Study of efficacy and safety of NDDPX08 in ALS patients

Study of efficacy and safety of NDDPX08 in ALS patients - NDDPX08-ALS clinical research

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008527

Enrollment

Registered

2012-07-25

Start date

2009-01-01

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

Amyotrophic Lateral Sclerosis

Interventions

For patients who begin to receive Rilutek treatment at the start or 4 weeks before the start of the observation period, the 12-week treatment with Rilutek alone (100 mg/day) during the observation per

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients diagnosed as having ALS and satisfying all of the following

Exclusion criteria

Exclusion criteria: Patients diagnosed as having ALS and satisfying all of the following

Design outcomes

Primary

Measure	Time frame
Statistical analysis of efficacy data at the end of the study is assigned to an outside contractor. The information about the subjects assigned to the active drug treatment and placebo groups is disclosed at the time of statistical analysis. Statistical analysis as to the efficacy of the test drug is carried out in comparison to the efficacy data from the placebo group, the time course of variables relative to estimates at the end of the 12-week observation period and the natural history of the disease. The ALS Treatment Plan Evaluation Committee evaluates and judges the safety and efficacy of NDDPX08 in patients with ALS on the basis of the results of the statistical analysis.	—

Measure

Time frame

Statistical analysis of efficacy data at the end of the study is assigned to an outside contractor. The information about the subjects assigned to the active drug treatment and placebo groups is disclosed at the time of statistical analysis. Statistical analysis as to the efficacy of the test drug is carried out in comparison to the efficacy data from the placebo group, the time course of variables relative to estimates at the end of the 12-week observation period and the natural history of the disease. The ALS Treatment Plan Evaluation Committee evaluates and judges the safety and efficacy of NDDPX08 in patients with ALS on the basis of the results of the statistical analysis.

—

Countries

Japan

Contacts

Public ContactJoh-E Ikeda

Tokai University School of Medicine Department of Molecular Life Sciences Basic Medical Science and Molecular Medicine

joh-e@mgcheo.med.uottawa.ca0463-91-5014

Outcome results

None listed

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