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AEVI-001

Phase 2

Attention Deficit Hyperactivity Disorder | Small molecule | Psychiatry |Avalo Therapeutics, Inc.|Last Updated: Jul 30, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials2
Total Enrollment178

FDA Designations

No designations recorded

Clinical trial landscape

AEVI-001 · 2 trials · 1 indication

Phase 2 2
NCT03609619PART B: Efficacy and Safety of AEVI-001 in Children and Adolescents With ADHD and Without mGluR MutationsAttention Deficit Hyperactivity Disorder
COMPLETED109 Analytics
NCT03265119PART A: Efficacy and Safety of AEVI-001 in Children and Adolescents With ADHD and With mGluR MutationsAttention Deficit Hyperactivity Disorder
COMPLETED69 Analytics
PHASE2COMPLETED
PART B: Efficacy and Safety of AEVI-001 in Children and Adolescents With ADHD and Without mGluR Mutations
Attention Deficit Hyperactivity DisorderUnlock trial analytics
PHASE2COMPLETED
PART A: Efficacy and Safety of AEVI-001 in Children and Adolescents With ADHD and With mGluR Mutations
Attention Deficit Hyperactivity DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale, Version 5 (ADHD-RS-5) Total Score
Baseline to Visit 8 (Week 6)

The ADHD-RS-5 is comprised of 18 frequency items and 12 impairment items. Each frequency item was scored on a scale from 0 = "Never or rarely" to 3 = "Very often". The ADHD-RS-5 total score was calculated as the sum of the 18 frequency item scores. The total score ranges from 0 to 54. Higher scores indicate greater symptom severity. Change from baseline value were calculated as the assessment value minus the baseline value.

Secondary Endpoints

Clinical Global Impression - Global Improvement (CGI -I) Response
Visit 3 to Visit 8 (Week 6)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEVI-001EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
AEVI-001DRUGOral doses of 100 mg, 200 mg or 400 mg of AEVI-001 will be administered twice daily, during the treatment period.
PlaceboDRUGOral doses of Placebo will be administered twice daily, during the treatment period.
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Eligibility Criteria

Age Range6 Years to 17 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Subject and parent/legally authorized representative (LAR) can speak English fluently and have provided written informed consent, and assent (as applicable) for this study. 2. Subject is 6 to 17 years of age (inclusive) at the time of consent/assent. The date of signature of ...

Countries:United States
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Frequently asked questions about AEVI-001

What is AEVI-001 used for?

AEVI-001 is an investigational small molecule being developed for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents. It is currently in Phase 2 clinical development and has been studied in two completed trials in the United States.

Who is developing AEVI-001?

AEVI-001 is being developed by Avalo Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol AVTX. The drug is currently in Phase 2 clinical development for Attention Deficit Hyperactivity Disorder.

What phase is AEVI-001 in?

AEVI-001 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 2 trials studying the drug in children and adolescents with ADHD have been completed.

What clinical trials has AEVI-001 been in?

AEVI-001 has been studied in two completed Phase 2 clinical trials. NCT03265119 enrolled 69 participants with ADHD and mGluR mutations, and NCT03609619 enrolled 109 participants with ADHD without mGluR mutations. Both trials were conducted in the United States.

Is AEVI-001 the same as any other drug?

AEVI-001 is the investigational name for the drug being developed by Avalo Therapeutics. No alternative names for this drug have been disclosed in the available clinical trial information.