Post Herpetic Neuralgia
Conditions
Keywords
PHN, Post Herpetic Neuralgia, Shingles, HZ roster
Brief summary
Study objective is to assess the safety and effectiveness of once- daily GRALISE in clinical practice
Detailed description
Open Label, single arm, 2wk titration, 6 wk stable dosing, 8 wk of total treatment, 1wk dose tapering
Interventions
None listed
Sponsors
Depomed
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men or Women 18 years or older who are suffering from PHN
Exclusion criteria
* Patient is Pregnant or a nursing mother * Patient has hypersensitivity to gabapentin * Patient has an estimated creatinine clearance of \<30 mL/min or is in hemodialysis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to End of Study in LOCF VAS | 8 weeks (Baseline and Week 8) | Change from baseline in pain score on visual analog scale (VAS) (intensity scored from No Pain (0mm) to Worst Possible Pain (100mm)) at Week 8 of treatment; last observation carried forward (LOCF) analysis |
Countries
United States
Participant flow
Pre-assignment details
201 patients were enrolled, but only 197 patients received study treatment.
Participants by arm
| Arm | Count |
|---|---|
| Open Label - Cohort >70 Yrs Old Cohort by age-
\- Patients \>70 Yrs old | 86 |
| Open Label - Cohort <=70 Yrs Old Cohort by age-
\- Patients \<=70 Yrs old | 111 |
| Total | 197 |
Baseline characteristics
| Characteristic | Open Label - Cohort <=70 Yrs Old | Open Label - Cohort >70 Yrs Old | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 45 Participants | 86 Participants | 131 Participants |
| Age, Categorical Between 18 and 65 years | 65 Participants | 0 Participants | 65 Participants |
| Age Continuous | 59.0 years STANDARD_DEVIATION 10.42 | 78.2 years STANDARD_DEVIATION 5.28 | 67.4 years STANDARD_DEVIATION 12.79 |
| Region of Enrollment United States | 111 participants | 86 participants | 197 participants |
| Sex: Female, Male Female | 75 Participants | 47 Participants | 122 Participants |
| Sex: Female, Male Male | 36 Participants | 39 Participants | 75 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 38 / 197 |
| serious Total, serious adverse events | 5 / 197 |
Outcome results
Primary
Change From Baseline to End of Study in LOCF VAS
Change from baseline in pain score on visual analog scale (VAS) (intensity scored from No Pain (0mm) to Worst Possible Pain (100mm)) at Week 8 of treatment; last observation carried forward (LOCF) analysis
Time frame: 8 weeks (Baseline and Week 8)
Population: The Number of Participants Analyzed was based on the available VAS.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Open Label - Cohort >70 Yrs Old | Change From Baseline to End of Study in LOCF VAS | -20.4 scores on a scale |
| Open Label - Cohort <=70 Yrs Old | Change From Baseline to End of Study in LOCF VAS | -21.3 scores on a scale |