Clinical trial • Phase II • Neurology|Rare Disease

EMRUSOLMIN for Multiple System Atrophy

Phase II trial of EMRUSOLMIN for Multiple System Atrophy. open-label. 149 participants.

Overview

Trial Therapeutic Area
Neurology|Rare Disease
Trial Disease
Multiple System Atrophy
Trial Stage
Phase II
Drug Modality
Small molecule
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
14-10-2025
First CTIS Authorization Date
04-02-2026

Trial design

open-label Phase II trial across 28 sites in Germany, Spain, Italy and others.

Open Label
Yes
Target Sample Size
149
Trial Duration For Participant
700

Eligibility

Recruits 149 Vulnerable populations are explicitly addressed: exclusion criterion states "Is of a vulnerable population (eg, people kept in detention or jail)." Consent handling: "Participant must provide consent, either by signature, spoken word, or gesture. If participant is physically unable to provide written informed consent, the completed ICF must be signed by one of the following in accordance with local regulation: (1) legally acceptable representative (LAR) or (2) acknowledgement of participant’s consent by an impartial witness. ... Caregiver consent will also be obtained in the circumstances where caregiver participation is applicable." Subject information and ICF documents are provided in multiple languages (German, Spanish, Italian, French) and include caregiver/legal representative versions..

Pregnancy Exclusion
2. Is a female participant who is pregnant, plans to become pregnant, or is breastfeeding during the OLE trial.
Vulnerable Population
Vulnerable populations are explicitly addressed: exclusion criterion states "Is of a vulnerable population (eg, people kept in detention or jail)." Consent handling: "Participant must provide consent, either by signature, spoken word, or gesture. If participant is physically unable to provide written informed consent, the completed ICF must be signed by one of the following in accordance with local regulation: (1) legally acceptable representative (LAR) or (2) acknowledgement of participant’s consent by an impartial witness. ... Caregiver consent will also be obtained in the circumstances where caregiver participation is applicable." Subject information and ICF documents are provided in multiple languages (German, Spanish, Italian, French) and include caregiver/legal representative versions.

Inclusion criteria

  • {"criterion_text":"- 1.\tCompletion of the treatment period and the week 48 (V9) visit of the DB trial whilst remaining compliant with trial requirements.\n- 2.\tIs able to swallow the IMP, as determined by a dysphagia evaluation during the OLE baseline visit; and is willing to swallow the IMP capsules whole, and as scheduled, throughout the duration of the OLE trial\n- 3.\tIn the investigator’s opinion, the participant and where applicable, participant’s caregiver(s), has (have) the ability to understand the nature of the OLE trial and its procedures, and is (are) able and willing to comply with the requirements of the OLE trial\n- 4.\tParticipant must provide consent, either by signature, spoken word, or gesture. If participant is physically unable to provide written informed consent, the completed ICF must be signed by one of the following in accordance with local regulation: (1) legally acceptable representative (LAR) or (2) acknowledgement of participant’s consent by an impartial witness. The process for consent should follow the local regulatory requirements. Caregiver consent will also be obtained in the circumstances where caregiver participation is applicable.\n- 5.\tFemales of childbearing potential (CBP) may be included only if they have a negative pregnancy test at the OLE baseline visit\n- 6.\tFemales of CBP whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods for the duration of the OLE trial and for 28 days after the last dose of IMP\n- 7.\tMales who are potentially fertile/reproductively competent (not surgically [eg, vasectomy] or congenitally sterile) and their female partners who are of CBP must use, together with their female partners, highly effective birth control methods for the duration of the OLE trial and for 28 days after the last dose of IMP"}

Exclusion criteria

  • {"criterion_text":"- 1.\tHas any clinically significant uncontrolled medical or psychiatric condition (treated or untreated), or any findings from vital signs, imaging, physical examination, electrocardiogram (ECG), or clinical laboratory, other than MSA related that could jeopardize or compromise the participant’s ability to participate in the OLE trial. The investigator should consult with the medical monitor or trial physician as needed.\n- 2.\tIs a female participant who is pregnant, plans to become pregnant, or is breastfeeding during the OLE trial.\n- 3.\tHas moderate to severe renal impairment as assessed by estimated glomerular filtration rate <60 mL/min/1.73m2. Minor deviations or borderline results (up to 10 mL/minute/1.73m2) may be acceptable for eligibility at the discretion of the Principal Investigator.\n- 4.\tCurrent or history of chronic liver or biliary disease, >2.5x the upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST), or 1.5x ULN total bilirubin (isolated bilirubin >1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).\n- 5.\tHas any clinically significant disorder that may interfere with absorption, distribution, metabolism, or excretion of IMP (including relevant gastrointestinal surgery, malabsorption syndrome) that makes the participant unsuitable for the trial.\n- 6.\tIs of a vulnerable population (eg, people kept in detention or jail).\n- 7.\tIs regularly using or consuming any prohibited concomitant medications within the specified exclusionary windows of this trial"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The primary safety and tolerability endpoints are as follows: • number (%) of participants experiencing an adverse event","definition_or_measurement_approach":"Count and percentage of participants experiencing an adverse event (safety/tolerability outcome as reported during the OLE)."}
  • {"endpoint_text":"- The primary safety and tolerability endpoints are as follows: • number (%) of participants who withdraw from the trial due to an adverse event","definition_or_measurement_approach":"Count and percentage of participants who withdraw from the trial due to an adverse event."}

Recruitment

Planned Sample Size
149
Recruitment Window Months
42
Consent Approach
Participants must provide consent by signature, spoken word, or gesture. If physically unable to provide written informed consent, the completed ICF must be signed by a legally acceptable representative (LAR) or by acknowledgement of the participant’s consent by an impartial witness, in accordance with local regulation. Caregiver consent is obtained where applicable. Subject information and ICF materials are provided in multiple languages (German, Spanish, Italian, French) and include caregiver and legal representative versions.

Geography

Total Number Of Sites
28
Total Number Of Participants
149

Germany

Earliest CTIS Part Ii Submission Date
15-01-2026
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
92
Number Of Sites
9
Number Of Participants
53

Sites

Site Name
Paracelsus-Kliniken Deutschland GmbH & Co. KGaA
Department Name
Center for Parkinsons Disease and Movement Disorder
Contact Person Name
Brit Mollenhauer
Contact Person Email
brit.mollenhauer@pkd.de
Site Name
Universitaet Leipzig
Department Name
Clinic and Polyclinic for Neurology
Contact Person Name
Jost-Julian Rumpf
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Clinic for Neurology
Contact Person Name
Alfons Schnitzler
Contact Person Email
Alfons.schnitzler@hhu.de
Site Name
LMU Klinikum Muenchen AöR
Department Name
Neurologic Clinic and Polyclinic
Contact Person Name
Gunter Hoglinger
Site Name
Universitaet Muenster
Department Name
Clinic for Neurology
Contact Person Name
Inga Claus
Contact Person Email
Inga.claus@ukmuenster.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Clinic for Neurology
Contact Person Name
Georg Bernhard Landwehrmeyer
Site Name
Technische Universitaet Dresden
Department Name
Clinic and Polyclinic for Neurology
Contact Person Name
Bjorn Falkenburger
Contact Person Email
bjoern.falkenburger@dzne.de
Site Name
Philipps-Universitaet Marburg
Department Name
Clinic for Neurology
Contact Person Name
Karla Maria Eggert
Contact Person Email
karlamaria.eggert@uk-gm.de
Site Name
Kliniken Beelitz GmbH
Department Name
Neurological specialist hospital for movement
Contact Person Name
Katarina Rukavina
Contact Person Email
Rukavina@kliniken-beelitz.de

Spain

Earliest CTIS Part Ii Submission Date
19-12-2025
Latest Decision Or Authorization Date
24-04-2026
Processing Time Days
127
Number Of Sites
9
Number Of Participants
51

Sites

Site Name
Hospital Universitario De Cruces
Department Name
Neurology service
Contact Person Name
Juan Carlos Gomez Esteban
Site Name
Hospital Universitario De La Princesa
Department Name
Neurology service
Contact Person Name
Lydia Lopez Manzanares
Contact Person Email
lydia.lopez@salud.madrid.org
Site Name
Hospital Clinic De Barcelona
Department Name
Neurology service
Contact Person Name
Francesc Valldeoriola Serra
Contact Person Email
fvallde@clinic.cat
Site Name
Hospital General Universitario De Elche
Department Name
Neurology service
Contact Person Name
Eric Freire Alvarez
Contact Person Email
dr.freyre@gmail.com
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Neurology service
Contact Person Name
Irene Martinez Torres
Contact Person Email
martinez_ire@gva.es
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Neurology service
Contact Person Name
Pablo Mir Rivera
Contact Person Email
pmir@us.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Neurology service
Contact Person Name
Jorge Hernandez Vara
Contact Person Email
jorge.hernandez@vallhebron.cat
Site Name
Hospital de la Santa Creu i Sant Pau
Department Name
Neurology service
Contact Person Name
Javier Pagonabarraga Mora
Contact Person Email
jpagonabarraga@santpau.cat
Site Name
Clinica Universidad De Navarra
Department Name
Neurology service
Contact Person Name
Maria Rosario Luquin Piudo
Contact Person Email
rluquin@unav.es

Italy

Earliest CTIS Part Ii Submission Date
08-01-2026
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
103
Number Of Sites
6
Number Of Participants
36

Sites

Site Name
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Department Name
Clinical Neurologica
Contact Person Name
Alessandra Nicoletti
Contact Person Email
anicolet@unict.it
Site Name
Azienda Ospedaliera di Padova
Department Name
U.O.C. Neurologia
Contact Person Name
Angelo Antoniny
Contact Person Email
angelo.antoniny@aopd.veneto.it
Site Name
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d'Aragona
Department Name
Clinical Neurologica
Contact Person Name
Maria Teresa Pellecchia
Contact Person Email
mpellecchia@unisa.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Dipartimento Neurologico
Contact Person Name
Maria Antonieta Volonté
Contact Person Email
volonte.mariaantonietta@hsr.it
Site Name
Irccs San Raffaele Roma S.r.l.
Department Name
Department of Neurology - Via di Val Cannuta 250, Rome, 00166
Contact Person Name
Fabrizio Stocchi
Site Name
Azienda Unita Sanitaria Locale Di Bologna
Department Name
UOC Clinica Neurologica Neuromet - IRCCS Instituto Delle Scienze Neurologiche di Bologna
Contact Person Name
Giovanna Calandra Buonaura
Contact Person Email
giovanna.calandra@unibo.it

France

Earliest CTIS Part Ii Submission Date
18-12-2025
Latest Decision Or Authorization Date
22-04-2026
Processing Time Days
126
Number Of Sites
4
Number Of Participants
9

Sites

Site Name
Centre Hospitalier Regional De Marseille
Department Name
Neurology and mevement diseases Department
Contact Person Name
Alexandre Eusebio
Contact Person Email
Alexandre.eusebio@ap-hm.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Department of Neurology for Neurodegenerative Diseases
Contact Person Name
Wassilios Meissner
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Neurology Department
Contact Person Name
Margherita Fabbri
Contact Person Email
fabbri.m@chu-toulouse.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Neurology Department
Contact Person Name
David Grabli
Contact Person Email
david.grabli@aphp.fr

Sponsor

Primary sponsor

Full Name
Teva Branded Pharmaceutical Products R&D LLC
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
Multiple operational responsibilities (codes: 1,12,13,14,15 (In-Home Services),2,4,5,6,8,9) as listed in sponsor duties
Name
Bioclinica Inc.
Responsibilities
MRI Imaging
Name
Eresearchtechnology Inc.
Responsibilities
Cardiac Safety, and Precision Motion service
Name
Perceptive Eclinical Limited
Responsibilities
eClinical services (code:3)
Name
Medidata Solutions Inc.
Responsibilities
Electronic Data Capture (EDC)
Name
Greenphire LLC
Responsibilities
Patient Retention

Third parties

  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"MRI Imaging","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"codes: 1,12,13,14,15 (In-Home Services),2,4,5,6,8,9","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Cardiac Safety, and Precision Motion service; code:7","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Perceptive Eclinical Limited","duties_or_roles":"code:3","organisation_type":"Pharmaceutical company"}
  • {"country":"India","full_name":"Watson Pharma Private Limited","duties_or_roles":"PK and CSF in Plasma","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"EDC","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"sample storage; code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Pharmacogenomics","organisation_type":"Pharmaceutical company"}
  • {"country":"Sweden","full_name":"Olink Proteomics AB","duties_or_roles":"Biomarker","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Activinsights Limited","duties_or_roles":"Companion Device (Wearable Biomarkers)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Retention","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
Emrusolmin
Active Substance
EMRUSOLMIN
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
prodAuthStatus: 1
Orphan Designation
Yes
Maximum Dose
300 mg/day

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