Last reviewed · How we verify
NCT00907283
Ferrochelating Treatment in Patients Affected by "Neurodegeneration With Brain Iron Accumulation" (NBIA)
Phase 2 trial testing Deferiprone in Neurodegenerative Disease in 20 participants. Status unknown.
1 December 2024
Quick facts
| Lead sponsor | Ente Ospedaliero Ospedali Galliera |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 November 2008 |
| Primary completion | 1 December 2024 |
| Estimated completion | 1 December 2024 |
| Sites | 3 locations across Italy |
Drugs / interventions tested
- Deferiprone (DEFERIPRONE) — full drug profile →
Conditions studied
- Neurodegenerative Disease — all drugs for Neurodegenerative Disease →
- Iron Overload — all drugs for Iron Overload →
Sponsor
Ente Ospedaliero Ospedali Galliera — full company profile →
Who can join
Adults 1 to 80, any sex, with Neurodegenerative Disease or Iron Overload. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
To evaluate the efficacy and safety of the chelator therapy with deferiprone on cerebral iron accumulations.
Time frame: 6 months + 6 months (plus one year extension)
Safety:CBC including ANC will be monitored weekly.If the liver enzymes are greater than 2.5 fold the upper limit of normal, the drug will be withheld and the assessment repeated in 1 week. If the laboratory values continue to be over 2.5 times the upper limit of normal or if the neutrophil counts decrease to less than 1.5 x 109/L (1500 cells/µl) the Patient will be withdrawn from the study. Neutro
Sponsor's own description
This trial is a multicenter, unblinded, single-arm pilot study, lasting one year (plus one year extension Amendment n.3 25 August 2009, plus two years follow-up Amendment n.7) , to evaluate the efficacy and safety of the chelator therapy with deferiprone on cerebral iron accumulations. The drug will be administered in the dosage of 15 mg/kg twice daily. The safety and tolerability of the drug will be evaluated by measuring hemochrome every seven days with leukocyte formula count. At 3, 6 and 12 months from the start of treatment, a neurological evaluation will be performed using several specific evaluation scales (International Cooperative Ataxia Rating Scale (ICARS); Unified Parkinson's Disease Rating Scale (UPDRS); Burke-Fahn-Marsden (BFM)). Every 6 months of treatment, a brain magnetic resonance image (MRI) aimed at measuring iron overload quantitatively, if possible.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
Targeting ferroptosis opens new avenues for the development of novel therapeutics.
Sun S, Shen J, Jiang J, Wang F, et al · · 2023 · cited 380× · PMID 37735472 · DOI 10.1038/s41392-023-01606-1 -
Advances in non-dopaminergic treatments for Parkinson's disease.
Stayte S, Vissel B. · · 2014 · cited 42× · PMID 24904259 · DOI 10.3389/fnins.2014.00113 -
Ferroptosis: mechanisms and therapeutic targets.
Zhou Q, Meng Y, Le J, Sun Y, et al · · 2024 · cited 32× · PMID 39568772 · DOI 10.1002/mco2.70010 -
Towards Precision Therapies for Inherited Disorders of Neurodegeneration with Brain Iron Accumulation.
Spaull RVV, Soo AKS, Hogarth P, Hayflick SJ, et al · · 2021 · cited 14× · PMID 34909266 · DOI 10.5334/tohm.661 -
Long-Term Neuroradiological and Clinical Evaluation of NBIA Patients Treated with a Deferiprone Based Iron-Chelation Therapy.
Romano N, Baiardi G, Pinto VM, Quintino S, et al · · 2022 · cited 11× · PMID 35956138 · DOI 10.3390/jcm11154524 -
Eye-of-the-tiger Sign in Neurodegeneration with Brain Iron Accumulation.
Goldberg M, Malik K, Jiswant R, Khaku AS. · · 2019 · cited 3× · PMID 31431841 · DOI 10.7759/cureus.4936 -
When Pathways Converge: Iron, Lipid Peroxidation, and α-Synuclein in Ferroptosis-Driven Dopaminergic Neurodegeneration.
Sperlich CL, Stockwell BR, Farina M. · · 2026 · PMID 41968973 · DOI 10.1111/jnc.70438
Verify or expand the search:
- PubMed search for NCT00907283
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Deferiprone
Trials testing the same drug.
- NCT07023666 — Early Screening and Treatment of Heart Complication in Sickle Cell Disease · Phase 2 · recruiting
- NCT03293069 — Conservative Iron Chelation as a Disease-modifying Strategy in Amyotrophic Lateral Sclerosis · Phase 2, PHASE3 · completed
- NCT02728843 — Study of Parkinson's Early Stage With Deferiprone · Phase 2 · completed
- NCT02655315 — Conservative Iron Chelation as a Disease-modifying Strategy in Parkinson's Disease · Phase 2 · completed
- NCT02443545 — Long-term Safety and Efficacy of Ferriprox® in Iron Overloaded Patients With Sickle Cell Disease or Other Anemias · Phase 4 · terminated
Other recruiting trials for Neurodegenerative Disease
Currently open trials in the same condition.
- NCT07361887 — Deciphering the Effect of Moderate Wine Consumption on Healthy Aging Through Postprandial Extracellular Vesicles. · NA · recruiting
- NCT07306598 — [18F]NIDF PET Imaging in Tau-related Diseases · recruiting
- NCT07285954 — Mindfulness Walking Intervention to Enhance Resilience (iWalk) · NA · recruiting
- NCT06821230 — Dyadic Mindfulness for People With Parkinson's Disease and Their Caregivers · NA · recruiting
- NCT06755164 — Effects of Combined Aerobic and Cognitive Training in a Simultaneous or Sequential Paradigm on Cognition and Brain Funct · NA · active not recruiting
Other Ente Ospedaliero Ospedali Galliera trials
Trials by the same sponsor.
- NCT07486336 — Awareness Neuraxial Versus General Anesthesia in Frail Patients Undergoing Laparoscopic or Robotic Abdominopelvic Surger · NA · not yet recruiting
- NCT07483840 — Analgesic Techniques for Robotic Prostatectomy Procedures · NA · not yet recruiting
- NCT06994208 — Characteristics of Adult Patients With Melanoma Diagnosis <40 Years Age. · recruiting
- NCT05601700 — Letrozole for Estrogen/Progesterone Receptor Positive Low-grade Serous Epithelial Ovarian Cancer (LEPRE Trial) · Phase 3 · recruiting
- NCT07187986 — Sound Acupuncture in Painful Chemotherapy-Related Neuropathies · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00907283 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 Ente Ospedaliero Ospedali Galliera
- Last refreshed: 7 February 2023
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/NCT00907283.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing