NCT00331721

Brief Summary

The main objective of this study is to investigate the tolerability of enecadin in patients with acute ischemic stroke. Furthermore, the pharmacokinetics of enecadin in both male and female patients with acute ischemic stroke will be assessed. Efficacy trends will be evaluated up to day 30 post stroke.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_2 stroke

Timeline
Completed

Started May 2006

Typical duration for phase_2 stroke

Geographic Reach
3 countries

26 active sites

Status
terminated

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

May 1, 2006

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

May 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

May 22, 2008

Status Verified

May 1, 2008

Enrollment Period

3 years

First QC Date

May 30, 2006

Last Update Submit

May 21, 2008

Conditions

Stroke

Keywords

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

  • Safety parameters, Pharmacokinetics & trends of efficacy

    One month

Study Arms (2)

1

ACTIVE COMPARATOR

Enecadin

Drug: Enecadin

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

EnecadinDRUG

Dose escalating

1
PlaceboDRUG

Placebo comparator

2

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with acute ischemic stroke (scoring 3-20 on the National Institutes of Health Stroke Scale \[NIHSS\]) with level of consciousness score: 0 or 1 (conscious patients) are eligible to be treated within 9 hours of onset of stroke symptoms.
  • For female patients: post-menopausal or surgically sterile (post-menopausal: age ≥55 years and last menses ≥3 years ago).

You may not qualify if:

  • Participation in any investigational study in the previous 30 days.
  • Patients unable to understand trial related information.
  • History or evidence of severe heart diseases further specified in the protocol.
  • History or evidence of additional diseases or results of baseline visit as specified in the protocol.
  • Use of concomitant and prior medications as defined in the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Investigational Site 1

Linz, Austria

Location

Investigational Site 2

Linz, Austria

Location

Investigational Site

Antwerp, Belgium

Location

Investigational Site

Bruges, Belgium

Location

Investigational Site

Leuven, Belgium

Location

Investigational Site

Aachen, Germany

Location

Investigational Site

Bad Neustadt an der Saale, Germany

Location

Investigational Site

Bergisch Gladbach, Germany

Location

Investigational Site

Berlin, Germany

Location

Investigational Site

Bochum, Germany

Location

Investigational Site

Dortmund, Germany

Location

Investigational Site

Dresden, Germany

Location

Investigational Site

Erlangen, Germany

Location

Investigational Site

Frankfurt, Germany

Location

Investigational Site

Freiburg im Breisgau, Germany

Location

Investigational Site

Hamburg, Germany

Location

Investigational Site

Hanover, Germany

Location

University of Heidelberg

Heidelberg, Germany

Location

Investigational Site

Ingolstadt, Germany

Location

Investigational Site

Leipzig, Germany

Location

Investigational Site

Magdeburg, Germany

Location

Investigational Site

Minden, Germany

Location

Investigational Site

Munich, Germany

Location

Investigational Site

Nuremberg, Germany

Location

Investigational Site

Remscheid, Germany

Location

Investigational Site

Wiesbaden, Germany

Location

MeSH Terms

Conditions

StrokeIschemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Peter A Ringleb, Dr.

    Heidelberg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 30, 2006

First Posted

May 31, 2006

Study Start

May 1, 2006

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

May 22, 2008

Record last verified: 2008-05

Locations

BE(3)AU(2)DE(21)