Recent Updates
Recently added Catalysts

Talampanel

Phase 2

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment559

FDA Designations

No designations recorded

Clinical trial landscape

Talampanel · 5 trials · 7 indications

Phase 2 3Phase 1 2
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

To determine the effects of Talampanel on cardiac repolarization after multiple therapeutic doses administered over 10 days
12 days

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
Unlock Study Endpoints

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
TalampanelEXPERIMENTAL -
MoxifloxacinOTHER -

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.
MoxifloxacinDRUGPlacebo administered three times a day over 9 days and a single dose of moxifloxacin administered on Day 10
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about Talampanel

What is Talampanel used for?

Talampanel is an investigational small molecule being studied in neurology for several conditions, including epilepsy, ALS, glioblastoma multiforme, dyskinesias, and Parkinson's disease. It has also been evaluated in healthy volunteers. Talampanel is not approved and remains in clinical development.

Who makes Talampanel?

Talampanel is being developed by Teva Pharmaceutical Industries Limited, whose stock trades under the ticker TEVA. The company has conducted clinical trials of Talampanel across multiple neurological indications.

What phase is Talampanel in?

Talampanel has completed Phase 1 and Phase 2 clinical trials. It is an investigational drug that has not received FDA approval and is not yet available commercially. The most advanced studies completed were Phase 2 trials in glioblastoma multiforme and ALS.

What clinical trials is Talampanel in?

Talampanel has been studied in several completed trials, including NCT00036296 in advanced Parkinson's disease, NCT00267592 in glioblastoma multiforme, NCT00696332 in ALS, and NCT00964730 in healthy volunteers. These trials were Phase 1 or Phase 2 and are all completed.

Is Talampanel the same as any other drug?

Talampanel is not known to have alternative names. It is a distinct investigational compound developed by Teva Pharmaceutical Industries. No other names for this drug have been reported.