NCT01863277

Brief Summary

The purpose of the study is to evaluate the effect of Melatonin (in a dosage of 14mg daily) for a better clinical outcome in the period three days post stroke.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 22, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 27, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Last Updated

May 27, 2013

Status Verified

April 1, 2013

Enrollment Period

9 months

First QC Date

May 22, 2013

Last Update Submit

May 24, 2013

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

  • Improvement of at least one point on the MRS score

    3 months

Study Arms (2)

Melatonin

ACTIVE COMPARATOR

Melatonin 14mg/daily given over 14 days

Drug: Melatonin

sugar pill

PLACEBO COMPARATOR

sugar pill given over 14 days

Drug: placebo

Interventions

MelatoninDRUG
Melatonin
placeboDRUG
sugar pill

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • within 72hours of ischemic stroke
  • age 18-80
  • both gender
  • ability to sign consent form

You may not qualify if:

  • intra-cerebral bleeding
  • tumour of brain
  • multiple sclerosis
  • s/p craniotomy
  • known allergy to melatonin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

E. Wolfson Medical Center

Holon, 58100, Israel

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Melatonin

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Yair Lampl

Study Record Dates

First Submitted

May 22, 2013

First Posted

May 27, 2013

Study Start

July 1, 2013

Primary Completion

April 1, 2014

Last Updated

May 27, 2013

Record last verified: 2013-04

Locations

IL(1)