Open-Label Extension of EryDex Study IEDAT-04-2022 (NCT06664853) | Clinical Trial Compass
TerminatedPhase 3
Open-Label Extension of EryDex Study IEDAT-04-2022
Stopped: eDSP development discontinued
United States, Denmark, Germany101 participantsStarted 2024-12-11
Plain-language summary
This is an international, multi-center, prospective, open-label, non-comparative study aiming to provide access to treatment with EryDex to ataxia telangiectasia (A-T) patients who completed the IEDAT-04-2022 trial which studied the neurological effects of EryDex on subjects with ataxia telangiectasia (NEAT trial).
Who can participate
Age range
6 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* body weight ≥15 kg
* participation in IEDAT-04-2022 study and its completion, including final efficacy and safety assessments
Exclusion Criteria:
* safety contraindications for continuation of treatment, as determined by the investigator
* clinically significant immune impairment that, in the opinion of the Investigator, precludes further treatment with corticosteroids
* Current neoplastic disease or previous neoplastic disease not in remission for at least 2 years.
* requiring treatment with a systemic corticosteroid
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Treatment Emergent Adverse Events
Timeframe: through study completion, up to approximately 13 months
2
Number of Participants With Treatment Emergent Adverse Events Leading to Intervention Discontinuation
Timeframe: through study completion, up to approximately 13 months
3
Number of Participants With Serious Adverse Events
Timeframe: through study completion, up to approximately 13 months