NCT04120883 is a Phase 1, PHASE2 clinical trial of Hydroxychloroquine lower dose in Retinitis Pigmentosa, sponsored by University of Michigan.

Who is sponsoring NCT04120883?

NCT04120883 is sponsored by University of Michigan.

What drugs are being tested in NCT04120883?

Interventions in NCT04120883: Hydroxychloroquine lower dose, Hydroxychloroquine higher dose.

What condition does NCT04120883 study?

NCT04120883 studies Retinitis Pigmentosa.

Is NCT04120883 still recruiting?

NCT04120883 is currently terminated. Last updated 26 October 2024.

Last reviewed 2024-10-26 · How we verify

NCT04120883

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Oral Hydroxychloroquine (HCQ) for Retinitis Pigmentosa Caused by P23H- Rhodopsin (RHO)

Terminated Phase 1, PHASE2 Last updated 26 October 2024

What this trial tests

Phase 1, PHASE2 trial testing Hydroxychloroquine lower dose in Retinitis Pigmentosa in 8 participants. Terminated before completion.

Timeline

25 February 2020

Primary endpoint
5 August 2024

5 August 2024

Quick facts

Lead sponsor	University of Michigan
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	single
Primary purpose	treatment
Enrollment	8
Start date	25 February 2020
Primary completion	5 August 2024
Estimated completion	5 August 2024
Sites	1 location across United States

Drugs / interventions tested

Hydroxychloroquine lower dose — full drug profile →
Hydroxychloroquine higher dose — full drug profile →

Conditions studied

Retinitis Pigmentosa — all drugs for Retinitis Pigmentosa →

Sponsor

University of Michigan

Who can join

18 and older, any sex, with Retinitis Pigmentosa. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This research study is being done to learn what effect 12 months of treatment with oral hydroxychloroquine (HCQ) will have on the retina in people with retinitis pigmentosa (RP). The hypothesis is that treatment with HCQ is safe and tolerable in patients with autosomal dominant retinitis pigmentosa (adRP) caused by P23H-RHO, and may arrest progression of retinal degeneration by altering the autophagy pathway in photoreceptors. Participants that meet eligibility and agree to the study will be asked to take the study medication (HCQ) for 12 months and have evaluations for up to approximately 18 months from the baseline visit. There will be a total of 6 visits (1 is a phone visit) and will include general examinations, blood work, electrocardiograms, along with special testing of the retina.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Sector Retinitis Pigmentosa: Extending the Molecular Genetics Basis and Elucidating the Natural History.
Georgiou M, Grewal PS, Narayan A, Alser M, et al · · 2021 · cited 39× · PMID 32795431 · DOI 10.1016/j.ajo.2020.08.004
Inherited Retinal Dystrophies: Role of Oxidative Stress and Inflammation in Their Physiopathology and Therapeutic Implications.
Pinilla I, Maneu V, Campello L, Fernández-Sánchez L, et al · · 2022 · cited 30× · PMID 35739983 · DOI 10.3390/antiox11061086
Recent advances in the understanding of cilia mechanisms and their applications as therapeutic targets.
Saito M, Otsu W, Miyadera K, Nishimura Y. · · 2023 · cited 10× · PMID 37780208 · DOI 10.3389/fmolb.2023.1232188

Verify or expand the search:

Other recruiting trials for Retinitis Pigmentosa

Currently open trials in the same condition.

NCT06891885 — A Study to Investigate the Safety of DSP-3077 After a Unilateral Eye Injection in Male and Female Participants 18 Years · Phase 1, PHASE2 · recruiting
NCT07408232 — A Phase 1/2 Study in Healthy Volunteers and Participants With Autosomal Dominant Retinitis Pigmentosa (RHO-adRP) · Phase 1, PHASE2 · recruiting
NCT07228793 — Natural History Study of Patients With EYS-Associated RP · recruiting
NCT06319872 — The Effects of Disulfiram (Antabuse®) on Visual Acuity in Patients With Retinal Degeneration · Phase 1 · recruiting
NCT06936787 — An Open-label, Dose-ascending Study of IGT001 for Retinitis Pigmentosa · Phase 1 · recruiting

Other University of Michigan trials

Trials by the same sponsor.

NCT07536919 — Integrating Care for Hypertension-Diabetes MULTImorbidity in Guatemala Through HEARTS Implementation · NA · not yet recruiting
NCT05509842 — Function-based Accelerated Stimulation Therapy (FAST-therapy) for Freezing of Gait (FOG) After Parkinson's Disease (PD) · NA · not yet recruiting
NCT06311188 — Exploring PTSD Symptoms, Barriers and Facilitators to Mindfulness · NA · not yet recruiting
NCT07471646 — Effects of Ramadan Fasting With Exercise on Cardiometabolic Health · NA · not yet recruiting
NCT06671925 — A Community Health Worker-Led Program for Chronic Pain and Loneliness in Older Adults · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04120883 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Michigan
Last refreshed: 26 October 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04120883.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing