NCT01115959

Brief Summary

This study examines early antiepileptic treatment with valproic acid for acute cerebral hemorrhage against a placebo group immediately post event to evaluate the outcome of these patients regarding seizures and neurological outcome.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2003

Longer than P75 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 4, 2010

Completed
Last Updated

June 12, 2014

Status Verified

May 1, 2010

Enrollment Period

5.7 years

First QC Date

May 2, 2010

Last Update Submit

June 11, 2014

Conditions

Post Cerebral Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • number of seizures

    study drug for 1 month and 1 year follow up

Secondary Outcomes (1)

  • neurological outcome NIHSS

    during 1 month study drug and 1 year post follow up

Study Arms (2)

valproic acid

ACTIVE COMPARATOR

Valproic acid given orally 400mg twice daily

Drug: valproic acidDrug: placebo bid

placebo

PLACEBO COMPARATOR

Placebo twice daily for one month

Drug: placebo bid

Interventions

valproic acidDRUG

treatment of 1 month dosage of 400 mg BID

valproic acid
placebo bidDRUG
placebovalproic acid

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • cerebral hemorrhage spontaneous

You may not qualify if:

  • early seizures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Valproic Acid

Intervention Hierarchy (Ancestors)

Pentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Study Officials

  • ronit gilad, md

    E Wolfson med center

    PRINCIPAL INVESTIGATOR

  • ronit gilad, md

    E wofson med center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Yair Lampl

Study Record Dates

First Submitted

May 2, 2010

First Posted

May 4, 2010

Study Start

February 1, 2003

Primary Completion

October 1, 2008

Study Completion

December 1, 2008

Last Updated

June 12, 2014

Record last verified: 2010-05