Clinical Trials Register

Summary
EudraCT Number:	2010-023507-95
Sponsor's Protocol Code Number:	2010B151
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2010-11-16
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Netherlands - Competent Authority

A.2

EudraCT number

2010-023507-95

A.3

Full title of the trial

Basilar Artery International Cooperation Study Trial

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

International basilar artery trial

A.3.2

Name or abbreviated title of the trial where available

BASICS Trial

A.4.1

Sponsor's protocol code number

2010B151

A.5.4

Other Identifiers

Name:

NTR

Number:

2617

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	BASICS Study Group
B.1.3.4	Country	Netherlands
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	St. Antonius Hospital
B.4.2	Country	Netherlands
B.4.1	Name of organisation providing support	NHS
B.4.2	Country	Netherlands
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	St. Antonius Hospital
B.5.2	Functional name of contact point	W. Schonewille
B.5.3	Address:
B.5.3.1	Street Address	Koekoekslaan 1
B.5.3.2	Town/ city	Nieuwegein
B.5.3.3	Post code	3435CM
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	0031(0)88320 30 00
B.5.5	Fax number	NA
B.5.6	E-mail	w.schonewille@antoniusziekenhuis.nl

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Medacinase
D.2.1.1.2	Name of the Marketing Authorisation holder	Medac Gesellschaft für Spezialpräparate mbH
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Powder for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intraarterial use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	UROKINASE
D.3.9.1	CAS number	9039-53-6
D.3.9.2	Current sponsor code	none
D.3.9.3	Other descriptive name	UROKINASE
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	15000000
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Actilyse
D.2.1.1.2	Name of the Marketing Authorisation holder	Boehringer Ingelheim B.V.
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Powder for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intraarterial use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ALTEPLASE
D.3.9.1	CAS number	105857236
D.3.9.2	Current sponsor code	none
D.3.9.3	Other descriptive name	ALTEPLASE
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	22
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Basilar artery occlusion.

E.1.1.1

Medical condition in easily understood language

Bloodcloth in artery providing blood to the brains.

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.0
E.1.2	Level	PT
E.1.2	Classification code	10063093
E.1.2	Term	Basilar artery thrombosis
E.1.2	System Organ Class	10029205 - Nervous system disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.0
E.1.2	Level	PT
E.1.2	Classification code	10048963
E.1.2	Term	Basilar artery occlusion
E.1.2	System Organ Class	10029205 - Nervous system disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the efficacy of additional IA therapy in addition to best medical treatment in terms of favourable outcome at 90 days, defined as a modified Rankin score of 0-3, in patients with an acute ischemic stroke caused by basilar artery occlusion.
Secondary analysis will compare outcome in the following pre-defined subgroups:
- patients with a baseline NIHSS of 10 -19, and those with a baseline NIHSS of ≥ 20.
- patients treated with IVT within 4.5 hours of symptom onset, and those treated beyond 4.5 hours of symptom onset within 4.5 hours of estimated time of basilar artery occlusion.
- patients treated with IVT and those with a contra-indication for IVT.

E.2.2

Secondary objectives of the trial

• To evaluate the efficacy of IAT in patients with a contra-indication for IVT in terms of favourable outcome at 90 days
• To evaluate the safety of a combined IV/IA approach compared to IV rt-PA alone. The primary measures of safety will be symptomatic intracranial haemorrhage(ICH) or ICH contributing to patients death
• To evaluate the efficacy of a combined IV/IA approach compared to IV rt-PA alone in terms of a favourable outcome at day 90 on other clinical and radiological maesures: 1) Excellent outcome defined as a mRS of 0-2, 2) mRS - not dichotomized, 3)NIHSS and EuroQol. 4) an improved early response to treatment as determined by a reduction in NIHSS by 5 points or more at 24 hours. 5) A CT or MR angiography assessment of basilar artery patency at 24 hours . 6) the volume of cerebral infarction as maesured by NCCT/CTA-SI at 24 hours.
• To evaluate the safety and efficacy of mechanical devices as part of a combined IV/IA approach as the BASICS trial progresses.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Symptoms and signs compatiblewith ischemia in the basilar artery territory
• Basilar artery occlusion confirmed by CTA or MRA
• Age18 or older (i.e., candidates must have had their 18th birthday).
• If IVT is considered as part of best medical treatment IV rt-PA needs to be initiated within 4.5 hours of estimated time of basilar artery occlusion. (Estimated time of basilar artery occlusion is defined as time of onset of acute symptoms leading to clinical diagnosis of basilar artery occlusion or if not known last time patient was seen normal prior to onset of these symptoms – this time is not necessarily the same as the time of onset of first symptoms).
• Initiation of IA therapy should be feasible within 6 hours of estimated time of basilar artery occlusion.

E.4

Principal exclusion criteria

•Pre-existing dependency with mRankin ≥3.
•Females of childbearing potential who are known to be pregnant and/or lactating or who have positive pregnancy tests on admission.
•Patients that require hemodialysis or peritoneal dialysis.
•Other serious, advanced, or terminal illness.
•Any other condition that the investigator feels would pose a significant hazard to the patient if thrombolytic therapy is initiated.
•Current participation in another research drug treatment protocol (patient cannot start another experimental agent until after 90 days).
•Informed consent is not or can not be obtained.

Imaging Exclusion Criteria:
•Lesion consistent with hemorrhage of any degree.
•Significant cerebellar mass effect or acute hydrocephalus
•Bilateral extended brainstem ischemia.

E.5 End points

E.5.1

Primary end point(s)

Favorable outcome at day 90 defined as a modified Rankin Score (mRS – functional scale) of 0-3.

E.5.1.1

Timepoint(s) of evaluation of this end point

Day 90

E.5.2

Secondary end point(s)

- Excellent outcome at day 90 defined as a modified Rankin Score (mRS – functional scale) of 0-2.
- Modified Rankin Score - not dichotomized.
- Institutes of Health Stroke Scale (NIHSS – acute assessment scale) at time of IVT, at time randomization, at 24 hours post treatment.
- EuroQol (quality of life) at day 90 and at 12 months

Radiologic outcomes:
-Recanalization at 24 hours, ± 6 hours, by CT angiography. -Volume of cerebral infarction on NCCT + CTA-SI

Safety outcomes:
-Symptomatic intracranial hemorrhage at 24 hours CT imaging, ± 6 hours.
-Mortality at 90 days.

E.5.2.1

Timepoint(s) of evaluation of this end point

90 days
-time of IVT, randomization, 24 hours post treatment
-day 90 and at 12 months

radiologic:
-24 hours, ± 6 hours

safety:
-24 hours, ± 6 hours
90 days

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Brazil

Czech Republic

Germany

Italy

Netherlands

Norway

Switzerland

United Kingdom

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

375

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

375

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2010-11-16.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

Yes

F.3.3.5

Emergency situation

Yes

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

In case of a comatose subject informed consent can be obtained from the patient’s proxy by telephone as long as the identity of the proxy can be confirmed.

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

100

F.4.2

For a multinational trial

F.4.2.1

In the EEA

600

F.4.2.2

In the whole clinical trial

750

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

expected normal treatment of that condition.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2010-12-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-01-20

P. End of Trial
P.	End of Trial Status	Ongoing

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