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This study will evaluate the safety and efficacy of AGN-214868 in patients with postherpetic neuralgia (PHN) - nerve pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AGN-214868 3.25 μg | Experimental | AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment. |
|
| AGN-214868 16.25 μg | Experimental | AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment. |
|
| Placebo | Placebo Comparator | Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGN-214868 | Drug | AGN-214868 injected into areas of postherpetic neuralgia pain for total dose per treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Average Pain Intensity Score at Week 12 | Participants rated the severity of their daily pain in the previous 7 days using a 10 point scale where 0=no pain to 10=pain as bad as you can imagine. A negative change from Baseline indicated improvement. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Area of Spontaneous Pain | A tracing of the area of spontaneous pain was made and sent to an independent central reading center for measurement. The area of spontaneous pain was measured in centimeters squared (cm^2) at Baseline and Week 12. A negative change from Baseline indicated improvement. | Baseline, Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando | Florida | United States | ||||
There were two Treatment Cycles in this study 12 weeks apart. In Treatment Cycle 1 participants were randomized to AGN-214868 3.25 μg, AGN-214868 16.25 μg or Placebo. In Treatment Cycle 2 participants were re-randomized to AGN-214868 3.25 μg, AGN-214868 16.25 μg or Placebo.
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| ID | Title | Description |
|---|---|---|
| FG000 | AGN-214868 3.25 μg | AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment. |
| FG001 | AGN-214868 16.25 μg | AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment. |
| FG002 | Placebo | Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Cycle 1 |
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| Treatment Cycle 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AGN-214868 3.25 μg | AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment. |
| BG001 | AGN-214868 16.25 μg | AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment. |
| Units | Counts |
|---|---|
| Participants |
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| 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 in the Average Pain Intensity Score at Week 12 | Participants rated the severity of their daily pain in the previous 7 days using a 10 point scale where 0=no pain to 10=pain as bad as you can imagine. A negative change from Baseline indicated improvement. | Modified intent to treat population included all randomized participants who received treatment and had at least 1 post-baseline pain intensity score. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 12 |
|
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The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
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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 | AGN-214868 3.25 μg_Cycle 1 | One treatment of AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure chronic | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.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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| Placebo to AGN-214868 | Drug | Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment. |
|
| Change From Baseline in Area of Allodynia |
A tracing of the area of allodynia (pain to touch) was made and sent to an independent central reading center for measurement. The area of allodynia was measured in centimeters squared (cm^2) at Baseline and Week 12. A negative change from Baseline indicated improvement. |
| Baseline, Week 12 |
| Change From Baseline in Evoked Pain Score in the Area of Allodynia | Participants were asked to rate the unpleasantness (pain to touch) after 3 brush strokes in the area of allodynia on a 100 point scale where 0=no pain to 100=worst pain imaginable. A negative change from Baseline indicated improvement. | Baseline, Week 12 |
| Brno |
| Czechia |
| Kiel | Kiel | Germany |
| Katowice | Poland |
|
| NOT COMPLETED |
|
| BG002 | Placebo | Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.
| OG002 | Placebo | Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment. |
|
|
| Secondary | Change From Baseline in Area of Spontaneous Pain | A tracing of the area of spontaneous pain was made and sent to an independent central reading center for measurement. The area of spontaneous pain was measured in centimeters squared (cm^2) at Baseline and Week 12. A negative change from Baseline indicated improvement. | Modified intent to treat population included all randomized participants who received treatment and had at least 1 post-baseline pain intensity score. | Posted | Mean | Standard Deviation | cm^2 | Baseline, Week 12 |
|
|
|
| Secondary | Change From Baseline in Area of Allodynia | A tracing of the area of allodynia (pain to touch) was made and sent to an independent central reading center for measurement. The area of allodynia was measured in centimeters squared (cm^2) at Baseline and Week 12. A negative change from Baseline indicated improvement. | Modified intent to treat population included all randomized participants who received treatment and had at least 1 post-baseline pain intensity score. | Posted | Mean | Standard Deviation | cm^2 | Baseline, Week 12 |
|
|
|
| Secondary | Change From Baseline in Evoked Pain Score in the Area of Allodynia | Participants were asked to rate the unpleasantness (pain to touch) after 3 brush strokes in the area of allodynia on a 100 point scale where 0=no pain to 100=worst pain imaginable. A negative change from Baseline indicated improvement. | Modified intent to treat population included all randomized participants who received treatment and had at least 1 post-baseline pain intensity score. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 12 |
|
|
|
| 1 |
| 84 |
| 1 |
| 84 |
| EG001 | AGN-214868 16.25 μg_Cycle 1 | One treatment of AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg. | 2 | 83 | 1 | 83 |
| EG002 | Placebo_Cycle 1 | One treatment of Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain. | 1 | 125 | 2 | 125 |
| EG003 | AGN-214868 3.25 μg_ Cycle 2 | One treatment of AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg. | 5 | 94 | 6 | 94 |
| EG004 | AGN-214868 16.25 μg_ Cycle 2 | One treatment of AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg. | 5 | 95 | 1 | 95 |
| EG005 | Placebo_Cycle 2 | One treatment of Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain. | 3 | 79 | 3 | 79 |
| Chest pain | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
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| Myocardial ischaemia | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
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| Gastroduodenitis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
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| VIIth nerve paralysis | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
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| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
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A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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