Status:
UNKNOWN
A Phase - IIa - IIb, Trial to Study the Safety, Tolerability and Efficacy of Memantine as a Long-term Treatment of SCD
Lead Sponsor:
HaEmek Medical Center, Israel
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
10+ years
Phase:
PHASE2
Brief Summary
Symptomatic sickle cell disease (SCD) is worldwide the most frequent cause for hereditary hemolytic anemia with recurrent pain crises. Hemolysis, vaso- occlusive and pain crises are hallmarks of this ...
Detailed Description
Background and Rationale: Symptomatic sickle cell disease (SCD) is worldwide the most frequent cause for hereditary hemolytic anemia with recurrent pain crises. Hemolysis, vaso- occlusive and pain cri...
Eligibility Criteria
Inclusion
- Documented symptomatic sickle cell disease (HbSS or HbS/beta thalassemia)
- Age 18 years or older (cohort 1) and 10 - 17 years old (cohort 2)
- 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 use of condom.
Exclusion
- 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 leukemia 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))
- Patients with Chronic Active Hepatitis - HCV or HBV
- History of malignancy
- Women who are pregnant or breast feeding
- Known epileptic disease and under treatment with anticonvulsive drugs
- The receipt of any investigational product within 30 days prior to this trial
Key Trial Info
Start Date :
February 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03247218
Start Date
February 2 2018
End Date
December 31 2020
Last Update
November 1 2019
Active Locations (1)
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1
Emek Medical Centre
Afula, Israel, 18101