Neuralgia, Postherpetic
Conditions
Brief summary
This study will evaluate the safety and efficacy of AGN-214868 in patients with postherpetic neuralgia (PHN) - nerve pain.
Interventions
DRUGAGN-214868
AGN-214868 injected into areas of postherpetic neuralgia pain for total dose per treatment.
DRUGPlacebo to AGN-214868
Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Persistent postherpetic neuralgia (PHN) with nerve pain present for at least 9 months after onset of herpes zoster skin rash
Exclusion criteria
* Female patients with reproductive potential * Active herpes zoster skin rash * Current or anticipated treatment with acupuncture, TNS, or steroids * Current or anticipated use of topical analgesic agents with PHN * Treatment with botulinum toxin therapy of any serotype within the prior 12 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Average Pain Intensity Score at Week 12 | Baseline, 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Area of Spontaneous Pain | Baseline, Week 12 | 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. |
| Change From Baseline in Area of Allodynia | Baseline, Week 12 | 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. |
| Change From Baseline in Evoked Pain Score in the Area of Allodynia | Baseline, Week 12 | 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. |
Countries
Czechia, Germany, Poland, United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| AGN-214868 3.25 μg AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment. | 84 |
| AGN-214868 16.25 μg AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment. | 84 |
| Placebo Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment. | 126 |
| Total | 294 |
Baseline characteristics
| Characteristic | AGN-214868 3.25 μg | AGN-214868 16.25 μg | Placebo | Total |
|---|---|---|---|---|
| Age, Customized 18 to < 40 Years | 2 Participants | 2 Participants | 2 Participants | 6 Participants |
| Age, Customized 40 to < 65 Years | 18 Participants | 29 Participants | 38 Participants | 85 Participants |
| Age, Customized 65 to < 75 Years | 42 Participants | 33 Participants | 57 Participants | 132 Participants |
| Age, Customized ≥ 75 Years | 22 Participants | 20 Participants | 29 Participants | 71 Participants |
| Sex: Female, Male Female | 44 Participants | 47 Participants | 73 Participants | 164 Participants |
| Sex: Female, Male Male | 40 Participants | 37 Participants | 53 Participants | 130 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 84 | 1 / 83 | 2 / 125 | 6 / 94 | 1 / 95 | 3 / 79 |
| serious Total, serious adverse events | 1 / 84 | 2 / 83 | 1 / 125 | 5 / 94 | 5 / 95 | 3 / 79 |
Outcome results
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.
Time frame: Baseline, Week 12
Population: Modified intent to treat population included all randomized participants who received treatment and had at least 1 post-baseline pain intensity score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AGN-214868 3.25 μg | Change From Baseline in the Average Pain Intensity Score at Week 12 | Baseline | 6.13 Score on a scale | Standard Deviation 1.248 |
| AGN-214868 3.25 μg | Change From Baseline in the Average Pain Intensity Score at Week 12 | Change from Baseline at Week 12 | -1.42 Score on a scale | Standard Deviation 1.876 |
| AGN-214868 16.25 μg | Change From Baseline in the Average Pain Intensity Score at Week 12 | Baseline | 6.04 Score on a scale | Standard Deviation 1.324 |
| AGN-214868 16.25 μg | Change From Baseline in the Average Pain Intensity Score at Week 12 | Change from Baseline at Week 12 | -1.35 Score on a scale | Standard Deviation 1.996 |
| Placebo | Change From Baseline in the Average Pain Intensity Score at Week 12 | Baseline | 6.05 Score on a scale | Standard Deviation 1.334 |
| Placebo | Change From Baseline in the Average Pain Intensity Score at Week 12 | Change from Baseline at Week 12 | -1.27 Score on a scale | Standard Deviation 2.036 |
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.
Time frame: Baseline, Week 12
Population: Modified intent to treat population included all randomized participants who received treatment and had at least 1 post-baseline pain intensity score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AGN-214868 3.25 μg | Change From Baseline in Area of Allodynia | Baseline | 184.28 cm^2 | Standard Deviation 145.259 |
| AGN-214868 3.25 μg | Change From Baseline in Area of Allodynia | Change from Baseline at Week 12 (N=81, 79, 117) | -32.40 cm^2 | Standard Deviation 89.849 |
| AGN-214868 16.25 μg | Change From Baseline in Area of Allodynia | Baseline | 195.11 cm^2 | Standard Deviation 149.355 |
| AGN-214868 16.25 μg | Change From Baseline in Area of Allodynia | Change from Baseline at Week 12 (N=81, 79, 117) | -43.56 cm^2 | Standard Deviation 107.183 |
| Placebo | Change From Baseline in Area of Allodynia | Baseline | 174.17 cm^2 | Standard Deviation 134.132 |
| Placebo | Change From Baseline in Area of Allodynia | Change from Baseline at Week 12 (N=81, 79, 117) | -15.27 cm^2 | Standard Deviation 116.338 |
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.
Time frame: Baseline, Week 12
Population: Modified intent to treat population included all randomized participants who received treatment and had at least 1 post-baseline pain intensity score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AGN-214868 3.25 μg | Change From Baseline in Area of Spontaneous Pain | Baseline | 87.44 cm^2 | Standard Deviation 51.312 |
| AGN-214868 3.25 μg | Change From Baseline in Area of Spontaneous Pain | Change from Baseline at Week 12 (N=81, 79, 117) | -4.83 cm^2 | Standard Deviation 62.374 |
| AGN-214868 16.25 μg | Change From Baseline in Area of Spontaneous Pain | Baseline | 118.17 cm^2 | Standard Deviation 74.858 |
| AGN-214868 16.25 μg | Change From Baseline in Area of Spontaneous Pain | Change from Baseline at Week 12 (N=81, 79, 117) | -17.18 cm^2 | Standard Deviation 62.694 |
| Placebo | Change From Baseline in Area of Spontaneous Pain | Baseline | 98.27 cm^2 | Standard Deviation 62.866 |
| Placebo | Change From Baseline in Area of Spontaneous Pain | Change from Baseline at Week 12 (N=81, 79, 117) | -6.13 cm^2 | Standard Deviation 68.99 |
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.
Time frame: Baseline, Week 12
Population: Modified intent to treat population included all randomized participants who received treatment and had at least 1 post-baseline pain intensity score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AGN-214868 3.25 μg | Change From Baseline in Evoked Pain Score in the Area of Allodynia | Baseline | 60.8 Score on a scale | Standard Deviation 22.39 |
| AGN-214868 3.25 μg | Change From Baseline in Evoked Pain Score in the Area of Allodynia | Change from Baseline at Week 12 (N=82, 80, 118) | -11.7 Score on a scale | Standard Deviation 25.36 |
| AGN-214868 16.25 μg | Change From Baseline in Evoked Pain Score in the Area of Allodynia | Baseline | 58.4 Score on a scale | Standard Deviation 24.04 |
| AGN-214868 16.25 μg | Change From Baseline in Evoked Pain Score in the Area of Allodynia | Change from Baseline at Week 12 (N=82, 80, 118) | -7.9 Score on a scale | Standard Deviation 28.61 |
| Placebo | Change From Baseline in Evoked Pain Score in the Area of Allodynia | Baseline | 60.0 Score on a scale | Standard Deviation 22.39 |
| Placebo | Change From Baseline in Evoked Pain Score in the Area of Allodynia | Change from Baseline at Week 12 (N=82, 80, 118) | -11.1 Score on a scale | Standard Deviation 27.64 |