CompletedPhase 2

Open Label, Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias

United States, Australia66 participantsStarted 2010-10

Plain-language summary

The purpose of this study is to generate long-term safety, tolerability and efficacy data for AFQ056 in patients who have participated in and completed any AFQ056 phase II study in PD-LID (Parkinson's disease, L-dopa induced dyskinesias).

Who can participate

SexALL

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Inclusion Criteria: * Outpatients with Parkinson's disease (PD), treated with L-Dopa, experiencing dyskinesias who have been eligible for, participated in and completed an AFQ056 phase II core study. Exclusion Criteria: * Surgical treatment for PD * Cancer within the past 5 years (other than localized skin cancer and prostate cancer that has been effectively treated) * Advanced, severe or unstable disease (other than PD) that may interfere with the study outcome evaluations Other protocol-defined inclusion/exclusion criteria may apply

What they're measuring

Incidence and severity of AEs/SAEs, changes in vital signs, lab assessments and ECGs, in cognitive function (MMSE), psychiatric symptoms (SCOPA-PC), and underlying symptoms of PD (UPDRS part III, CGIC, PGIC).

Timeframe: 3.5 years

Trial details

NCT IDNCT01173731

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-10

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