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Completed

NCT Number: NCT02221271

Phase III Clinical Trial of NPB-01 in Patients With Guillain-Barré Syndrome

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.

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Key information

Conditions

Guillain-Barré Syndrome Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Diseases Disease Attributes Guillain-Barre Syndrome Immune System Diseases Nervous System Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies Polyradiculoneuropathy Post-Infectious Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nihon Pharmaceutical Co., Ltd

Osaka, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

NPB-01

Drug

Primary outcomes

  1. proportion of patients with more than 1grade improvement in the Hughes functional grading scale(FG) relative to baseline at 4weeks.

    Time frame: Baseline,4weeks

Secondary outcomes

  1. 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

  2. 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

  3. changes in Hughes functional grading scale(FG)

    Time frame: Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks

  4. proportion of patients with more than 1 grade improvement in the Arm Grade(AG) relative to baseline at 4weeks.

    Time frame: Baseline,4weeks

  5. 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

  6. 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

  7. changes in Arm Grade(AG)

    Time frame: Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks

  8. changes in manual muscle testing(MMT)

    Time frame: Baseline,1,2,3,4,8,12 weeks

  9. changes in grip strength

    Time frame: Baseline,1,2,3,4,8,12 weeks

  10. changes in activity of daily living(ADL)

    Time frame: Baseline,1,2,3,4,8,12 weeks

  11. changes in electrophysiological findings

    Time frame: Baseline,4,12 weeks

Sponsors and collaborators

Lead sponsor

Nihon Pharmaceutical Co., Ltd

Industry

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 20, 2014
Registry last updated
Apr 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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