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Open-Label, Extension Study to 810P202

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Supernus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01416064
First received: August 8, 2011
Last updated: May 10, 2013
Last verified: May 2013
History of Changes
  Purpose

Open-label, extension study for subjects that completed 810P202 to examine long term safety and tolerability of repeated dosing of SPN-810M as an adjunctive therapy in children with Impulsive Aggression Comorbid with Attention-Deficit/Hyperactivity Disorder (ADHD).


Condition Intervention Phase
Impulsive Aggression Comorbid With ADHD in Children
 Drug: Molindone
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Extension Study to Evaluate the Safety of Molindone Hydrochloride Extended-Release Tablets as Adjunctive Therapy in Children With Impulsive Aggression Comorbid With Attention-Deficit/Hyperactivity Disorder (ADHD)

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Long Term Safety and tolerability of repeated oral dosing of 810M as an adjunctive therapy in children exhibiting impulsive aggression comorbid w/ ADHD [ Time Frame: over 6 months ] [ Designated as safety issue: Yes ]
    Safety Assessments include: Adverse Events, clinical lab tests, vital signs, physical examinations, ECGs, Simpson-Angus Scale, Barnes Akathisia Scale, Abnormal Involuntary Movement Scale (AIMS) and Columbia Suicise Severity Rating Scale (C-SSRS)


Secondary Outcome Measures:
  • Assess the efficacy of 810M [ Time Frame: over 6 months ] [ Designated as safety issue: No ]
    Secondary efficacy endpoints: Retrospective-Modified Overt Aggression Scale (R-MOAS), Clinical Global Impression - Severity Scale (CGI-S), Clinical Global Impression - Improvement Scale (CGI-I), Swanson, Nolan and Pelman Rating Scale-Revised (SNAP-IV) ADHD scale scores


Estimated Enrollment: 120
Study Start Date: September 2011
Study Completion Date: February 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Molindone
Extension study, all subjects will be given Molindone at different (established) dosage levels based on the patient's weight, response and investigator discretion.
 Drug: Molindone
The populations will be comprised of male and female pediatric subjects from the 810P202 study. Subject will be converted to a total daily dose of 18 or 36mg of molindone (depending on weight), following enrollment into 810P203. The dosage level may be adjusted at the investigators discretion.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Successful completion of the 810P202 study.
  2. Continues to be medically healthy and with clinically normal laboratory profiles, vital signs, and electrocardiograms (ECGs).
  3. Weight of at least 20kg.
  4. Able and willing to swallow tablets whole and not chewed, cut or crushed.
  5. Written informed consent/assent obtained from the subject's parent or legally-authorized representative (LAR), and written informed assent obtained from the subject if required.

Exclusion Criteria:

  1. Body Mass Index (BMI) in 97th percentile or above.
  2. Clinically significant change in health status that, in the opinion of the Investigator, would prevent the subject from participating in this study or successfully completing this study.
  3. Pregnancy or refusal to practice contraception during the study (for female subjects of childbearing potential).
  4. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study or complying with the study procedures.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01416064

  Show 28 Study Locations
Sponsors and Collaborators
Supernus Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Supernus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01416064     History of Changes
Other Study ID Numbers: 810P203
Study First Received: August 8, 2011
Last Updated: May 10, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Aggression
Attention Deficit Disorder with Hyperactivity
Behavioral Symptoms
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Molindone
Antipsychotic Agents
 Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 16, 2013