AzTrials
AzTrials

StrokePhase 2NCT00272909

Efficacy of SUN N4057 in Subjects With Acute Ischemic Stroke and Measurable Penumbra on Magnetic Resonance Imaging (MRI)

A Phase 2 study testing piclozotan low dose and piclozotan high dose in people with Stroke, run by Daiichi Sankyo at 47 sites in 7 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This research study is designed to evaluate the safety, tolerability, and efficacy of SUN N4057 (piclozotan) in subjects with acute ischemic stroke within 9 hours of the onset of symptoms. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Stroke
What is being tested?
piclozotan low dose and piclozotan high dose
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
43 participants
Where
47 sitesin 7 countries
Study dates
Sep 2004to Jan 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • General inclusion criteria:
  • Males or females >= 18 and <= 85 years of age at randomization. Female subjects must be either:
  • Surgically sterile;
  • Postmenopausal for at least 1 year; or
  • Non-pregnant, confirmed by a serum pregnancy test, and using a method of birth control that is acceptable to the investigator.
  • Neurological examination demonstrating localizing cortical signs
Show all 11Show fewer
  • Receipt of study drug less than 6 hours (50% of subjects) or between 6 and 9 hours, inclusive, (50% of subjects) after the onset of symptoms (for un-witnessed stroke, last time seen in normal state or at bedtime for un-witnessed stroke during sleep)
  • Signed informed consent from subject or legally acceptable representative
  • NIHSS score of 6 - 22, inclusive, or at least 2 on the aphasia item of the NIHSS with a location of MRI findings consistent with aphasia
  • MRI-determined inclusion criteria:
  • Acute ischemic stroke with substantial cortical involvement in the middle cerebral artery (MCA) distribution, as verified by the Screening DWI abnormality and/or Screening PWI abnormality. (Note: white matter involvement, in addition to cortex, is not an exclusion.)

Who cannot join

  • General exclusion criteria:
  • Two or more of the following:
  • Reduced level of consciousness (score >= 2 on NIHSS Q1a)
  • Forced eye deviation or total gaze paresis (score of 2 on NIHSS Q2)
  • Dense hemiplegia (no movement) of upper and lower extremities (score of 4 on NIHSS Q5 regarding motor arm and a score of 4 on NIHSS Q6 regarding motor leg)
  • Pre-stroke modified Rankin score >= 2 at Screening
Show all 10Show fewer
  • Rapid neurological improvement from Screening up to the start of drug infusion
  • Persistent systolic blood pressure (SBP) > 220 mmHg and/or diastolic blood pressure (DBP) > 120 mmHg (confirmed by at least three readings taken at least 3 minutes apart) prior to randomization. If subsequent readings are consistently below these levels, either spontaneously or following mild antihypertensive therapy, subject may be enrolled.
  • MRI-determined exclusion criteria:
  • Intracranial hemorrhage as verified by Screening MRI. (Note: intracranial hemorrhage on pre-screen computerized tomography [CT] scan also excludes subject.)

Trial locations and contacts

47 sites in 7 countries.

47 sites in 7 countries

United States25 sites

  • Summa Health System Neurology and Neuroscience Associates

    Akron, Ohio, 44309

  • Charleston Area Medical Center Health Education and Research Institute

    Charleston, West Virginia, 25304

  • Chattanooga Neurology Associates

    Chattanooga, Tennessee, 37404

  • Ruan Neurology Clinic and Clinical Research Center

    Des Moines, Iowa, 50314

  • Wayne State University

    Detroit, Michigan, 48201

  • Michigan State University, Sparrow Health System

    East Lansing, Michigan, 48824

  • INOVA Research Center

    Falls Church, Virginia, 22042

  • Advance Neurology Specialists

    Great Falls, Montana, 59405

  • Moses Cone Hospital

    Greensboro, North Carolina, 27401

  • The Stroke Center at Hartford Hospital

    Hartford, Connecticut, 06102

  • The Methodist Hospital Neurological Institute

    Houston, Texas, 77030

  • St. Luke's Hospital

    Kansas City, Missouri, 64111

  • Lakeland Regional Medical Center

    Lakeland, Florida, 33805

  • University of Kentucky, Sanders Brown Center on Aging/Stroke Program

    Lexington, Kentucky, 40536

  • UCLA Stroke Network

    Los Angeles, California, 90024

  • Methodist University Hospital

    Memphis, Tennessee, 38104

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • OCALA Neurodiagnostic Center

    Ocala, Florida, 34471

  • San Francisco Clinical Research Center

    San Francisco, California, 94109

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • SUNY at Stony Brook, University Hospital at Stony Brook

    Stony Brook, New York, 11794

  • St. Francis Medical Center

    Trenton, New Jersey, 08629

  • Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Clinical Research Center of Winston-Salem

    Winston-Salem, North Carolina, 27103

  • University of Massachusetts, Memorial Health Center, Department of Neurology

    Worcester, Massachusetts, 01655

Other trials in United States

Israel6 sites

  • Soroka University Medical Center

    Beersheba, 84101

  • Rambam Medical Center

    Haifa, 31096

  • Hadassah University Hospital

    Jerusalem, 91120

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 64239

  • Chaim Sheba Medical Center

    Tel HaShomer, 52621

  • Assaf Harofeh Medical Center

    Zrifin, 70300

Other trials in Israel

Germany4 sites

  • Universitatsklinikum Essen, Department of Neurology

    Essen, D-45147

  • Neurologische Universitatsklinik und Poliklinik - Neurzentrum

    Freiburg im Breisgau, 79106

  • Universitatsklinikum Leipzig Aor, Klinik And Poliklinok Fur Neurologie

    Leipzig, 04103

  • Neurologische Klinik, Klinikum Rechts Der Isar Der Tu Munchen

    München, 81675

Other trials in Germany

Belgium3 sites

  • General Hospital Middelheim, Dept. of Neurology

    Antwerp, 2020

  • Hopital Erasme - Dept. of Neurology, Universite Libre de Bruxelles

    Brussels, B-1070

  • Uz Gasthuisberg, Neurology

    Leuven, 3000

Other trials in Belgium

Poland3 sites

  • Centralny Szpital Kliniczny

    Katowice, 40-752

  • Collegium Medicum Jegiellonian University

    Krakow, 31-503

  • Military Institute of Medicine

    Warsaw, 00-909

Other trials in Poland

South Africa3 sites

  • St Augustines Hospital

    Durban, 4001

  • Vergelegen Medi-Clinic

    Somerset West, 7130

  • Sunninghill Hospital Cnr.

    Sunninghill, 2157

Other trials in South Africa

Spain3 sites

  • Hospital Universitari Germans Trias i Pujol

    Barcelona, 08916

  • University Hospital of Girona Dr. Josep Trueta, Neurology Department

    Girona, 17007

  • Hospitales Universitarios Virgen Del Rocio

    Seville, 41013

Other trials in Spain

About this study

Official title: A Phase IIb Randomized, Double-blind, Placebo-Controlled, Group-Sequential, Multicenter, Dose Finding Study of the Safety and Efficacy of SUN N4057 (Piclozotan) Administered for 72 Hours by Continuous Intravenous Infusion in Subjects With Acute Ischemic Stroke and Measurable Penumbra on MRI

This research study is designed to evaluate the safety, tolerability, and efficacy of SUN N4057 (piclozotan) in subjects with acute ischemic stroke within 9 hours of the onset of symptoms.

Read the detailed description

The primary objective of the study is to determine the efficacy of a 72 hour infusion of SUN N4057 (piclozotan) in subjects with clinical findings of an acute ischemic stroke and a magnetic resonance imaging (MRI) demonstrating a measurable penumbra (perfusion-weighted imaging [PWI] minus diffusion-weighted imaging [DWI] volume). Efficacy will be determined by comparing the proportion of subjects with no growth in stroke lesion volume as assessed by DWI at Screening to stroke lesion volume assessed by FLAIR (fluid-attenuated inversion recovery) on Day 28 in the piclozotan group versus the placebo group.

Conditions
Stroke
Being tested
piclozotan low dose, placebo, piclozotan high dose
Keywords
Acute Ischemic Stroke, 9-Hour window MRI, Serotonin receptor agonist
Medical subject headings
Stroke, Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • piclozotan low doseDrug

    Continuous IV infusion over a period of up to 72 hours of piclozotan

  • placeboDrug

    Continuous IV infusion over a period of up to 72 hours of placebo.

  • piclozotan high doseDrug

    Continuous IV infusion over a period of up to 72 hours of piclozotan

Study groups in NCT00272909
Study groupRoleWhat they receive
1Experimentalpiclozotan IV infusion, low dose, for 72 hours.
Receives: Drug: piclozotan low dose
2Experimentalpiclozotan IV infusion, high dose, for 72 hours.
Receives: Drug: piclozotan high dose
3Placebo comparatorplacebo (normal saline) IV infusion, for 72 hours.
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement in MRI

    Measured: 28 days

Secondary outcomes (3)

  1. The change in stroke lesion volume from Screening to day 28

    Measured: 28 days

  2. Clinical outcomes at Days 28 and 90 using the individual clinical scales (Modified Rankin Scale, Barthel Index, and National Institutes of Health Stroke Scale [NIHSS]).

    Measured: Days 28 and 90

  3. To assess the safety and tolerability of SUN N4057 (piclozotan) in subjects with acute stroke.

    Measured: Days 28, 60 and 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2006 (estimated)
  2. Study startSep 2004
  3. Primary completionOct 2006
  4. Study completionJan 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00272909
Sponsor's protocol ID
SPI-103
Status last verified
Oct 2015
First submitted
5 Jan 2006
Last updated
20 Oct 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing piclozotan low dose and piclozotan high dose in people with Stroke, run by Daiichi Sankyo at 47 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in United States, Israel, Germany, Belgium, Poland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in MRI (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00272909.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in