Effects of Huperzine A in Treatment of Moderate to Severe TBI
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|ClinicalTrials.gov Identifier: NCT01676311|
Recruitment Status : Recruiting
First Posted : August 30, 2012
Last Update Posted : September 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury||Drug: Huperzine A Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Huperzine A for the Treatment of Cognitive, Mood, and Functional Deficits After Moderate and Severe TBI|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||August 2018|
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).
Placebo Arm (blinded randomization) for Huperzine A Intervention
- Change in Cognition (learning and memory)from baseline [ Time Frame: Measured for approximately one year ]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 ]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 ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01676311
|Contact: Ross Zafonte, DOemail@example.com|
|Contact: Iris Monge||617-952-6193||IMONGE@PARTNERS.ORG|
|United States, Massachusetts|
|Spaulding Rehabilitation Hospital||Recruiting|
|Charlestown, Massachusetts, United States, 02129|
|Principal Investigator:||Ross Zafonte, DO||Spaulding Rehabilitation Hospital|