Erythropoietic Protoporphyria or X-Linked Protoporphyria
Conditions
Brief summary
Change from baseline in average daily sunlight exposure time (in minutes) to first prodromal symptom (burning, tingling, itching, or stinging) associated with sunlight exposure between 1-hour post-sunrise and 1 hour pre-sunset at Week 16.
Detailed description
Patient Global Impression of Change (PGIC) at Week 16., Total number of sunlight-induced pain events defined as prodromal symptoms (burning, tingling, itching, or stinging) with pain rating of 1-10 on the Likert scale during the 16-week double-blind treatment period., Total number of sunlight-induced non-prodrome, phototoxic reactions during the 16-week double-blind treatment period.
Interventions
DRUGMT-7117 Placebo
Sponsors
Mitsubishi Tanabe Pharma America Inc.
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in average daily sunlight exposure time (in minutes) to first prodromal symptom (burning, tingling, itching, or stinging) associated with sunlight exposure between 1-hour post-sunrise and 1 hour pre-sunset at Week 16. | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient Global Impression of Change (PGIC) at Week 16., Total number of sunlight-induced pain events defined as prodromal symptoms (burning, tingling, itching, or stinging) with pain rating of 1-10 on the Likert scale during the 16-week double-blind treatment period., Total number of sunlight-induced non-prodrome, phototoxic reactions during the 16-week double-blind treatment period. | — |
Countries
Bulgaria, Czechia, France, Italy, Netherlands, Poland, Spain
Outcome results
None listed