Back to resultsStudy to Compare the Efficacy and Safety of NT 201 (Botulinum Toxin) With Placebo for the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury (PATTERN)
Primary Purpose
Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
NT 201
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury
Eligibility Criteria
Inclusion Criteria:
- Female or male subject ≥ 18 years and ≤ 85 years at screening
- Diagnosis of lower limb spasticity with or without upper limb spasticity of the same body side caused by stroke or traumatic brain injury
- Disabling ankle flexor spasticity presenting as pes equinus or pes equinovarus
- Modified Ashworth Scale-Bohannon [MAS] score of 2 or 3 points in the ankle plantar flexor of the target lower limb (supine position, knee extended)
- Minimum passive range of motion in ankle of the target lower limb (supine position, knee extended): 10°dorsiflexion and 20°plantarflexion
- At least 4 months since last botulinum neurotoxin [BoNT] injection for treatment of spasticity or any other condition
- For subjects receiving anticoagulation therapy, the investigator confirms and documents that the subject has an:
- Activated partial thromboplastin time [aPTT] ≤ 80 seconds (subjects on dabigatran or other direct thrombin inhibitors) or
- International normalized ratio [INR] value of ≤ 2.5 (subjects on coumarins or other anticoagulants monitored by INR)
Exclusion Criteria:
- Generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert Eaton syndrome, amyotrophic lateral sclerosis) or any other significant peripheral neuromuscular dysfunction which might interfere with the study
- Bilateral lower limb paresis/paralysis/spasticity or tetraparesis/paralysis/spasticity
- Body weight < 50 kg
- Severe atrophy of the target limb muscles
- Previous, ongoing or planned treatments of spasticity with intrathecal baclofen
- Previous, ongoing, or planned treatments of spasticity in the target lower limb with any of the following procedures: Surgical Intervention; Alcohol or phenol block; Muscle afferent block
- Physiotherapy or use of orthoses or splints at the target limb initiated less than 4 weeks before screening or expected to change during the double blind phase of the study
- Current or planned treatment with parenterally administered drugs that interfere with neuromuscular transmission (e.g. intrathecal baclofen, tubocurarine type muscle relaxants used in anesthesia), or local anesthetics in the treated region within 2 weeks prior to screening
- Infection or inflammation at the injection sites
- Subjects with presence or history of aspiration pneumonia, recurrent lower respiratory tract infections, or compromised respiratory function as per investigator's clinical judgment
- Pregnancy (as verified by a positive pregnancy test) or breast feeding
Sites / Locations
- New England institute for clinical research; Merz Investigational Site #0010441Recruiting
- Howard A. Rusk Rehabilitation Center; Merz investigational site #0010283Recruiting
- Rehabilitation Hospital, Kessler Institute for Rehabilitation, Merz Investigational Site #0010199Recruiting
- Icahn School of Medicine at Mount Sinai, Neurology Department, Merz Investigational Site #0010191
- Weill Cornell Medical Center, Department of Rehabilitation Medicine; Merz Investigational Site #0010440Recruiting
- University of Pittsburgh Medical Center, Physical Medicine & Rehabiliation, Merz Investigational Site #0010211Recruiting
- UT Southwestern Medical Center, Department of Physical Medicine & Rehabilitation, Merz investigational site #0010082Recruiting
- University of Texas Health Science Center McGovern, Medical School Department of PM&R; merz investigational site #0010183Recruiting
- Medical College of Wisconsin,Department of PM&R, Merz Investigational Site #0010237Recruiting
- St George Hospital, Department of Rehabilitation Medicine, Merz Investigational Site #0610004
- Royal Melbourne Hospital, Department of Rehabilitation Medicine; Merz Investigational Site #0610002
- CHU Brugmann Neurology; Merz investigational site #0320015Recruiting
- UCL Bruxelles, Physical Medicine & Rehabilitation Department, Merz Investigational Site #0320013Recruiting
- UZ Leuven Pellenberg campus; Merz investigational site #0320014Recruiting
- UCL Mont Godinne, Physical Medicine & Rehabilitation Department; Merz Investigational Site #0320008Recruiting
- Neurology and Physiotherapy Skopalikova, Merz Investigational Site #4200049Recruiting
- University Hospital Ostrava; Neurology Departement, Merz investigational site #4200024Recruiting
- Pardubice Regional Hospital; Merz investigational site #4200025Recruiting
- Fakultni nemocnice Kralovske Vinohrady, Neurology Department, Merz Investigational Site #4200050Recruiting
- Raymond Poincaré University Hospital, Service de MPR Pôle Handicap-Rééducation, Merz Investigational site #00330018Recruiting
- Institut Universitaire de Readaptation Clemenceau, Physical Medicine / Rehabilitation Medecine, Merz Investigational site # 0330063Recruiting
- Rangueil Hospital-University Hospital Center (CHU) of Toulouse, Médecine physique et de réadaptation, Merz investigational site #0330025Recruiting
- Uniklinik RWTH Aachen, Neurologie, Merz Investigational Site #0490191Recruiting
- Neurologie Bewegt; Merz Investigational site #0490378
- Heinrich Heine University Duesseldorf, Department of Neurology; Merz Investigational Site #0490071Recruiting
- Universitätsklinikum Hamburg-Eppendorf, Merz Investigational site #0490079Recruiting
- CBBM, Institut für Neurogenetik, Haus 66; Merz Investigational Site #0490332
- DKD HELIOS Medical Center, Fachbereich Neurologie, Merz Investigational Site #0490081Recruiting
- Neurologische Klinik und Poliklinik des Universitätsklinikums Würzburg, Merz Investigational Site #0490302Recruiting
- St.Damjan Hospital, Kisvarda; Merz investigational site #0360019Recruiting
- University of Szeged, Department of Neurology, Merz investigational site #0360008Recruiting
- Ospedale Valduce, Villa Beretta Rehabilitation Center, Merz investigational site #0390005Recruiting
- Azienda Ospedaliera Universitaria Ospedali Riuniti Di Foggia; Merz Investigational Site #0390018Recruiting
- IRCCS Ospedale Policlinico S. Martino, U.O.Complessa Riabilitazione e Rieducazione Funzionale; Merz investigational site #0390020Recruiting
- Ospedale Maggiore della Carita, Dipartimento di Medicina fisica e Riabilitativa, Merz Investigational Site #0390017Recruiting
- Ospedale Alfredo Fiorini, UOSD Neurologia Universitaria; Merz Investigational site #0390022Recruiting
- AOUI -Ospedale Borgo Roma, U.O.C Neuroriabilitazione, Merz Investigational Site #0390014Recruiting
- Haukeland University Hospital, Dept of Neurology; Merz investigational site #0470001
- Sunnaas Rehabilitation Hospital, Merz Investigational Site #0470002
- Specjalistyczna Praktyka Lekarska Dr. n. med Stanisław Ochudło, Merz Investigational Site #0480077Recruiting
- Specjalistyczne Gabinety Sp z o.o., Merz Investigational Site #0480059Recruiting
- NeuroKlinika Gabinet Lekarski Prof Andrzej Bogucki, Merz Investigational Site #0480101Recruiting
- Indywidualna Praktyka Lekarska dr. hab. Med. Anna Szczepanska-Szerej, Merz Investigational Site #0480096Recruiting
- Filia 7 Centrum Kompleksowej Rehabilitacji Sp. z o.o., Merz Investigational Site #0480100Recruiting
- Projekt Samodzielni Sp z o.o., Merz Investigational Site #0480099Recruiting
- Instytut Psychiatrii i Neurologii, II Klinika Neurologiczna, Merz Investigational Site #0480023Recruiting
- Mazowiecki Szpital Brodnowski, Merz investigational site #0480064Recruiting
- Neuryt Diagnostyka I Terapia Neurologiczna, Merz investigational site #0480106Recruiting
- Federal State Budgetary Educational Institution of Higher Education "Krasnoyarsk State Medical University n.a. Professor V.F. Voino-Yasenetskiy of Ministry Healthcare of Russian Federation", Merz Investigational Site #0070306
- State Autonomous Institution of Healthcare of Moscow City "Moscow Scientific and Practical Centre of Medical Rehabilitation, Regenerative and Sports Medicine of Moscow City Healthcare Department", Merz Investigational Site #0070011
- Federal State Autonomous Institution "National Medical Research Centre "Treatment and Rehabilitation" of the Ministry of Health of the Russian Federation, Neurology department, Merz Investigational Site # 0070305
- Federal State Budgetary Institution "National Medical Research Centre of Psychiatry and Neurology n.a. V.M. Bekhterev" of the Ministry of Healthcare of the Russian Federation, Merz Investigational Site #0070009
- University Hospital Bratislav, 2nd Dept. of Neurology, Merz Investigational Site # 4210005Recruiting
- Neurologicka klinika, Fakultna nemocnica Trnava; Merz investigational site #4210009Recruiting
- Hospital Universitario La Paz, Merz Investigational Site #0340007Recruiting
- Hospital Universitari Mútua de Terrassa, Merz Investigational Site #0340003Recruiting
- University Hospital of Bern, Center of Parkinson's diseases and Movement disorders (ZfPB), Merz investigational site #0410015Recruiting
- Centre Hospitalier Universitaire Vaudois - Neurorehabilitation and Physical Medicine, Merz Investigational Site #0410013Recruiting
- HFR Fribourg - Hôpital Cantonal, Department of Rehabilitation, Merz Investigational site #0410014Recruiting
- Merz Investigational Site #3800019Recruiting
- Rivne City Hospital 2, Department of Clinical Neurology and Neurorehabilitation; Merz investigational site #3800016Recruiting
- NPE "Regional Clinical Centre of Neurosurgery and Neurology" Transcarpathian Regional Council; Merz investigational site #3800014Recruiting
- Cambridge University Hospitals NHS Foundation Trust; Merz Investigational Site 0440023Recruiting
- Royal Devon and Exeter Foundation Trust Hospital, Department of Neurology, Merz Investigational Site #0440047Recruiting
- The Walton Centre NHS Foundation Trust; Neuroscience Research Centre; Merz Investigational site #0440004Recruiting
- National Hospital for Neurology and Neurosurgery - UCLH; Merz Investigational Site #0440033
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
NT 201 (IncobotulinumtoxinA, Xeomin)
Placebo
Arm Description
Main Period (1 treatment cycle): subjects to receive intramuscular injection of NT 201 (400 units) into muscles of the lower limb. Open Label Extension Period (4-5 treatment cycles): subjects to receive intramuscular injection of NT 201 (up to 800 units) into muscles of the lower limb and upper limb, if indicated.
Main Period (1 treatment cycle): subjects to receive intramuscular placebo injection into muscles of the lower limb. Open Label Extension Period (4-5 treatment cycles): subjects to receive intramuscular injection of NT 201 (up to 800 units) into muscles of the lower limb and upper limb, if indicated.
Outcomes
Primary Outcome Measures
Change from baseline in derived Modified Ashworth Scale-Bohannon (MAS) ankle score (knee extended) at weeks 4 to 6
The MAS is a 6-grade scale
Co-Primary: Global Impression of Change Scale (GICS) assessed by physician at Week 4 to 6
The GICS s a 9-grade scale
Occurrence of treatment emergent adverse events [TEAEs] in the Main Period
Secondary Outcome Measures
Change from Study Baseline in Goal Attainment Scale [GAS] at Week 6
The GAS is a 6-grade scale
Global Impression of Change Scale (GICS) assessed by the study subject at Week 4 to 6
The GICS s a 9-grade scale
Global Impression of Change Scale (GICS) assessed by the caregiver at Week 4 to 6
The GICS s a 9-grade scale
Full Information
NCT ID
NCT03992404
First Posted
June 18, 2019
Last Updated
October 18, 2023
Sponsor
Merz Pharmaceuticals GmbH
1. Study Identification
Unique Protocol Identification Number
NCT03992404
Brief Title
Study to Compare the Efficacy and Safety of NT 201 (Botulinum Toxin) With Placebo for the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury
Acronym
PATTERN
Official Title
Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of NT 201 in the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury in Adult Subjects, Followed by an Open Label Extension With or Without Combined Upper Limb Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 16, 2019 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
April 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merz Pharmaceuticals GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether a single treatment with administration of 400 Units NT 201 (botulinum toxin) is superior to placebo (no medicine) for the treatment of lower limb spasticity caused by stroke or traumatic brain injury (Main Period). Participants will be assigned to the treatment groups by chance and neither the participants nor the research staff who interact with them will know the allocation.
The following 4 to 5 treatment cycles will investigate the safety and tolerability of treatment with NT 201 (botulinum toxin) when administered in doses between 400 and 800 Units (Open Label Extension Period). All participants will receive the treatment and the dose will depend on whether only lower limb spasticity or combined upper and lower limb spasticity are treated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NT 201 (IncobotulinumtoxinA, Xeomin)
Arm Type
Experimental
Arm Description
Main Period (1 treatment cycle): subjects to receive intramuscular injection of NT 201 (400 units) into muscles of the lower limb.
Open Label Extension Period (4-5 treatment cycles): subjects to receive intramuscular injection of NT 201 (up to 800 units) into muscles of the lower limb and upper limb, if indicated.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Main Period (1 treatment cycle): subjects to receive intramuscular placebo injection into muscles of the lower limb.
Open Label Extension Period (4-5 treatment cycles): subjects to receive intramuscular injection of NT 201 (up to 800 units) into muscles of the lower limb and upper limb, if indicated.
Intervention Type
Drug
Intervention Name(s)
NT 201
Other Intervention Name(s)
IncobotulinumtoxinA, Incobotulinumtoxin A, Xeomin, Botulinum toxin type A (150 kiloDalton), free from complexing proteins
Intervention Description
Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
Primary Outcome Measure Information:
Title
Change from baseline in derived Modified Ashworth Scale-Bohannon (MAS) ankle score (knee extended) at weeks 4 to 6
Description
The MAS is a 6-grade scale
Time Frame
Baseline to week 4-6
Title
Co-Primary: Global Impression of Change Scale (GICS) assessed by physician at Week 4 to 6
Description
The GICS s a 9-grade scale
Time Frame
Week 4-6
Title
Occurrence of treatment emergent adverse events [TEAEs] in the Main Period
Time Frame
Baseline to week 12
Secondary Outcome Measure Information:
Title
Change from Study Baseline in Goal Attainment Scale [GAS] at Week 6
Description
The GAS is a 6-grade scale
Time Frame
Baseline to week 6
Title
Global Impression of Change Scale (GICS) assessed by the study subject at Week 4 to 6
Description
The GICS s a 9-grade scale
Time Frame
Week 4-6
Title
Global Impression of Change Scale (GICS) assessed by the caregiver at Week 4 to 6
Description
The GICS s a 9-grade scale
Time Frame
Week 4-6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female or male subject ≥ 18 years and ≤ 85 years at screening
Diagnosis of lower limb spasticity with or without upper limb spasticity of the same body side caused by stroke or traumatic brain injury
Disabling ankle flexor spasticity presenting as pes equinus or pes equinovarus
Modified Ashworth Scale-Bohannon [MAS] score of 2 or 3 points in the ankle plantar flexor of the target lower limb (supine position, knee extended)
Minimum passive range of motion in ankle of the target lower limb (supine position, knee extended): 10°dorsiflexion and 20°plantarflexion
At least 4 months since last botulinum neurotoxin [BoNT] injection for treatment of spasticity or any other condition
For subjects receiving anticoagulation therapy, the investigator confirms and documents that the subject has an:
Activated partial thromboplastin time [aPTT] ≤ 80 seconds (subjects on dabigatran or other direct thrombin inhibitors) or
International normalized ratio [INR] value of ≤ 2.5 (subjects on coumarins or other anticoagulants monitored by INR)
Exclusion Criteria:
Generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert Eaton syndrome, amyotrophic lateral sclerosis) or any other significant peripheral neuromuscular dysfunction which might interfere with the study
Bilateral lower limb paresis/paralysis/spasticity or tetraparesis/paralysis/spasticity
Body weight < 50 kg
Severe atrophy of the target limb muscles
Previous, ongoing or planned treatments of spasticity with intrathecal baclofen
Previous, ongoing, or planned treatments of spasticity in the target lower limb with any of the following procedures: Surgical Intervention; Alcohol or phenol block; Muscle afferent block
Physiotherapy or use of orthoses or splints at the target limb initiated less than 4 weeks before screening or expected to change during the double blind phase of the study
Current or planned treatment with parenterally administered drugs that interfere with neuromuscular transmission (e.g. intrathecal baclofen, tubocurarine type muscle relaxants used in anesthesia), or local anesthetics in the treated region within 2 weeks prior to screening
Infection or inflammation at the injection sites
Subjects with presence or history of aspiration pneumonia, recurrent lower respiratory tract infections, or compromised respiratory function as per investigator's clinical judgment
Pregnancy (as verified by a positive pregnancy test) or breast feeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Public Disclosure Manager
Phone
+49 69 1503 0
Email
clinicaltrials@merz.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merz Medical Expert
Organizational Affiliation
Merz Pharmaceuticals GmbH
Official's Role
Study Director
Facility Information:
Facility Name
New England institute for clinical research; Merz Investigational Site #0010441
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Individual Site Status
Recruiting
Facility Name
Howard A. Rusk Rehabilitation Center; Merz investigational site #0010283
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Individual Site Status
Recruiting
Facility Name
Rehabilitation Hospital, Kessler Institute for Rehabilitation, Merz Investigational Site #0010199
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
Individual Site Status
Recruiting
Facility Name
Icahn School of Medicine at Mount Sinai, Neurology Department, Merz Investigational Site #0010191
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Weill Cornell Medical Center, Department of Rehabilitation Medicine; Merz Investigational Site #0010440
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pittsburgh Medical Center, Physical Medicine & Rehabiliation, Merz Investigational Site #0010211
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Name
UT Southwestern Medical Center, Department of Physical Medicine & Rehabilitation, Merz investigational site #0010082
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9055
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Texas Health Science Center McGovern, Medical School Department of PM&R; merz investigational site #0010183
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical College of Wisconsin,Department of PM&R, Merz Investigational Site #0010237
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Name
St George Hospital, Department of Rehabilitation Medicine, Merz Investigational Site #0610004
City
Kogarah
ZIP/Postal Code
2217
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Royal Melbourne Hospital, Department of Rehabilitation Medicine; Merz Investigational Site #0610002
City
Parkville
ZIP/Postal Code
3052
Country
Australia
Individual Site Status
Withdrawn
Facility Name
CHU Brugmann Neurology; Merz investigational site #0320015
City
Brussel
ZIP/Postal Code
1020
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UCL Bruxelles, Physical Medicine & Rehabilitation Department, Merz Investigational Site #0320013
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UZ Leuven Pellenberg campus; Merz investigational site #0320014
City
Pellenberg
ZIP/Postal Code
3212
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UCL Mont Godinne, Physical Medicine & Rehabilitation Department; Merz Investigational Site #0320008
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Neurology and Physiotherapy Skopalikova, Merz Investigational Site #4200049
City
Brno
ZIP/Postal Code
61500
Country
Czechia
Individual Site Status
Recruiting
Facility Name
University Hospital Ostrava; Neurology Departement, Merz investigational site #4200024
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Pardubice Regional Hospital; Merz investigational site #4200025
City
Pardubice
ZIP/Postal Code
530 03
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Kralovske Vinohrady, Neurology Department, Merz Investigational Site #4200050
City
Prague
ZIP/Postal Code
10034
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Raymond Poincaré University Hospital, Service de MPR Pôle Handicap-Rééducation, Merz Investigational site #00330018
City
Garches
ZIP/Postal Code
92380
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Universitaire de Readaptation Clemenceau, Physical Medicine / Rehabilitation Medecine, Merz Investigational site # 0330063
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Individual Site Status
Recruiting
Facility Name
Rangueil Hospital-University Hospital Center (CHU) of Toulouse, Médecine physique et de réadaptation, Merz investigational site #0330025
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
Uniklinik RWTH Aachen, Neurologie, Merz Investigational Site #0490191
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Individual Site Status
Recruiting
Facility Name
Neurologie Bewegt; Merz Investigational site #0490378
City
Berlin
ZIP/Postal Code
10627
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Heinrich Heine University Duesseldorf, Department of Neurology; Merz Investigational Site #0490071
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Hamburg-Eppendorf, Merz Investigational site #0490079
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Name
CBBM, Institut für Neurogenetik, Haus 66; Merz Investigational Site #0490332
City
Lübeck
ZIP/Postal Code
23562
Country
Germany
Individual Site Status
Withdrawn
Facility Name
DKD HELIOS Medical Center, Fachbereich Neurologie, Merz Investigational Site #0490081
City
Wiesbaden
ZIP/Postal Code
65191
Country
Germany
Individual Site Status
Recruiting
Facility Name
Neurologische Klinik und Poliklinik des Universitätsklinikums Würzburg, Merz Investigational Site #0490302
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Recruiting
Facility Name
St.Damjan Hospital, Kisvarda; Merz investigational site #0360019
City
Kisvárda
ZIP/Postal Code
4600
Country
Hungary
Individual Site Status
Recruiting
Facility Name
University of Szeged, Department of Neurology, Merz investigational site #0360008
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Ospedale Valduce, Villa Beretta Rehabilitation Center, Merz investigational site #0390005
City
Costa Masnaga
ZIP/Postal Code
23845
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria Ospedali Riuniti Di Foggia; Merz Investigational Site #0390018
City
Foggia
ZIP/Postal Code
71122
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Ospedale Policlinico S. Martino, U.O.Complessa Riabilitazione e Rieducazione Funzionale; Merz investigational site #0390020
City
Genova
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale Maggiore della Carita, Dipartimento di Medicina fisica e Riabilitativa, Merz Investigational Site #0390017
City
Novara
ZIP/Postal Code
28100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale Alfredo Fiorini, UOSD Neurologia Universitaria; Merz Investigational site #0390022
City
Terracina
ZIP/Postal Code
04019
Country
Italy
Individual Site Status
Recruiting
Facility Name
AOUI -Ospedale Borgo Roma, U.O.C Neuroriabilitazione, Merz Investigational Site #0390014
City
Verona
ZIP/Postal Code
37134
Country
Italy
Individual Site Status
Recruiting
Facility Name
Haukeland University Hospital, Dept of Neurology; Merz investigational site #0470001
City
Bergen
ZIP/Postal Code
5053
Country
Norway
Individual Site Status
Withdrawn
Facility Name
Sunnaas Rehabilitation Hospital, Merz Investigational Site #0470002
City
Bjornemyr
ZIP/Postal Code
1453
Country
Norway
Individual Site Status
Withdrawn
Facility Name
Specjalistyczna Praktyka Lekarska Dr. n. med Stanisław Ochudło, Merz Investigational Site #0480077
City
Katowice
ZIP/Postal Code
40-097
Country
Poland
Individual Site Status
Recruiting
Facility Name
Specjalistyczne Gabinety Sp z o.o., Merz Investigational Site #0480059
City
Krakow
ZIP/Postal Code
30-539
Country
Poland
Individual Site Status
Recruiting
Facility Name
NeuroKlinika Gabinet Lekarski Prof Andrzej Bogucki, Merz Investigational Site #0480101
City
Lodz
ZIP/Postal Code
90-640
Country
Poland
Individual Site Status
Recruiting
Facility Name
Indywidualna Praktyka Lekarska dr. hab. Med. Anna Szczepanska-Szerej, Merz Investigational Site #0480096
City
Lublin
ZIP/Postal Code
20-582
Country
Poland
Individual Site Status
Recruiting
Facility Name
Filia 7 Centrum Kompleksowej Rehabilitacji Sp. z o.o., Merz Investigational Site #0480100
City
Warsaw
ZIP/Postal Code
01-518
Country
Poland
Individual Site Status
Recruiting
Facility Name
Projekt Samodzielni Sp z o.o., Merz Investigational Site #0480099
City
Warsaw
ZIP/Postal Code
02-042
Country
Poland
Individual Site Status
Recruiting
Facility Name
Instytut Psychiatrii i Neurologii, II Klinika Neurologiczna, Merz Investigational Site #0480023
City
Warsaw
ZIP/Postal Code
02-957
Country
Poland
Individual Site Status
Recruiting
Facility Name
Mazowiecki Szpital Brodnowski, Merz investigational site #0480064
City
Warsaw
ZIP/Postal Code
03-242
Country
Poland
Individual Site Status
Recruiting
Facility Name
Neuryt Diagnostyka I Terapia Neurologiczna, Merz investigational site #0480106
City
Wroclaw
ZIP/Postal Code
50-305
Country
Poland
Individual Site Status
Recruiting
Facility Name
Federal State Budgetary Educational Institution of Higher Education "Krasnoyarsk State Medical University n.a. Professor V.F. Voino-Yasenetskiy of Ministry Healthcare of Russian Federation", Merz Investigational Site #0070306
City
Krasnoyarsk
ZIP/Postal Code
660049
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
State Autonomous Institution of Healthcare of Moscow City "Moscow Scientific and Practical Centre of Medical Rehabilitation, Regenerative and Sports Medicine of Moscow City Healthcare Department", Merz Investigational Site #0070011
City
Moscow
ZIP/Postal Code
105005
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Federal State Autonomous Institution "National Medical Research Centre "Treatment and Rehabilitation" of the Ministry of Health of the Russian Federation, Neurology department, Merz Investigational Site # 0070305
City
Moscow
ZIP/Postal Code
125367
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Federal State Budgetary Institution "National Medical Research Centre of Psychiatry and Neurology n.a. V.M. Bekhterev" of the Ministry of Healthcare of the Russian Federation, Merz Investigational Site #0070009
City
Saint Petersburg
ZIP/Postal Code
195119
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
University Hospital Bratislav, 2nd Dept. of Neurology, Merz Investigational Site # 4210005
City
Bratislava
ZIP/Postal Code
83305
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Neurologicka klinika, Fakultna nemocnica Trnava; Merz investigational site #4210009
City
Trnava
ZIP/Postal Code
917 01
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Paz, Merz Investigational Site #0340007
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Mútua de Terrassa, Merz Investigational Site #0340003
City
Terrassa
ZIP/Postal Code
08221
Country
Spain
Individual Site Status
Recruiting
Facility Name
University Hospital of Bern, Center of Parkinson's diseases and Movement disorders (ZfPB), Merz investigational site #0410015
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire Vaudois - Neurorehabilitation and Physical Medicine, Merz Investigational Site #0410013
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
HFR Fribourg - Hôpital Cantonal, Department of Rehabilitation, Merz Investigational site #0410014
City
Meyriez
ZIP/Postal Code
3280
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Merz Investigational Site #3800019
City
Kharkiv
ZIP/Postal Code
61000
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Rivne City Hospital 2, Department of Clinical Neurology and Neurorehabilitation; Merz investigational site #3800016
City
Rivne
ZIP/Postal Code
33001
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
NPE "Regional Clinical Centre of Neurosurgery and Neurology" Transcarpathian Regional Council; Merz investigational site #3800014
City
Uzhgorod
ZIP/Postal Code
88018
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Cambridge University Hospitals NHS Foundation Trust; Merz Investigational Site 0440023
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Royal Devon and Exeter Foundation Trust Hospital, Department of Neurology, Merz Investigational Site #0440047
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Walton Centre NHS Foundation Trust; Neuroscience Research Centre; Merz Investigational site #0440004
City
Liverpool
ZIP/Postal Code
L9 7LJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
National Hospital for Neurology and Neurosurgery - UCLH; Merz Investigational Site #0440033
City
London
ZIP/Postal Code
WC1N 3BG
Country
United Kingdom
Individual Site Status
Withdrawn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Compare the Efficacy and Safety of NT 201 (Botulinum Toxin) With Placebo for the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury
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