An observational study in Post Herpetic Neuralgia, sponsored by Depomed. Completed at 37 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-03-21.
Sponsored by Depomed · Observational
Study objective is to assess the safety and effectiveness of once- daily GRALISE in clinical practice
Open Label, single arm, 2wk titration, 6 wk stable dosing, 8 wk of total treatment, 1wk dose tapering
1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.
This study's enrollment of 201 is above the median of 100 across 260 observational studies indexed under Neuralgia.
Browse Neuralgia studies →Depomed is the lead sponsor of 14 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients currently suffering from Post Herpetic Neuralgia
Exclusion Criteria:
Cohort by age- - Patients \>70 Yrs old
Cohort by age- - Patients \< 70 Yrs old
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)
| Milestone | Open Label - Cohort >70 Yrs Old | Open Label - Cohort <=70 Yrs Old |
|---|---|---|
| Started | 86 | 111 |
| Completed | 55 | 84 |
| Not completed | 31 | 27 |
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
| scores on a scale | Open Label - Cohort >70 Yrs Old | Open Label - Cohort <=70 Yrs Old |
|---|---|---|
| Change From Baseline to End of Study in LOCF VAS | -20.4 (-26.5 to -14.4) | -21.3 (-26.8 to -15.8) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Open Label - Both Cohorts | — | 5/197 (2.5%) | 38/197 (19.3%) |
| Event | Open Label - Both Cohorts |
|---|---|
| Coronary artery diseaseCardiac disorders | 1/197 |
| Duodenal ulcerGastrointestinal disorders | 1/197 |
| PneumoniaInfections and infestations | 1/197 |
| GoutMetabolism and nutrition disorders | 1/197 |
| Confusional statePsychiatric disorders | 1/197 |
| HaematuriaRenal and urinary disorders | 1/197 |
| Event | Open Label - Both Cohorts |
|---|---|
| DizzinessNervous system disorders | 27/197 |
| SomnolenceNervous system disorders | 11/197 |
| Age, Categorical(Participants) | Open Label - Cohort >70 Yrs Old | Open Label - Cohort <=70 Yrs Old | Total |
|---|---|---|---|
| <=18 years | 0 | 1 | 1 |
| Between 18 and 65 years | 0 | 65 | 65 |
| >=65 years | 86 | 45 | 131 |
| Age Continuous(years) | Open Label - Cohort >70 Yrs Old | Open Label - Cohort <=70 Yrs Old | Total |
|---|---|---|---|
| Mean | 78.2 ± 5.28 | 59.0 ± 10.42 | 67.4 ± 12.79 |
| Sex: Female, Male(Participants) | Open Label - Cohort >70 Yrs Old | Open Label - Cohort <=70 Yrs Old | Total |
|---|---|---|---|
| Female | 47 | 75 | 122 |
| Male | 39 | 36 | 75 |
| Region of Enrollment(participants) | Open Label - Cohort >70 Yrs Old | Open Label - Cohort <=70 Yrs Old | Total |
|---|---|---|---|
| United States | 86 | 111 | 197 |
This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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Depomed