A Phase I/IIa, Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Study of the Safety, and Efficacy of SPN-812V in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Supernus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01107496
First received: April 19, 2010
Last updated: December 21, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
ADHD
Drug: SPN-812V
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: A Phase I/IIa Study of the Safety, and Efficacy of SPN-812V in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

Resource links provided by NLM:


Further study details as provided by Supernus Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Investigator-rated Conners' Adult ADHD Rating Scales (CAARS) [ Time Frame: At Baseline and at each study visit (V1-V8) ] [ Designated as safety issue: No ]
    Change from Baseline in the Investigator-rated Conners' Adult ADHD Rating Scales (CAARS) Total ADHD Symptom Score


Secondary Outcome Measures:
  • CGI-Improvement (CGI-I) Scale [ Time Frame: At each study visit (V1-V8) ] [ Designated as safety issue: No ]
    Changes from Baseline in the CGI-Improvement (CGI-I) Scale At Baseline: CGI-Severity (CGI-S)

  • Self rated CAARS [ Time Frame: Baseline and at each study visit (V1-V8) ] [ Designated as safety issue: No ]
    Changes from Baseline in the Self rated CAARS Total ADHD Symptom Score


Enrollment: 52
Study Start Date: June 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SPN-812V Drug: SPN-812V
SPN CTM
Placebo Comparator: Placebo Drug: Placebo
Control

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01107496

Locations
United States, Florida
Bradenton, Florida, United States
United States, Illinois
Libertyville, Illinois, United States
United States, Kentucky
Owensboro, Kentucky, United States
United States, Virginia
Herndon, Virginia, United States
Sponsors and Collaborators
Supernus Pharmaceuticals, Inc.
Investigators
Study Director: Marina Lowen Supernus Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Supernus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01107496     History of Changes
Other Study ID Numbers: 812P201
Study First Received: April 19, 2010
Last Updated: December 21, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014