Clinical Trials Register

Summary
EudraCT Number:	2010-023043-15
Sponsor's Protocol Code Number:	MRZ60201/SP/3001
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-06-07
Trial results	View 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

Germany - BfArM

A.2

EudraCT number

2010-023043-15

A.3

Full title of the trial

Prospective, double-blind, placebo-controlled, randomized, multi-center study with an open-label extension period to investigate the efficacy and safety of NT 201 in the treatment of post-stroke spasticity of the upper limb

A.3.1

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

Efficacy and safety study of Botulinum toxin type A against placebo to treat spasticity in the arm after a stroke

A.3.2

Name or abbreviated title of the trial where available

PURE

A.4.1

Sponsor's protocol code number

MRZ60201/SP/3001

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	Merz Pharmaceuticals GmbH
B.1.3.4	Country	Germany
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Merz Pharmaceuticals GmbH
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Merz Pharmaceuticals GmbH
B.5.2	Functional name of contact point
B.5.6	E-mail	clinicaltrials@merz.de

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	Xeomin
D.2.1.1.2	Name of the Marketing Authorisation holder	Merz Pharmaceuticals GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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.3.1	Product name	NT 201
D.3.2	Product code	NT 201
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	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	93384-43-1
D.3.9.2	Current sponsor code	NT 101
D.3.9.3	Other descriptive name	Botulinum neurotoxin type A
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
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.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Powder for solution for injection
D.8.4	Route of administration of the placebo	Intramuscular use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

post-stroke spasticity of the upper limb

E.1.1.1

Medical condition in easily understood language

increased muscle tension / uncontrollable muscle stiffness in the arm after a stroke

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	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10058977
E.1.2	Term	Spastic paresis
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 investigate the efficacy and safety of NT 201 compared to placebo in the first double-blind cycle, and in 3 subsequent open-label treatment cycles with a total exposure duration of 48 weeks in Botulinum toxin [BTX] treatment-naïve subjects with post-stroke spasticity in the upper limb. A fixed total dose of 400 units [U] NT 201 per cycle will be injected at a fixed interval of 12 weeks between injections.

E.2.2

Secondary objectives of the trial

there are no secondary objectives

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Age from 18-80 yrs
Upper limb spasticity
Time since stroke greater than 3 months
Need for 400 U Botulinum toxin type A

E.4

Principal exclusion criteria

Body weight below 50kg
Fixed contractures of the upper limb
Generalized disorders of muscle activity like Myasthenia gravis that preclude use of Botulinum toxin type A
Infection at the injection site

E.5 End points

E.5.1

Primary end point(s)

Change from baseline in Ashworth Scale Score of primary target clinical pattern. Primary target clinical pattern will be defined by the investigator for each subject individually at baseline visit (week 0) and will be one of the following: flexed wrist, clenched fist or flexed elbow.
Co-Primary end point: Investigator’s Global Impression of Change

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 4

E.5.2

Secondary end point(s)

• Response rates for the primary target clinical pattern at all post-baseline visits for subjects with an improvement (=reduction) of at least 1 point from baseline measured by the Ashworth Scale.
• Response rates in each treated muscle group (elbow, wrist, and finger flexors as well as thumb muscles and forearm pronators) at all post-baseline visits for subjects with an improvement (=reduction) of at least 1 point from baseline measured by the Ashworth Scale.
• Changes from baseline to all post-baseline visits in Ashworth Scale Score for each treated muscle group
• Changes from baseline to all post-baseline visits in Disability Assessment Scale (primary therapeutic target and additionally all 4 items regardless of chosen primary therapeutic target)

E.5.2.1

Timepoint(s) of evaluation of this end point

Week 4, 8, 12

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

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

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)

E.8.2.2

Placebo

Yes

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

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

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

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

India

Russian Federation

United States

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

end of trial is defined as the last visit of the last subject undergoing the trial

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