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Investigation of the effect of levodopa on the normal respiratory center

A single-group, non-blinded, non-controlled, non-randomized comparison study to investigate the effects of levodopa preparations on the respiratory center in healthy individuals

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031240275
Enrollment
24
Registered
2024-08-16
Start date
2025-05-16
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy individuals levodopa, respiration

Interventions

Administer a drip infusion by mixing 50 mg of Dopaston (in 20 mL) with 80 mL of normal saline.
levodopa

Sponsors

Tsunemi Taiji
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy individuals aged 40 to 80 years old (Healthy individuals are defined as those who do not have neurological or respiratory disorders and whose daily activities are not impaired). 2. Participants must be able to provide informed consent, and the acquisition of written consent must be possible based on the individual's free will. 3. Individuals who, after considering the selection and exclusion criteria, have been deemed eligible to participate in this study by the principal investigator (or participating physician).

Exclusion criteria

Exclusion criteria: 1. Those with neurological symptoms including subjective parkinsonism (tremor, akinesia, postural instability). 2. Individuals with a resting room air percutaneous oxygen saturation of 94% or less. 3. Those who experience respiratory distress at rest. 4. Individuals who have been indicated by blood tests conducted within the past year to have AST levels above 45 U/L, creatinine levels above 1.2 mg/dL for men, 1.0 mg/dL for women, and HbA1c levels above 6.5%. 5. Patients with a history of or current gastric or duodenal ulcers. 6. Those with severe cardiovascular or pulmonary diseases, bronchial asthma, or endocrine disorders. 7. Individuals with psychiatric symptoms such as suicidal tendencies. 8. Those with symptoms of closed-angle glaucoma. 9. Individuals with a history of hypersensitivity to the components of this drug. 10. Those planning pregnancy (both men and women). 11. Individuals who are pregnant or suspected to be pregnant. 12. Patients using reserpine preparations, antihypertensive drugs, antipsychotic drugs, general anesthetics, pyridoxine, antiparkinsonian drugs, NMDA receptor antagonists, papaverine hydrochloride, iron preparations, or isoniazid. 13. Individuals and their families who are affiliated with the Department of Neurology at Juntendo University Hospital. 14. Others deemed unsuitable as study subjects by the principal investigator (or co-investigator).

Design outcomes

Primary

MeasureTime frame
Change in P0.1 from before to after administration of levodopa preparation.

Secondary

MeasureTime frame
Ventilatory response Tidal volume Respiratory rate

Contacts

Public ContactTaiji Tsunemi

Juntendo University Hospital

t-tsunemi@juntendo.ac.jp+81-3-3813-3111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026