Open-Label, Extension Study to 810P202
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)
1 other identifier
interventional
78
1 country
28
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2011
Shorter than P25 for phase_2
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2011
CompletedFirst Posted
Study publicly available on registry
August 12, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedMay 2, 2017
April 1, 2017
1.3 years
August 8, 2011
April 28, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Long Term Safety and tolerability of repeated oral dosing of 810M as an adjunctive therapy in children exhibiting impulsive aggression comorbid w/ ADHD
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)
over 6 months
Secondary Outcomes (1)
Assess the efficacy of 810M
over 6 months
Study Arms (1)
Molindone
OTHERExtension study, all subjects will be given Molindone at different (established) dosage levels based on the patient's weight, response and investigator discretion.
Interventions
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 Criteria
You may qualify if:
- Successful completion of the 810P202 study.
- Continues to be medically healthy and with clinically normal laboratory profiles, vital signs, and electrocardiograms (ECGs).
- Weight of at least 20kg.
- Able and willing to swallow tablets whole and not chewed, cut or crushed.
- 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.
You may not qualify if:
- Body Mass Index (BMI) in 97th percentile or above.
- 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.
- Pregnancy or refusal to practice contraception during the study (for female subjects of childbearing potential).
- Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study or complying with the study procedures.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Unknown Facility
Dothan, Alabama, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Santa Ana, California, United States
Unknown Facility
Wildomar, California, United States
Unknown Facility
Washington D.C., District of Columbia, United States
Unknown Facility
Bradenton, Florida, United States
Unknown Facility
Gainesville, Florida, United States
Unknown Facility
Hialeah, Florida, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Maitland, Florida, United States
Unknown Facility
North Miami, Florida, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Libertyville, Illinois, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Terre Haute, Indiana, United States
Unknown Facility
Owensboro, Kentucky, United States
Unknown Facility
Toms River, New Jersey, United States
Unknown Facility
Stony Brook, New York, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Columbus, Ohio, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Pittsburgh, Pennsylvania, United States
Unknown Facility
Charleston, South Carolina, United States
Unknown Facility
Memphis, Tennessee, United States
Unknown Facility
Bellevue, Washington, United States
Unknown Facility
Bothell, Washington, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2011
First Posted
August 12, 2011
Study Start
September 1, 2011
Primary Completion
January 1, 2013
Study Completion
February 1, 2013
Last Updated
May 2, 2017
Record last verified: 2017-04