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 (PATTERN)

May 19, 2026 updated by: Merz Pharmaceuticals GmbH

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
603

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Brussels, Belgium, 1020
        • CHU Brugmann Neurology; Merz investigational site #0320015
      • Brussels, Belgium, 1200
        • UCL Bruxelles, Physical Medicine & Rehabilitation Department, Merz Investigational Site #0320013
      • Pellenberg, Belgium, 3212
        • UZ Leuven Pellenberg campus; Merz investigational site #0320014
      • Yvoir, Belgium, 5530
        • UCL Mont Godinne, Physical Medicine & Rehabilitation Department; Merz Investigational Site #0320008
  • Canada
      • Edmonton, Canada, T5G 0B7
        • Glenrose Rehabilitation Hospital, Merz investigational site #0010195
  • Czechia
      • Brno, Czechia, 61500
        • Neurology and Physiotherapy Skopalikova, Merz Investigational Site #4200049
      • Ostrava, Czechia, 708 52
        • University Hospital Ostrava; Neurology Departement, Merz investigational site #4200024
      • Pardubice, Czechia, 530 03
        • Pardubice Regional Hospital; Merz investigational site #4200025
  • France
      • Garches, France, 92380
        • Raymond Poincaré University Hospital, Service de MPR Pôle Handicap-Rééducation, Merz Investigational site #00330018
      • Lille, France, 59000
        • CHU Lille/Hôpital Swynghedauw; investigational site # 0330045
      • Rennes, France, 35000
        • Pôle Saint-Hélier; Merz investigational site #0330024
      • Strasbourg, France, 67000
        • Institut Universitaire de Readaptation Clemenceau, Physical Medicine / Rehabilitation Medecine, Merz Investigational site # 0330063
      • Toulouse, France, 31059
        • Rangueil Hospital-University Hospital Center (CHU) of Toulouse, Médecine physique et de réadaptation, Merz investigational site #0330025
  • Germany
      • Aachen, Germany, 52074
        • Uniklinik RWTH Aachen, Neurologie, Merz Investigational Site #0490191
      • Berlin, Germany, 10627
        • Neurologie Bewegt; Merz Investigational site #0490378
      • Bonn, Germany, 53127
        • University of Bonn Medical Center, Department of Neurodegenerative disease, Merz investigational site #0490390
      • Düsseldorf, Germany, 40225
        • Heinrich Heine University Duesseldorf, Department of Neurology; Merz Investigational Site #0490071
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf, Merz Investigational site #0490079
      • Wiesbaden, Germany, 65191
        • DKD HELIOS Medical Center, Fachbereich Neurologie, Merz Investigational Site #0490081
      • Würzburg, Germany, 97080
        • Neurologische Klinik und Poliklinik des Universitätsklinikums Würzburg, Merz Investigational Site #0490302
  • Hungary
      • Győr, Hungary, 9024
        • Petz Hospital, Neurology, Merz Investigational Site #0360010
      • Kisvárda, Hungary, 4600
        • St.Damjan Hospital, Kisvarda; Merz investigational site #0360019
      • Szeged, Hungary, 6725
        • University of Szeged, Department of Neurology, Merz investigational site #0360008
  • Italy
      • Foggia, Italy, 71122
        • Azienda Ospedaliera Universitaria Ospedali Riuniti Di Foggia; Merz Investigational Site #0390018
      • Genova, Italy, 16132
        • IRCCS Ospedale Policlinico S. Martino, U.O.Complessa Riabilitazione e Rieducazione Funzionale; Merz investigational site #0390020
      • Novara, Italy, 28100
        • Ospedale Maggiore della Carita, Dipartimento di Medicina fisica e Riabilitativa, Merz Investigational Site #0390017
      • Terracina, Italy, 04019
        • Ospedale Alfredo Fiorini, UOSD Neurologia Universitaria; Merz Investigational site #0390022
  • Poland
      • Katowice, Poland, 40-097
        • Specjalistyczna Praktyka Lekarska Dr. n. med Stanisław Ochudło, Merz Investigational Site #0480077
      • Krakow, Poland, 30-539
        • Specjalistyczne Gabinety Sp z o.o., Merz Investigational Site #0480059
      • Lodz, Poland, 90-640
        • NeuroKlinika Gabinet Lekarski Prof Andrzej Bogucki, Merz Investigational Site #0480101
      • Lublin, Poland, 20-582
        • Indywidualna Praktyka Lekarska dr. hab. Med. Anna Szczepanska-Szerej, Merz Investigational Site #0480096
      • Warsaw, Poland, 03-242
        • Mazowiecki Szpital Bródnowski, Merz Investigational Site #0480064
      • Warsaw, Poland, 01-518
        • Filia 7 Centrum Kompleksowej Rehabilitacji Sp. z o.o., Merz Investigational Site #0480100
      • Warsaw, Poland, 02-121
        • Projekt Samodzielni Sp z o.o., Merz Investigational Site #0480099
      • Warsaw, Poland, 02-957
        • Instytut Psychiatrii i Neurologii, II Klinika Neurologiczna, Merz Investigational Site #0480023
      • Wroclaw, Poland, 50-305
        • Neuryt Diagnostyka I Terapia Neurologiczna, Merz investigational site #0480106
  • Russia
      • Krasnoyarsk, Russia, 660049
        • 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
      • Moscow, Russia, 105005
        • 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, Russia, 125367
        • 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
      • Saint Petersburg, Russia, 195119
        • 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
  • Slovakia
      • Bratislava, Slovakia, 83305
        • University Hospital Bratislav, 2nd Dept. of Neurology, Merz Investigational Site # 4210005
      • Trnava, Slovakia, 917 01
        • Neurologicka klinika, Fakultna nemocnica Trnava; Merz investigational site #4210009
  • Spain
      • Huelva, Spain, 21005
        • Hospital Universitario Juan Ramón Jiménez, Merz Investigational Site #0340037
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz, Merz Investigational Site #0340007
      • Terrassa, Spain, 08221
        • Hospital Universitari Mútua de Terrassa, Merz Investigational Site #0340003
  • Switzerland
      • Bern, Switzerland, 3010
        • University Hospital of Bern, Center of Parkinson's diseases and Movement disorders (ZfPB), Merz investigational site #0410015
      • Meyriez, Switzerland, 3280
        • HFR Fribourg - Hôpital Cantonal, Department of Rehabilitation, Merz Investigational site #0410014
      • Sion, Switzerland, 1950
        • CRR, Mee Suva (Clinique romande de réadaptation), Merz investigational site #0410016
  • Ukraine
      • Kharkiv, Ukraine, 61000
        • Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine, MC "Neuron", Merz Investigational Site #3800018
      • Kharkiv, Ukraine, 61000
        • Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine; Merz Investigational Site #3800019
      • Lviv, Ukraine, 79010
        • Lviv regional clinical hospital; Merz investigational site # 3800020
      • Rivne, Ukraine, 33001
        • Rivne City Hospital 2, Department of Clinical Neurology and Neurorehabilitation; Merz investigational site #3800016
      • Uzhhorod, Ukraine, 88018
        • NPE "Regional Clinical Centre of Neurosurgery and Neurology" Transcarpathian Regional Council; Merz investigational site #3800014
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Cambridge University Hospitals NHS Foundation Trust; Merz Investigational Site 0440023
      • Exeter, United Kingdom, EX2 5DW
        • Royal Devon and Exeter Foundation Trust Hospital, Department of Neurology, Merz Investigational Site #0440047
      • Liverpool, United Kingdom, L9 7LJ
        • The Walton Centre NHS Foundation Trust; Neuroscience Research Centre; Merz Investigational site #0440004
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Physical Medicine and Rehabilitation at University of Alabama at Birmingham; Merz investigational site #0010479
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences, Merz investigational site #0010481
    • California
      • Downey, California, United States, 90242
        • Rancho Research Institute at Rancho Los Amigos National Rehabilitation Center; Merz investigational site #0010184
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • New England institute for clinical research; Merz Investigational Site #0010441
    • Florida
      • Brandenton, Florida, United States, 34209
        • Nova Clinical Research, Merz investigational site #0010474
      • Jacksonville, Florida, United States, 72204
        • Brooks Rehabilitation Clinical Integration and Research, Merz investigational site #0010483
      • Sarasota, Florida, United States, 34239
        • Sarasota Memorial Health Care System, Rehabilitation Medicine, Merz investigational site #0010478
    • Massachusetts
      • Foxborough, Massachusetts, United States, 02035
        • Neurology Center of New England P.C., Merz investigative site #0010476
    • Missouri
      • Columbia, Missouri, United States, 65203
        • Howard A. Rusk Rehabilitation Center; Merz investigational site #0010283
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai, Neurology Department, Merz Investigational Site #0010191
      • New York, New York, United States, 10065
        • Weill Cornell Medical Center, Department of Rehabilitation Medicine; Merz Investigational Site #0010440
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center, Physical Medicine & Rehabiliation, Merz Investigational Site #0010211
    • Texas
      • Dallas, Texas, United States, 75390-9055
        • UT Southwestern Medical Center, Department of Physical Medicine & Rehabilitation, Merz investigational site #0010082
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center McGovern, Medical School Department of PM&R; merz investigational site #0010183
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin,Department of PM&R, Merz Investigational Site #0010237

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: NT 201 (IncobotulinumtoxinA, Xeomin)

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.
Drug: NT 201
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).
Other Names:
  • Xeomin
  • Botulinum toxin type A (150 kiloDalton), free from complexing proteins
  • IncobotulinumtoxinA
  • Incobotulinumtoxin A
Placebo Comparator: Placebo

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.
Drug: Placebo
Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
Drug: NT 201
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).
Other Names:
  • Xeomin
  • Botulinum toxin type A (150 kiloDalton), free from complexing proteins
  • IncobotulinumtoxinA
  • Incobotulinumtoxin A

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline to week 4-6
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
Week 4-6
Occurrence of treatment emergent adverse events [TEAEs] in the Main Period
Time Frame: Baseline to week 12
Baseline to week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from Study Baseline in Goal Attainment Scale [GAS] at Week 6
Time Frame: Baseline to week 6
The GAS is a 6-grade scale
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
The GICS s a 9-grade scale
Week 4-6
Global Impression of Change Scale (GICS) assessed by the caregiver at Week 4 to 6
Time Frame: Week 4-6
The GICS s a 9-grade scale
Week 4-6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merz Pharmaceuticals GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Merz Medical Expert, Merz Pharmaceuticals GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 16, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 19, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 20, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M602011014
  • 2018-001639-35 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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