In a nutshell
The study evaluated the effectiveness of DA-9701 (Motilitone) on gastrointestinal symptom-related quality of life (GIS-QoL) in patients with Parkinson’s disease (PD) who are on stable dopaminergic medications. The main finding was that DA-9701 improved GIS-QoL in such patients.
Some background
Gastrointestinal symptoms (GIS) such as nausea, bloating, constipation are common in patients with PD. They worsen patients’ QoL. These can be the result of PD itself, but also side effects from medications for PD such as dopaminergic drugs.
DA-9701 relieves indigestion and constipation by enhancing the movement of the GI tract. It improved GIS in patients with PD in a small study. Large trials testing DA-9701’s effects on GIS-QoL and safety in patients with PD under daily dopaminergic drugs are lacking.
Methods & findings
The study included 144 Korean patients with PD and GIS who were under stable dopaminergic drug treatment. 72 received DA-9701 and the other 72 patients received a placebo for 4 weeks (period 1). Then both groups were given DA-9701 for 8 more weeks (period 2). GIS and GIS-QoL scores were measured with standardized patient-reported questionnaires.
Changes in GIS scores were similar among two groups but QoL scores improved in the DA-9701 group, during period 1. Patients with severe GIS showed improvement in QoL scores under DA-9701 in period 1 compared with the placebo, but not in patients with mild GIS.
GIS scores improved in both groups during period 2. While the DA-9701 group had major improvements in QoL scores during period 2, the placebo group had non-significant improvements.
Dyspepsia sum score (DSS) is a summation of 8 GIS including upper abdominal pain, burning, bloating, or nausea. The proportion of patients with a 50% or more reduction in DSS was 21.5% in DA-9701 and 12.3 % in placebo groups at period 1. This proportion was 30.8% for DA-9701 and 16.4% for placebo groups at the end of period 2.
PD-related movement symptoms were unchanged upon DA-9701 therapy in both groups during period-1 and 2. DA-9701 did not cause any severe toxicity in any group.
The bottom line
The authors concluded that DA-9701 improved GIS-QoL in patients with PD who are under stable dopaminergic drugs, without affecting movement symptoms.
The fine print
This trial was done in a Korean population. Therefore, the results may not apply to different ethnicities.
Published By :
Movement disorders: official journal of the Movement Disorder Society
Date :
Aug 06, 2020
