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Effect of Oral Cimetidine in the Protoporphyrias

NCT05020184 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2026-01-21

No results posted yet for this study

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

Conditions

Interventions

DRUG

Cimetidine

Oral Cimetidine 800mg twice daily.

DRUG

Placebo

Placebo twice daily

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    collaborator OTHER

  • The University of Texas Medical Branch, Galveston

    collaborator OTHER

  • Amy K. Dickey, M.D.

    lead OTHER

Principal Investigators

  • Amy K Dickey, MD · Massachusetts General Hospital

  • Karl Anderson, MD · University of Texas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-14
Primary Completion
2025-04-24
Completion
2025-04-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05020184 on ClinicalTrials.gov