UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I/II study to evaluate the safety and efficacy of intrathecal injection of KP-100IT in subjects with acute spinal cord injury
Title of the study (Brief title)	Phase I/II study of KP-100IT in acute spinal cord injury
Region	Japan

Condition
Condition	Spinal Cord Injury
Classification by specialty	Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Safety
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	Adverse events Change of ASIA motor score from baseline at 24 weeks
Key secondary outcomes	ASIA sensory score Grade change of modified Frankel scale Concentration of KP-100 in plasma and cerebrospinal fluid

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Intrathecal injection of KP-100IT
Interventions/Control_2	Intrathecal injection of placebo
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	18 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	-Spinal cord injury at cervical level -Grade A, B1 or B2 in the modified Frankel scale at 72 hours since the injury. -Patients able to provide written informed consent, which may require a reltative to sign if arm/hand function is compromised.
Key exclusion criteria	-Spinal cord injury at C1-C2 or C2-C3 level -Patients not able to start rehabilitation within a week, by setup of respirator, or other reason. -First dose of the study drug will not be given within 78 hours since the injury -History of spinal cord injury, abnormality in spinal cavity, or considerable meningeal damage -Evaluation of safety and efficacy will not be conducted adequately by damage on brain, organs or multiple injuries -High-dose steroid therapy within 30 days before the entry -Patients who have diseases such as serious liver disorder, renal disorder, heart disease, blood dyscrasia, metabolism disorder and infections -History of malignant tumor -Patients who participated in other clinical study within 30 days before the entry -Patients who have allergies to drugs scheduled to be used in the study -Administration of the study drug to the area of spinal cord injury is not appropriate because of intrathecal infections or intrathecal tumor -Patients not able to understand "informed consent" properly -Patients who are nursing or may be pregnant -Investigator considers that the patient is not appropriate for participating in the study
Target sample size	48

Research contact person
Name of lead principal investigator	Etsuro, Hashimura
Organization	Kringle Pharma, Inc.
Division name	Department of Pharmaceutical Development
Address	Saito Biotechnology Incubator, 7-7-15 Saito-Asagi, Ibaraki, Osaka 567-0085 Japan
TEL	072-641-8739
Email	hashimura@kringle-pharma.com

Public contact
Name of contact person	Daichika, Hayata
Organization	Kringle Pharma, Inc.
Division name	Department of Pharmaceutical Development
Address	Saito Biotechnology Incubator, 7-7-15 Saito-Asagi, Ibaraki, Osaka 567-0085 Japan
TEL	072-641-8739
Homepage URL
Email	hayata@kringle-pharma.com

Sponsor
Institute	Kringle Pharma, Inc.
Institute
Department

Funding Source
Organization	Japan Agent for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Keio University School of Medicine
Name of secondary funｄer(s)	Kringle Pharma, Inc.

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	総合せき損センター(福岡県)、 北海道せき損センター(北海道)、 村山医療センター(東京都)

Other administrative information
Date of disclosure of the study information	2014 Year 06 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 04 Month 23 Day
Anticipated trial start date	2014 Year 06 Month 30 Day
Last follow-up date	2018 Year 05 Month 11 Day
Date of closure to data entry
Date trial data considered complete	2018 Year 07 Month 31 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 06 Month 30 Day
Last modified on	2018 Year 12 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016795