Status and phase
Conditions
Treatments
About
The experimental design is an open-label two-week trial of tolcapone to evaluate which clinical domains are affected by tolcapone treatment and to identify "responders" to tolcapone treatment in the two subject groups (BI and NCD)
Full description
Each patient will receive a two-week specified dosing amount of tolcapone (100mg TID on Day 1; 200mg TID on Days 2-14). The patient will be instructed to take the study drug three times daily. Tolcapone will be tapered after Day 14 to avoid potential withdrawal reactions.
Clinical Instruments for patients:
Clinical Instruments for Informants:
Laboratory Measures:
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
TBI and ABI Patients Inclusion Criteria
NCD Patients Inclusion Criteria
Exclusion Criteria for All Patients:
Other Exclusion Criteria for TBI Patients
• Presence of pre-morbid/pre-TBI cognitive impairment or behavioral dysfunction, as per informant or medical documentation
Primary purpose
Allocation
Interventional model
Masking
100 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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