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Completed
NCT04744532
iPSC-based Drug Repurposing for ALS Medicine (iDReAM) Study
Conditions: Amyotrophic Lateral Sclerosis
Sex: All
Ages: 20 Years – 75 Years
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 46
Sponsor: Kyoto University
Location: Hiroshima University Hiroshima
Summary
This study consists of a phase 1 part and a phase 2 part.
Phase 1 part:
This is a phase 1, open-label, multicenter, dose escalation study to evaluate the safety and tolerability of bosutinib to determine the maximum tolerated dose(MTD) and a recommended phase 2 dose (RP2D) of bosutinib for treatment of ALS patients. Also, efficacy will be evaluated exploratory.
Phase 2 part:
This is an open label, multicenter, phase 2 part whose purpose is to evaluate the efficacy exploratorily and the long-term (for 24 weeks) safety of bosutinib for the treatment of ALS patients.
Eligibility Criteria
\[Phase 1 part\]
Inclusion criteria:
1. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study. To be additionaly signed by a delegate signer if the subject is unable to handwrite.
2. Patients aged ≥20 years and \
Source: ClinicalTrials.gov (NCT04744532). StuddyBuddy aggregates publicly available trial information.
