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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000034954
Receipt No. R000039856
Scientific Title Phase 1/2a, Double-blind, Placebo-controlled Study with an Open-label Extension of Ropinirole Hydrochloride Extended-Release Tablets -Explorative Assessment of the Safety, Tolerability, and Efficacy after Oral Treatment in Patients with Amyotrophic Lateral Sclerosis (ALS)-
Date of disclosure of the study information 2018/11/30
Last modified on 2019/05/26

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Basic information
Public title Phase 1/2a, Double-blind, Placebo-controlled Study with an Open-label Extension of Ropinirole Hydrochloride Extended-Release Tablets
-Explorative Assessment of the Safety, Tolerability, and Efficacy after Oral Treatment in Patients with Amyotrophic Lateral Sclerosis (ALS)-
Acronym Phase 1/2a Study of Ropinirole Hydrochloride Extended-Release Tablets in Patients with Amyotrophic Lateral Sclerosis (ALS)
Scientific Title Phase 1/2a, Double-blind, Placebo-controlled Study with an Open-label Extension of Ropinirole Hydrochloride Extended-Release Tablets
-Explorative Assessment of the Safety, Tolerability, and Efficacy after Oral Treatment in Patients with Amyotrophic Lateral Sclerosis (ALS)-
Scientific Title:Acronym Phase 1/2a Study of Ropinirole Hydrochloride Extended-Release Tablets in Patients with Amyotrophic Lateral Sclerosis (ALS)
Region
Japan

Condition
Condition amyotrophic lateral sclerosis (ALS)
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To exploratively assess the safety and tolerability of ropinirole hydrochloride, in terms of delay in the progression of ALS, after oral treatment in ALS patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The kind, frequency, severity and extent of adverse events, transition of laboratory values and the percentage of discontinued cases during double blined 24 weeks.
Key secondary outcomes After double blined 24 weeks,
1) Ratio of change in ALSFRS-R score per 4 weeks before and after treatment start
2) Change in ALSFRS-R score at 24 weeks in double-blind phase (double-blind day 1 to 24)
3) Change in ALSFRS-R score of the continuation period (final evaluation from first evaluation in continuation phase) and the whole administration period (day 1 in double-blind phase to final evaluation in continuation phase)
4) Completed Assessment of Function and Survival (CAFS) score at double-blind phase 24 weeks (day 1 to 24 weeks in double-blinded phase), continuation period (first evaluation to final evaluation in continuation phase) and whole administration period (day 1 in double-blind phase to final evaluation in continuation phase)
5) Combined evaluation by converting the following items into Z scores and adding them together
・Subscore for each ALSFRS-R domain (bulbar function, limb function, breathing function)
・ALS severity score
・Simple respiratory function test (FEV 1, FEV 6)
・Precise respiratory function test (VC, %FVC, FEV1%)
・Manual Muscle Test (MMT) score (limbs, trunk) and quantitative muscular strength
・Grip strength, pinch strength
・Modified Norris Scale (Bulbar Symptom Score)
・Tongue pressure
・Weight
・Physical activities, number of steps
・Objective muscle mass by skeletal muscle CT
・ALSAQ-40 score
6) Period until death or certain disease progression (death, inability to walk independently, abolition of one side upper limb function, tracheostomy, wearing of artificial respiratory equipment, intubation of nutrition, loss of practical conversation)
7) Period up to %FVC < 50%
8) Period until ALSFRS-R score decreased by 6 or more
9) Percentage of discontinued cases from day 1 in double-blind phase to final evaluation in continuation phase

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 YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Once daily ropinirole hydrochloride extended-release tablet with dose-escalation tolerable from 2mg to 16mg for double blinded 24 weeks
Interventions/Control_2 Once daily placebo tablet with dose-escalation tolerable from 2mg to 16mg for 24 weeks (Interventions)
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
80 years-old >=
Gender Male and Female
Key inclusion criteria (At provisional registration)
(1) Patients falling under probable laboratory-supported ALS, Clinically probable ALS or Clinically definite ALS in ALS diagnostic criteria (revised El Escorial criteria by the World Federation of Neurology), and within 60 months after onset
(2) Patients with severity classification of ALS (Ministry of Health, Labor and Welfare Specific Disease Research 2007.1.1) of 1 or 2
(3) Japanese patients who aged 20 to 80 years old
(4) Patients with the all items in ALSFRS-R (patients with the item in writing and feeding behavior (1) on one or both sides of 2 or more points) of 2 or more points
(5) Patients with percent FVC more than 70
(6) Patients who can submit written informed consent. If patients are duly capable of study consent but are unable to sign by themselves due to aggravation of disease condition, written informed consent can be obtained from a legally authorized representative who can sign on behalf of the patients after confirming the patients' agreement to study participation.
(7) Patients eligible for outpatient visit (and hospitalization) during trial period

(At definitive registration)
(8) Patients whose change in ALSFRS-R score is between -2 to -5 during 12 weeks of observation phase
(9) Patients who have not newly introduced riluzole since the start of observation phase, and who have not changed or discontinued the dose of riluzole
(10) Patients who did not administered edaravone and high-dose mecobalamin (25 mg or 50 mg) since the start of observation phase
(11) Patients eligible for outpatient visit (and hospitalization) during trial period
Key exclusion criteria (1) Patients with severe diseases such as hepatic disorder, kidney disorder, heart disease, lung disease, blood disorder, metabolic disorder and whom investigators judged inappropriate for trial
(2) Patients who participated in other clinical trials within 30 days prior to provisional registration
(3) Patients with cancer complicated, or not more than 5 years after cure
(4) Patients who have used ropinirole hydrochloride
(5) Patients with family history of ALS with SOD-1 mutation or who have previously been diagnosed with ALS with SOD-1 mutations
(6) Pregnant women or women who may be pregnant, lactating women
(7) Patients with orthostatic hypotension with subjective symptoms (dizziness, syncope etc.)
(8) Patients who have psychiatric disorders or psychiatric symptoms and are considered difficult to participate in this trial
(9) Patients whom investigators judged as inappropriate for trial
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Jin
Middle name
Last name Nakahara
Organization Keio University Hospital
Division name Department of Neurology
Zip code 160-0016
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL 03-3353-1211
Email nakahara@a6.keio.jp

Public contact
Name of contact person
1st name Shinichi
Middle name
Last name Takahashi
Organization Keio University Hospital
Division name Department of Neurology
Zip code 160-0016
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL 03-3353-1211
Homepage URL https://www.neurology.med.keio.ac.jp
Email takashin@tka.att.ne.jp

Sponsor
Institute Keio University Hospital
Institute
Department

Funding Source
Organization Japan Agency of Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) K Pharma, Inc

IRB Contact (For public release)
Organization Keio University Hospital Institutional Review Board
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
Tel 03-3353-1211
Email keio-chiken@adst.keio.ac.jp

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
2018 Year 11 Month 30 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 Suspended
Date of protocol fixation
2018 Year 10 Month 04 Day
Date of IRB
2018 Year 11 Month 01 Day
Anticipated trial start date
2018 Year 12 Month 05 Day
Last follow-up date
2020 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 11 Month 20 Day
Last modified on
2019 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039856

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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