Sickle Cell Disease Clinical Trial
Official title:
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
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.
During the study participants will be asked if medical occurrences (AEs) happened and
laboratory analysis (haematology, coagulation, chemistry) and urine samples will be taken. In
addition at each visit a physical examination and measurement of vital signs will be
performed.
In addition the number of hospital days and emergency consultations, the impact on working
ability (the number of days with inability to work, changes in iv%), the amount and type of
analgesic medication, the amount of RBC transfusions, the number of days that antibiotics
prescribed and haematology (at local and external laboratory) and chemistry laboratory
parameters will be assessed. For the impact on work and social life a questionnaire of
quality of life will be filled out monthly by the patient.
At screening and at the end of the study SCD specific assessments will be performed, which
include cardiologic examination (ECG, ECHO), abdominal sonography, ophthalmological
examination, lung function testing and neuroangiologic examination.
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