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Use of (-)-Epicatechin in the Treatment of Becker Muscular Dystrophy (Pilot Study)
Bu çalışma, Becker musküler distrofisi (Becker muscular dystrophy) olan hastalarda (-)-epicatechin adlı maddenin kullanımını incelemiştir. Araştırmaya, 18-60 yaş arası, tanısı distrofin testleri veya genetik testlerle doğrulanmış ve yardımcı cihaz olmadan yürüyebilen erkek hastalar dahil edilmiştir. Çalışma Faz 1/Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: * Male * Age 18 years to 60 years * Average to low daily physical activity * Ability to ambulate for 75 meters without assistive devices * Diagnosis of BMD confirmed by at least one the following: * Dystrophin immunofluorescence and/or immunoblot showing partial dystrophin deficiency, and clinical picture consistent with typical BMD, or * Gene deletions test positive (missing one or more exons) of the dystrophin gene, where reading frame can be predicted as 'in-frame', and clinical picture consistent with typical BMD, or * Complete dystrophin gene sequencing showing an alteration (point mutation, duplication, or other mutation resulting in a stop codon mutation) that can be definitely associated with BMD, with a typical clinical picture of BMD, or * Positive family history of BMD confirmed by one of the criteria listed above in a sibling or maternal uncle, and clinical picture typical of BMD. * Nutritional, herbal and antioxidant supplements taken with the intent of maintaining or improving skeletal muscle strength or functional mobility have been discontinued at least 2 weeks prior to screening (daily multivitamin use is acceptable). * Hematology profile within normal range * Baseline laboratory safety chemistry profile within normal range * No plan to change exercise regimen during study participation Exclusion Criteria: * Currently enrolled in another treatment clinical trial. * History of significant concomitant illness or significant impairment of renal or hepatic function. * Use of regular daily aspirin or other medication with antiplatelet effects within 3 weeks of first dose of study medication. * Regular participation in vigorous exercise. * Symptomatic heart failure with cardiac ejection fraction \<25%