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

4. august 2017 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

9

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Sveits
      • Zürich, Sveits, 8091
        • University Hospital Zurich

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Memantin arm
Memantinhydrochlorid, administered once per day during 12 month. Dosage is from 0-20 mg.
Legemiddel: 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 navn:
  • Memantin Mepha

Hva måler studien?

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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Zurich

Etterforskere

  • Studiestol: Jeroen Goede, MD, Universitätsspital Zürich

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. august 2015

Primær fullføring (Faktiske)

31. mars 2017

Studiet fullført (Faktiske)

1. juli 2017

Datoer for studieregistrering

Først innsendt

7. september 2015

Først innsendt som oppfylte QC-kriteriene

24. november 2015

Først lagt ut (Anslag)

26. november 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. august 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. august 2017

Sist bekreftet

1. juli 2017

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HbSS-MemSID

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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