Participants are screened and evaluated for neuropsychological impairment. Pending completion of a neurological examination, safety labs and meeting inclusion criteria criteria including demonstrated neropsychological impairment as defined by the protocol, patients are then randomized to either Lexipafant 250 mg po BID or placebo 250 mg po BID. Safety labs are repeated at screening, baseline and week 2, 6 and 10. Neuropsychological testing is done at screening, baseline and weeks 2, 6 and 10. Neuropsychological testing is done at screening and weeks 6 and 10. Neurological exam is performed at screening, baseline and week 10. After successful completion of the initial phase, participants can choose to go on the open label phase for 48 weeks, depending on the availability of the drug by the sponsor British Biotech. Patients come in for a final visit at the end of the open label for repeat safety labs, neuropsychological and neurological exams.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
3M01RR000052-38S2
Application #
6218302
Study Section
Project Start
1998-12-01
Project End
1999-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
38
Fiscal Year
1999
Total Cost
Indirect Cost
Name
Johns Hopkins University
Department
Type
DUNS #
045911138
City
Baltimore
State
MD
Country
United States
Zip Code
21218
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