NCT02618434Phase 3Completed

Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 2)

Study sponsor: Supernus Pharmaceuticals, Inc. · SUPN

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2019-11-15Actual

Enrollment · participants297Actual

Source updated2024-03-18Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Attention Deficit Hyperactivity Disorder (ADHD)

Treatments or interventions studied

SPN-810 (18 mg)Drug
SPN-810 (36 mg)Drug
PlaceboDrug

Primary outcomes · main study measures

Read the study measures

measure: Efficacy and Safety of SPN-810 on the Frequency of Impulsive Aggression (IA) Measured by the Impulsive Aggression Diary; description: The primary efficacy endpoint was percent change (PCHT) in the frequency (unweighted score) of IA behaviors per 7 days in the treatment (titration and maintenance) period relative to the Baseline period calculated over the number of days with non-missing IA diary data. PCHT was then calculated as 100 x (T - B)/B, where T and B are IA behavior frequencies per 7 days during the treatment period (from Day 2 through Visit 6, inclusive) and baseline period (Day ≤1), respectively. The IA behavior frequency per 7 days is defined as (SUM/DAY) x 7, where SUM is the total of the IA behaviors reported in the subject IA diary, and DAY is the number of days with a non-missing IA score in the subject IA diary during the specified study period.; timeFrame: Daily measure from Visit 2 (Week -2) to Visit 6 (Week 5) for a total of 7 weeks

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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