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Clinical Studies

In recent years, several multicenter, randomized, placebo-controlled, DFG- and BMBF-funded clinical trials have been conducted at the initiative of centers of the German ALS/MND Network:

  • LIPCAL-ALS (high-calorie high-fat dietary supplementation vs. placebo): 12 sites, enrollment of 207 patients in 14 months; NCT02306590. The study found evidence of a beneficial effect of high-calorie, high-fat supplementation on survival, motor function, body weight, and neurofilaments, especially in rapidly progressive cases.

Ludolph AC, Dorst J, Dreyhaupt J, et al. Effect of high-caloric nutrition on survival in amyotrophic lateral sclerosis. Annals of neurology 2019; 17(10): 25661.
Dorst J, Schuster J, Dreyhaupt J, et al. Effect of high-caloric nutrition on serum neurofilament light chain levels in amyotrophic lateral sclerosis. Journal of neurology, neurosurgery, and psychiatry 2020; 91(9): 1007-9.

  • RAS-ALS (rasagiline vs placebo) : 15 sites, enrollment of 252 patients in 15 months; NCT01879241. Post-hoc analyses of the study found evidence of prolonged survival and slowed loss of motor function in rapidly progressive patients on rasagiline.

Ludolph AC, Schuster J, Dorst J, et al. Safety and efficacy of rasagiline as an add-on therapy to riluzole in patients with amyotrophic lateral sclerosis: a randomised, double-blind, parallel-group, placebo-controlled, phase 2 trial. Lancet neurology 2018; 18(18): 30176-5.

  • GERP-ALS (pioglitazone vs placebo): 15 sites, enrolling 211 patients over 9 months; NCT00690118. This study found no evidence of efficacy of pioglitazone in ALS. There was evidence of altered metabolism and hypothalamic affection in ALS patients.

Dupuis L, Dengler R, Heneka MT, et al. A randomized, double blind, placebo-controlled trial of pioglitazone in combination with riluzole in amyotrophic lateral sclerosis. PloS one 2012; 7(6): e37885

  • ROCK-ALS (fasudil vs placebo): 15 sites, enrollment of 120 patients; NCT03792490. Enrollment for this study is complete and results are eagerly awaited.

Lingor P, Weber M, Camu W, et al. 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.

Collaborative projects with internal and external partners

  • JPND project NEEDSinALS with cooperation partners in Sweden and Poland
    http://www.NEEDSinALS.com
  • Establishment of ECAS in Germany together with MND-NET partners
    http://www.ECAS.network
  • Participation in the International Human Toponom (HUTO) project
    https://www.toposnomos.com/
  • Prognostic factors in ALS: A comparison between Germany and China
    https://pubmed.ncbi.nlm.nih.gov/30923935/
  • SOD1 mutations in ALS: A comparison between the Chinese and the German population
    https://pubmed.ncbi.nlm.nih.gov/34711284/
  • International collaborative project “The role of MSH3 and PMS2 in modifying C9orf72 related ALS”
  • premodiALS study: Multinational study on the presymptomatic signature of ALS
    https://www.premodials.med.tum.de
  • ROCK-ALS: A phase II clinical trial evaluating the safety, tolerability, and efficacy of the Rho-kinase inhibitor fasudil as a novel disease-modifying therapy in amyotrophic lateral sclerosis (ALS) with partners from France and Switzerland.
    NCT03792490
  • NISALS – Neuroimaging Society in Amyotrophic Lateral Sclerosis. NISALS has existed since 2010 and has a pool of MRI images of ALS patients
    https://nisals.com/
  • CALSNIC – Multidisciplinary team of neurologists, MR scientists, biostatisticians, etc., distributed among several academic centers
    https://calsnic.org/
  • Cooperation with DZNE: A cooperation agreement between MND-NET and DZNE regulates and enables joint projects
  • Boris Canessa ALS Foundation: NF-L study in ALS.
    https://canessa-als-stiftung.org
  • Ambulanzpartner care network ID-ALS study
    ambulanzpartner.de
  • DFG funded sequencing project, aiming to find new ALS genes: “Uncovering novel causes and modifiers of ALS by nuclear and mitochondrial genome sequencing”
  • Cooperation project of the TU Dresden: Deficits and potential for improvement in the psychosocial and palliative care of ALS patients in Germany
  • Preclinical gene carrier study for ALS and FTD
  • Hardship program Tofersen – Treatment of 25 patients of the MND-NET at 11 centers
  • Expert Committee Electrophysiology: Establishment of an electrophysiological standard in the context of ALS diagnosis
  • Consensus of the ALSFRS-R: MND-NET centers standardize the German version of the ALS Function Scale
  • Autopsy study (Prof. J. Weis, Aachen)
  • Swabian ALS-Register
  • ALS-Register Rhineland-Palatinate

Please contact the respective expert committee if you are interested. 

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