Phase 3
Completed N=371
A Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Diabetic Neuropathy
Painful Diabetic Neuropathy
Source: ClinicalTrials.gov NCT00220337 ↗
Enrolled (actual)
371
Serious AEs
22.4%
Results posted
Jul 2023
Primary outcomePrimary: Percentage of Subjects With Adverse Events (AE) Reported Spontaneously by the Subject or Observed by the Investigator — 80.9 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Adverse Events (AE) Reported Spontaneously by the Subject or Observed by the Investigator |
80.9 | — |
| PRIMARY Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Titration Period |
0.8; 0.5; 1.4; 1.1; 0; 0 | — |
| PRIMARY Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Maintenance Period |
6.2; 5.5; 2.8; 2.8; 2.8; 0.3 | — |
| PRIMARY Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Titration Period |
0.5; 0; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Maintenance Period |
0.6; 0.3; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Urine pH= 5.0 at Baseline, Categorized by Urine pH at Last Visit |
194; 35; 2; 3; 1; 0 | — |
| PRIMARY Number of Subjects With Urine pH= 6.0 at Baseline, Categorized by Urine pH at Last Visit |
52; 31; 4; 2; 1; 1 | — |
| PRIMARY Number of Subjects With Urine pH= 6.5 at Baseline, Categorized by Urine pH at Last Visit |
10; 7; 5; 0; 0; 1 | — |
| PRIMARY Number of Subjects With Urine pH= 7.0 at Baseline, Categorized by Urine pH at Last Visit |
4; 3; 1; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Urine pH= 7.5 at Baseline, Categorized by Urine pH at Last Visit |
3; 0; 3; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Urine pH= 8.0 at Baseline, Categorized by Urine pH at Last Visit |
0; 0; 1; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Urine White Blood Cell Count 'Negative' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit |
321; 7; 3; 5; 1; 7 | — |
| PRIMARY Number of Subjects With Urine White Blood Cell Count 'Trace' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit |
13; 1; 0; 0; 1; 0 | — |
| PRIMARY Number of Subjects With Urine White Blood Cell Count 'Positive +' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit |
3; 2; 0; 1; 0; 0 | — |
| PRIMARY Number of Subjects With Urine White Blood Cell Count 'Positive ++' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit |
3; 0; 2; 1; 0; 0 | — |
| PRIMARY Number of Subjects With Urine Nitrite Status 'Negative' at Baseline, Categorized by Urine Nitrite Status at Last Visit |
353; 5; 7 | — |
| PRIMARY Number of Subjects With Urine Nitrite Status 'Positive' at Baseline, Categorized by Urine Nitrite Status at Last Visit |
3; 3; 0 | — |
| PRIMARY Number of Subjects With Urine Urobilinogen Value 3 µmol/l at Baseline, Categorized by Urine Urobilinogen Value at Last Visit |
351; 3; 0; 0; 7 | — |
| PRIMARY Number of Subjects With Urine Urobilinogen Value 16 µmol/l at Baseline, Categorized by Urine Urobilinogen Value at Last Visit |
7; 1; 1; 0; 0 | — |
| PRIMARY Number of Subjects With Urine Urobilinogen Value 66 µmol/l at Baseline, Categorized by Urine Urobilinogen Value at Last Visit |
1; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Urine Protein Status 'Negative' at Baseline, Categorized by Urine Protein Status at Last Visit |
292; 13; 3; 1; 2; 6 | — |
| PRIMARY Number of Subjects With Urine Protein Status 'Trace' at Baseline, Categorized by Urine Protein Status at Last Visit |
27; 7; 4; 0; 0; 1 | — |
| PRIMARY Number of Subjects With Urine Protein Status 'Positive +' at Baseline, Categorized by Urine Protein Status at Last Visit |
3; 1; 1; 2; 0; 0 | — |
| PRIMARY Number of Subjects With Urine Protein Status 'Positive ++' at Baseline, Categorized by Urine Protein Status at Last Visit |
2; 0; 3; 0; 1; 0 | — |
| PRIMARY Number of Subjects With Urine Blood Status 'Negative' at Baseline, Categorized by Urine Blood Status at Last Visit |
319; 7; 1; 3; 4; 4 | — |
| PRIMARY Number of Subjects With Urine Blood Status 'Trace (N)' at Baseline, Categorized by Urine Blood Status at Last Visit |
14; 2; 0; 1; 0; 0 | — |
| PRIMARY Number of Subjects With Urine Blood Status 'Trace (H)' at Baseline, Categorized by Urine Blood Status at Last Visit |
4; 2; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Urine Blood Status 'Positive +' at Baseline, Categorized by Urine Blood Status at Last Visit |
1; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Urine Blood Status 'Positive ++' at Baseline, Categorized by Urine Blood Status at Last Visit |
1; 1; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Urine Ketone Status 'Negative' at Baseline, Categorized by Urine Ketone Status at Last Visit |
328; 8; 1; 0; 7 | — |
| PRIMARY Number of Subjects With Urine Ketone Status 'Trace' at Baseline, Categorized by Urine Ketone Status at Last Visit |
19; 0; 2; 0; 0 | — |
| PRIMARY Number of Subjects With Urine Ketone Status 'Small' at Baseline, Categorized by Urine Ketone Status at Last Visit |
2; 2; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Urine Ketone Status 'Moderate' at Baseline, Categorized by Urine Ketone Status at Last Visit |
2; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Urine Bilirubin Status 'Negative' at Baseline, Categorized by Urine Bilirubin Status at Last Visit |
351; 2; 0; 7 | — |
| PRIMARY Number of Subjects With Urine Bilirubin Status 'Positive +' at Baseline, Categorized by Urine Bilirubin Status at Last Visit |
8; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Urine Bilirubin Status 'Positive ++' at Baseline, Categorized by Urine Bilirubin Status at Last Visit |
3; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Urine Glucose Value 'Negative' at Baseline, Categorized by Urine Glucose Value at Last Visit |
194; 30; 16; 12; 4; 6 | — |
| PRIMARY Number of Subjects With Urine Glucose Value 5.5 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit |
18; 15; 2; 1; 0; 0 | — |
| PRIMARY Number of Subjects With Urine Glucose Value 14 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit |
6; 8; 0; 1; 2; 0 | — |
| PRIMARY Number of Subjects With Urine Glucose Value 28 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit |
10; 3; 3; 3; 0; 1 | — |
| PRIMARY Number of Subjects With Urine Glucose Value 55 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit |
5; 5; 1; 3; 1; 4 | — |
| PRIMARY Number of Subjects With Urine Glucose Value >=111 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit |
3; 2; 0; 2; 2; 1 | — |
| PRIMARY Percentage of Subjects With Marked Abnormalities in Vital Signs After Start of Treatment |
7.5; 0.3; 3.5; 0.8; 0.3; 0.8 | — |
| PRIMARY Percentage of Subjects With Marked Abnormalities in Physical Examination Findings After Start of Treatment. |
12.2; 15.2; 14.2; 2.1; 13.3; 5.2 | — |
| PRIMARY Percentage of Subjects With Marked Abnormalities in Neurological Examination Findings After Start of Treatment |
3.6; 13.4; 69.9; 13.4; 7.0; 3.7 | — |
| PRIMARY Percentage of Subjects With Abnormal Electrocardiogram (ECG) Findings |
4.7; 18.0 | — |
| PRIMARY Percentage of Subjects Who Withdrew Due to Adverse Events (AEs) |
16.4 | — |
| PRIMARY Number of Subjects With Urine Protein Status 'Positive +++' at Baseline, Categorized by Urine Protein Status at Last Visit |
0; 0; 0; 1; 1; 0 | — |
| SECONDARY Change in Average Pain Interference With Sleep From the Baseline Week to the 7 Days Prior to Each Visit |
-0.99; -1.35; -1.77; -1.25; -1.38; -2.62 | — |
| SECONDARY Change in Average Pain Interference With General Activity From the Baseline Week to the 7 Days Prior to Each Visit |
-0.99; -1.38; -1.66; -1.21; -1.62; -2.56 | — |
| SECONDARY Change in Current Pain From Visit 2 (Baseline) to Each Subsequent Visit as Measured by a 100 mm Visual Analogue Scale (VAS) |
-12.32; -20.79; -27.87; -14.80; -20.33; -35.23 | — |
| SECONDARY Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 4 |
0; 0; 0.9; 6.0; 27.1; 32.5 | — |
| SECONDARY Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 6 |
0; 0; 2; 8.4; 23.7; 34.8 | — |
| SECONDARY Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.0 |
0; 0.7; 1.4; 6.1; 18.8; 35.7 | — |
| SECONDARY Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.1 |
0.7; 0.4; 2.6; 5.6; 18.2; 37.2 | — |
| SECONDARY Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.2 |
0.4; 0.8; 4.0; 4.4; 17.3; 34.5 | — |
| SECONDARY Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.3 |
0; 1.3; 3.0; 4.2; 20.7; 34.6 | — |
| SECONDARY Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.4 |
0; 0.9; 4.4; 5.8; 18.6; 35.0 | — |
| SECONDARY Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.5 |
0; 1.9; 3.3; 6.6; 18.4; 34.4 | — |
| SECONDARY Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.6 |
0; 3.0; 1.5; 7.9; 19.3; 31.2 | — |
| SECONDARY Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.7 |
0.5; 2.2; 3.8; 6.0; 20.1; 31.5 | — |
| SECONDARY Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.8 |
0; 2.0; 4.1; 8.2; 10.2; 36.7 | — |
| SECONDARY Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Termination Visit |
0.9; 2.4; 3.6; 13.4; 20.4; 28.6 | — |
| SECONDARY Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 4 |
-3.1; -1.5; -2.6; -2.3; -2.6; -1.0 | — |
| SECONDARY Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 6 |
-2.9; -1.7; -2.5; -2.5; -2.6; -1.2 | — |
| SECONDARY Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.0 |
-3.0; -2.2; -2.7; -2.9; -2.9; -1.0 | — |
| SECONDARY Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.1 |
-3.1; -2.1; -2.8; -3.1; -2.9; -1.0 | — |
| SECONDARY Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.2 |
-3.2; -2.4; -2.7; -2.8; -3.0; -1.0 | — |
| SECONDARY Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.3 |
-3.1; -1.9; -2.6; -3.0; -2.8; -0.8 | — |
| SECONDARY Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.4 |
-2.8; -1.5; -2.3; -2.3; -2.8; -0.9 | — |
| SECONDARY Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.5 |
-3.1; -2.0; -2.4; -2.8; -2.8; -1.0 | — |
| SECONDARY Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.6 |
-3.0; -2.0; -2.8; -3.1; -2.8; -0.8 | — |
| SECONDARY Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.7 |
-3.2; -2.1; -2.2; -2.9; -2.5; -1.0 | — |
| SECONDARY Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.8 |
-2.3; -2.0; -1.7; -3.0; -2.5; -0.4 | — |
| SECONDARY Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Termination Visit |
-2.6; -1.5; -2.0; -2.1; -2.3; -1.0 | — |
| SECONDARY Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 2 (Baseline) |
37.6; 21.3; 19.1; 14.2; 7.8 | — |
| SECONDARY Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 4 |
10.9; 13.6; 17.3; 20.9; 37.3 | — |
| SECONDARY Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 6 |
12.6; 7.8; 11.7; 24.3; 43.7 | — |
| SECONDARY Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.0 |
11.1; 8.9; 10.0; 22.2; 47.8 | — |
| SECONDARY Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.1 |
9.3; 8.1; 15.1; 26.7; 39.5; 1.2 | — |
| SECONDARY Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.2 |
5.6; 9.7; 8.3; 22.2; 54.2 | — |
| SECONDARY Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.3 |
3.1; 3.1; 15.6; 28.1; 50.0 | — |
| SECONDARY Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.4 |
6.3; 11.1; 15.9; 22.2; 44.4 | — |
| SECONDARY Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.5 |
8.3; 6.7; 15.0; 21.7; 48.3 | — |
| SECONDARY Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.6 |
3.6; 10.7; 23.2; 17.9; 44.6 | — |
| SECONDARY Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.7 |
7.4; 7.4; 14.8; 16.7; 53.7 | — |
| SECONDARY Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.8 |
0; 10.5; 26.3; 26.3; 36.8 | — |
| SECONDARY Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Termination Visit |
16.1; 13.6; 16.9; 18.6; 34.7 | — |
| SECONDARY Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 2 (Baseline) |
6.4; 33.3; 20.6; 20.6; 19.1; 0 | — |
| SECONDARY Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 4 |
29.1; 39.1; 20.9; 5.5; 5.5; 0 | — |
| SECONDARY Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 6 |
26.9; 42.3; 20.2; 7.7; 2.9; 0 | — |
| SECONDARY Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.0 |
36.7; 35.6; 20.0; 5.6; 2.2; 0 | — |
| SECONDARY Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.1 |
28.7; 34.5; 20.7; 4.6; 10.3; 1.1 | — |
| SECONDARY Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.2 |
27.4; 49.3; 9.6; 9.6; 4.1; 0 | — |
| SECONDARY Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.3 |
27.0; 44.4; 20.6; 3.2; 4.8; 0 | — |
| SECONDARY Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.4 |
31.7; 33.3; 19.0; 11.1; 4.8; 0 | — |
| SECONDARY Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.5 |
35.0; 35.0; 21.7; 3.3; 5.0; 0 | — |
| SECONDARY Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.6 |
30.4; 44.6; 14.3; 5.4; 5.4; 0 | — |
| SECONDARY Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.7 |
33.3; 37.0; 16.7; 5.6; 7.4; 0 | — |
| SECONDARY Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.8 |
26.3; 52.6; 15.8; 0; 5.3; 0 | — |
| SECONDARY Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Termination Visit |
28.8; 35.6; 15.3; 11.0; 9.3; 0 | — |
| SECONDARY Change in Quality of Life From Visit 2 (Baseline) to Visit 4 |
7.4; 13.1; 20.8; 6.1; 8.5; 8.2 | — |
| SECONDARY Change in Quality of Life From Visit 2 (Baseline) to Visit 6 |
8.0; 12.1; 22.4; 7.2; 8.4; 8.4 | — |
| SECONDARY Change in Quality of Life From Visit 2 (Baseline) to Visit 9.0 |
10.4; 17.5; 25.3; 8.8; 10.5; 10.3 | — |
| SECONDARY Change in Quality of Life From Visit 2 (Baseline) to Visit 9.1 |
10.6; 18.4; 24.6; 7.3; 9.6; 10.6 | — |
| SECONDARY Change in Quality of Life From Visit 2 (Baseline) to Visit 9.2 |
9.6; 19.2; 23.8; 6.7; 9.7; 9.9 | — |
| SECONDARY Change in Quality of Life From Visit 2 (Baseline) to Visit 9.3 |
10.3; 20.2; 26.3; 8.3; 9.9; 9.8 | — |
| SECONDARY Change in Quality of Life From Visit 2 (Baseline) to Visit 9.4 |
9.3; 17.3; 24.1; 6.8; 8.7; 9.0 | — |
| SECONDARY Change in Quality of Life From Visit 2 (Baseline) to Visit 9.5 |
8.6; 19.1; 25.9; 7.9; 7.5; 8.2 | — |
| SECONDARY Change in Quality of Life From Visit 2 (Baseline) to Visit 9.6 |
8.6; 18.4; 24.8; 7.0; 7.9; 8.8 | — |
| SECONDARY Change in Quality of Life From Visit 2 (Baseline) to Visit 9.7 |
9.4; 18.6; 25.3; 7.1; 7.4; 8.7 | — |
| SECONDARY Change in Quality of Life From Visit 2 (Baseline) to Visit 9.8 |
6.9; 2.0; 22.2; 0.2; 3.2; 4.3 | — |
| SECONDARY Change in Quality of Life From Visit 2 (Baseline) to Termination Visit |
5.0; 7.8; 19.3; 4.1; 4.5; 4.2 | — |
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
Data sourced from ClinicalTrials.gov (NCT00220337). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.