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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-UMIN000026221
Date of registration:	01/03/2017
Prospective Registration:	Yes
Primary sponsor:	Department of Neurology, Juntendo University School of Medicine
Public title:	Safety of perampanel in patients with motor neuron disease
Scientific title:	Safety of perampanel in patients with motor neuron disease - Safety of perampanel in patients with motor neuron disease
Date of first enrolment:	2017/03/02
Target sample size:	15
Recruitment status:	Complete: follow-up complete
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030122
Study type:	Interventional
Study design:	Single arm Non-randomized
Phase:	Phase I

Countries of recruitment
Japan

Contacts

Name:	Kanai Kazuaki
Address:	2-1-1 Hongo, Bunkyo-ku, Tokyo Japan
Telephone:	03-3813-3111
Email:	kzkanai@juntendo.ac.jp
Affiliation:	Juntendo University School of Medicine Department of Neurology

Name:	Kanai Kazuaki
Address:	2-1-1 Hongo, Bunkyo-ku, Tokyo Japan
Telephone:	03-3813-3111
Email:	kzkanai@juntendo.ac.jp
Affiliation:	Juntendo University School of Medicine Department of Neurology

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: 1. Patients who are expected to show rapid symptomatic progression. 2. Patients with severe complications. 3. Patients with malignancy. 4. Patients with severe psychiatric symptoms. 5. Patients who participated in another cliniccal trial within 12 weeks. 6. Patients who are judged to be ineligible for study entry by the investigators.

Age minimum: 20years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

amyotrophic lateral sclerosis

Intervention(s)

Once daily perampanel with dose escalation from 2mg to 8mg.

Primary Outcome(s)

Persistency rate of perampanel at week 48

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

Department of Neurology, Juntendo University School of Medicine

Secondary Sponsor(s)

Ethics review

Status: YES
Approval date:
Contact:

Results

Results available:
Date Posted:
Date Completed:
URL:

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