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Trial record 1 of 2 for:    NCT02615847
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Clinical Trial to Study the Safety and Tolerability of Memantin Mepha® in Sickle Cell Disease Patients (MemSID)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02615847
First Posted: November 26, 2015
Last Update Posted: August 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Zurich
  Purpose

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.


Condition Intervention Phase
Sickle Cell Disease Drug: Memantinhydrochlorid Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Number of participants with treatment related adverse events as assessed by CTCAE version 4.0 [ Time Frame: 14 month ]

Secondary Outcome Measures:
  • Haemoglobin in g/l [ Time Frame: 38 month ]
    2 years before screening until end of study.

  • Erythrocytes in T/l [ Time Frame: 38 month ]
    2 years before screening until end of study.

  • Reticulocytes in G/l [ Time Frame: 38 month ]
    2 years before screening until end of study.

  • Haptoglobin in g/l [ Time Frame: 38 month ]
    2 years before screening until end of study.

  • Billirubin in micmol/l [ Time Frame: 38 month ]
    2 years before screening until end of study.

  • LDH (Lactat dehydrogenase) in U/l [ Time Frame: 38 month ]
    2 years before screening until end of study.

  • Ferritin in micg/l [ Time Frame: 38 month ]
    2 years before screening until end of study.

  • Transferrin saturation in % [ Time Frame: 38 month ]
    2 years before screening until end of study.

  • Number of days in hospital [ Time Frame: 38 month ]
    2 years before screening until end of study.

  • Number of days with inability to work [ Time Frame: 38 month ]
    2 years before screening until end of study.

  • Number of transfusions [ Time Frame: 38 month ]
    2 years before screening until end of study.

  • Number of days taken antibiotics [ Time Frame: 38 month ]
    2 years before screening until end of study.

  • Amount of pain medication in mg or ml [ Time Frame: 38 month ]
    2 years before screening until end of study.

  • Pain scale [ Time Frame: 38 month ]
    Scores range from 0 (no pain) to 10 (worst possible pain).


Enrollment: 9
Study Start Date: August 2015
Study Completion Date: July 2017
Primary Completion Date: March 31, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Memantin arm
Memantinhydrochlorid, administered once per day during 12 month. Dosage is from 0-20 mg.
Drug: Memantinhydrochlorid

Memantin Mepha® Lactabs (memantinehydrochlorid) will be provided as 5 mg, 10 mg, 15 mg and 20 mg tablets, packed in blister.

The study drug will be taken once a day per os, during 12 month.

Other Name: Memantin Mepha

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented symptomatic sickle cell disease (HbSS or HbS/beta thalassemia)

    • Age 18 years or older
    • Able and willing to provide written informed consent and to comply with the study protocol procedures
    • Willing to use two effective methods of contraception during study treatment until 6 months after stop of study treatment. Effective contraception methods are considered oral, injectable, implantative contraceptives or intrauterine contraceptive devices combined with the use of condom.

Exclusion Criteria:

  • History of transfusion during last three months before Screening

    • Patients with active bacterial, viral or fungal infection requiring systemic treatment
    • Patients with known infection with human immunodeficiency virus (HIV) of human T cell leukaemia virus 1 (HTLV-1)
    • Inadequate renal function: creatinine clearance < 30ml/min
    • Inadequate liver function: NCICTC Grade 3 liver function tests (AST, ALT > 5x upper limit of normal (ULN))
    • History of malignancy
    • Women who are pregnant or breast feeding
    • Previous known mental disorder or known family history of psychiatric diseases
    • Known epileptic disease
    • The receipt of any investigational product within 30 days prior to this trial
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02615847


Locations
Switzerland
University Hospital Zürich
Zürich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Study Chair: Jeroen Goede, MD Universitätsspital Zürich
  More Information

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02615847     History of Changes
Other Study ID Numbers: HbSS-MemSID
First Submitted: September 7, 2015
First Posted: November 26, 2015
Last Update Posted: August 7, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn