Safety, Blood Levels and Effects of AUT00201 in Patients With MEAK (NCT05873062) | Clinical Trial Compass
CompletedPhase 1
Safety, Blood Levels and Effects of AUT00201 in Patients With MEAK
United States6 participantsStarted 2023-05-12
Plain-language summary
A randomized, double-blind, placebo-controlled, crossover study to assess the safety, tolerability, and pharmacokinetics of single doses of AUT00201 at 100 mg or matching placebo in patients with myoclonus epilepsy and ataxia due to potassium channel mutation (MEAK).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Male or female patients aged 18 years or older at time of consenting.
* Diagnosed with MEAK, based on documented genetic evidence of the presence of the KCNC1 (c.959G\>A; p.Arg320His) variant.
* If take anticonvulsants, must be on a stable anticonvulsant regiment for at least 30 days prior to Visit 1 and anticipated to remain stable throughout the study or if not on an anticonvulsant regimen, must be stable in regards to seizures for at least 30 days prior to Visit 1 and anticipated to remain stable throughout the study.
* Must be able to participate and willing to give written informed consent. If patient is unable to provide written informed consent, a legally authorized representative can sign on their behalf.
* Must be willing to perform study assessments and comply with the study protocol.
* If the patient is dependent on a caregiver and/or will need assistance either travelling to the site, whilst attending clinic visits and/or helping to document study assessment responses provided by the patient (eg, questionnaires administered on a tablet device), they must have an identified caregiver, considered reliable by the Investigator, to provide support to the patient for the duration of the study. The caregiver must be willing and able to provide support to the patient and, if required, stay for the duration of the study.
* Medically stable based on Investigator's judgement for at least 90 days prior to Visit 1.
* Women of childbearing potential must …
What they're measuring
1
Number of Participants With Treatment-Related Adverse Events After Single Dose Treatment of AUT00201 Compared to Placebo