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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001897
Receipt No. 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

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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
Email

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
Email satanimu@m.ehime-u.ac.jp

Sponsor
Institute Ehime University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002296

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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