Visit 9.3
timeFrame: Baseline, Visit 9.3
measure: Change in Quality of Life From Visit 2 (Baseline) to Visit 9.4
timeFrame: Baseline, Visit 9.4
measure: Change in Quality of Life From Visit 2 (Baseline) to Visit 9.5
timeFrame: Baseline, Visit 9.5
measure: Change in Quality of Life From Visit 2 (Baseline) to Visit 9.6
timeFrame: Baseline, Visit 9.6
measure: Change in Quality of Life From Visit 2 (Baseline) to Visit 9.7
timeFrame: Baseline, Visit 9.7
measure: Change in Quality of Life From Visit 2 (Baseline) to Visit 9.8
timeFrame: Baseline, Visit 9.8
measure: Change in Quality of Life From Visit 2 (Baseline) to Termination Visit
timeFrame: Baseline, Termination Visit (last treatment visit)
Other outcomes:
Locations:
city: Monheim
country: Germany
Study officials:
affiliation: UCB (+1 844 599 2273)
name: UCB Cares
role: STUDY_DIRECTOR
References: