AG Paul

Research Outpatient Clinic

BERLimmun

Berlin Registry of Neuroimmunological Entities (BERLimmun) — a monocentric prospective observational study on the long-term course of neuroimmunological diseases.

Sponsor: IIT

Recruitment: yes

Local PI: PD Dr. Tanja Schmitz-Hübsch

Study Number: German Clinical Trial Register DRKS00026761

Akute ON

Acute Optic Neuritis Study (AON‑S), a monocentric, prospective observational study on symptomatology, diagnosis, therapy and prognosis of acute optic neuritis.

Sponsor: IIT

Recruitment: yes

Local PI: Dr. Susanna Asseyer/​Prof. Dr. Friedemann Paul

Study Number: NCT05605951

COGEMS II

Neural mechanisms of mental and emotional processes in multiple sclerosis and their relevance to disease severity.

Sponsor: IIT

Recruitment: yes

Local PI: PD Dr. Martin Weygandt

EFC16645 Hercules BTkI phase iii

A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis (HERCULES).

Sponsor: Sanofi

Recruitment: Screening closure 29.11.2022

Local PI: Prof. Dr. Friedemann Paul

Study Number: EudraCT 2020−000647−30 

EFC16035 PERSEUS BTkI phase iii

A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS).

Sponsor: Sanofi

Recruitment: yes

Local PI: Prof. Dr. Friedemann Paul

Study Number: EudraCT 2020−000645−14 

GenSeMS Project

Sponsor: IIT

Recruitment: yes

Local PI: Prof. Dr. Stefan Gold

HOPE-MS

Clinical validity of confirmed disease progression defined by marker-less home-based assessment of motor function in multiple sclerosis (HOPE-MS).

Sponsor: IIT (Celgene)

Recruitment: yes

Local PI: PD. Dr. Tanja Schmitz-Hübsch

Kyrios phase IV

Tracking the immune response to SARS-CoV‑2 modRNA vaccines in an open-label multicenter study in participants with relapsing multiple sclerosis treated with ofatumumab s.c. (KYRIOS).

Sponsor: Novartis

Recruitment: closed

Local PI: Prof. Dr. Friedemann Paul

WN43194 Satralizumab phase iii (Meteoroid)

A phase III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab as monotherapy or in addition to baseline therapy in patients with myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD).

Sponsor: Roche

Recruitment: yes

Local PI: PD. Dr. Tanja Schmitz-Hübsch

Study Number: NCT05271409

Study MOG001 (Parexel 247511) phase iii (CosMOG)

A Randomized, double-blind, Placebo-controlled, multicenter Phase 3 pivotal study to evaluate the efficacy and safety of rozanolixizumab to treat adult patients with Myelin Oligodendrocyte Glycoprotein (MOG) Antibody-Associated Disease (MOG-AD).

Sponsor: UCB

Recruitment: yes

Local PI: Prof. Dr. Friedemann Paul

Study number: NCT05063162

Motosense

Sensitivity of quantitative motor performance measures in multiple sclerosis – a prospective cohort study over two years using Microsoft Kinect.

Sponsor: IIT

Recruitment: closed

Local PI: Prof. Dr. Friedemann Paul

MSIM 7T

7 Tesla MRI in patients with multiple sclerosis and other neuroimmunological disorders.

Sponsor: IIT

Local PI: Prof. Dr. Friedemann Paul

PREPARE phase II

Prevention of paclitaxel-related neurologic adverse events with lithium — a randomized, double-blind, placebo-controlled, exploratory proof-of-concept phase II clinical trial for the prevention of chemotherapy-induced neurotoxicity.

Sponsor: IIT

Recruitment: yes

Local PI: Prof. Dr. Mathias Endres

QMS (MR Elastographie BCAN)

MR elastography in patients with multiple sclerosis.

Sponsor: IIT

Local PI: Prof. Dr. Ingolf Sack

RDoC

Sponsor: IIT

Recruitment: yes

Local PI: Prof. Dr. Stefan Gold/​Prof. Dr. Isabel Dziobek

PRECOMS Schwangersch. und MS

Database on family planning and pregnancies in multiple sclerosis and Neuromyelitis optica spectrum disease (PreCoMS).

Sponsor: IIT

Local PI: Prof. Dr. Friedemann Paul

TempiMS

Specified laboratory investigations in Portugal.

Sponsor: IIT

Recruitment: yes

Local PI: Prof. Dr. Friedemann Paul

TregNMO

Regulatory T cells in Neuromyelitis optica.

Sponsor: IIT

Recruitment: yes

Local PI: Dr. Maria Hastermann

Valkinect (incl Ataxie)

Determining the accuracy, reliability, validity, and responsiveness of video-operceptive motion analysis with Microsoft Kinect — VALKINECT.

Sponsor: IIT

Recruitment: yes

Local PI: Prof. Dr. Friedemann Paul

Neuroimmunological Outpatient Clinic (Hochschulambulanz)

CFS-CARE

Care Model for Patients with Chronic Fatigue Syndrome (ME/CFS).

Sponsor: IIT

Recruitment: yes

Local PI: Prof. Dr. Carmen Scheibenbogen

DMSG MS-Register

Patient registry of the German Multiple Sclerosis Society, Federal Association (DMSG) within the MS Research and Project Development GmbH (MSFP), DMSG MS-Register.

Sponsor: DMSG

Recruitment: yes

Local PI: Prof. Dr. Friedemann Paul

PreCoMS

Family planning and pregnancies in multiple sclerosis (PreCoMS)

Sponsor: IIT

Recruitment: yes

Local PI: Dr. Nadja Siebert

Study Number: NCT05010902

POST COVID Beobachtungsstudie (PA-COVID-19)

Analysis of the Pathophysiology and Pathology of Corona Virus Disease 2019 (Pa-COVID-19).

Sponsor: IIT

Recruitment: yes

Local PI: Prof. Carmen Scheibenbogen / Dr. Judith Bellmann-Strobl

PA-COVID-19-Unterstudie

Dynamic vascular analysis of the retina in the Pa-COVID-19 study.

Sponsor: IIT

Recruitment: yes

Local PI: Prof. Dr. Friedemann Paul

VERI-LONG

A study to investigate improvement in physical function in SF-36 with Vericiguat compared with Placebo in participants aged 18 to 50 years with post-COVID-19 syndrome (PCS and PCS/CFS).

Sponsor: IIT (Bayer)

Recruitment: yes

Local PI: Dr. Judith Bellmann-Strobl

Study Number: EudraCT 2021−005494−11 NCT05697640