A single-dose study of TMS-007 in patients with ischemic stroke (phase IIa study)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223786

Enrollment

Registered

2018-01-26

Start date

2018-02-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute ischemic stroke

Interventions

investigational material(s) Generic name etc : TMS-007 INN of investigational material : - Therapeutic category code : 339 Other agents relating to blood and body fluides Dosage and Administration for

1, 3, and 6 mg/kg control material(s) Generic name etc : Placebo INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : in

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Japanese who develop symptomatic cerebral infarction

Exclusion criteria

Exclusion criteria: 1 Patients who are suitable for rt-PA or endovascular treatment 2 High bleeding risk 3 High blood pressure or high blood glucose 4 Severe disease affecting the pathology of ischemic stroke 5 Pregnancy

Design outcomes

Primary

Measure	Time frame
safety Safety Adverse event, symptomatic intracranial hemorrhage, electrocardiogram, vital signs, laboratory tests, NIHSS, or mRS	—

Secondary

Measure	Time frame
efficacy Efficacy MRS, NIHSS, rate of reperfusion, Blood marker [FDP, D-dimer, MMP-9, etc]	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026