UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008477 |
|---|---|
| Receipt number | R000009452 |
| Scientific Title | Clinical study of selegiline hydrochloride ( FP OD tablet 2.5) to flexion of spine in Parkinson's disease. |
| Date of disclosure of the study information | 2012/07/19 |
| Last modified on | 2015/09/22 09:15:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Clinical study of selegiline hydrochloride ( FP OD tablet 2.5) to flexion of spine in Parkinson's disease.
Acronym
Clinical study of selegiline 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.
Scientific Title:Acronym
Clinical study of selegiline to flexion of spine in Parkinson's disease.
Region
| Japan |
Condition
Condition
Parkinson disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate effectiveness of selegiline hydrochloride (FP OD tablet 2.5) to the flexion of spine associated with Parkinson's disease. We use stabilometory to evaluate it objectively
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rsults of stabilometry (Gravicoder GS-3000; AeNIMA)
Key secondary outcomes
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.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Selegiline hydrochloride 5mg 8weeks, 7.5mg 8weeks and stop it, followed after 8weeks, and evaluate each points.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed as Parkinson' s disease and classified into Modified Hohen & Yahr staging Scale I through
2) Patients whose symptom of posture disorder is latent in supine position
3) Patients aged 20 or over when their consents given
4) Hospitalized patients/outpatients
Key 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
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Asako Yoritaka |
Organization
Juntendo Koshigaya Hospital
Division name
Neurology
Zip code
Address
Fukuroyama 560, Koshigaya-shi, Saitama, Japan
TEL
+81-48-975-0321
ayori@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Asako Yoritaka |
Organization
Juntendo Koshigaya Hospital
Division name
Neurology
Zip code
Address
Fukuroyama 560, Koshigaya-shi, Saitama, Japan
TEL
+81-48-975-0321
Homepage URL
ayori@juntendo.ac.jp
Sponsor or person
Institute
Department of Neurology, Juntendo Koshigaya Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Neurology, Juntendo Koshigaya Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
順天堂大学附属順天堂越谷病院 神経内科外来
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 05 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 19 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 19 | Day |
Date of closure to data entry
| 2015 | Year | 09 | Month | 10 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 19 | Day |
Last modified on
| 2015 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009452
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
