A study to investigate the Safety and Tolerability of AB-2004 in a Pediatric Autism Spectrum Disorder Populatio
- Conditions
- Pediatric Autism Spectrum DisorderHuman Genetics and Inherited Disorders - Other human genetics and inherited disordersMental Health - Autistic spectrum disorders
- Registration Number
- ACTRN12618001956291
- Lead Sponsor
- Axial Biotherapeutics Australia Pty Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 35
Participants must meet all inclusion criteria's (and not meet exclusion criteria) to be enrolled in the study. Following are the key Inclusion Criteria -
Inclusion Criteria:
1. Clinically diagnosed, documented Autism Spectrum Disorder (DSM-V criteria)
confirmed with ADOS-2 at Visit 1 or within 18 months prior to Visit 1.
2. Adolescents greater than or equal to 12 and less than 18 years of age at the time of consent
3. History of gastrointestinal symptoms (diarrhea, constipation, abdominal pain,
bloating) confirmed in the e-diary with at least 50% compliance of entry for at least
14 days during the screening period.
4. Male subjects who are post-pubertal must be sterile (surgically or otherwise) for at
least 6 months or are using single barrier contraception during the duration of the
trial and up until 1 month after the last dose AB-2004.
OR
Female subjects that are not lactating and have a negative pregnancy test at the
Screening and who are surgically sterile for at least 6 months or who agree to use
double-barrier contraception, an intrauterine device, or an oral contraceptive over the
duration of the trial and at least 4 weeks after the last dose of AB-2004
Participants must not meet any exclusion criteria (and meet all inclusion criteria) to be enrolled in the study. Following are the key Exclusion Criteria -
1. History of inflammatory bowel disease, bowel obstruction, diverticulosis or colon
polyps.
2. Oral, injected, inhaled antibiotic within 30 days prior to Screening
3. Currently taking a controlled or extended-release medication
4. History of significant gastric or intestinal surgery (excluding appendectomy).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the safety and tolerability of AB-2004 administered daily over a period of 8 weeks as assessed by the frequency and severity of adverse events, laboratory abnormalities. [Monitored daily through Screening Visit and 28 days after the last dose of study treatment for each treatment arm. The primary possible AEs being looked for are constipation/abdominal pain. Adverse events associated with AB-2004 will be captured via self-reported changes in bowel habits and pain. ]
- Secondary Outcome Measures
Name Time Method