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Additional levodopa for muscle and joint pain

Researchers are testing whether extra Parkinson's medicine changes pain compared with placebo tablets.

Testing a treatment or activity · Study reference: RBR-103bk9wn

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

This registry record was last updated over six months ago, or its update date is missing. Recruitment may have changed. Confirm with the team before making plans.

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Results reported

Start (reported date)
2025-08-01
Study finished (reported date)
2028-06-16

Planned dates can move. A study finishing does not tell us when a paper will be published.

Read the results reported in the registry

Changes we have recorded
  • 2026-10-11 — recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.

Who can join?

Ages 18y to 85y · Ask the team who can join

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: -

Inclusion criteria: Non-pregnant men and women aged between 18 and 85 years; idiopathic Parkinson’s disease; chronic nociceptive pain as defined by the Parkinson’s Disease Pain Classification System (PD-PCS); chronic pain of at least moderate intensity defined as a score equal to or greater than 4 on a 0–10 visual analog pain scale; capable of providing informed consent in accordance with current institutional policies Exclusion criteria: Patients with unstable psychiatric comorbidities; musculoskeletal pain intensity lower than 4 on a 0–10 visual analog scale; inability to provide free and informed consent; presence of uncontrolled active infection or severe decompensated clinical conditions; uncontrolled diabetes mellitus; uncontrolled systemic arterial hypertension; symptomatic pulmonary or cardiac diseases; concurrent participation in other clinical trials; and women who are pregnant or breastfeeding.
Full study name & original research details

Official study title

Efficacy of Additional Dopaminergic Replacement Therapy on Nociceptive Pain in Patients with Parkinson’s Disease: A Prospective Randomized Controlled Trial

Short title used by the registry

Benefit of increasing Levodopa in the treatment of musculoskeletal pain in Parkinson’s disease

Original description

Intervention: This is a randomized, double-blind, placebo-controlled clinical trial. Participants will be randomized to receive either additional dopaminergic replacement therapy (DRT group) or placebo tablets (placebo group). Randomization will be performed using a computer-generated sequence, and both participants and outcome assessors will remain blinded to treatment allocation. A total of 90 patients will be included, with 60 patients allocated to the DRT group and 30 patients allocated to the placebo group. Within the DRT group, 30 patients will receive a 10% increase in their daily levodopa equivalent dose (LED) using levodopa/benserazide (Prolopa®) tablets, and 30 patients will receive a 20% increase in their daily LED with the same formulation. Within the placebo group, 15 patients will receive placebo tablets in a number equivalent to a 10% increase in LED, and 15 patients will receive placebo tablets in a number equivalent to a 20% increase in LED. Levodopa/benserazide (Prolopa®) will be used as the active drug in the intervention group, with dosages individually adjusted to provide either a 10% or 20% increase in baseline daily LED while maintaining the existing therapeutic regimen. Placebo tablets will be identical in appearance, size, and color to the active tablets. All placebo tablets will be manufactured to be indistinguishable from the active levodopa/benserazide tablets, with packaging, labeling, and dispensing following good clinical practice standards to ensure complete blinding of participants, investigators, and outcome assessors. The intervention period will last for 2 weeks, after which participants will undergo reassessment according to the study protocol, and the assigned treatment will be discontinued. Primary outcome: Proportion of individuals presenting with 50% or more reduction in the average pain intensity, assessed by the verbal numeric pain rating scale (Brief Pain Inventory item 5) at the end of two-week follow-up period, when compared to baseline values. Secondary outcome: The total score of the Parkinson's Disease Pain Classification System (PD-PCS) at the end of the 2-week follow-up period.;The scores of the Brief Pain Inventory at the end of the two-week follow-up period.;The score of the PDQ-8 (8-item Parkinson's Disease Questionnaire) at the end of the 2-week follow-up period.;The total score of The Hospital Anxiety and Depression Scale (HADS), as well as of its anxiety and depression subscales, at the end of the 2-week follow-up period.;The score of the Clinical Global Impression of Change scale at the end of the 2-week follow-up period.;The scores of the Patient Global Impression of Change scale at the end of the 2-week follow-up period.;The score of the MDS-UPDRS (Movement Disorders Society - Unified Parkinson's Disease Rating Scale) Part III scale at the end of the end of the 2-week follow-up period.

Conditions reported: Parkinson Disease; Other chronic pain Pain, not elsewhere classified

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

Study type
Interventional
Interventions
This is a randomized, double-blind, placebo-controlled clinical trial. Participants will be randomized to receive either additional dopaminergic replacement therapy (DRT group) or placebo tablets (placebo group). Randomization will be performed using a computer-generated sequence, and both participants and outcome assessors will remain blinded to treatment allocation. A total of 90 patients will be included, with 60 patients allocated to the DRT group and 30 patients allocated to the placebo group. Within the DRT group, 30 patients will receive a 10% increase in their daily levodopa equivalent dose (LED) using levodopa/benserazide (Prolopa®) tablets, and 30 patients will receive a 20% increase in their daily LED with the same formulation. Within the placebo group, 15 patients will receive placebo tablets in a number equivalent to a 10% increase in LED, and 15 patients will receive placebo tablets in a number equivalent to a 20% increase in LED. Levodopa/benserazide (Prolopa®) will be used as the active drug in the intervention group, with dosages individually adjusted to provide either a 10% or 20% increase in baseline daily LED while maintaining the existing therapeutic regimen. Placebo tablets will be identical in appearance, size, and color to the active tablets. All placebo tablets will be manufactured to be indistinguishable from the active levodopa/benserazide tablets, with packaging, labeling, and dispensing following good clinical practice standards to ensure complete blinding of participants, investigators, and outcome assessors. The intervention period will last for 2 weeks, after which participants will undergo reassessment according to the study protocol, and the assigned treatment will be discontinued.
Phases
4
Sponsor
Centro de Dor do Departamento de Neurologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Start date reported by registry
2025-08-01 (reported)

Registry updated: Not reported · Status last verified by the registry submitter: Not reported

Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Gabriel Kubota · +55 (11) 2661-7585 · gabriel.kubota@hc.fm.usp.br

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

Facility not reported

BR

Status not reported

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.