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A Phase I/IIa, Randomized, Double-Blind Study of the Safety and Efficacy of SPN-812 in Adults With ADHD

Sponsor
Supernus Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01107496
Collaborator
(none)
52
Enrollment
4
Locations
2
Arms
6
Duration (Months)
13
Patients Per Site
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This will be a randomized, double-blind, placebo-controlled, parallel group, safety and tolerability study in adults with ADHD. The target subjects are healthy male or female adults aged 18 to 64 years, inclusive, with a diagnosis of ADHD. A total of fifty subjects will be enrolled at approximately 5 sites in the US. Subjects will be randomized (1:1) to one of two treatment groups, SPN-812V or placebo.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
A Phase I/IIa Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of SPN-812 in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Study Start Date :
Jun 1, 2010
Actual Primary Completion Date :
Dec 1, 2010
Actual Study Completion Date :
Dec 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: SPN-812

viloxazine, oral, 300mg, tid, 6 weeks

Drug: SPN-812
Viloxazine, oral, 300mg, tid, 6 weeks
Other Names:
  • viloxazine

    		•
    Placebo Comparator: Placebo

    placebo, oral, tid, 6weeks

    Drug: Placebo
    Placebo, oral, tid, 6 weeks

    Outcome Measures

    Primary Outcome Measures

    1. Investigator-rated Conners' Adult ADHD Rating Scales (CAARS) [At Baseline and at each study visit (V1-V8)]

      Change from Baseline in the Investigator-rated Conners' Adult ADHD Rating Scales (CAARS) Total ADHD Symptom Score

    Secondary Outcome Measures

    1. CGI-Improvement (CGI-I) Scale [At each study visit (V1-V8)]

      Changes from Baseline in the CGI-Improvement (CGI-I) Scale At Baseline: CGI-Severity (CGI-S)

    2. Self rated CAARS [Baseline and at each study visit (V1-V8)]

      Changes from Baseline in the Self rated CAARS Total ADHD Symptom Score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:

    1. Able to provide informed consent prior to any study procedure being conducted.

    2. Capable and willing to comply with study procedures.

    3. Male or female aged 18 to 64, inclusive.

    4. Subjects with a current diagnosis of ADHD as confirmed by the Conners' Adult ADHD Diagnostic Interview for DSM-IV (CAADID)

    5. Clinical Global Impression - Severity (CGI-S) score of 4 or higher.

    6. On no treatment for ADHD or willing to be withdrawn from an ongoing treatment after a washout of at least 10 days.

    7. Body Mass Index (BMI) between 18.0 and 34.0 inclusive.

    8. Subject must be in general good health as determined by medical history, ECG, and other analysis that, in the judgment of the Investigator, would confirm the Subject's good health.

    9. Females of childbearing potential (FOCP) who, if sexually active, agree to use acceptable forms of contraception (including oral, transdermal, or implanted contraceptives; intrauterine device; female condom with spermicide; diaphragm with spermicide; cervical cap; abstinence; use of condom with spermicide by sexual partner or sterile [at least 6 months prior to SM administration] sexual partner) at least 14 days prior to start of study drug administration, throughout the study, and for 30 days following the last dose of SM.

    10. Postmenopausal females with amenorrhea for at least 2 years or females who are permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy).

    Exclusion Criteria

    1. Current or past history of psychotic disorder or major depressive disorder with psychotic features.

    2. Presence of another primary DSM-IV-TR disorder.

    3. Suicidality, defined as either active suicidal plan/intent or active suicidal thoughts, in the 6 months before the Screening Visit or more than 1 lifetime suicide attempt. (The Columbia-Suicide Severity Rating Scales [C-SSRS] will be administered at each visit.)

    4. Substance or alcohol abuse/dependence within previous 6 months, or a positive urine drug screen at screening or baseline prior to first dose of study medication (SM).

    5. Any known or suspected significant medical or psychiatric illnesses that, in the judgment of the Investigator, may impair interpretation of study results or constitute a significant safety concern in the context of the clinical trial

    6. ECG abnormalities (clinically significant according to Investigator's opinion) or vital sign abnormalities (systolic blood pressure [SBP] <90 or >140 millimeters of mercury [mmHg], diastolic blood pressure [DBP] <40 or >90mmHg, or heart rate [HR] <40 or >100 beats per minute [BPM]) at screening.

    7. Clinically significant laboratory abnormalities; including presence of potential hepatic function impairment as shown by, but not limited to alanine aminotransferase (ALT/SGPT) values >2 times upper limit of normal (ULN), aspartate aminotransferase (AST/SGOT) > 2 times ULN, gamma-glutamyl transpeptidase (GGT) >3 times ULN, or total bilirubin >1.5 ULN .

    8. Medications, including health food supplements judged by the Investigator to be likely to have central nervous system activity (for example, St John's Wort, gingko leaf, and melatonin), are not permitted during the study. If the subject is taking the medication prior to study entry, there must be a 7 day washout period prior to first dose of SM.

    9. Lifetime history of tic disorder, Tourette's Disease, or organic brain disorder; or family history of Tourette's Disease.

    10. Current or lifetime history of hyperthyroidism unless treated and stable for at least 6 months.

    11. Participation in or plan to begin behavioral therapy during the study.

    12. Subject has a prior history of allergy or any significant adverse reaction (including rash) to study medication, or any of the product components.

    13. Females who are pregnant or lactating or are unwilling to use an acceptable form of contraception throughout the study.

    14. Difficulty swallowing whole capsules.

    15. History of seizures or risk factors for seizures (e.g., head trauma), not including febrile seizures.

    16. Use of an investigational drug or participation in an investigational study within 30 days prior to first dose of SM.

    17. Any reason which, 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 Bradenton Florida United States
    2 Libertyville Illinois United States
    3 Owensboro Kentucky United States
    4 Herndon Virginia United States

    Sponsors and Collaborators

    • Supernus Pharmaceuticals, Inc.

    Investigators

    • Study Director: Marina Lowen, Supernus Pharmaceuticals, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Supernus Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT01107496
    Other Study ID Numbers:
    • 812P201
    First Posted:
    Apr 21, 2010
    Last Update Posted:
    May 5, 2017
    Last Verified:
    May 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Viloxazine

    Study Results

    No Results Posted as of May 5, 2017