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Clinical Trial to Study the Safety and Tolerability of Memantin Mepha® in Sickle Cell Disease Patients (MemSID)

4. august 2017 opdateret af: University of Zurich

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

9

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Schweiz
      • Zürich, Schweiz, 8091
        • University Hospital Zurich

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Memantin arm
Memantinhydrochlorid, administered once per day during 12 month. Dosage is from 0-20 mg.
Medicin: 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.

Andre navne:
  • Memantin Mepha

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Number of participants with treatment related adverse events as assessed by CTCAE version 4.0
Tidsramme: 14 month
14 month

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Haemoglobin in g/l
Tidsramme: 38 month
2 years before screening until end of study.
38 month
Erythrocytes in T/l
Tidsramme: 38 month
2 years before screening until end of study.
38 month
Reticulocytes in G/l
Tidsramme: 38 month
2 years before screening until end of study.
38 month
Haptoglobin in g/l
Tidsramme: 38 month
2 years before screening until end of study.
38 month
Billirubin in micmol/l
Tidsramme: 38 month
2 years before screening until end of study.
38 month
LDH (Lactat dehydrogenase) in U/l
Tidsramme: 38 month
2 years before screening until end of study.
38 month
Ferritin in micg/l
Tidsramme: 38 month
2 years before screening until end of study.
38 month
Transferrin saturation in %
Tidsramme: 38 month
2 years before screening until end of study.
38 month
Number of days in hospital
Tidsramme: 38 month
2 years before screening until end of study.
38 month
Number of days with inability to work
Tidsramme: 38 month
2 years before screening until end of study.
38 month
Number of transfusions
Tidsramme: 38 month
2 years before screening until end of study.
38 month
Number of days taken antibiotics
Tidsramme: 38 month
2 years before screening until end of study.
38 month
Amount of pain medication in mg or ml
Tidsramme: 38 month
2 years before screening until end of study.
38 month
Pain scale
Tidsramme: 38 month
Scores range from 0 (no pain) to 10 (worst possible pain).
38 month

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Zurich

Efterforskere

  • Studiestol: Jeroen Goede, MD, Universitatsspital Zurich

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2015

Primær færdiggørelse (Faktiske)

31. marts 2017

Studieafslutning (Faktiske)

1. juli 2017

Datoer for studieregistrering

Først indsendt

7. september 2015

Først indsendt, der opfyldte QC-kriterier

24. november 2015

Først opslået (Skøn)

26. november 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. august 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. august 2017

Sidst verificeret

1. juli 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HbSS-MemSID

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Seglcellesygdom

Kliniske forsøg med Memantinhydrochlorid

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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