Guillain-Barré SyndromePhase 3NCT02221271
Phase III Clinical Trial of NPB-01 in Patients With Guillain-Barré Syndrome
A Phase 3 study testing NPB-01 in people with Guillain-Barré Syndrome, run by Nihon Pharmaceutical Co., Ltd at 1 site in Japan.
Trial summary
Patients diagnosed with Guillain-Barré syndrome were confirmed based on the diagnostic criteria for Guillain-Barré syndrome. Patients who meet all inclusion criteria and do not conflict with the exclusion criteria will receive NPB-01 (intravenous immunoglobulin) 400mg/kg/day for five consecutive days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Guillain-Barré Syndrome
- What is being tested?
- NPB-01
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2014to Aug 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In principle, patients are able to receive study drug within 2weeks(with limits of 4weeks) from the start of symptoms.
- Patients with predominant motor neuropathy and Hughes's Functional Grade(FG) is grade4 or grade5(in this regard, if symptoms is progressive, patients with FG is grade3 involve in this study).
- Patients with plasmapheresis, steroids(in prednisolone equivalent, more than 100mg/day) and immune globulin therapy is no operation for this onset.
- Patients with greater than or equal to 18 years old at informed consent.
Who cannot join
- Patients with history of shock for NPB-01.
- Patients with history of hypersensitivity for NPB-01.
- Patients with history of volatile organic solvent abuse, abnormal porphyrin metabolism, history of pharynx or cutaneous diphtheria, plumbism, tephromyelitis, botulism, hysterical paralysis, toxic neuropathy(nitrofurantoin, dapsone, organophosphorous compound), serious diabetic neuropathy,peripheral neuropathy due to HIV,impaired peripheral neuropathy except Guillain-Barré syndrome.
- Patients with malignancy at informed consent.
- Patients treated with immune globulin at 8 weeks before informed consent.
- Patients with IgA deficiency.
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- Patients with impaired liver function.
- Patients with impaired renal function.
- Patients with cerebro- or cardiovascular disorders.
- Patients with high risk of thromboembolism.
- Patients with hemolytic/hemorrhagic anemia.
- Patients with decreased cardiac function.
- Patients with decreased platelet.
Trial locations and contacts
1 site in 1 country.
About this study
Patients diagnosed with Guillain-Barré syndrome were confirmed based on the diagnostic criteria for Guillain-Barré syndrome. Patients who meet all inclusion criteria and do not conflict with the exclusion criteria will receive NPB-01 (intravenous immunoglobulin) 400mg/kg/day for five consecutive days.
Patients evaluate the Functional Grade（FG） and Arm Grade（AG） et al.
As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse events by the start of the study treatment.
- Conditions
- Guillain-Barré Syndrome
- Being tested
- NPB-01
- Medical subject headings
- Guillain-Barre Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPB-01Drug
| Study group | Role | What they receive |
|---|---|---|
| NPB-01 | Experimental | Not described Receives: Drug: NPB-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients with more than 1grade improvement in the Hughes functional grading scale(FG) relative to baseline at 4weeks.
Measured: Baseline,4weeks
Secondary outcomes (11)
days required for 1 grade improvement of the Hughes functional grading scale(FG)
Measured: Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks
days required for 2 grade improvement of the Hughes functional grading scale(FG)
Measured: Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks
changes in Hughes functional grading scale(FG)
Measured: Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks
proportion of patients with more than 1 grade improvement in the Arm Grade(AG) relative to baseline at 4weeks.
Measured: Baseline,4weeks
days required for 1 grade improvement of the Arm Grade(AG)
Measured: Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks
days required for 2 grade improvement of the Arm Grade(AG)
Measured: Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks
changes in Arm Grade(AG)
Measured: Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks
changes in manual muscle testing(MMT)
Measured: Baseline,1,2,3,4,8,12 weeks
changes in grip strength
Measured: Baseline,1,2,3,4,8,12 weeks
changes in activity of daily living(ADL)
Measured: Baseline,1,2,3,4,8,12 weeks
changes in electrophysiological findings
Measured: Baseline,4,12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Guillain-Barré SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nihon Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02221271
- Sponsor's protocol ID
- NPB-01-13/C-01
- Status last verified
- Apr 2017
- First submitted
- 12 Aug 2014
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Clinical Trial of NPB-01 in Patients With Guillain-Barré Syndrome
- ClinicalTrials.gov ID
- NCT02221271
- Acronym / sponsor ID
- NPB-01-13/C-01
- Conditions
- Guillain-Barré Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Nihon Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2014 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 20 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients diagnosed with Guillain-Barré syndrome were confirmed based on the diagnostic criteria for Guillain-Barré syndrome. Patients who meet all inclusion criteria and do not conflict with the exclusion criteria will receive NPB-01 (intravenous immunoglobulin) 400mg/kg/day for five consecutive days.
Patients evaluate the Functional Grade（FG） and Arm Grade（AG） et al.
As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse events by the start of the study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NPB-01 | Experimental | Drug: NPB-01 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- In principle, patients are able to receive study drug within 2weeks(with limits of 4weeks) from the start of symptoms.
- Patients with predominant motor neuropathy and Hughes's Functional Grade(FG) is grade4 or grade5(in this regard, if symptoms is progressive, patients with FG is grade3 involve in this study).
- Patients with plasmapheresis, steroids(in prednisolone equivalent, more than 100mg/day) and immune globulin therapy is no operation for this onset.
- Patients with greater than or equal to 18 years old at informed consent.
Key exclusion criteria (13 listed)
- Patients with history of shock for NPB-01.
- Patients with history of hypersensitivity for NPB-01.
- Patients with history of volatile organic solvent abuse, abnormal porphyrin metabolism, history of pharynx or cutaneous diphtheria, plumbism, tephromyelitis, botulism, hysterical paralysis, toxic neuropathy(nitrofurantoin, dapsone, organophosphorous compound), serious diabetic neuropathy,peripheral neuropathy due to HIV,impaired peripheral neuropathy except Guillain-Barré syndrome.
- Patients with malignancy at informed consent.
- Patients treated with immune globulin at 8 weeks before informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NPB-01 | Drug | NPB-01 |
Primary outcome
proportion of patients with more than 1grade improvement in the Hughes functional grading scale(FG) relative to baseline at 4weeks.
Time frame: Baseline,4weeks
11 secondary outcomes
days required for 1 grade improvement of the Hughes functional grading scale(FG)
Time frame: Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks
days required for 2 grade improvement of the Hughes functional grading scale(FG)
Time frame: Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks
changes in Hughes functional grading scale(FG)
Time frame: Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks
proportion of patients with more than 1 grade improvement in the Arm Grade(AG) relative to baseline at 4weeks.
Time frame: Baseline,4weeks
days required for 1 grade improvement of the Arm Grade(AG)
Time frame: Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks
days required for 2 grade improvement of the Arm Grade(AG)
Time frame: Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks
changes in Arm Grade(AG)
Time frame: Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks
changes in manual muscle testing(MMT)
Time frame: Baseline,1,2,3,4,8,12 weeks
changes in grip strength
Time frame: Baseline,1,2,3,4,8,12 weeks
changes in activity of daily living(ADL)
Time frame: Baseline,1,2,3,4,8,12 weeks
changes in electrophysiological findings
Time frame: Baseline,4,12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NPB-01 in people with Guillain-Barré Syndrome, run by Nihon Pharmaceutical Co., Ltd at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of patients with more than 1grade improvement in the Hughes functional grading scale(FG) relative to baseline at 4weeks. (time frame: Baseline,4weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2017.