German ALS Study Group
Mission of the German ALS Study Group
Amyotrophic Lateralsklerosis (ALS) is a serious and progressive neurological disease that so far cannot be cured. The aim of available therapy is to slow the disease (neuroprotective therapy) and treat symptoms and disabilities due to ALS (symptomatic therapy).
The members of the German ALS Study Group are clinical and scientific experts in diagnosing and treating ALS and other motor neuron diseases. Beyond the endeavor providing a comprehensive treatment approach to all patients, the mission of the study group is to support new therapeutics during the clinical testing. Especially in the field of fatal diseases with very limited treatment options we feel the unambiguous need to develop new evidence based treatments for our patients.
History
During the last decade a clinical trial network, comprising 20 German ALS centers, has been established. Starting with the clinical and scientific network of German motor neuron disease centers (MND-NET), a German-wide infrastructure including a patient register and standards in diagnosis and treatment have been established. Funding has been granted by the German Ministry for Science and Technology. Beyond the many research projects established to get more depth understanding of the ALS disease, several Investigator Initiated Trials (IIT) have been conducted to reach out for new therapies (e.g. GERP-ALS, NCT00690118; RAS-ALS, NCT01879241, LIPCAL-ALS, NCT02306590). Members of the German ALS Study Group participated in many multi-national ALS trials driven by the pharmaceutical industry, and provided substantive contribution to the successful recruitment. Please see “Expertise” for more detailed information.
Streamlined start up process and reduced timelines by
- centralized feasibility answering system, single point of contact (joachim.schuster@uni-ulm.de)
- budget negotiation done by a contact person of the study group. Case payment will apply to all group members.
- common submission documents and certificates on hand
Patient register and site specific patient databases support recruitment of feasible and interested subjects within given timelines
All sites fulfill gold-standard of clinical trials (dedicated study personnel trained in ICH-GCP, local regulations, disease, electronic data capture, IATA, etc; dedicated infrastructure for patient treatment, bio sample handling and storage, study drug (IMP) handling and storage, documentation, monitoring, etc.)
- LIPCAL-ALS, NCT02306590, high calorie dietary in ALS (double blind national IIT, recruitment started Q1 2015)
- RAS-ALS, Phase IIb, NCT01879241, 2011-004482-32 (national IIT, 250 patients enrolled within 15 months)
- CY 4026, Phase IIb, NCT01709149, 2012-004987-23 (10 % of 711 patients enrolled by 3 German sites)
- SOD1, Phase I/II , NCT01083667, 2011-004798-99
- NOG112264, Phase II, NCT01753076, 2012-003349-13 (22 % of 303 patients enrolled by 5 German sites)
- 223AS304 ENVISION, Phase III, NCT01622088, 2011-006119-70
- 223AS302 EMPOWER, Phase III, NCT01281189, 2010-022818-19
- TRO19622 CL E Q 1015-1, Phase II/III, NCT00868166, 2008-007320-25
- ALS-TAL-201, Phase II, NCT00696332, 2008-002062-62
- GERP ALS, Phase III, NCT00690118, 2006-005410-13 (national IIT, 211 patients enrolled within 15 months)
- ONO2506POE014 / SIRONA, Phase II, NCT00403104, 2006-002660-26
- ALS-GA-201 Phase II, NCT00326625, 2006-001688-49
- TCH346, Phase IIb, NCT00230074, 2004-002855-15
- ONO2506PO (ONO2506 in patients with ALS), Phase II, NCT00403104
Prof. Dr. A. C. Ludolph
RKU - Universitäts- und Rehabilitationskliniken gGmbH
Oberer Eselsberg 45, 89081 Ulm
phone: +49 731 177 1200
fax: +49 731 177 1202
email: albert.ludolph@rku.de
Prof. Dr. Thomas Meyer
Ambulanz für ALS und andere Motoneuronenerkrankungen
Charité-Universitätsmedizin Berlin
CharitéCentrum für Neurologie, Neurochirurgie und Psychiatrie
Augustenburger Platz 1, 13353 Berlin
phone: +49 30 450 660032
fax: +49 30 450 560907
email: thomas.meyer@charite.de
Dr. Torsten Grehl
Leiter der ALS Ambulanz
Oberarzt der Neurologischen Klinik
Alfried Krupp Krankenhaus
Rüttenscheid
Alfried-Krupp-Str. 21
45131 Essen
Telefon +49 201 434.41426
email: torsten.grehl@krupp-krankenhaus.de
Web: http://als-krupp-krankenhaus.de
Prof. Dr. Susanne Petri
Medizinische Hochschule Hannover
Neurologische Poliklinik Bereich ALS
Carl-Neubergstr. 1, 30625 Hannover
phone: +49 511 5323740
fax: +49 511 5323115
email: petri.susanne@mh-hannover.de
PD Dr. Julian Grosskreutz
Universitätsklinikum Jena
Abteilung Neurologie
Erlanger Allee 101, 07747 Jena
phone: +49 3641 932 3428
email: Julian.grosskreutz@med.uni-jena.de
Prof. Dr. med. Dr. rer. med. Andreas Hermann
Universitätsklinikum Carl Gustav Carus Dresden
Abteilung Neurologie
Fetscherstraße 74, 01307 Dresden
phone: +49 (0)351 458 2532
email: Andreas.Hermann@uniklinikum-dresden.de