"An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)"
Jared Brosch, MD
Primary Investigator
Overview
The primary purpose of this extension study is to test whether or not ABBV-8E12 is effective and safe in subjects with Progressive Supranuclear Palsy (PSP). The study will also collect information from Magnetic Resonance Imaging (MRI) scans of the brain, and examine the levels of ABBV-8E12 and several other proteins in blood and cerebrospinal fluid (CSF). This is being done to try to determine whether ABBV-8E12 appears to have an effect on the PSP disease process.
Description
The primary purpose of this extension study is to test whether or not ABBV-8E12 is effective and safe in subjects with Progressive Supranuclear Palsy (PSP). The study will also collect information from Magnetic Resonance Imaging (MRI) scans of the brain, and examine the levels of ABBV-8E12 and several other proteins in blood and cerebrospinal fluid (CSF). This is being done to try to determine whether ABBV-8E12 appears to have an effect on the PSP disease process.
Eligibility
You may be eligible for this study if you meet the following criteria:
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Conditions:
Progressive Supranuclear Palsy
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Age: Between 18 Years - 100 Years
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Gender: All
Inclusion Criteria
The patientt completed the 52-week treatment period in Study M15-562 ((IRB #1609422086)
In the opinion of the investigator, the patient was compliant during participation in Study M15-562
The patient has an identified, reliable study partner (e.g., caregiver, family member, social worker, or friend), who has frequent contact with the subject (at least 10 hours per week) and who can accompany the subject to study visits to provide information regarding the subject's functional abilities.
If female, the patient must be either postmenopausal or a woman of childbearing potential (WOCBP) practicing at least 1 protocol-specified method of birth control, starting on Study Day 1 through at least 20 weeks after the last dose of study drug.
If a male patient is sexually active, he must agree from Study Day 1 through at least 20 weeks after the last dose of study drug, to practice protocol specified contraception.
Female patients of childbearing potential must have a negative serum pregnancy test result on Day 1.
Exclusion Criteria
The patient weighs less than 44 kg (97 lbs) at study entry.
The patient has any contraindication or inability to tolerate brain MRI (e.g., a pacemaker or any other implanted device or condition that would preclude proximity to a strong magnetic field).
The patient has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results. The Investigator must re-evaluate the subject for continuing participation and consider any factors including the interim development of any clinically significant neurological, hematological, autoimmune, endocrine, cardiovascular, neoplastic, renal, hepatic, metabolic, psychiatric, pulmonary, gastrointestinal, or other major disorder.
More than 8 weeks have elapsed since the patient received his/her last dose of study drug in Study M15-562.
The patient is concurrently enrolled in another interventional clinical study involving a therapeutic agent.
The patient is considered by the investigator, for any reason, to be an unsuitable candidate to receive ABBV-8E12 or the subject is considered by the investigator to be unable or unlikely to comply with the dosing schedule or study evaluations.
The patient is female and is pregnant, breastfeeding, or is considering becoming pregnant during the study or for approximately 20 weeks after the last dose of study drug.
The patient is male and is considering fathering a child or donating sperm during the study or for approximately 20 weeks after the last dose of study drug.
