Main
|
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-UMIN000008477 |
Date of registration:
|
19/07/2012 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
Public title:
|
Clinical study of selegiline hydrochloride ( FP OD tablet 2.5) to flexion of spine in Parkinson's disease.
|
Scientific title:
|
Clinical study of selegiline hydrochloride ( FP OD tablet 2.5) to flexion of spine in Parkinson's disease. - Clinical study of selegiline to flexion of spine in Parkinson's disease. |
Date of first enrolment:
|
2012/07/19 |
Target sample size:
|
20 |
Recruitment status: |
Complete: follow-up complete |
URL:
|
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009452 |
Study type:
|
Interventional |
Study design:
|
Single arm Non-randomized
|
Phase:
|
Not selected
|
|
Countries of recruitment
|
Japan
| | | | | | | |
Contacts
|
Name:
|
Asako Yoritaka |
Address:
|
Fukuroyama 560, Koshigaya-shi, Saitama, Japan
|
Telephone:
|
+81-48-975-0321 |
Email:
|
ayori@juntendo.ac.jp |
Affiliation:
|
Juntendo Koshigaya Hospital Neurology |
|
Name:
|
Asako Yoritaka |
Address:
|
Fukuroyama 560, Koshigaya-shi, Saitama, Japan
|
Telephone:
|
+81-48-975-0321 |
Email:
|
ayori@juntendo.ac.jp |
Affiliation:
|
Juntendo Koshigaya Hospital Neurology |
| |
Key inclusion & exclusion criteria
|
Inclusion criteria:
Exclusion criteria: 1) Patients receiving drugs prohibited for concomitant 2) Patients who have lumber spine deformation evaluated by an X-ray examination 3) Patients whit orthostatic hypotension 4) Patients receiving medical treatment for epilepsy 5) Patient who have symptoms of serious nerve and / or psychiatric disorders such as disturbance of consciousness , hallucination , delusions and abnormal behavior 6) Patient with severs disease of heart , blood vessels , liver , renal , blood and other life-threatening diseases 7) Patients who have or had schizophrenia 8) Patients who have or had addiction to central nerve system stimulants such as cocaine 9) Patients who are pregnant during the period of study 10) Patients addiction to alcohol or drugs 11) Patients who are determined as unfit for the study by attending physicians for reasons other than those stated above
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
|
Health Condition(s) or Problem(s) studied
|
Parkinson disease
|
Intervention(s)
|
Selegiline hydrochloride 5mg 8weeks, 7.5mg 8weeks and stop it, followed after 8weeks, and evaluate each points.
|
Primary Outcome(s)
|
Rsults of stabilometry (Gravicoder GS-3000; AeNIMA)
|
Secondary Outcome(s)
|
1. Modified Hoehn & Yahr stage of Parkinson's Disease 2. Iapanese version, UPDRS Part I, Part II, Part III, Part IV 3. Degree of posture flexion (degree of antero flexion/ degree of side flexion) using photo. 4. Pain evaluation with VAS scale. 5. Safety evaluation, side effects.
|
Source(s) of Monetary Support
|
Department of Neurology, Juntendo Koshigaya Hospital
|
Ethics review
|
Status: YES
Approval date:
Contact:
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
19/12/2014 |
URL:
|
|
|
|