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talampanel

Phase 2

ALS | Small molecule | Neurology |Teva Pharmaceutical Industries Limited|Trials Updated: May 19, 2016

talampanel development status

Highest phase Phase 2
Registered trials 7 across 1 sponsor since May 2002

talampanel target and mechanism

Molecular targetGRIA1, GRIA2
Target classAntagonist
ModalitySmall molecule

Also known as AMPA antagonist

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials4
Total Enrollment843

FDA Designations

No designations recorded

talampanel clinical trials

talampanel · 4 trials · 6 indications

Phase 2 3Phase 1 1
NCT00696332Talampanel for Amyotrophic Lateral Sclerosis (ALS)ALS
COMPLETED559 Analytics
NCT00267592Safety and Efficacy of Talampanel in Glioblastoma MultiformeGlioblastoma Multiforme
COMPLETED72 Analytics
NCT00034814Multicenter Trial for Adults With Partial SeizuresEpilepsy
COMPLETED190 Analytics
PHASE2COMPLETED
Talampanel for Amyotrophic Lateral Sclerosis (ALS)
ALSUnlock trial analytics
PHASE2COMPLETED
Safety and Efficacy of Talampanel in Glioblastoma Multiforme
Glioblastoma MultiformeUnlock trial analytics
PHASE2COMPLETED
Multicenter Trial for Adults With Partial Seizures
EpilepsyUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in ALS Functional Rating Score (ALSFRS-R slope)
52 weeks
Overall Survival
24 months
Reduction in frequency of partial seizures
12 weeks

Change in frequency of recognizable seizures as measured by entries in a seizure diary

Secondary Endpoints

Time from baseline to the first occurrence of either death, tracheostomy or permanent assisted ventilation.
52 weeks
Talampanel-related toxicity
29 months
The number of seizure-free days and percent responders
12 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Talampanel 50mgEXPERIMENTAL50mg Talampanel 3 times per day
Talampanel 25mgEXPERIMENTAL25mg Talampanel 3 times per day
PlaceboPLACEBO_COMPARATORplacebo 3 times per day
enzyme-inducing antiseizure drugEXPERIMENTALA single-arm study with all subjects assigned to one treatment (radiation + temozolomide + talampanel) but subjects receiving concomitant anti-seizure drugs which could increase study drug elimination had a slightly modified dose/schedule of study drug. The primary endpoint is analyzed as a single group.
1PLACEBO_COMPARATOREnzyme-inducing placebo TID
2EXPERIMENTALEnzyme-inducing Talampanel 35 mg TID
3EXPERIMENTALEnzyme-inducing TLP 50mg TID
4PLACEBO_COMPARATORNon-enzyme-inducing placebo TID
5EXPERIMENTALNon-enzyme-inducing TLP 25mg TID
6EXPERIMENTALNon-enzyme-inducing TLP 35mg TID

Interventions

NameTypeDescription
TalampanelDRUGcapsules Talampanel, 3 times per day, 52 weeks
placeboOTHERcapsules, placebo, 3 times a day, for 52 weeks
Radiation Therapy (RT) 5 days a week +RADIATION -
temozolomide(TMZ) 75mgDRUGtemozolomide(TMZ) 75mg 3 times daily (TID) for 6 weeks
adjuvant TMZ 200mgDRUGadjuvant TMZ 200mg TID for 5 consecutive days each month for a total of 6 months.
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites24

Subjects with sporadic or familial ALS classified as definite, probable, or laboratory-supported probable ALS according to the revised El Escorial criteria. Inclusion Criteria: 1. Diagnosis of definite or probable ALS in accordance with the El-Escorial criteria. 2. Subject has experienced his/her ...

Countries:United StatesBelgiumCanadaFranceGermanyHungaryIsraelItalyNetherlandsSpain
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Frequently asked questions about talampanel

What is talampanel?

Talampanel is an investigational small molecule developed by Teva Pharmaceutical Industries Limited (ticker TEVA). It has been studied in Phase 2 clinical trials for neurology indications including amyotrophic lateral sclerosis (ALS), epilepsy, glioblastoma multiforme, and dyskinesias in Parkinson's disease. It is not described as approved and remains an investigational agent.

What does talampanel target?

Talampanel targets GRIA1 and GRIA2, subunits of the AMPA-type glutamate receptor. It acts as an antagonist at these receptors, blocking AMPA receptor mediated glutamate signaling. This target class places talampanel among anti-glutamatergic compounds explored for neurological conditions such as ALS and epilepsy.

Who makes talampanel?

Talampanel is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva sponsored the clinical trial program evaluating the compound across neurology indications, including ALS, epilepsy, glioblastoma multiforme, and dyskinesias in Parkinson's disease.

What phase is talampanel in?

Talampanel is in Phase 2 development. Its clinical program includes Phase 2 trials in ALS, epilepsy, and glioblastoma multiforme, plus a Phase 1 trial in advanced Parkinson's disease and dyskinesias. All listed trials are completed, and no active trials are ongoing.

What clinical trials is talampanel in?

Talampanel has been studied in completed trials including NCT00696332, a Phase 2 placebo-controlled ALS trial enrolling 559 patients across the United States, Europe, Canada, and Israel; NCT00267592 in glioblastoma multiforme; NCT00034814 in partial seizures; and NCT00036296 in advanced Parkinson's disease and dyskinesias.

What is talampanel used for in ALS?

Talampanel was studied as a treatment for amyotrophic lateral sclerosis in a Phase 2, randomized, double-blind, placebo-controlled trial, NCT00696332, which enrolled 559 adults aged 18 and older across ten countries. The trial is completed. Talampanel is investigational and is not described as an approved ALS therapy.