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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)

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.
 
ClinicalTrials.gov Identifier: NCT02615847
Recruitment Status : Completed
First Posted : November 26, 2015
Last Update Posted : August 7, 2017
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Tracking Information
First Submitted Date  ICMJE September 7, 2015
First Posted Date  ICMJE November 26, 2015
Last Update Posted Date August 7, 2017
Study Start Date  ICMJE August 2015
Actual Primary Completion Date March 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 24, 2015)
Number of participants with treatment related adverse events as assessed by CTCAE version 4.0 [ Time Frame: 14 month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2015)
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial to Study the Safety and Tolerability of Memantin Mepha® in Sickle Cell Disease Patients
Official Title  ICMJE 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
Brief Summary

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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sickle Cell Disease
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Memantin arm
Memantinhydrochlorid, administered once per day during 12 month. Dosage is from 0-20 mg.
Intervention: Drug: Memantinhydrochlorid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 4, 2017)
9
Original Estimated Enrollment  ICMJE
 (submitted: November 24, 2015)
13
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date March 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02615847
Other Study ID Numbers  ICMJE HbSS-MemSID
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University of Zurich
Original Responsible Party Jeroen Goede, University of Zurich, Dr. med.
Current Study Sponsor  ICMJE University of Zurich
Original Study Sponsor  ICMJE Jeroen Goede
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jeroen Goede, MD Universitätsspital Zürich
PRS Account University of Zurich
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP