Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-24 @ 10:08 PM
NCT ID:
NCT00152035
Eligibility Criteria:
Inclusion Criteria:
* Subject satisfied all entry criteria for the antecedent protocol (SPD465-301 or SPD465-303) and completed a minimum of 4 of the 7 weeks of double-blind treatment without experiencing any clinically significant adverse events.
* Subject must be male or non-pregnant female who agrees to comply with using acceptable contraceptive methods.
Exclusion Criteria:
* Subject was terminated from antecedent protocol (SPD465-301 or SPD465-303) for non-compliance and/or experienced a serious adverse event or adverse event resulting in termination from the protocol.
* Comorbid psychiatric diagnosis with significant symptoms such as Axis II disorders or severe Asix I disorders.
* History of seizure, tic disorder, or a current diagnosis and/or family history of Tourette's Disorder.
* Females who are pregnant of lactating.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00152035
Study Brief:
Protocol Section:
NCT00152035