Trial · NCT04744532
iPSC-based Drug Repurposing for ALS Medicine (iDReAM) Study
NCT04744532, Phase 1, Phase 2, Completed, Kyoto University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. iPSC-based Drug Repurposing for ALS Medicine (iDReAM) Study. Trials, record NCT04744532. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04744532
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- iPSC-based Drug Repurposing for ALS Medicine (iDReAM) Study
- NCT number
- NCT04744532
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 46 participants, actual
- Lead sponsor
- Kyoto University
- Conditions
- Amyotrophic Lateral Sclerosis
- Interventions
- Bosutinib (Phase 1 part), Bosutinib (Phase 2 part)
- First posted
- 2021-02-09
- Last updated
- 2026-08-10
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1 part: Dose-limiting toxicity (DLT) | During the first 4 weeks of treatment with bosutinib | Dose limiting toxity (DLT) for 4 weeks after initiating bosutinib |
| Primary | Phase 1 part: Dose-limiting toxicity (DLT) | Up to 12 weeks of treatment with bosutinib | Dose limiting toxity (DLT) during all treatment period (12 weeks) |
| Primary | Phase 2 part: Change in ALSFRS-R from baseline to week 24 in each 200mg and 300mg group compared with the external published data of placebo group | Up to 24 weeks of treatment with bosutinib | Change from baseline in ALSFRS-R at week 24 in each 200mg and 300mg group will be compared with the external published data of placebo group excluded bulbar-onset type in edaravone study (MCI186-19) |
| Primary | Phase 2 part: Adverse events | Up to 24 weeks of treatment with bosutinib | Safety in each dose group and pooled dose group during 24 weeks of treatment. Adverse events will be evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v.4.03). |
| Primary | Phase 2 part: Incidence of abnormal laboratory test results | Up to 24 weeks of treatment with bosutinib | Hematology, Blood chemistry, Coagulation test, etc. |
| Primary | Phase 2 part: Incidence of abnormal vital signs | Up to 24 weeks of treatment with bosutinib | Blood pressure, Pulse rate, Body temperature |
| Primary | Phase 2 part: Incidence of abnormal ECG recordings | Up to 24 weeks of treatment with bosutinib | ECG; electrocardiogram |
| Primary | Phase 2 part: Incidence of abnormal X-ray findings | Up to 24 weeks of treatment with bosutinib | chest X-ray examination |
| Secondary | Phase 1 part: Adverse events | Up to 12 weeks of treatment with bosutinib | Adverse events are graded based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v.4.03. |
| Secondary | Phase 1 part: Incidence of abnormal laboratory test results | Up to 12 weeks of treatment with bosutinib | Hematology, Blood chemistry, Coagulation test, etc. |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04744532
GET https://conductscience.org/api/trials/v1/NCT04744532/registered?page=2