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



Status:Recruiting
Conditions:Psychiatric, ADHD
Therapuetic Areas:Psychiatry / Psychology, Other
Healthy:No
Age Range:12 - 17
Updated:9/7/2018
Start Date:October 20, 2017
End Date:October 20, 2018
Contact:Fatima Chowdhry, MD
Email:fchowdhry@supernus.com
Phone:240-403-5375

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Evaluation of SPN 812 ER 200 and 400 mg Efficacy and Safety in Adolescents With ADHD - A Double-Blind, Placebo-Controlled, Pivotal Trial

This study will evaluate the efficacy and safety of low doses of SPN-812 ER in adolescents
12-17 years of age.

This is a multicenter, randomized, double-blind, placebo-controlled, 3-arm, parallel-group
study, to assess the efficacy and safety of SPN-812 ER as monotherapy for the treatment of
adolescents 12-17 years old with ADHD.

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-5 (DSM-5), confirmed with the Mini International Neuropsychiatric Interview
for Children and Adolescents (MINI-KID).

3. Attention Deficit/Hyperactivity Disorder Rating Scale-5-Home Version: Adolescent,
Investigator Administered and Scored (ADHD-RS-5) 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 psychiatric 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 screen for drugs of abuse at the Screening Visit. A positive test for
amphetamines is allowed for subjects receiving a stimulant ADHD medication at
Screening as long as the subject agrees to discontinue the stimulant for the duration
of 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)
We found this trial at
12
sites
Orange, California 92868
Phone: 714-289-1100
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Arlington, Texas 76015
Phone: 817-538-9902
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Dothan, Alabama 36303
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Hialeah, Florida 33012
Phone: 305-825-6588
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Houston, Texas 77098
Phone: 713-527-8839
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Jacksonville, Florida 32216
Phone: 904-281-5757
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Memphis, Tennessee 38119
Principal Investigator: Dolores DiGaetano, MD
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Meridian, Idaho 83642
Phone: 208-377-8653
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Miami, Florida 33155
Phone: 305-443-6496
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Phone: 212-659-8775
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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Rochester, New York 14618
Phone: 585-241-9670
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The Woodlands, Texas 77381
Phone: 832-616-2674
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