deltatrials
Completed PHASE2 INTERVENTIONAL 2-arm NCT01212679

Effects of Intranasal Nerve Growth Factor for Traumatic Brain Injury

Pilot Study of Intranasal Nerve Growth Factor for Traumatic Brain Injury(TBI)

Sponsor: Jinling Hospital, China

Updated 7 times since 2017 Last updated: Oct 30, 2017 Started: Dec 31, 2010 Primary completion: Oct 31, 2017 Completion: Oct 31, 2017
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Traumatic Brain Injury, this trial is completed. The trial is conducted by Jinling Hospital, China and has accumulated 7 data snapshots since 2010. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

Early NGF concentration in the cerebral spinal fluid(CSF)correlates significantly with the severity of head injury, and NGF upregulation correlates with better neurologic outcomes and could be useful to obtain clinical and prognostic information in patients with serve TBI. However, the clinical use of NGF is difficulty associated with delivering them to the CNS because of the existing of blood-brain barrier(BBB). Intranasal delivery drug is a noninvasive and convenient novel method bypassing BBB, which results in targeting therapeutics to the CNS rapidly. The proposed study is a randomized, double-blind, placebo-controlled trail of NGF, starting between 24 to 72 hours post TBI, continuing for 2 weeks.

Early NGF concentration in the cerebral spinal fluid(CSF)correlates significantly with the severity of head injury, and NGF upregulation correlates with better neurologic outcomes and could be useful to obtain clinical and prognostic information in patients with serve TBI.

However, the clinical use of NGF is difficulty associated with delivering them to the CNS because of the existing of blood-brain barrier(BBB). Intranasal delivery drug is a noninvasive and convenient novel method bypassing BBB, which results in targeting therapeutics to the CNS rapidly.

The proposed study is a randomized, double-blind, placebo-controlled trail of NGF, starting between 24 to 72 hours post TBI, continuing for 2 weeks.

Status Flow

~Jan 2017 – ~Nov 2017 · 10 months · monthly snapshotActive Not Recruiting~Nov 2017 – ~Jun 2018 · 7 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

7 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Present [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE2

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE2

Show 2 earlier versions
  1. Nov 2017 — Jun 2018 [monthly]

    Completed PHASE2

    Status: Active Not RecruitingCompleted

  2. Jan 2017 — Nov 2017 [monthly]

    Active Not Recruiting PHASE2

    First recorded

Dec 2010

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Jinling Hospital, China
Data source: Jinling Hospital, China

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations