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Assessment of the efficacy and the influence on swallowing function of transdermal scopolamine for ALS patinets' drooling

Assessment of the efficacy and the influence on swallowing function of transdermal scopolamine for ALS patinets' drooling - SCOPOLA-D

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000011494
Enrollment
10
Registered
2013-09-02
Start date
2013-09-02
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

amyotrophic lateral sclerosis

Interventions

scopolamine patch 7days-washout 7days-placebo patch 7days placebo patch 7days-washout 7days-scopolamine patch 7days

Sponsors

Mie University Graduate school of medicine,Department of neurology
Lead Sponsor
Matsusaka Chuou Hospital National Mie Hospital
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.ALS patients with drooling who were diagnosed by EI Escorial revised Airlie House criteria as clinically definite,clinically probable or clinically pssible ALS. 2.The patients who consented to commit to this research in writing after sufficient informed consent

Exclusion criteria

Exclusion criteria: 1.diagnosed as progressive case delta FS is over 0.67 2.diagnosed as severe hypoventilation and the patient doesn't want to use NIPPV 3.diagnosed as glaucoma 4.diagnosed as benign prostatic hypertrophy 5.past history of intestinal obstruction 6.allergy to this drug 7.pregnant or expecting to be pregnant 8.judged as an inadequate patient by responsible doctors

Design outcomes

Primary

MeasureTime frame
Efficacy of transdermal scopolamine for ALS patients' drooling assessed by VAS(visual analogue scale) and SSS(sialorrhea scoring scale).

Secondary

MeasureTime frame
Efficacy of transdermal scopolamine for ALS patients' drooling assessed by other scales besides VAS and SSS. Influences on the swallowing dysfunction worthning. Adverse ivents.

Countries

Japan

Contacts

Public ContactYugo Narita

Mie University graduate school of medicine Department of neurology

yug@clin.medic.mie-u.ac.jp059-232-1111

Outcome results

None listed

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