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NCT01676311 · ClinicalTrials.gov registry record · Phase 2

Effects of Huperzine A in Treatment of Moderate to Severe TBI

A Phase 2 study, sponsored by Spaulding Rehabilitation Hospital.

Terminated
Registry status
Phase 2
Development phase
14
Enrollment target

NCT01676311: Clinical Trial Phase 2 study, sponsored by Spaulding Rehabilitation Hospital.

NCT01676311 is a Phase 2 study that was terminated before completion, run by Spaulding Rehabilitation Hospital. The registered enrollment target is 14 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01676311, a Phase 2 study, was terminated before completion, sponsored by Spaulding Rehabilitation Hospital.

TERMINATED
Registry status
Phase 2
Development phase
14 participants
Enrollment target

Study Summary

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.

Primary Outcome

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: 1. California Verbal Learning Test- 2nd Edition- Total Learning \[CVLT-II-TL\] (Minimum score=0; Maximum score= 80) 2. California Verbal Learning Test- 2nd Edition- Short delay free recall \[CVLT-II-SDFR\] (Minimum score=0; Maximum score=16) 3. California Verbal Learning Test- 2nd Edition- Long dela

Interventions

  • DRUG Placebo
  • DRUG Huperzine A

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2013-12
Est. Completion 2018-08
Phase Phase 2
Spaulding Rehabilitation Hospital

101 total trials

Why NCT01676311 stopped before completion

NCT01676311 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01676311 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01676311 about?

NCT01676311 is a clinical study titled "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 the...

What is the current status of trial NCT01676311?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2013-12. Estimated completion is 2018-08.

What interventions are being tested in trial NCT01676311?

The interventions under investigation include: Placebo (DRUG), Huperzine A (DRUG).

Who is sponsoring clinical trial NCT01676311?

This trial is sponsored by Spaulding Rehabilitation Hospital, which has 101 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01676311's enrollment target sits among peer trials

14 1941st of 2000 higher than 54 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01676311, the US trial registry maintained by the National Library of Medicine. NCT01676311 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.