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ADX48621

Phase 2

Parkinson's Disease | Small molecule | Neurology |Addex Therapeutics Ltd|Last Updated: Jul 16, 2012

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment83
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01336088ADX48621 for the Treatment of Levodopa Induced Dyskinesia in Patients With Parkinson's DiseasePHASE2 COMPLETED 83Apr 1, 2011Feb 1, 2012Jul 16, 201225 United States, Austria +2
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Study Endpoints
Primary Endpoints
Number of patients with abnormal safety and tolerability assessment parameters
4 weeks

Physical and neurological examination, heart rate and blood pressure, 12-lead ECG, hematology and biochemistry assessments, use of concomitant medications, adverse events and serious adverse events.

Secondary Endpoints
Dyskinesia severity score measured by mAIMS
4 weeks
Change in Parkinson's disease severity
4 weeks
Patient-rated and clinician-rated global impression of change in dyskinesia and Parkinson's disease
4 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ADX48621EXPERIMENTAL -
ADX48621 Matching PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
ADX48621DRUGoral administration
PlaceboDRUGoral administration
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Eligibility Criteria
Age Range30 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites25

Inclusion Criteria: * outpatient with idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnosis Criteria (UKPDSBBCDC) * experiences moderately disabling dyskinesia (screening visit UPDRS 33 score≥2) * has an mAIMS score at baseline ≥ 7 with a score ≥ 3 in at least ...

Countries:United StatesAustriaFranceGermany
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