Attention Deficit Hyperactivity Disorder (ADHD)Phase 3NCT02691182

Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 4)

A Phase 3 study testing SPN-810 in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Supernus Pharmaceuticals, Inc. at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 6 to 17 years
Conditions the study is for: Attention Deficit Hyperactivity Disorder (ADHD)
What is being tested?: SPN-810
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 491 participants
Where: 1 siteUnited States
Study dates: Apr 2016to May 2021
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Healthy male or female subjects, who completed and converted from a satisfactory participation in the study 810P301, 810P302, 810P503 and 810P204 or discontinued early from the previous study during the maintenance phase and allowed to enroll only after consultation between the Investigator, the Medical Monitor and the Sponsor.
Medically healthy and with clinically normal laboratory profiles, vital signs, and electrocardiograms (ECGs).
Existing diagnosis of ADHD, as described by DSM-5 and confirmed by the K-SADS PL 2013 from study 810P301 or 810P302 or by the MINI-KID from study 810P503 or 810P204.
Currently receiving monotherapy treatment with FDA-approved ADHD medication (stimulants and non-stimulants).
Weight of at least 20 kg.
Written Informed Consent obtained from the subject's parent or legally authorized representative (LAR), and written Informed Assent obtained from the subject if appropriate.

Who cannot join

Body Mass Index (BMI) in 99th percentile or above.
Clinically significant change in health status, safety concern or any other reason that, in the opinion of the Sponsor or the Investigator, would prevent the subject from participating in this study or successfully completing this study.
Pregnancy or refusal to practice contraception during the study (for female subjects of childbearing potential and sexually active males).
Current substance or alcohol use.
Suicidal thoughts or behaviors confirmed at Visit 7 for 810P301 or 810P302, Visit 8 for 810P503 or Visit 6 for 810P204 studies.

Trial locations and contacts

1 site in 1 country.

United States1 site

CNS Healthcare of Orlando
Orlando, Florida, 32801

Other trials in United States

About this study

Official title: Open-Label Extension Study to Evaluate the Long-Term Safety of Molindone Hydrochloride Extended-Release Tablets for the Treatment of Impulsive Aggression in Pediatric and Adolescent Subjects With Attention Deficit/Hyperactivity Disorder (ADHD) in Conjunction With Standard ADHD Treatment

Children between the ages of 6-12 years who are diagnosed with impulsive aggression comorbid with ADHD and have participated in the 810P301 or 810P302 study were invited to participate in this study. This was a Phase 3 open-label extension (OLE) study to collect long-term safety data on the use of SPN-810 in treating impulsive aggression in pediatric subjects with ADHD when taken in conjunction with standard ADHD treatment. After confirmation of eligibility, all subjects were treated with SPN-810. Subjects were given a choice to extend participation in this study every 6 months for up to 36 months.

Read the detailed description

Study 810P304 is a multicenter, open-label, extension study aimed to assess safety of SPN-810 in the treatment of IA in patients aged 6-17 years with ADHD in conjunction with standard ADHD treatment.

The study has three phases: Optimization, Maintenance, and Taper. All subjects who complete the randomized, double-blind portion of study 810P301, 810P302, 810P503 or 810P204 will have the option to participate in the OLE study in which all subjects will receive active Study Medication (SM) treatment. Subjects who choose to participate in the OLE will receive blinded conversion medication kits at Visit 6 of the previous SPN-810 double-blind randomization study (810P301, 810P302) or at Visit 4 for subjects completing the 810P204 study. Subjects, who have completed the 810P503 study and, chose to participate in this study, will receive the blinded conversion card at Visit 7.

Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Being tested: SPN-810
Medical subject headings: Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SPN-810Drug

Study groups in NCT02691182
Study group	Role	What they receive
Open-label treatment with SPN-810	Experimental	Subjects aged 6-17 years were treated with SPN-810 starting on day 1 with 18 mg/day. The clinician was able to adjust the dose of SPN-810 throughout the study based on subject's response and tolerability within the limits of 6 mg/day and 36 mg/day or, up to 54 mg/day for subjects with a body weight ≥ 30 kg. The subjects were given a choice of extending their participation in the study every 6-month period for up to 36 months Receives: Drug: SPN-810

What is being measured

The primary outcome is the main question the study is designed to answer.

Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score
R-MOAS scale gauges the severity of aggressive behavior: the frequency of the 16 behaviors is rated over the past week in 4 areas (VE, PH, PR, SE). For each open question in each area, the parent-rated the aggressive behaviors on a scale from 0 to 5 or more times. To each area corresponds a weighted category: Verbal Incidents (VE)=1, Incidents Toward Other (PH) =4, Incidents Involving Property (PR)=2 and Incidents Directed Toward Self (SE)=3. Therefore, the sum of each area yields a maximum weighted score of 20 (VE), 120 (PH), 60 (PR), and 90 (SE). The total score is the sum of the four area scores or 0-290; the higher the score, the more severe the aggressive behavior is.
The data represent the total score change from baseline at each visit for the duration of the study, a total of 60 months. The baseline score represents the total score at the last visit of each double-blind study.
Measured: 17-time points: Months 3 (V5), 6 (V6), 9 (V7), 12 (V8), 15 (V9), 18 (V10), 21 (V11), 24 (V12), 27 (V13), 30 (V14), 33 (V15), 36 (V16), 39 (V17), 42 (V18), 45 (V19), 48 (V20) and month 60 (Visit 24).
Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S)
The Clinical Global Impression - Severity of Illness (CGI-S) is a single item clinician rating of clinician's assessment of the severity of IA behaviors. CGI-S was evaluated by the Investigator at each visit on a 7- point scale with 1=Normal, 2=Borderline ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Extremely ill.
Data represent the change from baseline to each visit during the study. The baseline score represents the total score at the last visit of each double-blind study.
Measured: 20-time points: Week 2 (V2), Week 4 (V3), Week 8 (V4), Months 3 (V5), 6 (V6), 9 (V7), 12 (V8), 15 (V9),18 (V10), 21 (V11), 24 (V12), 27 (V13), 30 (V14), 33 (V15), 36 (V16), 39 (V17), 42 (V18), 45 (V19), 48 (V20) and month 60 (Visit 24).
Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I)
The Clinical Global Impression - Improvement Scale (CGI-I) is a clinician's assessment of how much the IA behaviors have improved or worsened relative to a baseline state at the beginning of treatment. CGI-I was evaluated by the Investigator at each visit on a 7-point scale with 1=Very much improved, 2= Much improved, 3= Minimally improved, 4= No change, 5= Minimally worse, 6= Much worse, 7= Very much worse.
Data represent the score at each visit during the study.
Measured: 20-time points: Week 2 (V2), Week 4 (V3), Week 8 (V4), Months 3 (V5), 6 (V6), 9 (V7), 12 (V8), 15 (V9),18 (V10), 21 (V11), 24 (V12), 27 (V13), 30 (V14), 33 (V15), 36 (V16), 39 (V17), 42 (V18), 45 (V19), 48 (V20) and Month 60 (Visit 24).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2016May 2021

First posted25 Feb 2016 (estimated)
Study startApr 2016
Primary completionMay 2021
Study completionMay 2021

Why it stopped: The program was shut down due to a lack of efficacy.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 491 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02691182
Sponsor's protocol ID: 810P304
Status last verified: Apr 2024
First submitted: 2 Feb 2016
Last updated: 16 May 2024
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Conduct Disorder
RecruitingObservational study
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Recruiting
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Attention Deficit Hyperactivity Disorder (ADHD)
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All Attention Deficit Hyperactivity Disorder (ADHD) trials

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-Label Extension Study to Evaluate the Long-Term Safety of Molindone Hydrochloride Extended-Release Tablets for the Treatment of Impulsive Aggression in Pediatric and Adolescent Subjects With Attention Deficit/Hyperactivity Disorder (ADHD) in Conjunction With Standard ADHD Treatment
ClinicalTrials.gov ID: NCT02691182
Acronym / sponsor ID: 810P304
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: The program was shut down due to a lack of efficacy.
Enrolment: 491 participants (actual)
Lead sponsor: Supernus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: Apr 2016 (actual)
Primary completion: May 2021 (actual)
Study completion: May 2021 (actual)
First posted: 25 Feb 2016 (estimated)
Results: Posted 16 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study 810P304 is a multicenter, open-label, extension study aimed to assess safety of SPN-810 in the treatment of IA in patients aged 6-17 years with ADHD in conjunction with standard ADHD treatment.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Open-label treatment with SPN-810	Experimental	Drug: SPN-810Subjects aged 6-17 years were treated with SPN-810 starting on day 1 with 18 mg/day. The clinician was able to adjust the dose of SPN-810 throughout the study based on subject's response and tolerability within the limits of 6 mg/day and 36 mg/day or, up to 54 mg/day for subjects with a body weight ≥ 30 kg. The subjects were given a choice of extending their participation in the study every 6-month period for up to 36 months

Who may qualify

Ages: 6 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

Healthy male or female subjects, who completed and converted from a satisfactory participation in the study 810P301, 810P302, 810P503 and 810P204 or discontinued early from the previous study during the maintenance phase and allowed to enroll only after consultation between the Investigator, the Medical Monitor and the Sponsor.
Medically healthy and with clinically normal laboratory profiles, vital signs, and electrocardiograms (ECGs).
Existing diagnosis of ADHD, as described by DSM-5 and confirmed by the K-SADS PL 2013 from study 810P301 or 810P302 or by the MINI-KID from study 810P503 or 810P204.
Currently receiving monotherapy treatment with FDA-approved ADHD medication (stimulants and non-stimulants).
Weight of at least 20 kg.

Key exclusion criteria (5 listed)

Body Mass Index (BMI) in 99th percentile or above.
Clinically significant change in health status, safety concern or any other reason that, in the opinion of the Sponsor or the Investigator, would prevent the subject from participating in this study or successfully completing this study.
Pregnancy or refusal to practice contraception during the study (for female subjects of childbearing potential and sexually active males).
Current substance or alcohol use.
Suicidal thoughts or behaviors confirmed at Visit 7 for 810P301 or 810P302, Visit 8 for 810P503 or Visit 6 for 810P204 studies.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SPN-810	Drug	Open-label treatment with SPN-810

Primary outcome

Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score
Time frame: 17-time points: Months 3 (V5), 6 (V6), 9 (V7), 12 (V8), 15 (V9), 18 (V10), 21 (V11), 24 (V12), 27 (V13), 30 (V14), 33 (V15), 36 (V16), 39 (V17), 42 (V18), 45 (V19), 48 (V20) and month 60 (Visit 24).
R-MOAS scale gauges the severity of aggressive behavior: the frequency of the 16 behaviors is rated over the past week in 4 areas (VE, PH, PR, SE). For each open question in each area, the parent-rated the aggressive behaviors on a scale from 0 to 5 or more times. To each area corresponds a weighted category: Verbal Incidents (VE)=1, Incidents Toward Other (PH) =4, Incidents Involving Property (PR)=2 and Incidents Directed Toward Self (SE)=3. Therefore, the sum of each area yields a maximum weighted score of 20 (VE), 120 (PH), 60 (PR), and 90 (SE). The total score is the sum of the four area scores or 0-290; the higher the score, the more severe the aggressive behavior is. The data represent the total score change from baseline at each visit for the duration of the study, a total of 60 months. The baseline score represents the total score at the last visit of each double-blind study.
Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S)
Time frame: 20-time points: Week 2 (V2), Week 4 (V3), Week 8 (V4), Months 3 (V5), 6 (V6), 9 (V7), 12 (V8), 15 (V9),18 (V10), 21 (V11), 24 (V12), 27 (V13), 30 (V14), 33 (V15), 36 (V16), 39 (V17), 42 (V18), 45 (V19), 48 (V20) and month 60 (Visit 24).
The Clinical Global Impression - Severity of Illness (CGI-S) is a single item clinician rating of clinician's assessment of the severity of IA behaviors. CGI-S was evaluated by the Investigator at each visit on a 7- point scale with 1=Normal, 2=Borderline ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Extremely ill. Data represent the change from baseline to each visit during the study. The baseline score represents the total score at the last visit of each double-blind study.
Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I)
Time frame: 20-time points: Week 2 (V2), Week 4 (V3), Week 8 (V4), Months 3 (V5), 6 (V6), 9 (V7), 12 (V8), 15 (V9),18 (V10), 21 (V11), 24 (V12), 27 (V13), 30 (V14), 33 (V15), 36 (V16), 39 (V17), 42 (V18), 45 (V19), 48 (V20) and Month 60 (Visit 24).
The Clinical Global Impression - Improvement Scale (CGI-I) is a clinician's assessment of how much the IA behaviors have improved or worsened relative to a baseline state at the beginning of treatment. CGI-I was evaluated by the Investigator at each visit on a 7-point scale with 1=Very much improved, 2= Much improved, 3= Minimally improved, 4= No change, 5= Minimally worse, 6= Much worse, 7= Very much worse. Data represent the score at each visit during the study.

Results and safety

Results posted to the registry on 16 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
<18 mg SPN-810	38	0
18 mg to < 24 mg SPN-810	159	1
24 mg to < 36 mg SPN-810	131	2
36 mg to ≤54 mg SPN-810	163	1

Primary outcome: Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score

Time frame: 17-time points: Months 3 (V5), 6 (V6), 9 (V7), 12 (V8), 15 (V9), 18 (V10), 21 (V11), 24 (V12), 27 (V13), 30 (V14), 33 (V15), 36 (V16), 39 (V17), 42 (V18), 45 (V19), 48 (V20) and month 60 (Visit 24).. Mean (Standard Deviation). Unit: score on a scale

Measure	<18 mg SPN-810 n = 38	18 mg to < 24 mg SPN-810 n = 159	24 mg to < 36 mg SPN-810 n = 131	36 mg to ≤54 mg SPN-810 n = 163
VE Score Month 3	-7.1 (5.18)	-6.8 (5.57)	-5.5 (5.41)	-6.4 (5.84)
PH Score Month 3	-23.7 (17.41)	-18.5 (21.57)	-13.5 (17.28)	-16.9 (17.78)
PR Score Month 3	-16.1 (11.47)	-13.6 (13.48)	-9.9 (10.26)	-12.6 (11.90)
SE Score Month 3	-7.3 (10.15)	-6.3 (10.19)	-6.4 (9.42)	-5.3 (8.80)
Total Score Month 3	-54.1 (32.78)	-45.2 (40.50)	-35.2 (30.97)	-41.3 (34.02)
VE Score Month 6	-7.0 (4.62)	-5.4 (6.05)	-6.2 (4.93)	-5.9 (5.67)
PH Score Month 6	-23.6 (12.84)	-19.2 (24.44)	-16.1 (15.55)	-15.9 (17.62)
PR Score Month 6	-14.4 (10.54)	-12.5 (13.35)	-11.6 (11.27)	-11.8 (13.21)

Population analysed: Safety Population: Safety population is defined as all subjects who received at least 1 dose of study drug during the study.

Primary outcome: Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S)

Time frame: 20-time points: Week 2 (V2), Week 4 (V3), Week 8 (V4), Months 3 (V5), 6 (V6), 9 (V7), 12 (V8), 15 (V9),18 (V10), 21 (V11), 24 (V12), 27 (V13), 30 (V14), 33 (V15), 36 (V16), 39 (V17), 42 (V18), 45 (V19), 48 (V20) and month 60 (Visit 24).. Mean (Standard Deviation). Unit: score on a scale

Measure	<18 mg SPN-810 n = 38	18 mg to < 24 mg SPN-810 n = 159	24 to < 36 mg SPN-810 n = 131	36 mg to ≤54 mg SPN-810 n = 163
Week 2	-1.2 (1.33)	-1.8 (1.13)	-1.0 (0.94)	-1.0 (0.95)
Week 4	-1.6 (1.26)	-2.1 (1.10)	-1.2 (1.12)	-1.3 (1.06)
Week 8	-2.0 (1.20)	-2.1 (1.18)	-1.4 (1.13)	-1.5 (1.02)
Month 3	-1.9 (1.37)	-2.2 (1.08)	-1.5 (1.15)	-1.6 (0.98)
Month 6	-2.0 (0.95)	-2.2 (1.07)	-1.5 (0.95)	-1.8 (0.95)
Month 9	-1.9 (0.90)	-2.2 (1.02)	-1.8 (0.92)	-1.8 (0.97)
Month 12	-1.5 (1.13)	-2.3 (0.96)	-2.0 (1.01)	-1.8 (1.03)
Month 15	-1.7 (1.25)	-2.3 (0.93)	-1.9 (0.90)	-1.8 (0.97)

Population analysed: Safety Population: Safety population is defined as all subjects who received at least 1 dose of study drug during the study.

Primary outcome: Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I)

Time frame: 20-time points: Week 2 (V2), Week 4 (V3), Week 8 (V4), Months 3 (V5), 6 (V6), 9 (V7), 12 (V8), 15 (V9),18 (V10), 21 (V11), 24 (V12), 27 (V13), 30 (V14), 33 (V15), 36 (V16), 39 (V17), 42 (V18), 45 (V19), 48 (V20) and Month 60 (Visit 24).. Mean (Standard Deviation). Unit: score on a scale

Measure	<18 mg SPN-810 n = 38	18 mg to < 24mg SPN-810 n = 159	24 to <36 mg SPN-810 n = 131	36 to ≤54 mg SPN-810 n = 163
Week 2	2.7 (1.25)	2.1 (0.96)	2.9 (1.19)	2.9 (0.98)
Week 4	2.1 (1.00)	1.9 (0.94)	2.6 (1.18)	2.7 (1.02)
Week 8	1.9 (0.80)	1.9 (1.05)	2.4 (0.97)	2.5 (1.05)
Month 3	1.9 (0.98)	1.8 (0.84)	2.4 (1.11)	2.3 (1.06)
Month 6	1.7 (0.66)	1.7 (0.78)	2.2 (1.13)	2.2 (1.02)
Month 9	1.8 (0.65)	1.7 (0.69)	2.0 (0.80)	2.1 (0.91)
Month 12	2.5 (1.33)	1.8 (1.10)	1.9 (0.80)	2.1 (0.92)
Month 15	2.3 (1.77)	1.8 (1.11)	2.0 (0.76)	2.1 (0.80)

Population analysed: Safety Population: Safety population is defined as all subjects who received at least 1 dose of study drug during the study.

Adverse events

Time frame: Adverse events were collected at each study visit: Visit 1 (last visit in the double-blind study), weeks 2,4 and 8, and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48 and 60 (months).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
<18 mg SPN-810	3 of 38 (7.9%)	18 of 38 (47.4%)	0 of 38
18 mg to < 24 mg SPN-810	5 of 159 (3.1%)	56 of 159 (35.2%)	0 of 159
24 mg to < 36 mg SPN-810	5 of 131 (3.8%)	56 of 131 (42.7%)	0 of 131
36 mg to ≤54 mg SPN-810	9 of 163 (5.5%)	66 of 163 (40.5%)	0 of 163

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gianpiera Ceresoli-Borroni, PhD study director

Supernus Pharmaceuticals, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SPN-810 in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Supernus Pharmaceuticals, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score (time frame: 17-time points: Months 3 (V5), 6 (V6), 9 (V7), 12 (V8), 15 (V9), 18 (V10), 21 (V11), 24 (V12), 27 (V13), 30 (V14), 33 (V15), 36 (V16), 39 (V17), 42 (V18), 45 (V19), 48 (V20) and month 60 (Visit 24).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02691182.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.