UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008527 |
|---|---|
| Receipt number | R000005640 |
| Scientific Title | Study of efficacy and safety of NDDPX08 in ALS patients |
| Date of disclosure of the study information | 2012/07/25 |
| Last modified on | 2015/12/11 17:48:03 |
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Basic information
Public title
Study of efficacy and safety of NDDPX08 in ALS patients
Acronym
NDDPX08-ALS clinical research
Scientific Title
Study of efficacy and safety of NDDPX08 in ALS patients
Scientific Title:Acronym
NDDPX08-ALS clinical research
Region
| Japan |
Condition
Condition
Amyotrophic Lateral Sclerosis
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Amyotrophic lateral sclerosis (ALS) is a motor neuron disease involving selective impairment of motor nerves and presenting with progressive muscular weakness and atrophy. Its etiology remains to be clarified, and no drug adequately effective against this disease is available at present. Thus, it has been desired to develop new methods of treatment for this disease. In our previous studies using a system of cultured cells exposed to oxidative stress, it was shown that NDDPX08 (a compound currently used clinically as a means of treating Parkinson's disease) uppresses loss of nerve cell viability. Furthermore, treatment with NDDPX08 after the onset of ALS was shown to improve motor function and extend the survival period of transgenic mice (mice transfected with the familial ALS type 1 mutant SOD-1 gene, an animal model of ALS).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Statistical analysis of efficacy data at the end of the study is assigned to an outside contractor. The information about the subjects assigned to the active drug treatment and placebo groups is disclosed at the time of statistical analysis. Statistical analysis as to the efficacy of the test drug is carried out in comparison to the efficacy data from the placebo group, the time course of variables relative to estimates at the end of the 12-week observation period and the natural history of the disease.
The ALS Treatment Plan Evaluation Committee evaluates and judges the safety and efficacy of NDDPX08 in patients with ALS on the basis of the results of the statistical analysis.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
For patients who begin to receive Rilutek treatment at the start or 4 weeks before the start of the observation period, the 12-week treatment with Rilutek alone (100 mg/day) during the observation period is followed by combined treatment (Rilutek + NDDPX08). The NDDPX08 dose level begins at 1.25 mg/day and is increased in steps to 15 mg/day during the 12-week treatment period according to the dose escalation schedule given on the next page (Fig. 1). If any serious adverse reaction arises following a dose increase to 10 mg/day and it is judged to be difficult to maintain this dose level, the dose level of 7.5 mg/day is regarded as the maintenance dose level. If alleviation of symptoms is noted during dose escalation steps, the dose level producing alleviation of symptoms is used as the maintenance dose level.
The total NDDPX08 treatment period is 58-90 weeks (including the 4 weeks during which the dose level is reduced in steps). Follow-up of adverse events is continued until 1 month after the end of NDDPX08 treatment.
Interventions/Control_2
Placebo (lactose) is administered to 10 of the 50 subjects planned to be enrolled in the study.
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed as having ALS and satisfying all of the following
Key exclusion criteria
Patients diagnosed as having ALS and satisfying all of the following
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Joh-E Ikeda |
Organization
Tokai University School of Medicine
Division name
Department of Molecular Life Sciences Basic Medical Science and Molecular Medicine
Zip code
Address
143 Shimokasuya, Isehara-shi, Kanagawa
TEL
0463-93-1121
joh-e@mgcheo.med.uottawa.ca
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Joh-E Ikeda |
Organization
Tokai University School of Medicine
Division name
Department of Molecular Life Sciences Basic Medical Science and Molecular Medicine
Zip code
Address
143 Shimokasuya, Isehara-shi, Kanagawa
TEL
0463-91-5014
Homepage URL
joh-e@mgcheo.med.uottawa.ca
Sponsor or person
Institute
FeGALS
Institute
Department
Personal name
Funding Source
Organization
Health Labour Sciences Research Grant
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
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
| 2012 | Year | 07 | Month | 25 | 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
| 2008 | Year | 11 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2012 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 25 | Day |
Last modified on
| 2015 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005640
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| Registered date | File name |
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