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Open-Label Extension of EryDex in A-T (OLE NEAT)
EU CTIS ID: 2024-513618-37-00
What this study is testing
Safety Objective: To evaluate the safety and tolerability of eDSP in participants with A-T. Exploratory Objective: To evaluate the effects of eDSP on neurological symptoms in participants with A-T.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Males and females ≥ 6 years of age, with body weight ≥15 kg, who completed the IEDAT-04-2022 trial, including final efficacy assessments (Visit 9).
- Participant’s body weight ≥15 kg.
- Participant does not meet any of the criteria for treatment discontinuation and does not present safety contraindications for continuation of treatment as determined by the investigator.
- In the investigator’s opinion, the potential benefit of receiving the investigational treatment in the OLE trial outweighs the potential risks of receiving the investigational treatment in the OLE trial.
You likely can't join if
- Females who are pregnant, or breastfeeding. Females of childbearing potential using adequate birth control as determined by their healthcare provider will be eligible.
- Participant has clinically significant immune impairment that, in the opinion of the investigator, precludes further treatment with corticosteroids.
- Participant has confirmed hemoglobinopathies, e.g., hemoglobin C disease, sickle cell anemia, hereditary spherocytosis, or thalassemia.
- Participants with suicidal ideation.
- Participant requires treatment with a systemic corticosteroid. Treatment with inhaled or intranasal corticosteroids for asthma or allergies, as well as use of topical corticosteroids will be permitted.
- Participant requires any concomitant medication prohibited by the protocol, including strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4).
See the full eligibility criteria
- Males and females ≥ 6 years of age, with body weight ≥15 kg, who completed the IEDAT-04-2022 trial, including final efficacy assessments (Visit 9).
- Participant’s body weight ≥15 kg.
- Participant does not meet any of the criteria for treatment discontinuation and does not present safety contraindications for continuation of treatment as determined by the investigator.
- In the investigator’s opinion, the potential benefit of receiving the investigational treatment in the OLE trial outweighs the potential risks of receiving the investigational treatment in the OLE trial.
- Females who are pregnant, or breastfeeding. Females of childbearing potential using adequate birth control as determined by their healthcare provider will be eligible.
- Participant has clinically significant immune impairment that, in the opinion of the investigator, precludes further treatment with corticosteroids.
- Participant has confirmed hemoglobinopathies, e.g., hemoglobin C disease, sickle cell anemia, hereditary spherocytosis, or thalassemia.
- Participants with suicidal ideation.
- Participant requires treatment with a systemic corticosteroid. Treatment with inhaled or intranasal corticosteroids for asthma or allergies, as well as use of topical corticosteroids will be permitted.
- Participant requires any concomitant medication prohibited by the protocol, including strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4).
- Current neoplastic disease or previous neoplastic disease not in remission for at least 2 years.
- Current participation in another clinical trial. Participation in observational, non-interventional studies is allowed as long as trial investigational endpoint raters can remain blinded to the assessments from other studies, and as long as the other trial participation does not interfere with participation in this trial.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Switzerland
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Switzerland; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.