A Phase 2 interventional study of AEVI-001 and Placebo in Attention Deficit Hyperactivity Disorder, sponsored by Aevi Genomic Medicine, LLC, a Cerecor company. Completed at 1 site in United States. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2021-07-07.
Sponsored by Aevi Genomic Medicine, LLC, a Cerecor company · Phase 2, Interventional, and Treatment
Among 807 studies in Attention Deficit Disorder with Hyperactivity with a site in United States — 98 open to participants now, 116 under way, 5 of them phase 3. Attention Deficit Disorder with Hyperactivity · United States.
Among the 807 studies in Attention Deficit Disorder with Hyperactivity with a site in United States, this one is the 356th largest by enrollment of the 706 interventional ones that give a count, is one of 34 that started in 2017, is one of 80 in phase 2, and was the 509th registered.
1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 296 are open to participants now.
Browse Attention Deficit Disorder with Hyperactivity studies →98 of the 807 studies in Attention Deficit Disorder with Hyperactivity with a site in United States are open now. Recruiting first, the newest first:
National Institute of Mental Health (NIMH) · Sites in United States
National Institute of Mental Health (NIMH) · Sites in United States
National Institute of Mental Health (NIMH) · Sites in United States
Otsuka Pharmaceutical Development & Commercialization, Inc. · Sites in United States
Alkermes, Inc. · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 201 Attention Deficit Disorder with Hyperactivity studies recruiting now, 27 (13%) set no upper age limit and 169 (84%) stop at 75 or younger; 141 take children under 18; 55 take healthy volunteers.
This study: 6 Years to 17 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
807 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 62 · Phase 2 108 · Phase 3 135 · Phase 4 148
First in 1985; this study’s year is marked. 34 started in 2017.
This study's enrollment of 69 is close to the median of 71 across 1,437 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Median enrollment 70 across the 706 interventional studies, 115 across the 98 observational. Of the 644 that completed or were terminated, 302 (47%) have results posted.
This tab as a report to print or save as PDF → With an account.
262 of 807 have an industry lead sponsor. The 10 most frequent:
Aevi Genomic Medicine, LLC, a Cerecor company is the lead sponsor of 12 studies on the registry; none are open to participants now.
Aevi Genomic Medicine, LLC, a Cerecor company has 7 studies filed under Attention Deficit Disorder with Hyperactivity — fewer than ten, so there is no comparison to draw.
34 of the studies in Attention Deficit Disorder with Hyperactivity with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07759154Phase 3Otsuka Pharmaceutical Development & Commercialization, Inc.A Study to Test the Effects of Centanafadine in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation | 2027-05-27 |
| NCT04278404Duke UniversityPharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) | 2026-11 |
| NCT04946253University of PittsburghSKIP for PA Study: Team and Leadership Level Implementation Support for Collaborative Care | 2026-11 |
| NCT05683756University of PittsburghOptimizing Attention and Sleep Intervention Study | 2026-12 |
| NCT07594730New York State Psychiatric InstituteBrief Intervention Addressing Stigma Among Parents of Children With Mental Health Problems | 2026-12-01 |
Among the 807 studies in Attention Deficit Disorder with Hyperactivity with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is PART A of a 2-part, 6-week, double-blind, dose-optimization, parallel-group study in children and adolescents (ages 6-17 years) with ADHD with and without CNVs in specific genes implicated in glutamatergic signaling and neuronal activity. Parts A will include subjects determined to have a specific gene mutations implicated in glutamatergic signaling and neuronal connectivity.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: AEVI-001
Drug: Placebo
Oral doses of 100 mg, 200 mg or 400 mg of AEVI-001 will be administered twice daily during the treatment period.
Also known as: MDGN-001, NFC-1
Oral doses of 100 mg, 200 mg or 400 mg of Placebo will be administered twice daily during the treatment period.
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale, Version 5 (ADHD-RS-5) Total Score
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.
Time frame: Baseline to Visit 8 (Week 6)
Clinical Global Impression - Global Improvement (CGI -I) Response
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
Time frame: Visit 8 (Week 6)
| Milestone | AEVI-001 | Placebo |
|---|---|---|
| Started | 34 | 35 |
| Completed | 24 | 28 |
| Not completed | 10 | 7 |
| Withdrew: Adverse event | 2 | 1 |
| Withdrew: Lack of efficacy | 3 | 0 |
| Withdrew: Protocol violation | 1 | 2 |
| Withdrew: Withdrawal by subject | 2 | 4 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Lack of compliance | 1 | 0 |
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.
| units on a scale | AEVI-001 | Placebo |
|---|---|---|
| Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale, Version 5 (ADHD-RS-5) Total Score | -9.17 ± 2.235 | -11.34 ± 2.122 |
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
| Participants | AEVI-001 | Placebo |
|---|---|---|
| Clinical Global Impression - Global Improvement (CGI -I) Response | 9 | 11 |
Collected over 1 year, 1 month, 4 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AEVI-001 | 0/34 (0%) | 1/34 (2.9%) | 12/34 (35.3%) |
| Placebo | 0/35 (0%) | 0/35 (0%) | 11/35 (31.4%) |
| Event | AEVI-001 | Placebo |
|---|---|---|
| IrritabilityPsychiatric disorders | 1/34 | 0/35 |
| Event | AEVI-001 | Placebo |
|---|---|---|
| Weight increasedInvestigations | 4/34 | 4/35 |
| HeadacheNervous system disorders | 3/34 | 4/35 |
| FatigueGeneral disorders | 1/34 | 3/35 |
| Abdominal pain upperGastrointestinal disorders | 2/34 | 1/35 |
| PyrexiaGeneral disorders | 2/34 | 0/35 |
| Upper respiratory tract infectionInfections and infestations | 2/34 | 1/35 |
| SedationNervous system disorders | 2/34 | 0/35 |
| Age, Continuous(years) | AEVI-001 | Placebo | Total |
|---|---|---|---|
| Mean | 9.9 ± 2.95 | 10.8 ± 2.86 | 10.4 ± 2.92 |
| Age, Customized(Participants) | AEVI-001 | Placebo | Total |
|---|---|---|---|
| 6 to 12 years | 26 | 27 | 53 |
| 13 to 17 years | 8 | 8 | 16 |
| Sex: Female, Male(Participants) | AEVI-001 | Placebo | Total |
|---|---|---|---|
| Female | 7 | 14 | 21 |
| Male | 27 | 21 | 48 |
| Ethnicity (NIH/OMB)(Participants) | AEVI-001 | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | 4 | 10 |
| Not Hispanic or Latino | 28 | 31 | 59 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | AEVI-001 | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 24 | 20 | 44 |
| White | 7 | 12 | 19 |
| More than one race | 2 | 3 | 5 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | AEVI-001 | Placebo | Total |
|---|---|---|---|
| United States | 34 | 35 | 69 |
| Attention Deficit Hyperactivity Disorder Rating Scale, Version 5 (ADHD-RS-5) Total Score(units on a scale) | AEVI-001 | Placebo | Total |
|---|---|---|---|
| Mean | 39.0 ± 6.76 | 38.1 ± 8.29 | 38.6 ± 7.53 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Aug 2017 to primary completion in Sep 2018, 12 months.
Results were first posted in Jul 2019, 9 months after primary completion.
Of 24 industry-sponsored phase 2 interventional studies under Attention Deficit Disorder with Hyperactivity, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 14. This study's 12 months is above that.
Counting every sponsor, half of 40 studies reached it within 15 months; a quarter within 5 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Fasoracetam
Attention Deficit Disorder with Hyperactivity →
Aevi Genomic Medicine, LLC, a Cerecor company