Overview
Following adolescent concussion, poor sleep health is common and relates to the development of persisting post-concussion symptoms, and uninjured adolescents (independent of concussion) also commonly experience sleep insufficiency. Given the sparse guidance that exists for clinicians to provide evidence-based sleep health recommendations for adolescents with a concussion, the primary objectives of this prospective randomized clinical trial of adolescents with a recent concussion are to discover if a multidimensional and prescriptive sleep health intervention leads to: 1) faster symptom resolution time, better sleep quality, or longer sleep duration; and 2) improved sleep habits, mental health, or academic engagement, relative to standard-of-care post-concussion sleep health guidance. Findings from this research will provide the basis for more precise sleep health recommendations for adolescents who experience a concussion.
Description
This is a single-arm phase 2, two-stage, non-randomized multicenter Phase 2 study designed to evaluate the clinical activity (response frequency) of senaparib and temozolomide (TMZ) in patients with recurrent or persistent clear cell or endometrioid ovarian cancer.
Up to 18 adult female subjects will be enrolled and receive senaparib 80mg orally daily Days 1-28 and TMZ 20mg daily Days 1-21 of a 28 day cycle. Tumor assessments will be performed every 8 weeks for first 3 cycles then every 12 weeks thereafter until progressive disease is confirmed. Treatment will continue until either unacceptable toxicity, progression of disease, or withdrawal of consent.
Eligibility
Inclusion Criteria:
- Participants will be symptomatic at the time of enrollment (Post-Concussion Symptom Inventory \[PCSI\] score ≥9)
- Diagnosed with a concussion by a healthcare provider using the American Congress of Rehabilitation Medicine diagnostic criteria
- 10-19 years of age (aligned with World Health Organization definition of 'adolescent')
Exclusion Criteria:
- History of treatment for pre-concussion sleep-related disorders
