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A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment With PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects With Parkinson's Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED)

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Trial Profile

A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment With PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects With Parkinson's Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 03 Mar 2022

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At a glance

  • Drugs Foliglurax (Primary)
  • Indications Parkinson's disease
  • Focus Proof of concept; Therapeutic Use
  • Acronyms AMBLED
  • Sponsors Prexton Therapeutics

    • Most Recent Events

    • 26 Feb 2022 Results published in the Movement Disorders
    • 27 Mar 2020 Primary endpoint(Change from baseline to end of Treatment Period in the daily awake OFF time based on subject Hauser diary entries) has not been met, as per results published in Lundbeck A/S Media Release
    • 27 Mar 2020 According to Lundbeck A/S Media Release, the development programme of foliglurax will be terminated as foliglurax did not demonstrate sufficient efficacy for patients living with Parkinsons disease.

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