Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain InjuryPhase 3PATTERNNCT03992404
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
A Phase 3 study testing NT 201 in people with Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury, run by Merz Pharmaceuticals GmbH at 71 sites in 15 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury
- What is being tested?
- NT 201
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 603 participants
- Where
- 71 sitesin 15 countries
- Study dates
- 16 Sep 2019to Apr 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- 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
Show all 9Show fewer
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
71 sites in 15 countries.
71 sites in 15 countries
United States15 sites
Physical Medicine and Rehabilitation at University of Alabama at Birmingham; Merz investigational site #0010479
Birmingham, Alabama, 35233
Nova Clinical Research, Merz investigational site #0010474
Brandenton, Florida, 34209
Howard A. Rusk Rehabilitation Center; Merz investigational site #0010283
Columbia, Missouri, 65203
UT Southwestern Medical Center, Department of Physical Medicine & Rehabilitation, Merz investigational site #0010082
Dallas, Texas, 75390-9055
Rancho Research Institute at Rancho Los Amigos National Rehabilitation Center; Merz investigational site #0010184
Downey, California, 90242
Neurology Center of New England P.C., Merz investigative site #0010476
Foxborough, Massachusetts, 02035
University of Texas Health Science Center McGovern, Medical School Department of PM&R; merz investigational site #0010183
Houston, Texas, 77030
Brooks Rehabilitation Clinical Integration and Research, Merz investigational site #0010483
Jacksonville, Florida, 72204
University of Arkansas for Medical Sciences, Merz investigational site #0010481
Little Rock, Arkansas, 72205
Medical College of Wisconsin,Department of PM&R, Merz Investigational Site #0010237
Milwaukee, Wisconsin, 53226
Icahn School of Medicine at Mount Sinai, Neurology Department, Merz Investigational Site #0010191
New York, New York, 10029
Weill Cornell Medical Center, Department of Rehabilitation Medicine; Merz Investigational Site #0010440
New York, New York, 10065
University of Pittsburgh Medical Center, Physical Medicine & Rehabiliation, Merz Investigational Site #0010211
Pittsburgh, Pennsylvania, 15213
Sarasota Memorial Health Care System, Rehabilitation Medicine, Merz investigational site #0010478
Sarasota, Florida, 34239
New England institute for clinical research; Merz Investigational Site #0010441
Stamford, Connecticut, 06905
Poland9 sites
Specjalistyczna Praktyka Lekarska Dr. n. med Stanisław Ochudło, Merz Investigational Site #0480077
Katowice, 40-097
Specjalistyczne Gabinety Sp z o.o., Merz Investigational Site #0480059
Krakow, 30-539
NeuroKlinika Gabinet Lekarski Prof Andrzej Bogucki, Merz Investigational Site #0480101
Lodz, 90-640
Indywidualna Praktyka Lekarska dr. hab. Med. Anna Szczepanska-Szerej, Merz Investigational Site #0480096
Lublin, 20-582
Filia 7 Centrum Kompleksowej Rehabilitacji Sp. z o.o., Merz Investigational Site #0480100
Warsaw, 01-518
Projekt Samodzielni Sp z o.o., Merz Investigational Site #0480099
Warsaw, 02-121
Instytut Psychiatrii i Neurologii, II Klinika Neurologiczna, Merz Investigational Site #0480023
Warsaw, 02-957
Mazowiecki Szpital Brodnowski, Merz investigational site #0480064
Warsaw, 03-242
Neuryt Diagnostyka I Terapia Neurologiczna, Merz investigational site #0480106
Wroclaw, 50-305
Germany7 sites
Uniklinik RWTH Aachen, Neurologie, Merz Investigational Site #0490191
Aachen, 52074
Neurologie Bewegt; Merz Investigational site #0490378
Berlin, 10627
University of Bonn Medical Center, Department of Neurodegenerative disease, Merz investigational site #0490390
Bonn, 53127
Heinrich Heine University Duesseldorf, Department of Neurology; Merz Investigational Site #0490071
Düsseldorf, 40225
Universitätsklinikum Hamburg-Eppendorf, Merz Investigational site #0490079
Hamburg, 20246
DKD HELIOS Medical Center, Fachbereich Neurologie, Merz Investigational Site #0490081
Wiesbaden, 65191
Neurologische Klinik und Poliklinik des Universitätsklinikums Würzburg, Merz Investigational Site #0490302
Würzburg, 97080
France5 sites
Raymond Poincaré University Hospital, Service de MPR Pôle Handicap-Rééducation, Merz Investigational site #00330018
Garches, 92380
CHU Lille/Hôpital Swynghedauw; investigational site # 0330045
Lille, 59000
Pôle Saint-Hélier; Merz investigational site #0330024
Rennes, 35000
Institut Universitaire de Readaptation Clemenceau, Physical Medicine / Rehabilitation Medecine, Merz Investigational site # 0330063
Strasbourg, 67000
Rangueil Hospital-University Hospital Center (CHU) of Toulouse, Médecine physique et de réadaptation, Merz investigational site #0330025
Toulouse, 31059
Ukraine5 sites
Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine, MC "Neuron", Merz Investigational Site #3800018
Kharkiv, 61000
Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine; Merz Investigational Site #3800019
Kharkiv, 61000
Lviv regional clinical hospital; Merz investigational site # 3800020
Lviv, 79010
Rivne City Hospital 2, Department of Clinical Neurology and Neurorehabilitation; Merz investigational site #3800016
Rivne, 33001
NPE "Regional Clinical Centre of Neurosurgery and Neurology" Transcarpathian Regional Council; Merz investigational site #3800014
Uzhhorod, 88018
Belgium4 sites
CHU Brugmann Neurology; Merz investigational site #0320015
Brussels, 1020
UCL Bruxelles, Physical Medicine & Rehabilitation Department, Merz Investigational Site #0320013
Brussels, 1200
UZ Leuven Pellenberg campus; Merz investigational site #0320014
Pellenberg, 3212
UCL Mont Godinne, Physical Medicine & Rehabilitation Department; Merz Investigational Site #0320008
Yvoir, 5530
Italy4 sites
Azienda Ospedaliera Universitaria Ospedali Riuniti Di Foggia; Merz Investigational Site #0390018
Foggia, 71122
IRCCS Ospedale Policlinico S. Martino, U.O.Complessa Riabilitazione e Rieducazione Funzionale; Merz investigational site #0390020
Genova, 16132
Ospedale Maggiore della Carita, Dipartimento di Medicina fisica e Riabilitativa, Merz Investigational Site #0390017
Novara, 28100
Ospedale Alfredo Fiorini, UOSD Neurologia Universitaria; Merz Investigational site #0390022
Terracina, 04019
Russia4 sites
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
Krasnoyarsk, 660049
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
Moscow, 105005
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
Moscow, 125367
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
Saint Petersburg, 195119
Czechia3 sites
Neurology and Physiotherapy Skopalikova, Merz Investigational Site #4200049
Brno, 61500
University Hospital Ostrava; Neurology Departement, Merz investigational site #4200024
Ostrava, 708 52
Pardubice Regional Hospital; Merz investigational site #4200025
Pardubice, 530 03
Hungary3 sites
Petz Hospital, Neurology, Merz Investigational Site #0360010
Győr, 9024
St.Damjan Hospital, Kisvarda; Merz investigational site #0360019
Kisvárda, 4600
University of Szeged, Department of Neurology, Merz investigational site #0360008
Szeged, 6725
Spain3 sites
Hospital Universitario Juan Ramón Jiménez, Merz Investigational Site #0340037
Huelva, 21005
Hospital Universitario La Paz, Merz Investigational Site #0340007
Madrid, 28046
Hospital Universitari Mútua de Terrassa, Merz Investigational Site #0340003
Terrassa, 08221
Switzerland3 sites
University Hospital of Bern, Center of Parkinson's diseases and Movement disorders (ZfPB), Merz investigational site #0410015
Bern, 3010
HFR Fribourg - Hôpital Cantonal, Department of Rehabilitation, Merz Investigational site #0410014
Meyriez, 3280
CRR, Mee Suva (Clinique romande de réadaptation), Merz investigational site #0410016
Sion, 1950
United Kingdom3 sites
Cambridge University Hospitals NHS Foundation Trust; Merz Investigational Site 0440023
Cambridge, CB2 0QQ
Royal Devon and Exeter Foundation Trust Hospital, Department of Neurology, Merz Investigational Site #0440047
Exeter, EX2 5DW
The Walton Centre NHS Foundation Trust; Neuroscience Research Centre; Merz Investigational site #0440004
Liverpool, L9 7LJ
Slovakia2 sites
University Hospital Bratislav, 2nd Dept. of Neurology, Merz Investigational Site # 4210005
Bratislava, 83305
Neurologicka klinika, Fakultna nemocnica Trnava; Merz investigational site #4210009
Trnava, 917 01
Canada1 site
Glenrose Rehabilitation Hospital, Merz investigational site #0010195
Edmonton, T5G 0B7
About this study
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
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.
- Conditions
- Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury
- Being tested
- NT 201, Placebo
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NT 201Drug
Also called IncobotulinumtoxinA, Incobotulinumtoxin A, Xeomin, Botulinum toxin type A (150 kiloDalton), free from complexing proteins
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).
PlaceboDrug
Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
| Study group | Role | What they receive |
|---|---|---|
| NT 201 (IncobotulinumtoxinA, Xeomin) | Experimental | 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. Receives: Drug: NT 201 |
| Placebo | Placebo comparator | 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. Receives: Drug: NT 201; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to week 4-6
Co-Primary: Global Impression of Change Scale (GICS) assessed by physician at Week 4 to 6
The GICS s a 9-grade scale
Measured: Week 4-6
Occurrence of treatment emergent adverse events [TEAEs] in the Main Period
Measured: Baseline to week 12
Secondary outcomes (3)
Change from Study Baseline in Goal Attainment Scale [GAS] at Week 6
The GAS is a 6-grade scale
Measured: Baseline to week 6
Global Impression of Change Scale (GICS) assessed by the study subject at Week 4 to 6
The GICS s a 9-grade scale
Measured: Week 4-6
Global Impression of Change Scale (GICS) assessed by the caregiver at Week 4 to 6
The GICS s a 9-grade scale
Measured: Week 4-6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start16 Sep 2019
- Primary completion19 Jun 2025
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 603 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Merz Medical Expert, Study director, Merz Pharmaceuticals GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03992404
- Sponsor's protocol ID
- M602011014
- Other IDs
- 2018-001639-35, 2018
- Acronym
- PATTERN
- Status last verified
- Oct 2026
- First submitted
- 18 Jun 2019
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03992404
- Acronym / sponsor ID
- PATTERN / M602011014
- Conditions
- Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 603 participants (actual)
- Lead sponsor
- Merz Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 19 Jun 2025 (actual)
- Study completion
- Apr 2027 (estimated)
- First posted
- 20 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NT 201 (IncobotulinumtoxinA, Xeomin) | Experimental | Drug: NT 201Main 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. |
| Placebo | Placebo comparator | Drug: NT 201, Drug: PlaceboMain 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NT 201Also: IncobotulinumtoxinA, Incobotulinumtoxin A, Xeomin, Botulinum toxin type A (150 kiloDalton), free from complexing proteinsActive ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). | Drug | NT 201 (IncobotulinumtoxinA, Xeomin), Placebo |
| PlaceboSolution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). | Drug | Placebo |
Primary outcome
Change from baseline in derived Modified Ashworth Scale-Bohannon (MAS) ankle score (knee extended) at weeks 4 to 6
Time frame: Baseline to week 4-6
The MAS is a 6-grade scale
Co-Primary: Global Impression of Change Scale (GICS) assessed by physician at Week 4 to 6
Time frame: Week 4-6
The GICS s a 9-grade scale
Occurrence of treatment emergent adverse events [TEAEs] in the Main Period
Time frame: Baseline to week 12
3 secondary outcomes
Change from Study Baseline in Goal Attainment Scale [GAS] at Week 6
Time frame: Baseline to week 6
Global Impression of Change Scale (GICS) assessed by the study subject at Week 4 to 6
Time frame: Week 4-6
Global Impression of Change Scale (GICS) assessed by the caregiver at Week 4 to 6
Time frame: Week 4-6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merz Medical Expert study director
Merz Pharmaceuticals GmbH
71 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NT 201 in people with Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury, run by Merz Pharmaceuticals GmbH at 71 sites in 15 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 9 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 71 sites in United States, Poland, Germany, France, Ukraine and 10 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Change from baseline in derived Modified Ashworth Scale-Bohannon (MAS) ankle score (knee extended) at weeks 4 to 6 (time frame: Baseline to week 4-6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2026.