Indirect treatment comparison of ropinirole and pramipexole for management of symptoms in patients with advanced Parkinson’s disease

Trial description: Parkinson’s disease (PD), one of the most frequently observed neurological disorders in elderly people, is caused by a loss of dopaminergic nerve cells in certain areas of the brain. Levodopa (LD) and dopamine agonist (DA) are used commonly in China. Use of LD in the early stages of PD, particularly at higher doses might lead to motor complications such as abnormal involuntary movements (dyskinesia) and motor fluctuations (early wearing-off after each dose of medication and unpredictable switching between the mobile ‘on’ phase and the relatively immobile ‘off’ phase). Ropinirole, a non-ergoline dopamine agonist (DA) and Pramipexole (immediate-release [IR] and extended-release [ER]) a non-ergot DA are used in treatment of PD and are perceived as best comparator for China market. In the absence of any head-to-head randomised controlled clinical trials (RCTs) directly comparing ropinirole versus pramipexole, this network meta-analysis (NMA) will compare the two treatments indirectly, by synthesising available RCT evidence via common comparators. The Indirect treatment comparison (ITC) will provide key evidence of the relative effectiveness and safety of ropinirole versus pramipexole in advanced Parkinson’s disease subjects to support reimbursement dossiers in China. This study will be conducted to evaluate the comparative clinical efficacy and safety of ropinirole and pramipexole as adjunctive therapies to L-dopa for the management of advanced Parkinson’s disease, via a systematic review and network meta-analysis. The studies considered for each of the endpoints will not necessarily be the same across endpoints. Network meta-analysis with ITC: In order to satisfy ITC methodological requirements in different settings, a Bayesian network meta-analysis, with meta-regression and bias adjustment in the presence of heterogeneity will be conducted.