Effects of Huperzine A in Treatment of Moderate to Severe TBI
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|ClinicalTrials.gov Identifier: NCT01676311|
Recruitment Status : Terminated (Insufficient accrual rate: 14 participants enrolled (target of 30).)
First Posted : August 30, 2012
Results First Posted : October 7, 2019
Last Update Posted : November 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury||Drug: Huperzine A Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 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|
|Actual Study Start Date :||December 2013|
|Actual Primary Completion Date :||August 2018|
|Actual 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
- California Verbal Learning Test- 2nd Edition (CVLT-II): Learning and Memory [ Time Frame: Baseline, 6 weeks, 12 weeks, 24 weeks and at 52 weeks. ]
Measure of learning and memory function. Three indices of the CVLT-II were calculated. The full name, abbreviated name, and the minimum and maximum possible scores of each index are indicated below:
- California Verbal Learning Test- 2nd Edition- Total Learning [CVLT-II-TL] (Minimum score=0; Maximum score= 80)
- California Verbal Learning Test- 2nd Edition- Short delay free recall [CVLT-II-SDFR] (Minimum score=0; Maximum score=16)
- California Verbal Learning Test- 2nd Edition- Long delay free recall [CVLT-II-LDFR] (Minimum score=0; Maximum score=16)
High scores are indicative of greater memory and learning for each index (i.e. better outcome).
- Amplitude of Event Related Potentials (ERPs) P50 and P300 [ Time Frame: Baseline, 12 Weeks ]Event Related Potentials (ERPs): P50 and P300 are neurophysiological measurements that index cortical electrical activity associated with a given stimulus. P50 and P300 were measured using auditory stimuli. P50 represents an index of activity in the cholinergic system and has been used to characterize presynaptic cholinergic deficit. P300 is a measure of general cognitive processing elicited during attention, memory, and executive tasks.
- Latency of Event Related Potentials (ERPs) P50 and P300 [ Time Frame: Baseline, 12 weeks ]Event Related Potentials (ERPs): P50 and P300 are neurophysiological measurements that index cortical electrical activity associated with a given stimulus. P50 and P300 were measured using auditory stimuli. P50 represents an index of activity in the cholinergic system and has been used to characterize presynaptic cholinergic deficit and P300 is a measure of general cognitive processing elicited during attention, memory, and executive tasks.
- Number of Participants Who Experienced Post-traumatic Seizure During 12-week Treatment Window [ Time Frame: Baseline and weekly for 12 weeks. ]To determine whether Huperzine A changes the prevalence of post-traumatic seizure after moderate and severe TBI as compared to placebo at 12 weeks post-enrollment (immediate seizures prevalence).
- Number of Participants With Self-reported Side Effects During 12-week Treatment Window [ Time Frame: Baseline and weekly for 12 weeks. ]To evaluate the safety and tolerability of Huperzine A in this patient population as compared to placebo the frequency of self-reported side effects during the 12-week treatment window were grouped categorically by system (behavioral, cardiac-respiratory, dermatological,gastrointestinal, genitourinary/neurological, hematological, musculoskeletal, neurological).
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
|United States, Massachusetts|
|Spaulding Rehabilitation Hospital|
|Charlestown, Massachusetts, United States, 02129|
|Principal Investigator:||Ross Zafonte, DO||Spaulding Rehabilitation Hospital|