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AFQ056 with L-dopa

Phase 2

Parkinson's Disease | Small molecule | Neurology |Novartis AG|Last Updated: Dec 23, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment82

FDA Designations

No designations recorded

Clinical trial landscape

AFQ056 with L-dopa · 3 trials · 2 indications

Phase 2 3
NCT01092065Efficacy and Safety of AFQ056 When Combined With Increased Doses of L-dopa in Parkinson's Disease Patients With Moderate-severe L-dopa Induced DyskinesiaParkinson's Disease
COMPLETED23 Analytics
NCT00888004Efficacy and Safety of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Disease PatientsParkinson's Disease
COMPLETED28 Analytics
NCT00582673Efficacy and Safety of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Disease Patients, and Safety in Combination With L-dopaParkinson's Disease
COMPLETED31 Analytics
PHASE2COMPLETED
Efficacy and Safety of AFQ056 When Combined With Increased Doses of L-dopa in Parkinson's Disease Patients With Moderate-severe L-dopa Induced Dyskinesia
Parkinson's DiseaseUnlock trial analytics
PHASE2COMPLETED
Efficacy and Safety of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Disease Patients
Parkinson's DiseaseUnlock trial analytics
PHASE2COMPLETED
Efficacy and Safety of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Disease Patients, and Safety in Combination With L-dopa
Parkinson's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline to the last-observation-carried-forward (LOCF) endpoint at week 5 in total OFF time collected from the Hauser et al. patient diary
5 weeks
Number and severity of Dyskinesias and the safety and tolerability of administering AFQ056 in combination with L-dopa
20 days

Secondary Endpoints

Change from baseline to the LOCF endpoint at week 5 in ON time with dyskinesia collected from the Hauser et al. patient diary.
5 weeks
Effect of increasing L-dopa doses on the underlying symptoms of Parkinson's Disease (PD) as measured by the United Parkinson's Disease Rating Scale (UPDRS) Part III.
5 weeks
Change in dyskinesia from baseline to the LOCF endpoint at week 5 as measured by the modified Abnormal Involuntary Movement Scale (AIMS), patient diary and Unified Dyskinesia Rating Scale (UDysRS) Parts I-IV.
5 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AFQ056 100 mg (Bid)EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
ActiveEXPERIMENTAL -
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
AFQ056 with L-dopaDRUGhard gelatin capsule to be taken bid for six weeks
PlaceboDRUGhard gelatin capsule to be taken bid for six weeks
AFQ056DRUG -
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Eligibility Criteria

Age Range30 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Outpatients with Parkinson's Disease (PD), treated with L-dopa, experiencing OFF time and dyskinesias for at least three months Exclusion Criteria: * Surgical treatment for PD * Cancer within the past 5 years (other than localized skin cancer and prostate cancer that has bee...

Countries:United StatesGermany
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Frequently asked questions about AFQ056 with L-dopa

What is AFQ056 used for?

AFQ056 is an investigational small molecule being studied for multiple conditions, including L-dopa induced dyskinesias in Parkinson's disease, hepatic impairment, cocaine use disorder, and Fragile X syndrome. It has been evaluated in clinical trials for these indications, though it remains in development and is not approved.

Who makes AFQ056?

AFQ056 is being developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. Novartis has sponsored multiple clinical trials of AFQ056 across various indications and phases of development.

What phase is AFQ056 in?

AFQ056 has been studied in Phase 1 and Phase 2 clinical trials. The most advanced trials are Phase 2 studies for Parkinson's disease with L-dopa induced dyskinesias and cocaine use disorder. All four completed trials are finished, and the drug remains investigational.

What clinical trials is AFQ056 in?

AFQ056 has completed four clinical trials. NCT00986414 and NCT01173731 are Phase 2 studies in Parkinson's disease with L-dopa induced dyskinesias. NCT01456663 is a Phase 1 pharmacokinetic study in hepatic impairment. NCT03242928 is a Phase 2 study in cocaine use disorder.

Is AFQ056 the same as other names?

AFQ056 is the primary identifier for this investigational drug in clinical trial registries. No alternative names have been reported in the available data. Researchers and investors should refer to it as AFQ056 when searching for information about this compound.