Effects of Huperzine A in Treatment of Moderate to Severe TBI
We will explore the use of Huperzine A in patients who have sustained a moderate to severe Traumatic Brain Injury. We aim to determine whether Huperzine A, as compared with placebo, would have an effect on memory function after TBI. Additionally, we aim to determine whether use of Huperzine A in these patients can change brain activity (as indexed by EEG and Transcranial Magnetic Stimulation - TMS), and reduce prevalence/frequency of post-traumatic seizures. We also aim to evaluate the safety of Huperzine A in this population as compared with placebo.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Huperzine A for the Treatment of Cognitive, Mood, and Functional Deficits After Moderate and Severe TBI|
- Change in Cognition (learning and memory)from baseline [ Time Frame: Measured for approximately one year ] [ Designated as safety issue: No ]To determine whether Huperzine A, as compared to placebo, has a differential effect on learning and memory functions after moderate to severe TBI, as measured by the California Verbal Learning Test- II (CVLT-II). This CVLT-II will be measured at baseline, 6 weeks, 12 weeks and at 52 weeks.
- Changes in neurophysiological markers (EEG and TMS)from baseline [ Time Frame: Measured for approximately one year ] [ Designated as safety issue: No ]To determine whether administration of Huperzine A produces significant differences in neurophysiologic markers (as indexed by EEG event related potentials (P50 and P300) and TMS-indexed cortical excitability (cholinergic activity)) associated with cognition relative to a placebo. This will be measured at baseline, 6 weeks, 12 weeks, 24 weeks and 52 weeks.
- Changes in seizure activity from baseline [ Time Frame: Measured for approximately 12 weeks ] [ Designated as safety issue: No ]To determine whether Huperzine A reduces the prevalence/frequency of post-traumatic seizures after moderate and severe TBI as compared to placebo at 12 weeks post-enrollment (immediate seizures prevalence). Seizures will be continually monitored through the study.
- Safety of Huperzine-A [ Time Frame: Measured for approximately one year ] [ Designated as safety issue: Yes ]To evaluate the safety and tolerability of Huperzine A in this patient population as compared to placebo. Safety and tolerability will be assessed by a comparison of the frequency and intensity of adverse effects, as measured throughout the study participation.
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: Huperzine A
Huperzine A will be administered to patients, titrating dose up from 100mcg/day to 600mcg per day over the course of 20 days - and remaining on the dose of 600mcg/day for the remainder of the drug phase (64 days) - for a total of 12 weeks on Huperzine A.
Drug: Huperzine A
Huperzine A will be administered for 12 weeks as outlined in the Arm Description
Placebo Comparator: Placebo
Placebo will be administered to patients at the same frequency/intervals as the experimental arm (Huperzine-A).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01676311
|Contact: Ross Zafonte, DOfirstname.lastname@example.org|
|Contact: Laura Burns, MBAemail@example.com|
|United States, Massachusetts|
|Spaulding Rehabilitation Hospital||Recruiting|
|Charlestown, Massachusetts, United States, 02129|
|Principal Investigator:||Ross Zafonte, DO||Spaulding Rehabilitation Hospital|