UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007062 |
|---|---|
| Receipt number | 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 16:41:55 |
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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
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
info@kringle-pharma.com
Sponsor or person
Institute
Kringle Pharma, Inc.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007316
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
