Recent Updates
Recently added Catalysts

AFQ056 with L-dopa

Phase 2

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment82
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01092065Efficacy and Safety of AFQ056 When Combined With Increased Doses of L-dopa in Parkinson's Disease Patients With Moderate-severe L-dopa Induced DyskinesiaPHASE2 COMPLETED 23Mar 1, 2010Jul 1, 2011Dec 23, 20204 United States
NCT00888004Efficacy and Safety of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Disease PatientsPHASE2 COMPLETED 28Mar 1, 2009 -Apr 19, 20165 Germany
NCT00582673Efficacy and Safety of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Disease Patients, and Safety in Combination With L-dopaPHASE2 COMPLETED 31Oct 1, 2007 -May 14, 20105 Germany
Unlock Drug Trial Details
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
Unlock Study Endpoints
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 -
Unlock Study Design Details
Eligibility Criteria
Age Range30 Years — 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
Unlock Eligibility Criteria