UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001897 |
|---|---|
| Receipt number | R000002296 |
| Scientific Title | The safety and efficacy of Yokukansan in treating neuropsychiatric symptoms of patients with Fronto-Temporal Lobar Degeneration (FTLD) |
| Date of disclosure of the study information | 2009/04/20 |
| Last modified on | 2009/04/20 13:51:17 |
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Basic information
Public title
The safety and efficacy of Yokukansan in treating neuropsychiatric symptoms of patients with Fronto-Temporal Lobar Degeneration (FTLD)
Acronym
The safety and efficacy of Yokukansan in treating neuropsychiatric symptoms of patients with Fronto-Temporal Lobar
Scientific Title
The safety and efficacy of Yokukansan in treating neuropsychiatric symptoms of patients with Fronto-Temporal Lobar Degeneration (FTLD)
Scientific Title:Acronym
The safety and efficacy of Yokukansan in treating neuropsychiatric symptoms of patients with Fronto-Temporal Lobar
Region
| Japan |
Condition
Condition
Fronto-Temporal Lobar Degeneration (FTLD)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating the safety and efficacy of Yokukansan in treating neuropsychiatric symptoms of patients with Fronto-Temporal Lobar Degenneration (FTLD)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
NPI-D
Key secondary outcomes
SRI, Barthel Index, Zaril Caregiver Burden Scale
MMSE, swallowing ability, appetite level, questionnaire regarding eating patterns, cerebral blood flow
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
Dosage is 7.5 g/day divided into 2 to 3 oral doses, and taken before or between meals.
Dosage may be adjustd according to the patient's age, weight and symptoms.
Administration period : 8 weeks
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
| 40 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patientsw diagnosed with Fronto-Temporal Dementia (FTD) or Semantic Dementia (SD) according to the clinical criteria of Intrenational Working Group(Neary D. et al, 1998) of Fronto-Temporal Lober Degeneration.
2) Patients with NPI-D score of 4 and hugher in 1 or more items at the start f the treatment.
3) Patients with serum potassium levels within the standard range of the facility when measured within 8 weeks before the start of teatment.
4) Medical Consultation : Outpatients as a general ule, but inpatients from hospitals, clinics and medical facilities are also accepted (changes in medical setting where patients receive care during the study, however, is unacceptable).
5) Outpatients must have a reliable caregiver at home during the entire duration of the study who can tranport the patient to the hospital for conculusion.
6)Inpatients must have been receiving care at their respective medical facility for least 2 weeks before the strart of the study, and must also have a caregiver or belong to a nursing home during the entire dution of the study.
Key exclusion criteria
1) Patients with concomitant diagnosis of malignant cancer.
2) Patients with concomitant diagnosis o sevious heart, liver, lung or kidney disease, blood disorders, or other life-threatening diseases.
3) Ptients with other forms of dementia (AD, VD, DLB) besides Fronto-Temporal Degeneration (FTLD)
4) Patients who fail to meet the DSM-IV diagnostic criteria for our study, but show symptoms of BPSD due to other concomitant neurodegerative disease, Scizophrenia, Bipolar disorder, Major depressive disorder or other psychiatric disorders.
5) Patients with delirium due to alcohol or drug addicution, metabolic poisoning, or inflammatory disease.
6) Patients who are unable to take oral medications.
7) Patients who altered their dosage or method of administration of SSRI, 8 weeks before the start of the study.
8) Ptients who took long acting antipsychotic durgs (such as haloperidol decanoate) 4 weeks before the start of treatment.
9) 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 | Satoshi TANIMUKAI |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Neuropsychiatry, Neuroscience
Zip code
Address
Shitsukawa, Toon-shi, Ehime, JAPAN
TEL
089-960-53115
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi TANIMUKAI |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Neuropsychiatry, Neuroscience
Zip code
Address
Shitsukawa, Toon-shi, Ehime, JAPAN
TEL
089-960-5315
Homepage URL
satanimu@m.ehime-u.ac.jp
Sponsor or person
Institute
Ehime University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tsumura Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
JAPAN
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 04 | Month | 20 | 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
Date of protocol fixation
| 2009 | Year | 03 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 04 | Month | 20 | Day |
Last modified on
| 2009 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002296
