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New treatment option for Friedreich Ataxia
Official title A Multiple Ascending Dose Study of DT-216P2 in Patients With Friedreich's Ataxia
ClinicalTrials.gov ID: NCT06874010
What this study is testing
What is DT-216P2?
DT-216P2 is an investigational medicine, being studied as a potential treatment for friedreich ataxia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the safety and tolerability, and pharmacokinetics of DT-216P2 administered multiple ascending doses in patients with FA.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Participants must be 18-65 years of age inclusive, at the time of signing the informed consent.
- Genetically confirmed diagnosis of FA, with homozygous GAA repeat expansions in the frataxin gene.
- Stage 5.5 or less on the FSA at screening.
- BMI between 16 and 32 kg/m2 at screening; weight should be \<= 100 kg at screening.
- Male and/or female using protocol defined and regulatory approved contraception.
You likely can't join if
- Any concomitant medical condition that in the opinion of the investigator, puts the participant at risk or precludes participant from completing the...
- Any clinically significant nonmedical conditions and psychiatric disorders that could put the participant at higher risk for participation in the...
- Received an investigational agent within the last 30 days or 5 half-lives, whichever longer, prior to the first dose of study drug, or are in...
- Is not willing to comply with the contraceptive requirements during the study period, as per protocol.
See the full eligibility criteria
- Participants must be 18-65 years of age inclusive, at the time of signing the informed consent.
- Genetically confirmed diagnosis of FA, with homozygous GAA repeat expansions in the frataxin gene.
- Stage 5.5 or less on the FSA at screening.
- BMI between 16 and 32 kg/m2 at screening; weight should be \<= 100 kg at screening.
- Male and/or female using protocol defined and regulatory approved contraception.
- Capable of giving signed informed consent.
- Any concomitant medical condition that in the opinion of the investigator, puts the participant at risk or precludes participant from completing the study protocol.
- Any clinically significant nonmedical conditions and psychiatric disorders that could put the participant at higher risk for participation in the study, influence the participant's ability to participate in the study...
- Received an investigational agent within the last 30 days or 5 half-lives, whichever longer, prior to the first dose of study drug, or are in follow-up of another clinical study prior to study enrollment. Exception...
- Is not willing to comply with the contraceptive requirements during the study period, as per protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Sydney, New South Wales, Australia
- East Melbourne, Victoria, Australia
- Melbourne, Victoria, Australia
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 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sydney, New South Wales, Australia; East Melbourne, Victoria, Australia; Melbourne, Victoria, Australia. 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 ClinicalTrials.gov; the study team decides eligibility.