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TCH346

Phase 2

Amyotrophic Lateral Sclerosis | Small molecule | Neurology |Novartis AG|Trials Updated: Nov 24, 2011

TCH346 development status

Highest phase Phase 2
Registered trials 3 across 2 sponsors since May 2002

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials4
Total Enrollment1,246

FDA Designations

No designations recorded

TCH346 clinical trials

TCH346 · 4 trials · 2 indications

Phase 2 3Phase 1 1
NCT00230074A Long-term Extension Study of TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis(ALS)Amyotrophic Lateral Sclerosis
COMPLETED350 Analytics
NCT00072709Study Evaluating TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis
COMPLETED551 Analytics
NCT00036413A 12-week, Multicenter, Safety and Dose-ranging Study of 3 Oral Doses of TCH346 in Patients With Amyotrophic Lateral SclerosisAmyotrophic Lateral Sclerosis
COMPLETED44 Analytics
PHASE2COMPLETED
A Long-term Extension Study of TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis(ALS)
Amyotrophic Lateral SclerosisUnlock trial analytics
PHASE2COMPLETED
Study Evaluating TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral SclerosisUnlock trial analytics
PHASE2COMPLETED
A 12-week, Multicenter, Safety and Dose-ranging Study of 3 Oral Doses of TCH346 in Patients With Amyotrophic Lateral Sclerosis
Amyotrophic Lateral SclerosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Rate of functional decline as defined by the ALS Functional Rating Scale-Revised
Safety of three oral doses of TCH346 versus placebo administered for up to 12 weeks to patients with ALS
Time to the need for symptomatic treatment with dopaminergic agents", defined as the number of days from the first dose of TCH346 study treatment to the date when it symptomatic treatment is required as determined by the investigator
Safety assessments as based on the frequency of adverse events and the number of laboratory values that fall outside of the ranges.

Secondary Endpoints

Survival time
Functional outcome measures including pulmonary function and manual muscle strength assessments (every visit)
Functional outcome measures including pulmonary function and manual muscle strength assessments (every visit except screening)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
TCH346DRUG -
TCH346 (dibenz[b,f]oxepin-10-ylmethyl-prop-2-ynyl-amine, hydrogen maleate salt)DRUG -
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Eligibility Criteria

Age Range21 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Completed original protocol, Study No. CTCH346A2211 * Be capable of satisfying the requirements of the extension protocol and must sign informed consent after the nature of the extension protocol has been fully explained Exclusion Criteria: * Exclusion criteria as described ...

Countries:United StatesBelgiumCanadaFranceGermanyItalyNetherlandsSwitzerlandUnited KingdomBrazilPortugal
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Frequently asked questions about TCH346

What is TCH346?

TCH346 is an investigational small molecule developed by Novartis AG for neurological conditions. It was studied in amyotrophic lateral sclerosis (ALS) and Parkinson's disease. It is also known as dibenz[b,f]oxepin-10-ylmethyl-prop-2-ynyl-amine, hydrogen maleate salt. All of its clinical trials have been completed, and no trials are currently active.

What is TCH346 used for?

TCH346 was studied for the treatment of amyotrophic lateral sclerosis (ALS) and Parkinson's disease. Its clinical program included three completed trials in ALS and one completed trial in early Parkinson's disease. It is an investigational agent and is not described as an approved therapy for either indication.

Who makes TCH346?

TCH346 was developed by Novartis AG, which trades under the ticker NVS. Novartis sponsored the clinical trial program evaluating the drug in amyotrophic lateral sclerosis and Parkinson's disease.

What phase is TCH346 in?

TCH346 reached Phase 2 clinical development. Its trials include Phase 2 studies in amyotrophic lateral sclerosis and a Phase 1 study in early Parkinson's disease. All of these trials are completed, and no TCH346 trials are currently active.

What clinical trials is TCH346 in?

TCH346 was evaluated in completed trials including NCT00072709 and NCT00230074 in amyotrophic lateral sclerosis, NCT00036413, a 12-week safety and dose-ranging study in ALS, and NCT00407212, a study of three doses in early Parkinson's disease. These trials enrolled a combined total of 945 participants.