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The primary objective of the study is to assess the efficacy of eslicarbazepine acetate (ESL) as therapy for patients with post-herpetic neuralgia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESL 400 mg twice-daily | Experimental | ESL 400 mg twice-daily |
|
| ESL 800 mg once-daily | Experimental | ESL 800 mg once-daily |
|
| ESL 600 mg twice daily | Experimental | ESL 600 mg twice daily |
|
| ESL 1200 mg once daily | Experimental | ESL 1200 mg once daily |
|
| ESL 800 mg twice daily | Experimental | ESL 800 mg twice daily |
|
| placebo | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eslicarbazepine acetate | Drug | Scored tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Pain (NRPS) From Baseline to Endpoint in Mean Pain | The primary efficacy variable will be based upon an 11-point (0-10) Numeric Rating Pain Scale (NRPS), where 0 = no pain and 10 = worst possible pain, to be recorded in a patient's diary upon awakening each morning. This score should reflect the patient's mean pain over the previous 24 hours. Please note that the change from baseline to endpoint in mean pain, i.e. the difference between endpoint mean pain and baseline mean pain, which are defined as follows:
| baseline and 13 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Pain (NRPS) From Baseline to Endpoint by Total Daily Dose | Details of neuropathic pain, as recorded in a subject diary, were used for the primary assessment of analgesic efficacy. Subjects assessed their pain using an 11-point (0 "no pain" to 10 "worst possible pain") NRPS upon awakening each morning and recorded the results in the subject diary. This score reflected the subject's mean pain over the previous 24 hours. Subjects were trained how to record their pain reliably. Investigators were trained in the subject's NRPS use during site initiation visits and at the investigators' meeting. |
Inclusion Criteria:
Exclusion Criteria:
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An up to 2-week baseline was followed by a 1-week titration period, an 8-week maintenance period, and a 2-week safety follow-up period. If subjects had a creatinine clearance between 30 and 60 mL/min, they received half of the assigned dose, and subjects with a creatinine clearance below 30 mL/min were not enrolled in this study.
First subject enrolled 06 November 2007; Date last subject completed: 19 January 2009.
Number of subjects:
Planned: 540 subjects (90 in each of the 6 treatment groups). Randomised and treated: 567. Analysed for efficacy (per-protocol): 396 Analysed for safety: 567.
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| ID | Title | Description |
|---|---|---|
| FG000 | ESL 1200 mg Once Daily | ESL 1200 mg once daily Eslicarbazepine acetate : Scored tablets |
| FG001 | ESL 400 mg Twice-daily | ESL 400 mg twice-daily Eslicarbazepine acetate : Scored tablets |
| FG002 | ESL 600 mg Twice Daily | ESL 600 mg twice daily Eslicarbazepine acetate : Scored tablets |
| FG003 | ESL 800 mg Once-daily | ESL 800 mg once-daily Eslicarbazepine acetate : Scored tablets |
| FG004 | ESL 800 mg Twice Daily | ESL 800 mg twice daily Eslicarbazepine acetate : Scored tablets |
| FG005 | Placebo | placebo Placebo : oral route |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ESL 1200 mg Once Daily | ESL 1200 mg once daily Eslicarbazepine acetate : Scored tablets |
| BG001 | ESL 400 mg Twice-daily | ESL 400 mg twice-daily Eslicarbazepine acetate : Scored tablets |
| 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 in Mean Pain (NRPS) From Baseline to Endpoint in Mean Pain | The primary efficacy variable will be based upon an 11-point (0-10) Numeric Rating Pain Scale (NRPS), where 0 = no pain and 10 = worst possible pain, to be recorded in a patient's diary upon awakening each morning. This score should reflect the patient's mean pain over the previous 24 hours. Please note that the change from baseline to endpoint in mean pain, i.e. the difference between endpoint mean pain and baseline mean pain, which are defined as follows:
| Posted | Least Squares Mean | Standard Error | Points | baseline and 13 weeks |
|
All TEAEs, i.e. those 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 Once Daily | ESL 1200 mg once daily Eslicarbazepine acetate : Scored tablets |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthritis reactive | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Research Section | Bial-Portela & Cª, S.A. | +351 22 986 6100 | clinical.trials@bial.com |
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| ID | Term |
|---|---|
| D051474 | Neuralgia, Postherpetic |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C416835 | eslicarbazepine acetate |
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|
| Placebo | Drug | oral route |
|
| baseline and 13 weeks |
| BG002 | ESL 600 mg Twice Daily | ESL 600 mg twice daily Eslicarbazepine acetate : Scored tablets |
| BG003 | ESL 800 mg Once-daily | ESL 800 mg once-daily Eslicarbazepine acetate : Scored tablets |
| BG004 | ESL 800 mg Twice Daily | ESL 800 mg twice daily Eslicarbazepine acetate : Scored tablets |
| BG005 | Placebo | placebo Placebo : oral route |
| BG006 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
total daily dose;oral route
| OG001 | ESL 400 mg Twice-daily | total daily dose;oral route |
| OG002 | ESL 600 mg Twice Daily | total daily dose;oral route |
| OG003 | ESL 800 mg Once-daily | total daily dose;oral route |
| OG004 | ESL 800 mg Twice Daily | total daily dose;oral route |
| OG005 | Placebo | total daily dose;oral route |
|
|
| Other Pre-specified | Change in Mean Pain (NRPS) From Baseline to Endpoint by Total Daily Dose | Details of neuropathic pain, as recorded in a subject diary, were used for the primary assessment of analgesic efficacy. Subjects assessed their pain using an 11-point (0 "no pain" to 10 "worst possible pain") NRPS upon awakening each morning and recorded the results in the subject diary. This score reflected the subject's mean pain over the previous 24 hours. Subjects were trained how to record their pain reliably. Investigators were trained in the subject's NRPS use during site initiation visits and at the investigators' meeting. | Posted | Least Squares Mean | Standard Error | Points | baseline and 13 weeks |
|
|
|
| 1 |
| 102 |
| 48 |
| 102 |
| EG001 | ESL 400 mg Twice-daily | ESL 400 mg twice-daily Eslicarbazepine acetate : Scored tablets | 4 | 94 | 41 | 94 |
| EG002 | ESL 600 mg Twice Daily | ESL 600 mg twice daily Eslicarbazepine acetate : Scored tablets | 4 | 94 | 42 | 94 |
| EG003 | ESL 800 mg Once-daily | ESL 800 mg once-daily Eslicarbazepine acetate : Scored tablets | 2 | 94 | 46 | 94 |
| EG004 | ESL 800 mg Twice Daily | ESL 800 mg twice daily Eslicarbazepine acetate : Scored tablets | 1 | 90 | 49 | 90 |
| EG005 | Placebo | placebo Placebo : oral route | 0 | 93 | 29 | 93 |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Biliary tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pneumonia klebsiella | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| GGT increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
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| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |