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A double-blind, randomized clinical trial to evaluate the efficacy of Duloxetine against pain associated with Parkinson's disease with depression (Pain reduction in PD patients with depression: double blind, randomized clinical trial of duloxetine)

Pain reduction in PD patients with depression: double blind, randomized clinical trial of duloxetine (Pain reduction in PD patients with depression: double blind, randomized clinical trial of duloxetine.)

46

A total of 47 people with Parkinson’s disease, all Asians, were enrolled in this study. One participant withdrew consent after randomization and before taking the study drug. The remaining 46 participants were all included in the analyses. In summary, the average age was 68 years old and slightly more female were included. They were in the early progressive stage of Parkinson’s disease, with mild to distressing pain. The 2 most frequent parts with pain were the body and the lower extremities, and medication for Parkinson’s disease was not typically effective.

May, 2015: The first participant enrolled March, 2016: The 20th participant enrolled Feburary, 2018: The 40th participant enrolled May, 2019: The last participant (47th) enrolled

A total of 9 participants could not complete the study; among these, 7 participants withdrew, or were withdrawn, due to adverse events. Most of the people (7 out of 9) who discontinued the study were in the duloxetine arm, although the rate was not statistically different between the 2 arms (P = 0.13). In total, there were 56 adverse events inclulding one serious event (falling followed by hospitalization). Notably, the 3 “severe” adverse events were all found in the duloxetine arm. All were resolved shortly after withdrawal.

The primary outcome, of the change in pain measured using the VAS, did not significantly differ between the duloxetine arm and the placebo arm; the secondary outcome, of the change in Timed Up and Go, did not significantly differ, either. In exploratory analyses, the changes from baseline were significantly better in people in the duloxetine arm in terms of scores on the UPDRS-III and in 3 domains of the PDQ-39: activities of daily living, emotional well-being, and communication. We also conducted the same analysis only including the participants who completed the study (per-protocol analysis), but we obtained the same conclusions.

We could not confirm the effect of duloxetine on pain as well as walking speed. Exploratory analyses indicated that treatment with duloxetine was associated with improved scores on the Unified Parkinson’s Disease Rating Scale Part III and 3 domains of the Parkinson’s Disease Questionnaire – 39.

Oct. 01, 2019

No

No plan for IPD sharing

https://jrct.niph.go.jp/latest-detail/jRCTs061180028

Ando Rina

Ehime University Hospital

Sitsukawa 454, Toon, Ehime

ando.rina.cn@ehime-u.ac.jp

Iwaki Hirotaka

Ehime University

Shitsukawa 454, Toon, Ehime

+81-899605095

h-iwaki@m.ehime-u.ac.jp

Complete

Oct. 01, 2014

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- Male or Female, 20 years old or older
- Diagnosed with Parkinson's disease
- Having pain associated with PD and depression.
-Provide written informed consent signed by the subject

-Concomitant use of duloxetine within 2 weeks
-Subject with contraindication to duloxetine
-Suicidal ideation
-Renal transplantation or dialysis therapy
-History of any kidney diseases or baseline creatinine clearance below 30 (mL/min/1.73 m2)
-Woman who are pregnant or lactating
-Evidence of clinically significant disease
- Subjects on antipsychotics
-Have had multiple drug allergies or a severe drug reaction
-History of drug or alcohol dependency or abuse
-History of treatment with antipsychotics within 1 year before Visit 1
- Other inadequate status for clinical trial

Both

Parkinson's disease

The treatment groups consist of an active treatment arm (40mg/day Duloxetine) and a placebo arm. During the Titration Period (2 weeks), all subjects will be started on 1 capsule (10mg or placebo). During the Maintenance Period (10 weeks), subjects will take 2 capsules. Subjects who are unable to increase their dose can stay at 1 capsule.

D010300

Visual analogue scale

The short-form McGill Pain Questionnaire, Beck's Depression Scale, Parkinson's Disease Questionnaire-39, Unified Parkinson's Disease Rating Scale, Up and Go Test

+81-89-960-5172

Jan. 28, 2019

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