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Also known as MDGN-001, NFC-1
AEVI-001 · 6 trials · 4 indications
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.
The CGI-I item is rated on a 7-point scale from 1 = "Very much improved", 2 = "Much improved", 3 = "Minimally improved", 4 = "No change", 5 = "Minimally worse", 6 = "Much worse", 7 = "Very much worse". Response is defined as achieving a CGI-I score of 1 or 2, scores of 3 to 7 or missing are defined as Non Response
| Arm | Type | Description |
|---|---|---|
| AEVI-001 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| NFC-1 | EXPERIMENTAL | Doses of NFC-1 will be administered as 100, 200, or 400 mg twice daily as capsules for oral administration. |
| NFC-1 100 mg | EXPERIMENTAL | Single Dose of NFC-1 100 mg |
| NFC-1 200 mg | EXPERIMENTAL | Single Dose of NFC-1 200 mg |
| NFC-1 400 mg | EXPERIMENTAL | Single Dose of NFC-1 400 mg |
| NFC-1 800 mg | EXPERIMENTAL | Single Dose of NFC-1 800 mg |
| Single arm of 30 subjects | EXPERIMENTAL | Subjects will be administered single dose of NFC-1 to assess safety, tolerability, and pharmacokinetics, then proceed to continuous, daily administration of NFC-1 for 4 weeks to assess safety, tolerability, and impact on ADHD severity. |
| Name | Type | Description |
|---|---|---|
| AEVI-001 | DRUG | Oral doses of 100 mg, 200 mg or 400 mg of AEVI-001 will be administered twice daily, during the treatment period. |
| Placebo | DRUG | Oral doses of Placebo will be administered twice daily, during the treatment period. |
| NFC-1 | DRUG | NFC-1 is supplied as size 2 hard gelatin capsules. |
| NFC-1 100 mg | DRUG | - |
| NFC-1 200 mg | DRUG | - |
| NFC-1 400 mg | DRUG | - |
| NFC-1 800 mg | DRUG | - |
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 ...
AEVI-001 is an investigational small molecule being developed by Avalo Therapeutics, Inc. for Attention Deficit Hyperactivity Disorder. It has been studied in Phase 2 clinical trials in children and adolescents. It is not an approved therapy and remains in clinical development.
AEVI-001 is being studied for the treatment of Attention Deficit Hyperactivity Disorder in children and adolescents. Two completed Phase 2 trials evaluated its efficacy and safety in this population, one in patients with mGluR mutations and one in patients without those mutations.
AEVI-001 is being developed by Avalo Therapeutics, Inc., which trades under the ticker AVTX. The company has sponsored the clinical program evaluating the drug in Attention Deficit Hyperactivity Disorder.
AEVI-001 is in Phase 2 development. Both of its clinical trials in Attention Deficit Hyperactivity Disorder have been completed, and no trials are currently active. The drug is investigational and has not been approved for any indication.
AEVI-001 has been evaluated in two completed Phase 2 trials. NCT03609619 studied children and adolescents with ADHD without mGluR mutations and enrolled 109 participants. NCT03265119 studied children and adolescents with ADHD and mGluR mutations and enrolled 69 participants. Both were randomized, double-blind, and placebo-controlled.
Both Phase 2 trials of AEVI-001 were randomized, double-blind, and placebo-controlled. They enrolled a combined 178 participants aged 6 years and older in the United States. NCT03609619 enrolled 109 patients without mGluR mutations, and NCT03265119 enrolled 69 patients with mGluR mutations.