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COMPLETED
NCT05020184
PHASE2

Effect of Oral Cimetidine in the Protoporphyrias

Sponsor: Amy K. Dickey, M.D.

View on ClinicalTrials.gov

Summary

Erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP) result from genetic defects of heme biosynthesis that cause life-long, painful cutaneous sensitivity to light. The objective of this study is to determine the efficacy and safety of oral cimetidine administration for treatment of the protoporphyrias. Efficacy will be based on protoporphyrin levels, photosensitivity, and quality of life questionnaires. Funding Source- FDA OOPD

Key Details

Gender

All

Age Range

15 Years - Any

Study Type

INTERVENTIONAL

Enrollment

26

Start Date

2022-06-14

Completion Date

2025-04-24

Last Updated

2026-09-04

Healthy Volunteers

No

Interventions

DRUG

Cimetidine

Oral Cimetidine 800mg twice daily.

DRUG

Placebo

Placebo twice daily

Locations (3)

Massachusetts General Hospital

Boston, Massachusetts, United States

Atrium Health Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

University of Texas Medical Branch

Galveston, Texas, United States