Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05020184 · ClinicalTrials.gov registry record · Phase 2
Effect of Oral Cimetidine in the Protoporphyrias
A Phase 2 study of Erythropoietic Protoporphyria and X-linked Protoporphyria, sponsored by Amy K. Dickey, M.D..
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
- 3
- Study locations
NCT05020184: Completed Phase 2 study of Erythropoietic Protoporphyria and X-linked Protoporphyria, sponsored by Amy K. Dickey, M.D..
NCT05020184 is a Phase 2 study of Erythropoietic Protoporphyria and X-linked Protoporphyria that has completed, run by Amy K. Dickey, M.D.. The registered enrollment target is 26 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05020184, a Phase 2 study of Erythropoietic Protoporphyria and X-linked Protoporphyria, has completed, sponsored by Amy K. Dickey, M.D..
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
- 3
- Study locations
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
Primary Outcome
Percent change in erythrocyte total protoporphyrin levels after treatment period versus before.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Cimetidine
Study Locations (3)
Massachusetts
- Massachusetts General Hospital - Boston
North Carolina
- Atrium Health Wake Forest Baptist Medical Center - Winston-Salem
Texas
- University of Texas Medical Branch - Galveston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2022-06-14 |
| Est. Completion | 2025-04-24 |
| Phase | Phase 2 |
What the finished NCT05020184 record still lists
NCT05020184 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 2 conditions, with Erythropoietic Protoporphyria appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05020184 reports a single indexed study location in Massachusetts, North Carolina, Texas.
Frequently Asked Questions
What is clinical trial NCT05020184 about?
NCT05020184 is a clinical study titled "Effect of Oral Cimetidine in the Protoporphyrias". 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 ...
What is the current status of trial NCT05020184?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2022-06-14. Estimated completion is 2025-04-24.
What conditions does trial NCT05020184 study?
This clinical trial studies the following conditions: Erythropoietic Protoporphyria, X-linked Protoporphyria.
What interventions are being tested in trial NCT05020184?
The interventions under investigation include: Placebo (DRUG), Cimetidine (DRUG).
Who is sponsoring clinical trial NCT05020184?
This trial is sponsored by Amy K. Dickey, M.D., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05020184 being conducted?
This trial has 3 study locations across Massachusetts, North Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05020184's enrollment target sits among peer trials
26 1708th of 2000 higher than 282 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02646475 · 26 participants · Phase 1
Metabolic Effects of Angiotensin-(1-7)
- NCT03603223 · 26 participants · Phase 2
Pembrolizumab in Treating Participants With Leukoplakia
- NCT04063592 · 26 participants · NA
AMI Construction in Lower Extremity Residual Limbs
- NCT04906460 · 26 participants · Phase 1
Open-label Study of WVE-N531 in Patients With Duchenne Muscular Dystrophy (FORWARD-53)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI