Traumatic Neuroprotection and Epilepsy Prevention of Valproate Acid

NCT02027987 | Unknown Phase 1 DMC

• 1 other identifier: 20130814-7
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Background:
2. 2.Objectives:
3. 3.Methods:

Conditions

Traumatic Brain Injury

Keywords

valproate acid; traumatic brain injury; brain protection; epilepsy

Outcome Measures

Primary Outcomes (1)

• DRS scores

  The DRS score includes measures of eye opening, verbalization, and motor response (derived from the Glasgow Coma Scale); cognitive understanding of feeding, dressing, and grooming; degree of assistance and supervision required; and employability. Scores range from 0 to 29, with higher values indicating greater disability.

  On the 0,7th,14th,21st,28th,35th,42nd days since admitted into the study

Secondary Outcomes (3)

• the time of break out and state of epilepsy

  from 0 to 42 days when the epilepsy break out

• brain MRI scan

  6 weeks after treatment

• the blood concentration of VPA

  On the 0,7th,14th,21st,28th,35th,42nd days since admitted into the study

Other Outcomes (5)

• CRS-R score

  On the 0,7th,14th,21st,28th,35th,42nd days since admitted into the study

• function of kidney

  On the 0,7th,14th,21st,28th,35th,42nd days since admitted into the study

• function of liver

  On the 0,7th,14th,21st,28th,35th,42nd days since admitted into the study

Study Arms (2)

valproate acid

EXPERIMENTAL

The patients began receiving treatment at a dose of 400 mg VPA twice daily on the day after randomization by intravenous drip, with this dose continued for 14 days.The dose was increased to 500 mg twice daily at week 3 and to 400 mg three times daily at week 4 if the DRS score had not improved by at least 2 points from baseline. After the week 4 assessment, the study drug was tapered over a period of 2 to 3 days, with assessment of the patients continued through week 6. Additional procedural details are provided in the study protocol.

Drug: valproate acid

placebo

PLACEBO COMPARATOR

Interventions

valproate acid DRUG

valproate acid is a common drug which is applied for epilepsy prevention and treatment.

Also known as: Sodium valproate

valproate acid

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible patients were 16 to 65 years of age with all genders.
• The patients had sustained a nonpenetrating traumatic brain injury 4 to 16 weeks before enrollment, with the confirmation of CT or MRI.
• Additional eligibility criteria were a vegetative state or a minimally conscious state, as indicated by a Disability Rating Scale (DRS) score greater than 11.
• There was an inability both to follow commands consistently and to engage in functional communication, as assessed by the score on the Coma Recovery Scale-Revised (CRS-R)
• All the patients had provided written informed consent.
• The patients were receiving usual inpatient rehabilitation and treatment at each site.

You may not qualify if:

• unstable health state,including:Be allergic to VPA, or with serious allergic diseases or allergic constitutions;With serious cardiovascular diseases, hepatic, renal, or psychiatric diseases;With serious respiratory, endocrine, or blood system diseases;With serious infections or malignant tumors; With weakened immunologic status;Addison's diseases;With alcohol or drug abuse.
• Any disability related to the central nervous system that predated the traumatic brain injury.
• Pregnancy or breastfeeding females.
• More than one seizure in the previous month.
• Prior treatment with VPA
• In the case of patients who were undergoing evaluation for ventricular shunt placement or receiving a psychoactive medication, enrollment was deferred until shunt placement had been completed or psychoactive medications discontinued.
• The patients had enrolled the other studies in the past three months or are engaging the other studies.
• The patients were assessed as unqualified for the study according to the comprehensive evaluation opinion brought forward by the research team.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Institute of Neurosurgery, Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Epilepsy

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Fei Zhou, M.D., Ph.D.

  Institute of Neurosurgery, Xijing Hospital, Fourth Military Medical University

  STUDY DIRECTOR

Central Study Contacts

Hu S Jie, M.D., Ph.D.

CONTACT

086-29-84773307; hushijie@fmmu.edu.cn

Hu S Jie, M.D., Ph.D.

CONTACT

086 13992888996; hushijie1979@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2013
• First Posted: January 6, 2014
• Study Start: October 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 6, 2014

Record last verified: 2013-11

Locations

CN (1)