NCT02615847: MemSID

A Phase II, Open Label, Single Center Trial to Study the Safety and Tolerability of Memantin Mepha® as Supportive Long Term Treatment in Symptomatic Sickle Cell Disease

Completed Phase 2 Last updated 4 August 2017

What this trial tests

Phase 2 trial testing Memantinhydrochlorid in Sickle Cell Disease in 9 participants. Completed in 1 July 2017.

Timeline

1 August 2015

Primary endpoint
31 March 2017

1 July 2017

Quick facts

Lead sponsor	University of Zurich
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	1 August 2015
Primary completion	31 March 2017
Estimated completion	1 July 2017
Sites	1 location across Switzerland

Drugs / interventions tested

• Memantinhydrochlorid — full drug profile →

Conditions studied

• Sickle Cell Disease — all drugs for Sickle Cell Disease →

Sponsor

University of Zurich

Who can join

18 and older, any sex, with Sickle Cell Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of participants with treatment related adverse events as assessed by CTCAE version 4.0
  Time frame: 14 month

Sponsor's own description

Symptomatic sickle cell disease is worldwide the most frequent cause for hereditary hemolytic anemia with recurrent pain crisis. Hemolysis, vaso- occlusive and pain crises are hallmarks of this disease and are causative for an important socio-economic burden worldwide, especially in Africa.

Aside from allogenic stem cell transplantation, which is rarely available and very expensive, at present there is no curative treatment for patients with sickle cell disease (SCD). The current standard of care includes treatment with hydroxycarbamide and symptomatic care such as transfusions, antibiotic/analgesic treatment.

This study has the aim to study the safety and tolerability of Memantin in patients with sickle cell disease.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. New insights into the pathophysiology and development of novel therapies for sickle cell disease.
   Moerdler S, Manwani D. · · 2018 · cited 24× · PMID 30504350 · DOI 10.1182/asheducation-2018.1.493
2. A pilot clinical phase II trial MemSID: Acute and durable changes of red blood cells of sickle cell disease patients on memantine treatment.
   Mahkro A, Hegemann I, Seiler E, Simionato G, et al · · 2020 · cited 15× · PMID 35847705 · DOI 10.1002/jha2.11
3. <i>N</i>-Methyl-D-Aspartate Receptors in Hematopoietic Cells: What Have We Learned?
   Kalev-Zylinska ML, Hearn JI, Makhro A, Bogdanova A. · · 2020 · cited 11× · PMID 32625106 · DOI 10.3389/fphys.2020.00577
4. MEMSID: Results From a Phase 2 Pilot Study on Memantine Treatment for Sickle Cell Disease.
   Hegemann I, Sasselli C, Valeri F, Makhro A, et al · · 2020 · cited 8× · PMID 32885144 · DOI 10.1097/hs9.0000000000000452
5. RedTell: an AI tool for interpretable analysis of red blood cell morphology.
   Sadafi A, Bordukova M, Makhro A, Navab N, et al · · 2023 · cited 7× · PMID 37304818 · DOI 10.3389/fphys.2023.1058720
6. MeMAGEN: A Phase IIa/IIb open-label trial of memantine testing safety and tolerability in sickle cell patients.
   Koren A, Levin C, Livshits L, Valeri F, et al · · 2026 · PMID 41531666 · DOI 10.1002/hem3.70278