Trial Outcomes & Findings for Open-Label Study of the Safety and Tolerability of STX209 in Subjects With Autism Spectrum Disorders (NCT NCT00846547)

Last Updated: 2013-06-14

Results Overview

The Aberrant Behavior Checklist-Community Edition (ABC-C) is a 58-item questionnaire composed of five different independent subscales. The questionnaire is completed by the parent/caregiver and lists aberrant behaviors and asks about the severity of the problem. ABC-Irritability is one of the subscales and comprises of 15 items. Minimum score is 0, maximum is 45. A decreased score indicates few aberrant behaviors and clinical improvement. The entire ABC-C assessment is administered at baseline and then at the end of each Intervention Period (4 weeks after Baseline).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

32 participants

Primary outcome timeframe

At 8 weeks during the treatment period

Results posted on

2013-06-14

Participant Flow

Participant milestones

Participant milestones
Measure	Arbaclofen Arbaclofen (STX209) : variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period
Overall Study STARTED	32
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Open-Label Study of the Safety and Tolerability of STX209 in Subjects With Autism Spectrum Disorders

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arbaclofen n=32 Participants Arbaclofen (STX209) : variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period
Age, Categorical <=18 years	32 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age Continuous	11.8 years STANDARD_DEVIATION 3.13 • n=93 Participants
Sex: Female, Male Female	3 Participants n=93 Participants
Sex: Female, Male Male	29 Participants n=93 Participants
Region of Enrollment United States	32 participants n=93 Participants

PRIMARY outcome

Timeframe: At 8 weeks during the treatment period

Outcome measures

Outcome measures
Measure	Arbaclofen n=32 Participants Arbaclofen (STX209) : variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period
Irritability Subscale of the Aberrant Behavior Checklist, Community Version	-8.9 Points on a scale Standard Error 1.73

Adverse Events

Arbaclofen

Serious events: 1 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arbaclofen n=32 participants at risk Arbaclofen (STX209) : variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period
Psychiatric disorders increased aggression	3.1% 1/32 • Number of events 1

Other adverse events

Other adverse events
Measure	Arbaclofen n=32 participants at risk Arbaclofen (STX209) : variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period
Psychiatric disorders agitation	21.9% 7/32
Psychiatric disorders irritability	21.9% 7/32
Psychiatric disorders psychomotor hyperactivity	15.6% 5/32
Psychiatric disorders insomnia	12.5% 4/32
Psychiatric disorders aggression	9.4% 3/32
Psychiatric disorders disturbance in attention	9.4% 3/32
Psychiatric disorders self injurious behaviour	6.2% 2/32
Gastrointestinal disorders diarrhoea	12.5% 4/32
Gastrointestinal disorders abdominal pain upper	6.2% 2/32
Gastrointestinal disorders vomiting	6.2% 2/32
Infections and infestations nasopharyngitis	9.4% 3/32
Infections and infestations pharyngitis streptococcal	6.2% 2/32
Infections and infestations upper respiratory tract infection	6.2% 2/32
General disorders fatigue	15.6% 5/32
Nervous system disorders headache	9.4% 3/32
Nervous system disorders dizziness	6.2% 2/32
Respiratory, thoracic and mediastinal disorders cough	6.2% 2/32
Metabolism and nutrition disorders decreased appetite	6.2% 2/32

Additional Information

Dr. Paul Wang, Vice President of Clinical and Medical Affairs

Seaside Therapeutics

Phone: 617-374-9009

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Seaside Therapeutics agreements with investigators vary; constant is our right to restrict communications regarding trial results prior to public release for ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Publication restrictions are in place

Restriction type: OTHER