Effects of Huperzine A in Treatment of Moderate to Severe TBI
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|