<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03792490</url>
  </required_header>
  <id_info>
    <org_study_id>01742</org_study_id>
    <secondary_id>2017-003676-31</secondary_id>
    <secondary_id>01GM1704A</secondary_id>
    <secondary_id>01GM1704B</secondary_id>
    <secondary_id>00013948</secondary_id>
    <nct_id>NCT03792490</nct_id>
  </id_info>
  <brief_title>Inhibition of Rho Kinase (ROCK) With Fasudil as Disease-modifying Treatment for ALS</brief_title>
  <acronym>ROCK-ALS</acronym>
  <official_title>Inhibition of Rho Kinase (ROCK) With Fasudil as Disease-modifying Treatment for ALS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medical Center Goettingen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Medical Center Goettingen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disorder and&#xD;
      therapeutic options are limited. The rho kinase (ROCK) inhibitor Fasudil was shown to be&#xD;
      neuroprotective, induced axonal regeneration and improved survival and behavioral outcome in&#xD;
      models of ALS and other neurodegenerative diseases. The aim of this phase IIa, multi-center&#xD;
      and double-blind study is to analyze the safety, tolerability and efficacy of fasudil in two&#xD;
      different doses compared to placebo in approximately 16 trial sites in Germany, France and&#xD;
      Switzerland. Intravenous application of fasudil will be performed in 80 patients and placebo&#xD;
      in 40 patients two times daily for 20 treatment days. The hypothesis is that fasudil is safe&#xD;
      and well-tolerated and its application will significantly improve the clinical outcome in&#xD;
      patients with ALS.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 20, 2019</start_date>
  <completion_date type="Anticipated">November 2023</completion_date>
  <primary_completion_date type="Actual">November 30, 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety (proportion of patients without treatment-related serious adverse events (SAE) up to day 180) and tolerability (proportion of patients without significant drug intolerance during the treatment period)</measure>
    <time_frame>From baseline (day 1) to last follow-up (day 180 ± 5)</time_frame>
    <description>Primary endpoint is the proportion of patients without significant drug intolerance during the treatment period (tolerability) and the proportion of patients without treatment-related serious adverse events (SAE) up to day 180 (safety).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Survival time</measure>
    <time_frame>From baseline (day 1) to end of treatment (day 26 to 30), second follow-up (day 90 ± 4), last follow-up (day 180 ± 5)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ALS Functional Rating Scale (ALSFRS-R)</measure>
    <time_frame>From baseline (day 1) to end of treatment (day 26 to 30), second follow-up (day 90 ± 4), last follow-up (day 180 ± 5)</time_frame>
    <description>Amyotrophic lateral sclerosis functional rating scale - revised (ALSFRS-R):&#xD;
a scale to determine different aspects of functionality in patients with ALS, minimum 0 points, maximum 48 points, derived from a questionnaire with 12 questions, each of which can yield up to 4 points, higher score indicates better functionality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ALS Assessment Questionnaire (ALSAQ-5)</measure>
    <time_frame>From baseline (day 1) to end of treatment (day 26 to 30), second follow-up (day 90 ± 4), last follow-up (day 180 ± 5)</time_frame>
    <description>Amyotrophic lateral sclerosis assessment questionnaire (ALSAQ-5):&#xD;
a patient self-report five-item scale to determine the health status and quality of life in patients with ALS, higher scores show worse quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Edinburgh Cognitive and Behavioral ALS Screen (ECAS)</measure>
    <time_frame>From baseline (day 1) to end of treatment (day 26 to 30), second follow-up (day 90 ± 4), last follow-up (day 180 ± 5)</time_frame>
    <description>Edinburgh Cognitive and Behavioral Amyotrophic Lateral Sclerosis Screen (ECAS):&#xD;
a scale to determine the cognitive function of patients with ALS, minimum 0 points, maximum 136 points, higher scores show better cognitive performance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor Unit Number Index (MUNIX)</measure>
    <time_frame>From baseline (day 1) to end of treatment (day 26 to 30), second follow-up (day 90 ± 4), last follow-up (day 180 ± 5)</time_frame>
    <description>Motor Unit Number Index (MUNIX):&#xD;
a neurophysiological method based on surface EMG recordings to estimate the number of motor units, higher scores indicate a higher number of motor units</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>slow Vital capacity (VC)</measure>
    <time_frame>From baseline (day 1) to end of treatment (day 26 to 30), second follow-up (day 90 ± 4), last follow-up (day 180 ± 5)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety (proportion of patients without treatment-related serious adverse events (SAE) up to end of treatment (day 26 to 30)) and tolerability (proportion of patients without significant drug intolerance during the treatment period)</measure>
    <time_frame>From baseline (day 1) to end of treatment (day 26 to 30)</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Amyotrophic Lateral Sclerosis</condition>
  <arm_group>
    <arm_group_label>Fasudil 30 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fasudil (Fasudil hydrochloride hydrate IV solution) Dosage form: intravenous, application over 45 minutes Dosage: 30 mg/ day Frequency: 2 x 15 mg Duration of treatment: 20 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fasudil 60 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fasudil (Fasudil hydrochloride hydrate IV solution) Dosage form: intravenous, application over 45 minutes Dosage: 60 mg/ day Frequency: 2 x 30 mg Duration of treatment: 20 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Sodium chloride (NaCl) 0.9% Dosage form: intravenous, application over 45 minutes Dosage: 100 ml Frequency: 2 x Duration of treatment: 20 days Do2 x 1 ml, NaCl 0.9%</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fasudil</intervention_name>
    <description>Fasudil hydrochloride hydrate IV solution</description>
    <arm_group_label>Fasudil 30 mg</arm_group_label>
    <arm_group_label>Fasudil 60 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo to Fasudil hydrochloride hydrate, NaCl 0,9%</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Probable (clinically or laboratory) or definite ALS according to the revised version&#xD;
             of the El Escorial World Federation of Neurology criteria&#xD;
&#xD;
          -  Disease duration more than 6 months and less than 24 months (inclusive). Disease onset&#xD;
             defined as date of first muscle weakness, excluding fasciculations and cramps&#xD;
&#xD;
          -  Vital capacity more than 65% of normal (slow vital capacity; best of three&#xD;
             measurements)&#xD;
&#xD;
          -  Age: ≥ 18 years&#xD;
&#xD;
          -  Patients have to be treated with Riluzole (2 x 50mg/d), must be stable for at least&#xD;
             four weeks before randomization&#xD;
&#xD;
          -  Patients who have started on Edaravone therapy shall continue Edaravone treatment.&#xD;
             Edaravone treatment must not be discontinued for reasons of trial participation.&#xD;
&#xD;
          -  Women of childbearing age must be non-lactating and surgically sterile or using a&#xD;
             highly effective method of birth control and have a negative pregnancy test.&#xD;
             Acceptable methods of birth control with a low failure rate i.e. less than 1% per&#xD;
             year) when used consistently and correct are such as implants, injectables, combined&#xD;
             oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or&#xD;
             vasectomized partner&#xD;
&#xD;
          -  Capable of thoroughly understanding all information given and giving full informed&#xD;
             consent according to good clinical practice (GCP)&#xD;
&#xD;
          -  Patients have to have a valid health insurance, when recruited in a center in France&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous participation in another clinical study involving trial medication within the&#xD;
             preceding 12 weeks or five terminal half times of the longest to be eliminated trial&#xD;
             medications (whichever is longer) or previous participation in this trial&#xD;
&#xD;
          -  Tracheostomy or continuous assisted ventilation of any type during the preceding three&#xD;
             months before randomization or a significant pulmonary disorder not attributed to ALS,&#xD;
             which may complicate the evaluation of respiratory function, intermittent non-invasive&#xD;
             ventilation is permitted,&#xD;
&#xD;
          -  Patients with a history of intracranial bleeding, known intracerebral aneurysms or&#xD;
             Moyamoya disease, or positive family history for the above. If only family history&#xD;
             positive, magnetic resonance (MR)- or x-ray-based cranial imaging not older than 24&#xD;
             months must confirm absence of bleeding, aneurysms or Moyamoya.&#xD;
&#xD;
          -  Gastrostomy&#xD;
&#xD;
          -  Any medical condition known to have an association with motor neuron dysfunction or&#xD;
             involving neuromuscular weakness or another neurodegenerative disease, e.g.&#xD;
             Parkinson's disease (PD) or Alzheimer's disease (AD), which might confound or obscure&#xD;
             the diagnosis of ALS&#xD;
&#xD;
          -  Presence of any concomitant life-threatening disease or impairment likely to interfere&#xD;
             with functional assessment&#xD;
&#xD;
          -  Patients with known arterial hypotension (resting blood pressure &lt;90/60 mmHg) or&#xD;
             previous hypotensive episodes or requiring treatment for increasing of blood pressure,&#xD;
             such as fludrocortisone, midodrine, etilefrine, cafedrine or theodrenaline&#xD;
&#xD;
          -  Patients with an uncontrollable or unstable arterial hypertensive disease (resting&#xD;
             blood pressure &gt;180 mmHg systolic and/or &gt;120 mmHg diastolic under current&#xD;
             antihypertensive medication)&#xD;
&#xD;
          -  Known pulmonary hypertension and any medication prescribed for treatment of pulmonary&#xD;
             hypertension&#xD;
&#xD;
          -  Confirmed hepatic insufficiency or abnormal liver function (stable aspartate&#xD;
             transaminase (ASAT) and/or alanine aminotransferase (ALAT) greater than 3 times the&#xD;
             upper limit of the normal range) and determined to be non-transient through repeat&#xD;
             testing&#xD;
&#xD;
          -  Renal insufficiency with a glomerular filtration rate (GFR) &lt;60 ml/min/1,73m²&#xD;
             (calculated by Modification of Diet in Renal Disease (MDRD) equation) and determined&#xD;
             to be non-transient through repeat testing&#xD;
&#xD;
          -  Major psychiatric disorder, significant cognitive impairment or clinically evident&#xD;
             dementia precluding evaluation of symptoms&#xD;
&#xD;
          -  Hypersensitivity to any component of the study drug&#xD;
&#xD;
          -  Liable to be not cooperative or comply with the trial requirements (as assessed by the&#xD;
             investigator), or unable to be reached in the case of emergency&#xD;
&#xD;
          -  Pregnant or breast-feeding females or females with childbearing potential, if no&#xD;
             adequate contraceptive measures are used&#xD;
&#xD;
          -  Prisoners or subjects who are involuntary incarcerated&#xD;
&#xD;
          -  Patients subject to legal protection measures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Marseille</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Montpellier</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Nice</name>
      <address>
        <city>Nice</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Tours</name>
      <address>
        <city>Tours</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Carl Gustav Carus Dresden</name>
      <address>
        <city>Dresden</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Center Göttingen</name>
      <address>
        <city>Göttingen</city>
        <zip>37075</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Halle (Saale)</name>
      <address>
        <city>Halle (Saale)</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Hochschule Hannover</name>
      <address>
        <city>Hannover</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Jena</name>
      <address>
        <city>Jena</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Leipzig</name>
      <address>
        <city>Leipzig</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum rechts der Isar der Technischen Universität München</name>
      <address>
        <city>München</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Ulm</name>
      <address>
        <city>Ulm</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Würzburg</name>
      <address>
        <city>Würzburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kantonsspital St. Gallen</name>
      <address>
        <city>Saint Gallen</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Germany</country>
    <country>Switzerland</country>
  </location_countries>
  <link>
    <url>http://rock-als.uni-goettingen.de</url>
    <description>Information for patients and physicians</description>
  </link>
  <reference>
    <citation>Lingor P, Weber M, Camu W, Friede T, Hilgers R, Leha A, Neuwirth C, Gunther R, Benatar M, Kuzma-Kozakiewicz M, Bidner H, Blankenstein C, Frontini R, Ludolph A, Koch JC; ROCK-ALS Investigators. ROCK-ALS: Protocol for a Randomized, Placebo-Controlled, Double-Blind Phase IIa Trial of Safety, Tolerability and Efficacy of the Rho Kinase (ROCK) Inhibitor Fasudil in Amyotrophic Lateral Sclerosis. Front Neurol. 2019 Mar 27;10:293. doi: 10.3389/fneur.2019.00293. eCollection 2019.</citation>
    <PMID>30972018</PMID>
  </reference>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>December 28, 2018</study_first_submitted>
  <study_first_submitted_qc>December 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>May 10, 2023</last_update_submitted>
  <last_update_submitted_qc>May 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Technical University of Munich</investigator_affiliation>
    <investigator_full_name>Paul Lingor</investigator_full_name>
    <investigator_title>International Coordinator</investigator_title>
  </responsible_party>
  <keyword>Motor neuron disease</keyword>
  <keyword>Neurodegenerative disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Motor Neuron Disease</mesh_term>
    <mesh_term>Amyotrophic Lateral Sclerosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fasudil</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03792490
org study id: 01742
secondary id: 2017-003676-31
secondary id: 01GM1704A
secondary id: 01GM1704B
secondary id: 00013948
nct id: NCT03792490
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disorder and
      therapeutic options are limited. The rho kinase (ROCK) inhibitor Fasudil was shown to be
      neuroprotective, induced axonal regeneration and improved survival and behavioral outcome in
      models of ALS and other neurodegenerative diseases. The aim of this phase IIa, multi-center
      and double-blind study is to analyze the safety, tolerability and efficacy of fasudil in two
      different doses compared to placebo in approximately 16 trial sites in Germany, France and
      Switzerland. Intravenous application of fasudil will be performed in 80 patients and placebo
      in 40 patients two times daily for 20 treatment days. The hypothesis is that fasudil is safe
      and well-tolerated and its application will significantly improve the clinical outcome in
      patients with ALS.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Safety (proportion of patients without treatment-related serious adverse events (SAE) up to day 180) and tolerability (proportion of patients without significant drug intolerance during the treatment period)
time frame: From baseline (day 1) to last follow-up (day 180 ± 5)
description: Primary endpoint is the proportion of patients without significant drug intolerance during the treatment period (tolerability) and the proportion of patients without treatment-related serious adverse events (SAE) up to day 180 (safety).
measure: Survival time
time frame: From baseline (day 1) to end of treatment (day 26 to 30), second follow-up (day 90 ± 4), last follow-up (day 180 ± 5)
measure: ALS Functional Rating Scale (ALSFRS-R)
time frame: From baseline (day 1) to end of treatment (day 26 to 30), second follow-up (day 90 ± 4), last follow-up (day 180 ± 5)
description: Amyotrophic lateral sclerosis functional rating scale - revised (ALSFRS-R):
a scale to determine different aspects of functionality in patients with ALS, minimum 0 points, maximum 48 points, derived from a questionnaire with 12 questions, each of which can yield up to 4 points, higher score indicates better functionality
measure: ALS Assessment Questionnaire (ALSAQ-5)
time frame: From baseline (day 1) to end of treatment (day 26 to 30), second follow-up (day 90 ± 4), last follow-up (day 180 ± 5)
description: Amyotrophic lateral sclerosis assessment questionnaire (ALSAQ-5):
a patient self-report five-item scale to determine the health status and quality of life in patients with ALS, higher scores show worse quality of life
measure: Edinburgh Cognitive and Behavioral ALS Screen (ECAS)
time frame: From baseline (day 1) to end of treatment (day 26 to 30), second follow-up (day 90 ± 4), last follow-up (day 180 ± 5)
description: Edinburgh Cognitive and Behavioral Amyotrophic Lateral Sclerosis Screen (ECAS):
a scale to determine the cognitive function of patients with ALS, minimum 0 points, maximum 136 points, higher scores show better cognitive performance
measure: Motor Unit Number Index (MUNIX)
time frame: From baseline (day 1) to end of treatment (day 26 to 30), second follow-up (day 90 ± 4), last follow-up (day 180 ± 5)
description: Motor Unit Number Index (MUNIX):
a neurophysiological method based on surface EMG recordings to estimate the number of motor units, higher scores indicate a higher number of motor units
measure: slow Vital capacity (VC)
time frame: From baseline (day 1) to end of treatment (day 26 to 30), second follow-up (day 90 ± 4), last follow-up (day 180 ± 5)
measure: Safety (proportion of patients without treatment-related serious adverse events (SAE) up to end of treatment (day 26 to 30)) and tolerability (proportion of patients without significant drug intolerance during the treatment period)
time frame: From baseline (day 1) to end of treatment (day 26 to 30)
arm group label: Fasudil 30 mg
arm group type: Experimental
description: Fasudil (Fasudil hydrochloride hydrate IV solution) Dosage form: intravenous, application over 45 minutes Dosage: 30 mg/ day Frequency: 2 x 15 mg Duration of treatment: 20 days
arm group label: Fasudil 60 mg
arm group type: Experimental
description: Fasudil (Fasudil hydrochloride hydrate IV solution) Dosage form: intravenous, application over 45 minutes Dosage: 60 mg/ day Frequency: 2 x 30 mg Duration of treatment: 20 days
arm group label: Placebo
arm group type: Placebo Comparator
description: Sodium chloride (NaCl) 0.9% Dosage form: intravenous, application over 45 minutes Dosage: 100 ml Frequency: 2 x Duration of treatment: 20 days Do2 x 1 ml, NaCl 0.9%
intervention type: Drug
intervention name: Fasudil
description: Fasudil hydrochloride hydrate IV solution
arm group label: Fasudil 30 mg
arm group label: Fasudil 60 mg
intervention type: Drug
intervention name: Placebo
description: Placebo to Fasudil hydrochloride hydrate, NaCl 0,9%
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
country: Germany
country: Switzerland
url: http://rock-als.uni-goettingen.de
description: Information for patients and physicians
citation: Lingor P, Weber M, Camu W, Friede T, Hilgers R, Leha A, Neuwirth C, Gunther R, Benatar M, Kuzma-Kozakiewicz M, Bidner H, Blankenstein C, Frontini R, Ludolph A, Koch JC; ROCK-ALS Investigators. ROCK-ALS: Protocol for a Randomized, Placebo-Controlled, Double-Blind Phase IIa Trial of Safety, Tolerability and Efficacy of the Rho Kinase (ROCK) Inhibitor Fasudil in Amyotrophic Lateral Sclerosis. Front Neurol. 2019 Mar 27;10:293. doi: 10.3389/fneur.2019.00293. eCollection 2019.
PMID: 30972018
responsible party type: Principal Investigator
investigator affiliation: Technical University of Munich
investigator full name: Paul Lingor
investigator title: International Coordinator
mesh term: Motor Neuron Disease
mesh term: Amyotrophic Lateral Sclerosis
mesh term: Fasudil
sharing ipd: Undecided