Evaluation of SPN-812 ER High Dose in Adolescents With ADHD

Evaluation of SPN-812 ER High Dose in Adolescents With ADHD



Sponsors


Source

Supernus Pharmaceuticals, Inc.

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

Yes

Is Fda Regulated Device

No


Brief Summary

This study will evaluate the efficacy and safety of high doses of SPN-812 ER in adolescents
(12-17 years old)

Overall Status

Not yet recruiting

Start Date

2017-10-01

Completion Date

2018-10-01

Primary Completion Date

2018-10-01

Phase

Phase 3

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Efficacy of SPN-812 ER assessed by ADHD-RS- V Rating Scale
7 weeks

Secondary Outcome

Measure

Time Frame

Effect of SPN-812 ER assessed by Conners 3 Rating Scale
7 weeks
Effect of SPN-812 ER assessed by 30% Responder Rate
7 weeks
Effect of SPN-812 ER assessed by ADHD Subscores
7 weeks
Effect of SPN-812 ER assessed by Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
7 weeks
Effect of SPN-812 ER assessed by Stress Index for Parents of Adolescents (SIPA)
7 weeks
Effect of SPN-812 ER assessed by Clinical Global Impression-Severity of Illness and Improvement (CGI-S/I) Scale
7 weeks

Enrollment

234

Condition


Intervention

Intervention Type

Drug

Intervention Name


Description

Placebo will be administered once daily

Arm Group Label

Placebo


Intervention Type

Drug

Intervention Name


Description

SPN-812 ER high dose A will be administered once daily and compared to Placebo

Arm Group Label

SPN-812 ER High Dose A


Intervention Type

Drug

Intervention Name


Description

SPN-812 ER high dose B will be administered once daily and compared to Placebo

Arm Group Label

SPN-812 ER High Dose B



Eligibility

Criteria

Inclusion Criteria:

1. Healthy male or female subjects, 12-17 years of age, inclusive.

2. Diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental
Disorders-V (DSM V), confirmed with the Mini International Neuropsychiatric Interview
for Children and Adolescents (MINI-KID).

3. Attention Deficit/Hyperactivity Disorder Rating Scale-V, Home Version: Adolescent,
Investigator Administered and Scored (ADHD-RS-V) score of at least 28.

4. CGI-S score of at least 4 at screening.

5. Weight of at least 35 kg.

6. Free of medication for the treatment of ADHD for at least one week prior to
randomization and agreement to remain so throughout the study.

7. Considered medically healthy by the Investigator via assessment of physical
examination, medical history, clinical laboratory tests, vital signs, and
electrocardiogram.

8. Written informed consent obtained from the subject's parent or legal representative
and informed assent from the subject, if applicable.

9. Females of childbearing potential (FOCP) must be either sexually inactive (abstinent)
or, if sexually active, must agree to use one of the following acceptable birth
control methods beginning 30 days prior to the first dose, throughout the study:

1. simultaneous use of male condom and intra-uterine contraceptive device placed at
least four weeks prior to the first study drug administration

2. surgically sterile male partner

3. simultaneous use of male condom and diaphragm with spermicide

4. established hormonal contraceptive

Exclusion Criteria:

1. Current diagnosis of major psychological disorders. Subjects with Major Depressive
Disorder are allowed in the study if the subject is free of episodes both currently
and for the last six months.

2. Current diagnosis of major neurological disorders. Subjects with seizures or a history
of seizure disorder within the immediate family (siblings, parents), or a history of
seizure-like events are excluded from the study.

3. Current diagnosis of significant systemic disease.

4. Evidence of suicidality (defined as either active suicidal plan/intent or active
suicidal thoughts, or more than one lifetime suicide attempt) within the six months
before Screening or at Screening.

5. BMI greater than 95th percentile for the appropriate age and gender.

6. History of an allergic reaction to viloxazine or related drugs.

7. Any food allergy, intolerance, restriction or special diet that, in the opinion of the
Investigator, could contraindicate the subject's participation in this study.

8. Subjects who received any investigational drug within the longer of 30 days or 5
half-lives prior to Day 1 dosing of SM.

9. Any reason, which, in the opinion of the Investigator, would prevent the subject from
participating in the study.

10. Positive drug screen at the Screening Visit. A positive test for amphetamines is
allowed for subjects receiving a stimulant ADHD medication at Screening; the subject
will be required to discontinue the stimulant for the study, beginning at least one
week prior to the Baseline Visit.

11. Pregnancy or refusal to practice abstinence or acceptable birth control during the
study (for female subjects of childbearing potential)

Gender

All

Minimum Age

12 Years

Maximum Age

17 Years

Healthy Volunteers

No


Overall Contact

Last Name

Janet Johnson, PhD

Phone

301-502-7856

Email



Verification Date

2017-08-01

Lastchanged Date

2017-08-09

Firstreceived Date

2017-08-09

Responsible Party

Responsible Party Type

Sponsor


Has Expanded Access

No

Number Of Arms

3

Arm Group

Arm Group Label

Placebo

Arm Group Type

Experimental


Arm Group Label

SPN-812 ER High Dose A

Arm Group Type

Active Comparator


Arm Group Label

SPN-812 ER High Dose B

Arm Group Type

Active Comparator



Firstreceived Results Date

N/A

Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Treatment

Masking

Participant, Care Provider, Investigator, Outcomes Assessor



ClinicalTrials.gov processed this data on August 11, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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