NCT00445172 is a Phase 2/Phase 3 clinical trial of E0302 (mecobalamin) in Amyotrophic Lateral Sclerosis (ALS), sponsored by Eisai Co., Ltd..

Who is sponsoring NCT00445172?

NCT00445172 is sponsored by Eisai Co., Ltd..

What drugs are being tested in NCT00445172?

Interventions in NCT00445172: E0302 (mecobalamin).

What condition does NCT00445172 study?

NCT00445172 studies Amyotrophic Lateral Sclerosis (ALS).

Is NCT00445172 still recruiting?

NCT00445172 is currently completed. Last updated 16 June 2023.

Last reviewed 2023-06-16 · How we verify

NCT00445172

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Long-Term Study in Patients With Amyotrophic Lateral Sclerosis (ALS)

Completed Phase 2/Phase 3 Last updated 16 June 2023

What this trial tests

Phase 2/Phase 3 trial testing E0302 (mecobalamin) in Amyotrophic Lateral Sclerosis (ALS) in 135 participants. Completed in 31 March 2017.

Timeline

1 February 2008

Primary endpoint
31 March 2017

31 March 2017

Quick facts

Lead sponsor	Eisai Co., Ltd.
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	135
Start date	1 February 2008
Primary completion	31 March 2017
Estimated completion	31 March 2017
Sites	42 locations across Japan

Drugs / interventions tested

E0302 (mecobalamin) — full drug profile →

Conditions studied

Amyotrophic Lateral Sclerosis (ALS) — all drugs for Amyotrophic Lateral Sclerosis (ALS) →

Sponsor

Eisai Co., Ltd. — full company profile →

Who can join

20 and older, any sex, with Amyotrophic Lateral Sclerosis (ALS). Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Number of participants with Adverse Events as a Measure of safety
Time frame: Every 3 months

Sponsor's own description

The purpose of this study is to investigate the safety and efficacy of long-term E0302 administration in patients with Amyotrophic Lateral Sclerosis (ALS).

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Amyotrophic lateral sclerosis: update and new developments.
Pratt AJ, Getzoff ED, Perry JJ. · · 2012 · cited 56× · PMID 23019386 · DOI 10.2147/dnnd.s19803
Blood-Brain Barrier Driven Pharmacoresistance in Amyotrophic Lateral Sclerosis and Challenges for Effective Drug Therapies.
Mohamed LA, Markandaiah S, Bonanno S, Pasinelli P, et al · · 2017 · cited 25× · PMID 28779378 · DOI 10.1208/s12248-017-0120-6
ABC transporter-driven pharmacoresistance in Amyotrophic Lateral Sclerosis.
Jablonski M, Miller DS, Pasinelli P, Trotti D. · · 2015 · cited 20× · PMID 25175835 · DOI 10.1016/j.brainres.2014.08.060
The Ying and Yang of Hydrogen Sulfide as a Paracrine/Autocrine Agent in Neurodegeneration: Focus on Amyotrophic Lateral Sclerosis.
Spalloni A, de Stefano S, Gimenez J, Greco V, et al · · 2023 · cited 3× · PMID 37443723 · DOI 10.3390/cells12131691

Verify or expand the search:

Other recruiting trials for Amyotrophic Lateral Sclerosis (ALS)

Currently open trials in the same condition.

NCT06608004 — Influence of Olfacto-gustatory Sensoriality on the Nutritional Status of Patients With Amyotrophic Lateral Sclerosis · recruiting
NCT07187388 — Investigating the Impact of Electrical Stimulation on Facial Pain, Jaw Movement and Oral Health in People With Motor Neu · NA · recruiting
NCT07233148 — Healing ALS Registry Observational Study (HAROS) · recruiting
NCT07257302 — Lung Insufflation Capacity Training and Respiratory Function in Amyotrophic Lateral Sclerosis · NA · recruiting
NCT07118319 — The Safety, Tolerability and Preliminary Efficacy of Derived Motor Neuron Progenitor Cells (XS228CN) in Subjects With Am · Phase 1 · recruiting

Other Eisai Co., Ltd. trials

Trials by the same sponsor.

NCT07515014 — A Study of E6742 in Participants With Systemic Lupus Erythematosus · Phase 2 · not yet recruiting
NCT06793709 — A Post-marketing Observational Study of Tasfygo in Participants With Unresectable Biliary Tract Cancer With Fibroblast G · recruiting
NCT06657378 — A Study to Evaluate the Safety of Fycompa Injection in Participants With Partial-Onset Seizures or Primary Generalized T · recruiting
NCT06322667 — A Post Marketing Study in Participants With Early Alzheimer's Disease Treated With Lecanemab · recruiting
NCT05633108 — A Study Based on the French National Health Insurance Database in Participants With Psychotic Disorders · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00445172 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eisai Co., Ltd.
Last refreshed: 16 June 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00445172.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing