Clinical Trial Page

Summary
EudraCT Number:2006-000073-29
Sponsor's Protocol Code Number:MRZ 60201-0528/1
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:2006-04-25
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
A. Protocol Information
A.1Member State ConcernedGermany - BfArM
A.2EudraCT number2006-000073-29
A.3Full title of the trial
Prospective, randomised, double-blind, placebo-controlled multicentre pilot trial to investigate the impact of an early use of NT 201 in patients with an acute cerebrovascular event on the development of upper limb spasticity
A.3.2Name or abbreviated title of the trial where available
NT Early
A.4.1Sponsor's protocol code numberMRZ 60201-0528/1
A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorMerz Pharmaceuticals GmbH
B.1.3.4CountryGermany
B.3.1 and B.3.2Status of the sponsorCommercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing support
B.4.2Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisation
B.5.2Functional name of contact point
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name Xeomin
D.2.1.1.2Name of the Marketing Authorisation holderMerz Pharmaceuticals GmbH
D.2.1.2Country which granted the Marketing AuthorisationGermany
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameXeomin
D.3.2Product code NT 201
D.3.4Pharmaceutical form Powder for solution for injection
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPIntramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNBotulinum A Toxin
D.3.9.2Current sponsor codeNT 101
D.3.9.3Other descriptive nameClostridium Botulinum Neurotoxin type A (150 kD) free complexing proteins
D.3.10 Strength
D.3.10.1Concentration unit IU international unit(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number100
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin No
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product Yes
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.8 Information on Placebo
D.8 Placebo: 1
D.8.1Is a Placebo used in this Trial?Yes
D.8.3Pharmaceutical form of the placeboPowder for solution for injection
D.8.4Route of administration of the placeboIntramuscular use
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Patients with acute cerebrovascular event showing signs of beginning upper limb spasticity
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 9.0
E.1.2Level LLT
E.1.2Classification code 10041416
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
The primary objective of the study is to assess the efficacy of NT 201 versus placebo in the treatment of patients with beginning upper limb spasticity after acute cerebrovascular event in terms of change in MAS for wrist flexors from baseline to 48 weeks after baseline
E.2.2Secondary objectives of the trial
The secondary objectives of the study are to asses the efficacy of NT 201 versus placebo in terms of:
- Change in MAS for wrist flexors fro baseline over time
- Change in MAS for elbow flexors ( if treated) from baseline over time
- Change in ADL score from baseline over time
- Change in DAS from baseline over time
- Change in PROM for wrist from baseline over time
- Change in pain intensity in the upper limb from baseline over time as assessed on the VAS
- Physicians and patients global assessment of efficacy of treatment at week 48

As part of the safety evaluation during the study the incidence of adverse events, routine haematology and clinical chemistry values, ECG and the formation of neutralising botulinum toxin antibodies will be investigated.
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
- Female or male patients aged ≥18 years
- Acute cerebrovascular event (e.g. any kind of stroke or cerebral haemorrhage)
- Necessity for rehabilitation measure
- Newly developed focal spasticity in upper limb
- Spasticity with ≥ 1 point on the MAS in the wrist flexors or spasticity with
≥1 point on the MAS in the wrist flexors and elbow flexors
- Start of injection of trial medication within 3 to 30 days after the event
- Written informed consent obtained by patient or a witness in case the patient
is unable to write
- Negative urine pregnancy test at trial entry for women of childbearing potential
E.4Principal exclusion criteria
- Current or previous treatment with botulinum toxin of any serotype and for any body region
- Severe aphasia resulting in inability of the patient to follow the consent procedure
- Severe atrophy of the target limb muscles
- Any rheumatic or orthopaedic disease of the affected limb
- Planned surgery of the target limb
- Surgical treatment in the target limb for any indication within 8 weeks prior to screening
- Hypersensitivity to human serum albumin, sucrose or botulinum neurotoxin type A
- Anticoagulation therapy which requires an INR >2.5
- Treatment with intravenously administered heparin within 24 hours prior to first injection of trial medication
- Infection in the area of the planned injection points or systemic infections presenting a hazard for local injections
- Diagnosis of myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis or any other significant neuromuscular disease which might interfere with the study
- Use of non-authorised concomitant medication
- Severe and/or unstable hypertension
- Severe or uncontrolled systemic disease (e.g. cardiac, renal, pulmonary, hepatic or gastrointestinal), current malignancy or anamnestic HIV infection
- Clinically relevant pathological findings in laboratory parameters, indicating active disease of vital organs
- Nursing mothers and women of childbearing potential without reliable means of contraception (hormonal contraception or barrier contraception combined with intrauterine contraception device) and women planning pregnancy during the course of the trial
- Participation in a clinical study within the last 1 month prior to screening
- Previous randomisation in this clinical study
- In the opinion of the investigator the patient is unlikely to complete all visits
- Other contraindications which in the investigator’s opinion preclude participation in the study
E.5 End points
E.5.1Primary end point(s)
The primary efficacy endpoint is defined as the change in the MAS for wrist flexors from baseline to 48 weeks after baseline, compared between treatment groups.
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis Information not present in EudraCT
E.6.2Prophylaxis Information not present in EudraCT
E.6.3Therapy Information not present in EudraCT
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic Information not present in EudraCT
E.6.7Pharmacodynamic Information not present in EudraCT
E.6.8Bioequivalence Information not present in EudraCT
E.6.9Dose response Information not present in EudraCT
E.6.10Pharmacogenetic Information not present in EudraCT
E.6.11Pharmacogenomic Information not present in EudraCT
E.6.12Pharmacoeconomic Information not present in EudraCT
E.6.13Others Information not present in EudraCT
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) Information not present in EudraCT
E.7.1.1First administration to humans Information not present in EudraCT
E.7.1.2Bioequivalence study Information not present in EudraCT
E.7.1.3Other Information not present in EudraCT
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) Yes
E.7.3Therapeutic confirmatory (Phase III) No
E.7.4Therapeutic use (Phase IV) No
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised Yes
E.8.1.2Open Information not present in EudraCT
E.8.1.3Single blind Information not present in EudraCT
E.8.1.4Double blind Yes
E.8.1.5Parallel group Yes
E.8.1.6Cross over No
E.8.1.7Other No
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) No
E.8.2.2Placebo Yes
E.8.2.3Other No
E.8.3 The trial involves single site in the Member State concerned No
E.8.4 The trial involves multiple sites in the Member State concerned Yes
E.8.4.1Number of sites anticipated in Member State concerned2
E.8.5The trial involves multiple Member States No
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA No
E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
E.8.7Trial has a data monitoring committee No
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
The last visit of the last patient will be defined as end of the trial.
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years2
E.8.9.1In the Member State concerned months6
E.8.9.1In the Member State concerned days
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero Information not present in EudraCT
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
F.1.1.3Newborns (0-27 days) Information not present in EudraCT
F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
F.1.1.5Children (2-11years) Information not present in EudraCT
F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
F.1.2Adults (18-64 years) Yes
F.1.3Elderly (>=65 years) Yes
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Information not present in EudraCT
F.3.3.1Women 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 2006-04-25. Yes
F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally No
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state11
F.4.2 For a multinational trial
F.4.2.1In the EEA 11
F.4.2.2In the whole clinical trial 11
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2006-07-10
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2006-06-30
P. End of Trial
P.End of Trial StatusCompleted
P.Date of the global end of the trial2008-07-02

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