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

NCT02615847 | Completed Phase 2

• 1 other identifier: HbSS-MemSID
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment related adverse events as assessed by CTCAE version 4.0

  14 month

Secondary Outcomes (14)

• Haemoglobin in g/l

  38 month

• Erythrocytes in T/l

  38 month

• Reticulocytes in G/l

  38 month

• Haptoglobin in g/l

  38 month

• Billirubin in micmol/l

  38 month

Study Arms (1)

Memantin arm

EXPERIMENTAL

Memantinhydrochlorid, administered once per day during 12 month. Dosage is from 0-20 mg.

Drug: Memantinhydrochlorid

Interventions

Memantinhydrochlorid DRUG

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.

Also known as: Memantin Mepha

Memantin arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zürich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jeroen Goede, MD

  Universitätsspital Zürich

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2015
• First Posted: November 26, 2015
• Study Start: August 1, 2015
• Primary Completion: March 31, 2017
• Study Completion: July 1, 2017
• Last Updated: August 7, 2017

Record last verified: 2017-07

Locations

CH (1)