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NCT01285583COMPLETEDanonymous

An Open-label Safety Extension Study of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) Patients Treated With Riluzole

Sponsor

Source record

Hoffmann-La Roche

Phase

Source record

Phase 2/3

Modality

AI-normalized

small molecule

Target

AI-normalized

TRO19622 (Olesoxime) is a small molecule that targets mitochondrial function and neuroprotection, potentially modulating cellular stress responses in motor neurons.

Indication / condition

AI-normalized

Amyotrophic Lateral Sclerosis

Intervention

Source record

TRO19622

Source & freshness

Source record

NCT ID

NCT01285583

Original source

ClinicalTrials.gov

Source last updated

Nov 22, 2016

Ingested at

Jun 16, 2026

Internal sync

Jun 16, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

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View original source fields

NCT ID

NCT01285583

Title

An Open-label Safety Extension Study of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) Patients Treated With Riluzole

Sponsor

Hoffmann-La Roche

Status

COMPLETED

Phase

Phase 2/3

Condition raw

Amyotrophic Lateral Sclerosis

Condition normalized

Amyotrophic Lateral Sclerosis

Modality raw

small molecule

Modality normalized

small molecule

Target raw

TRO19622 (Olesoxime) is a small molecule that targets mitochondrial function and neuroprotection, potentially modulating cellular stress responses in motor neurons.

Target normalized

TRO19622 (Olesoxime) is a small molecule that targets mitochondrial function and neuroprotection, potentially modulating cellular stress responses in motor neurons.

Interventions

TRO19622

Public preview

Source record

TRO19622 is being evaluated as an add-on therapy to riluzole for the treatment of Amyotrophic Lateral Sclerosis (ALS), a market with significant unmet medical need and limited treatment options. The completion of this safety extension study suggests a commitment from Hoffmann-La Roche to further explore the therapeutic potential of TRO19622 in ALS, which may enhance its competitive positioning against existing therapies. The ALS market is characterized by high demand for innovative treatments, and successful outcomes could lead to substantial market share. However, the competitive landscape includes established therapies like edaravone and ongoing research into novel agents, necessitating thorough diligence on clinical efficacy and safety profiles.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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