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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	JPRN
Last refreshed on:	17 October 2023
Main ID:	JPRN-UMIN000011494
Date of registration:	02/09/2013
Prospective Registration:	Yes
Primary sponsor:	Mie University Graduate school of medicine,Department of neurology
Public title:	Assessment of the efficacy and the influence on swallowing function of transdermal scopolamine for ALS patinets' drooling
Scientific title:	Assessment of the efficacy and the influence on swallowing function of transdermal scopolamine for ALS patinets' drooling - SCOPOLA-D
Date of first enrolment:	2013/09/02
Target sample size:	10
Recruitment status:	Complete: follow-up complete
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013085
Study type:	Interventional
Study design:	Cross-over Randomized
Phase:	Not applicable

Countries of recruitment
Japan

Contacts

Name:	Yugo Narita
Address:	2-174 Edobashi Tsu, Mie 514-8507, Japan Japan
Telephone:	059-232-1111
Email:	yug@clin.medic.mie-u.ac.jp
Affiliation:	Mie University graduate school of medicine Department of neurology

Name:	Yugo Narita
Address:	2-174 Edobashi Tsu, Mie 514-8507, Japan Japan
Telephone:	059-232-1111
Email:	yug@clin.medic.mie-u.ac.jp
Affiliation:	Mie University Faculty of medicine school of nursing

Key inclusion & exclusion criteria

Inclusion 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

Age minimum: Not applicable
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

amyotrophic lateral sclerosis

Intervention(s)

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

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

Source(s) of Monetary Support

Group which MHLW(Ministry of health,labor and welfare)pays subsidies for the reserches of medical improvement and supports for the patients with intractable diseases

Secondary Sponsor(s)

Matsusaka Chuou Hospital National Mie Hospital

Ethics review

Status: YES
Approval date:
Contact:

Results

Results available:	Yes
Date Posted:
Date Completed:	31/03/2016
URL:

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