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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2007-002461-12 |
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The primary objective of the study is to assess the efficacy of eslicarbazepine acetate (ESL) as therapy for patients with painful diabetic neuropathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESL 400 mg BID | Experimental | ESL 400 mg twice daily (BID) |
|
| ESL 800 mg QD | Experimental | ESL 800 mg once-daily (QD) |
|
| ESL 600 mg BID | Experimental | Eslicarbazepine 600 mg twice daily |
|
| ESL 1200 mg QD | Experimental | Eslicarbazepine acetate 1200 mg once daily |
|
| ESL 800 mg BID | Experimental | Eslicarbazepine acetate 800 mg twice daily |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eslicarbazepine acetate | Drug | Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Endpoint in Mean Pain, Scored Daily on a on an 11-point (0-10) Numeric Rating Pain Scale (NRPS), Where 0 = no Pain and 10 = Worst Possible Pain | Endpoint mean pain was defined as the mean of the last 4 available pain scores in the last 7 days of the treatment period. Likewise, baseline mean pain was defined as the mean of the last 4 available pain scores in the last 7 days of the baseline period. | 17 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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During the 2week baseline period,current neuropathic pain drug therapy was discontinued and subjects had to be free of any medication that could affect efficacy(except authorized rescue medication)for 2weeks before start of double-blind study treatment.In case of unbearable pain, this drug-free period could be reduced,but had to be at least 7 days.
Date first subject enrolled: 06 Nov 2007 Date last subject completed: 18 Nov 2008 Randomised and treated: 557. Analyzed for efficacy (per-protocol [PP]): 403. Analyzed for safety: 557.
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| ID | Title | Description |
|---|---|---|
| FG000 | ESL 1200 mg QD | Eslicarbazepine acetate (ESL) 1200 mg once daily. ESL tablets, scored to allow dose titration during the titration period. |
| FG001 | ESL 400 mg BD | ESL 400 mg twice daily ESL tablets, scored to allow dose titration during the titration period. |
| FG002 | ESL 600 mg BID | ESL 600 mg twice daily ESL tablets, scored to allow dose titration during the titration period. |
| FG003 | ESL 800 mg BID | ESL 800 mg twice daily ESL tablets, scored to allow dose titration during the titration period. |
| FG004 | ESL 800 mg QD | ESL 800 mg once-daily ESL tablets, scored to allow dose titration during the titration period. |
| FG005 | Placebo | Placebo Placebo : oral route |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ESL 1200 mg QD | Eslicarbazepine acetate 1200 mg once daily Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period. |
| BG001 | ESL 400 mg BD |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to Endpoint in Mean Pain, Scored Daily on a on an 11-point (0-10) Numeric Rating Pain Scale (NRPS), Where 0 = no Pain and 10 = Worst Possible Pain | Endpoint mean pain was defined as the mean of the last 4 available pain scores in the last 7 days of the treatment period. Likewise, baseline mean pain was defined as the mean of the last 4 available pain scores in the last 7 days of the baseline period. | Posted | Least Squares Mean | Standard Error | units on a scale | 17 weeks |
|
All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ESL 1200 mg QD | Eslicarbazepine acetate 1200 mg once daily Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | General disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Research Section | BIAL - Portela & Ca, SA | 351 22 986 6100 | clinical.trials@bial.com |
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| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
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| ID | Term |
|---|---|
| C416835 | eslicarbazepine acetate |
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|
| Placebo | Drug | oral route |
|
ESL 400 mg twice daily
Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.
| BG002 | ESL 600 mg BID | Eslicarbazepine 600 mg twice daily Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period. |
| BG003 | ESL 800 mg BID | Eslicarbazepine acetate 800 mg twice daily Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period. |
| BG004 | ESL 800 mg QD | ESL 800 mg once-daily Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period. |
| BG005 | Placebo | Placebo Placebo : oral route |
| BG006 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
ESL 400 mg twice daily
Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.
| OG002 | ESL 600 mg BID | Eslicarbazepine 600 mg twice daily Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period. |
| OG003 | ESL 800 mg BID | Eslicarbazepine acetate 800 mg twice daily Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period. |
| OG004 | ESL 800 mg QD | ESL 800 mg once-daily Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period. |
| OG005 | Placebo | Placebo Placebo : oral route |
|
|
| 7 |
| 85 |
| 11 |
| 85 |
| EG001 | ESL 400 mg BD | ESL 400 mg twice daily Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period. | 3 | 89 | 0 | 89 |
| EG002 | ESL 600 mg BID | Eslicarbazepine 600 mg twice daily Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period. | 0 | 95 | 23 | 95 |
| EG003 | ESL 800 mg BID | Eslicarbazepine acetate 800 mg twice daily Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period. | 4 | 100 | 35 | 100 |
| EG004 | ESL 800 mg QD | ESL 800 mg once-daily Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period. | 1 | 92 | 0 | 92 |
| EG005 | Placebo | Placebo Placebo : oral route | 0 | 96 | 6 | 96 |
| Angina pectoris | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Bradyarrhythmia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Hydronephrosis | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Loss of consciousness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Bundle branch block left | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
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| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |