Clincosm LogoSign in Get a demo

Open-label Long-Term Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD

Sponsor
Supernus Pharmaceuticals, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04143217
Collaborator
(none)
366
Enrollment
38
Locations
1
Arm
41.2
Anticipated Duration (Months)
9.6
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Open label, flexible dose, long-term multicenter study of safety and efficacy of SPN-812 in adult ADHD patients

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

This is a multicenter, open-label extension study aimed to assess long-term safety and efficacy of SPN-812 when administered alone or in conjunction with an Food and Drug Administration (FDA)-approved Attention-Deficit Hyperactivity Disorder (ADHD) medication in the treatment of ADHD in adult subjects who completed a blinded study of SPN-812 (812P306). Subjects initiate SPN-812 dosing at 200 mg/day once daily (QD) during first 2 weeks. At or after Visit 2 (Week 2), per the Investigator's discretion and based on Investigator's assessment of subject's clinical response and tolerability, the dose of SPN-812 can be titrated up or tapered down in increments of 50 mg/day, 100 mg/day, 150 mg/day, or 200 mg/day per week to a target dose within the ranges between 200 and 600 mg/day. Additionally, after 12 weeks of dosing (after Visit 4), at the discretion of the Investigator and based on subject's clinical response, the optimized dose of SPN-812 may be supplemented with an adjunctive FDA-approved stimulant treatment. Total treatment duration per subject from Visit 1 to Visit 22 (end of study) is approximately 3 years (156 weeks ± 1 week) or until SPN-812 becomes commercially available.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
366 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Single Group AssignmentSingle Group Assignment
Masking:
None (Open Label)
Masking Description:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) in Adults With Attention-Deficit/Hyperactivity Disorder
Actual Study Start Date :
Jan 23, 2020
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Open-Label Treatment

SPN-812 Open-Label Treatment 200mg to 600mg SPN-812 once daily for up to 156 weeks

Drug: SPN-812
SPN-812 200 to 600 mg/day
Other Names:
  • SPN-812 ER

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of adverse events [Weeks 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, 124, 132, 140, 148 and 156]

      Change from baseline

    Secondary Outcome Measures

    1. ADHD symptoms as measured by the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score [Weeks 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, 124, 132, 140, 148 and 156]

      Change from baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) total score by visit

    2. Global assessment of severity as measured by the Clinical Global Impression - Severity of Illness (CGI-S) scale for ADHD [Weeks 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, 124, 132, 140, 148 and 156]

      Change from baseline in CGI-S by visit

    3. Clinical response rate of severity of illness as measured by the categorical CGI-S Responder Rate (CGI-S score of 1 or 2) [Weeks 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, 124, 132, 140, 148 and 156]

      Percentage of subjects with a CGI-S score of 1 (Normal, not at all ill) or 2 (Borderline ill) by visit

    4. Global assessment of improvement as measured by the Clinical Global Impression - Improvement scale (CGI-I) for ADHD [Weeks 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, 124, 132, 140, 148 and 156]

      CGI-I score by visit

    5. Clinical response rate of improvement as measured by the categorical CGI-I Responder Rate (CGI-I score of 1 or 2) [Weeks 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, 124, 132, 140, 148 and 156]

      Percentage of subjects with CGI-I score of 1 (Very much improved) or 2 (Much improved) by visit

    6. Anxiety symptoms as measured by the Generalized Anxiety Disorder 7-Item scale (GAD-7) [Weeks 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, 124, 132, 140, 148 and 156]

      Change from baseline in the GAD-7 total score by visit

    7. Clinician-rated ADHD symptoms as measured by the AISRS Inattention subscale and AISRS Hyperactivity/Impulsivity subscale [Weeks 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, 124, 132, 140, 148 and 156]

      Change from baseline in the AISRS Inattention subscale score by visit and AISRS Hyperactivity/Impulsivity subscale score by visit

    8. Clinician response rate of ADHD symptom reduction as measured by the 50% responder rate in Adult ADHD Investigator Symptom Rating Scale (AISRS total score) [Weeks 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, 124, 132, 140, 148 and 156]

      Percentage of ≥50%AISRS responders (responder defined as the percentage of subjects with a ≥ 50% reduction in the CFB AISRS total score) by visit

    9. Clinician response rate of ADHD symptom reduction as measured by the 30% responder rate in Adult ADHD Investigator Symptom Rating Scale (AISRS) total score [Weeks 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, 124, 132, 140, 148 and 156]

      Percentage of ≥30% AISRS responders (responder defined as the percentage of subjects with a ≥ 30% reduction in the CFB AISRS total score) by visit

    10. Executive functioning as measured by the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A; Self Report) [Weeks 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, 124, 132, 140, 148 and 156]

      Change from Baseline in the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Global Executive Composite (GEC) T-score by visit

    11. Aspects of executive function and problems of self-regulation as measured by the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A; Self Report) Summary Index Scales and subscales [Weeks 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, 124, 132, 140, 148 and 156]

      Change from baseline in the BRIEF-A T-score by each Summary Index Scale and subscale by visit

    12. Depressive symptoms as measured by the Symptoms of Depression Questionnaire (SDQ) [Weeks 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, 124, 132, 140, 148 and 156]

      Change from baseline in the Symptoms of Depression Questionnaire (SDQ) Total score by visit

    13. Depressive-related symptom features as measured by the Symptoms of Depression Questionnaire (SDQ) [Weeks 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, 124, 132, 140, 148 and 156]

      Change from baseline in the Symptoms of Depression Questionnaire (SDQ) subscale scores by visit

    14. Overall Quality of Life as assessed by the Adult ADHD Quality of Life Scale (AAQoL) [Weeks 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, 124, 132, 140, 148 and 156]

      Change from baseline in the Adult ADHD Quality of Life Scale (AAQoL) Total score by visit

    15. Aspects of Quality of Life as assessed by the Adult ADHD Quality of Life Scale (AAQoL) [Weeks 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, 124, 132, 140, 148 and 156]

      Change from baseline in the Adult ADHD Quality of Life Scale (AAQoL) subscale scores by visit

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria

    1. Is a male or female who completed Study 812P306 and opts/consents to participate in the study if approved by PI.

    2. Continues to be medically healthy and with clinically normal laboratory profiles, vital signs, and electrocardiograms (ECGs), in the opinion of the Investigator, assessed at Visit 1.

    3. Is able to read and understand the Informed Consent Form (ICF).

    4. Has signed the ICF.

    5. Is willing and able to attend study appointments within specified time windows.

    6. Is a female of childbearing potential (FOCP) who is either sexually inactive (abstinent) or, if sexually active, agrees to use one of the following acceptable birth control methods beginning at least 30 days prior to the first dose of SM and throughout the study:

    7. Simultaneous use of male condom and intra-uterine contraceptive device placed at least 4 weeks prior to first SM administration

    8. Surgically sterile male partner

    9. Simultaneous use of male condom and diaphragm with spermicide

    10. Established hormonal contraceptive Females are considered not to be of childbearing potential if they are either post-menopausal (amenorrhea for at least 2 years and serum follicle stimulating hormone [FSH] level of >40 IU/L) or permanently sterilized (e.g., bilateral tubal ligation, hysterectomy, bilateral oophorectomy for 6 months minimum prior to their Visit 1).

    11. Is a male who:

    12. Agrees to use 2 methods of contraception in combination if his female partner is of childbearing potential; this combination of contraceptive methods must be used from Visit 1 to ≥ 1 month after the last dose of SM, OR

    13. Has been surgically sterilized prior to Visit 1.

    Exclusion Criteria

    1. Is currently participating in another clinical trial other than Study 812P306.

    2. Has any current psychiatric disorder per Diagnostic and Statistical Manual of Mental Disorders - 5th Edition (DSM-5) criteria other than ADHD with the following exceptions: ADHD is primary diagnoses with comorbidity/secondary diagnoses of major depression disorder (MDD), nicotine dependence, social anxiety disorder, generalized anxiety disorder, or phobias.

    3. Current diagnosis of significant systemic disease and/or of a major psychiatric or neurological disorder, including history or family history of seizures or seizure-like disorders.

    4. Current evidence of suicidality (suicidal thoughts or behaviors).

    5. Female subjects who are pregnant, lactating and/or sexually active and not agreeing to use one of the acceptable birth control methods throughout the study.

    6. Has a positive result on urine drug screen at Visit 1.

    7. Use of prohibited concomitant medications including known CYP1A2 substrates (e.g., theophylline, melatonin) at the Visit 1 for the duration of the study.

    8. Has a clinical laboratory value, vital sign value or ECG result at Visit 1 that is considered to be clinically significant in the opinion of the Investigator.

    9. Has one or more clinical laboratory test values outside the reference range at Visit 1 that, in the opinion of the Investigator, are clinically significant, or any of the following (see Note below):

    • Serum creatinine > 1.5 times the upper limit of normal (ULN);

    • Serum total bilirubin > 1.5 times ULN;

    • Serum alanine aminotransferase or aspartate aminotransferase > 2 times ULN.

    1. Has any of the following cardiology findings at Visit 1 (see Note below):

    • Abnormal ECG that is, in the Investigator's opinion, clinically significant;

    • PR interval > 220 ms;

    • QRS interval > 130 ms;

    • QTcF interval > 450 ms (for men) or > 470 ms (for women) (QT corrected using Fridericia's method);

    • Second- or third-degree atrioventricular block;

    • Any rhythm, other than sinus rhythm, that is interpreted by the Investigator to be clinically significant.

    1. Any reason that, in the opinion of the Investigator, would prevent the subject from participating in the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 South California Research LLC Beverly Hills California United States 90210
    2 Collaborative Neuroscience Network Garden Grove California United States 92845
    3 Pharmacology Research Institute Los Alamitos California United States 90720
    4 Pharmacology Research Institute Newport Beach California United States 92660
    5 Artemis Research Institue for Clinical Research Riverside California United States 92078
    6 Artemis Institute for Clinical Research San Diego California United States 92103
    7 Artemis Institute for Clinical Rearch San Marcos California United States 92078
    8 Collaborative Neuroscience Network LLC Torrance California United States 90502
    9 Gulfcoast Research Center Fort Myers Florida United States 33912
    10 Research Centers of America Hollywood Florida United States 33024
    11 Clinical Neuroscience Solutions, Inc Jacksonville Florida United States 32217
    12 Meridien Research Lakeland Florida United States 33805
    13 Florida Clinical Research Center, LLC Maitland Florida United States 32751
    14 Medical Research Group of Central Florida Orange City Florida United States 32763
    15 Clinical Neuroscience Solutions Inc. Orlando Florida United States 32801
    16 CNS Healthcare Orlando Florida United States 32806
    17 Meridien Research Tampa Florida United States 33634
    18 Atlanta Center for Medical Research Atlanta Georgia United States 30331
    19 iResearch Atlanta Decatur Georgia United States 30030
    20 Psych Atlanta Marietta Georgia United States 30060
    21 Psychiatric Associates Overland Park Kansas United States 66211
    22 St. Charles Psychiatric Associates Midwest Research Center Saint Charles Missouri United States 63304
    23 Alivation Research, LLC Lincoln Nebraska United States 68526
    24 Altea Research Institute Las Vegas Nevada United States 10549
    25 Center for Psychiatry and Behavioral Medicine, Inc. Las Vegas Nevada United States 89128
    26 Hassman Research Institute Berlin New Jersey United States 08009
    27 Center for Emotional Fitness Cherry Hill New Jersey United States 08002
    28 Hassmann Research Institute Marlton New Jersey United States 08053
    29 Princeton Medical Institute Princeton New Jersey United States 08540
    30 Bioscience Research Mount Kisco New York United States 10549
    31 The Medical Research Network LLC New York New York United States 10128r
    32 Paradigm Research Professionals Oklahoma City Oklahoma United States 73188
    33 Clinical Neuroscience Solutions Memphis Tennessee United States 38119
    34 BioBehavioral Research of Austin P.C. Austin Texas United States 78759
    35 FutureSearch Trials of Dallas, LLP Dallas Texas United States 75231
    36 Houston Clinical Trials Houston Texas United States 77098
    37 Family Psychiatry of the Woodlands The Woodlands Texas United States 77381
    38 Northwest Clinical Trials Bellevue Washington United States 98007

    Sponsors and Collaborators

    • Supernus Pharmaceuticals, Inc.

    Investigators

    • Study Director: Jonathan Rubin, MD, Chief Medical Officer

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Supernus Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT04143217
    Other Study ID Numbers:
    • 812P311
    First Posted:
    Oct 29, 2019
    Last Update Posted:
    Jul 14, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hyperkinesis
    Attention Deficit Disorder with Hyperactivity

    Study Results

    No Results Posted as of Jul 14, 2021