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NCT00036413COMPLETEDanonymous

A 12-week, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter, Safety and Dose-ranging Study of Three Oral Doses (0.5 mg, 2.5 mg and 10 mg Once Daily) of TCH346 in Patients With Amyotrophic Lateral Sclerosis.

Sponsor

Source record

Novartis Pharmaceuticals

Phase

Source record

Phase 2

Modality

AI-normalized

small molecule

Target

AI-normalized

TCH346 is a novel compound with a specific mechanism of action yet to be fully elucidated in the context of ALS treatment.

Indication / condition

AI-normalized

Amyotrophic Lateral Sclerosis

Intervention

Source record

TCH346

Source & freshness

Source record

NCT ID

NCT00036413

Original source

ClinicalTrials.gov

Source last updated

Nov 24, 2011

Ingested at

Jun 13, 2026

Internal sync

Jun 13, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT00036413

Title

A 12-week, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter, Safety and Dose-ranging Study of Three Oral Doses (0.5 mg, 2.5 mg and 10 mg Once Daily) of TCH346 in Patients With Amyotrophic Lateral Sclerosis.

Sponsor

Novartis Pharmaceuticals

Status

COMPLETED

Phase

Phase 2

Condition raw

Amyotrophic Lateral Sclerosis

Condition normalized

Amyotrophic Lateral Sclerosis

Modality raw

small molecule

Modality normalized

small molecule

Target raw

TCH346 is a novel compound with a specific mechanism of action yet to be fully elucidated in the context of ALS treatment.

Target normalized

TCH346 is a novel compound with a specific mechanism of action yet to be fully elucidated in the context of ALS treatment.

Interventions

TCH346

Public preview

Source record

TCH346 represents a potential advancement in the treatment landscape for Amyotrophic Lateral Sclerosis (ALS), a disease with significant unmet medical need and limited therapeutic options. The study's completion indicates Novartis Pharmaceuticals' commitment to addressing ALS, which could enhance its portfolio in neurology. The competitive landscape includes existing therapies such as Riluzole and Edaravone, but TCH346's unique dosing regimen and mechanism may provide a differentiated offering. Market diligence should focus on the efficacy and safety outcomes from this trial, as well as the potential for further development and commercialization strategies, including partnerships or licensing opportunities.

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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TrialSignal

Clinical trial intelligence report

A 12-week, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter, Safety and Dose-ranging Study of Three Oral Doses (0.5 mg, 2.5 mg and 10 mg Once Daily) of TCH346 in Patients With Amyotrophic Lateral Sclerosis.

Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.

Generated

Jun 16, 2026

NCT ID

NCT00036413

Status

COMPLETED

Phase

Phase 2

Sponsor

Novartis Pharmaceuticals

Executive brief

Investment-Ready Snapshot

TCH346 represents a potential advancement in the treatment landscape for Amyotrophic Lateral Sclerosis (ALS), a disease with significant unmet medical need and limited therapeutic options. The study's completion indicates Novartis Pharmaceuticals' commitment to addressing ALS, which could enhance its portfolio in neurology. The competitive landscape includes existing therapies such as Riluzole and Edaravone, but TCH346's unique dosing regimen and mechanism may provide a differentiated offering. Market diligence should focus on the efficacy and safety outcomes from this trial, as well as the potential for further development and commercialization strategies, including partnerships or licensing opportunities.

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedNov 24, 2011
Internal syncJun 13, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT00036413

Indication

Amyotrophic Lateral Sclerosis

Modality

small molecule

Target

TCH346 is a novel compound with a specific mechanism of action yet to be fully elucidated in the context of ALS treatment.

Intervention

TCH346

Source record

Protocol Description

Detailed source ingestion pending.

Source record

Outcome Measures

Detailed source ingestion pending.

Source record

Eligibility

Detailed source ingestion pending.

AI analysis

Known Results And Readout Context

Detailed source ingestion pending.

IP intelligence

Patent And IP Landscape

Detailed source ingestion pending.

Source record

Contacts

Detailed source ingestion pending.