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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007062
Receipt No. R000007316
Scientific Title A Phase I, Dose-Escalating Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Intrathecal Infusion of KP-100IT through SM-1500 in Subjects with Amyotrophic Lateral Sclerosis (ALS)
Date of disclosure of the study information 2012/01/16
Last modified on 2015/07/14

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Basic information
Public title A Phase I, Dose-Escalating Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Intrathecal Infusion of KP-100IT through SM-1500 in Subjects with Amyotrophic Lateral Sclerosis (ALS)
Acronym A Phase I, Dose-Escalating Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Intrathecal Infusion of KP-100IT through SM-1500 in Subjects with Amyotrophic Lateral Sclerosis (ALS)
Scientific Title A Phase I, Dose-Escalating Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Intrathecal Infusion of KP-100IT through SM-1500 in Subjects with Amyotrophic Lateral Sclerosis (ALS)
Scientific Title:Acronym A Phase I, Dose-Escalating Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Intrathecal Infusion of KP-100IT through SM-1500 in Subjects with Amyotrophic Lateral Sclerosis (ALS)
Region
Japan

Condition
Condition Amyotrophic lateral sclerosis (ALS)
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and tolerability of single and multiple intrathecal doses of KP-100IT by assessing adverse events in subjects with ALS
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Safety and tolerability of KP-100IT
Safety of SM-1500
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 5
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Single intrathecal infusion of KP-100IT at the low dose
Interventions/Control_2 Single intrathecal infusion of KP-100IT at the middle dose
Interventions/Control_3 Single intrathecal infusion of KP-100IT at the high dose
Interventions/Control_4 Multiple intrathecal infusion of KP-100IT
at the middle dose
Interventions/Control_5 Multiple intrathecal infusion of KP-100IT at the high dose
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
65 years-old >
Gender Male and Female
Key inclusion criteria - 'Clinically Definite ALS', 'Clinically Probable ALS' or 'Clinically Possible-Laboratory-supported ALS' by El Escorial Criteria
- Within 3 years after onset of the disease
- Stage I or II in ALS severity classification
Key exclusion criteria -Have a serious disorder in any systems or have a serious metabolic defect, so that the investigators decide to be unsuitable for participation in the trial.
-Have hemoglobin A1c 6.1 (JDS value) or more.
-Any observation of diseases/symptomes below; malignant neoplasm, intrathecal infection/mass, proliferative retinopathy, %VC less than 70% in spirogram
-Have a history of intolerance to transplantation of medical devices
-Have received an investigational drugs or devices within a month before onformed consent
-Be unsuitable for participation in the trial for any reason, according to the investigators.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masashi Aoki, MD, PhD
Organization Touhoku University School of Medicine
Division name Neurology
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574 Japan
TEL 022-717-7189
Email aokim@med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsushi Abe
Organization Kringle Pharma, Inc.
Division name Department of Pharmaceutical Development
Zip code
Address Saito Biotechnology Incubator, 7-7-15 Saito-Asagi, Ibaraki,, Osaka 560-0082 Japan
TEL 072-641-8739
Homepage URL http://www.kringle-pharma.com
Email info@kringle-pharma.com

Sponsor
Institute Kringle Pharma, Inc.
Institute
Department

Funding Source
Organization Japan Agenct for MedicalResearch and Development
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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 2011.6.3.、 初回

Institutions
Institutions 東北大学病院(宮城県)

Other administrative information
Date of disclosure of the study information
2012 Year 01 Month 16 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
2011 Year 09 Month 13 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 16 Day
Last follow-up date
2014 Year 08 Month 07 Day
Date of closure to data entry
2014 Year 08 Month 28 Day
Date trial data considered complete
2014 Year 09 Month 25 Day
Date analysis concluded
2015 Year 08 Month 30 Day

Other
Other related information

Management information
Registered date
2012 Year 01 Month 13 Day
Last modified on
2015 Year 07 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007316

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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