Guillain-Barre SyndromeNCT01655394
Change of Nerve Conduction Properties in IVIg Dependent Neuropathies
An observational study of Guillain-Barre Syndrome and CIDP, run by University of Cologne at 1 site in Germany.
Trial summary
IVIg exert a variety of different immunomodulatory effects and several mechanism of action have been proposed for IVIg. In this study the role of IVIg on short term nerve conduction in patients with immune-mediated neuropathies will be explored. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Guillain-Barre Syndrome, CIDP, Multifocal Motor Neuropathy
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2012to Jun 2016
- Phase
- Observational
- 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
Study population: patients with immune neuropathies
Who may be able to join
- immune neuropathy
- age above 18 y
- IVIg treatment
Who cannot join
- no IVIg treatment
Trial locations and contacts
1 site in 1 country.
About this study
IVIg exert a variety of different immunomodulatory effects and several mechanism of action have been proposed for IVIg. In this study the role of IVIg on short term nerve conduction in patients with immune-mediated neuropathies will be explored.
Read the detailed description
IVIg exert a variety of different immunomodulatory effects and several mechanism of action have been proposed for IVIg. In this study the role of IVIg on short term nerve conduction in patients with immune-mediated neuropathies will be explored
- Conditions
- Guillain-Barre Syndrome, CIDP, Multifocal Motor Neuropathy
- Medical subject headings
- Guillain-Barre Syndrome, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Improvement
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2014
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Guillain-Barre 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helmar Lehmann, University of Cologne
- Investigators
- Helmar C. Lehmann, PD Dr. med., Principal investigator, PI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655394
- Sponsor's protocol ID
- 01607831337
- Status last verified
- Dec 2014
- First submitted
- 30 Jul 2012
- Last updated
- 12 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change of Nerve Conduction Properties in IVIg Dependent Neuropathies
- ClinicalTrials.gov ID
- NCT01655394
- Acronym / sponsor ID
- 01607831337
- Conditions
- Guillain-Barre Syndrome, CIDP, Multifocal Motor Neuropathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jun 2016 (estimated)
- First posted
- 1 Aug 2012 (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.
IVIg exert a variety of different immunomodulatory effects and several mechanism of action have been proposed for IVIg. In this study the role of IVIg on short term nerve conduction in patients with immune-mediated neuropathies will be explored.
Detailed description
IVIg exert a variety of different immunomodulatory effects and several mechanism of action have been proposed for IVIg. In this study the role of IVIg on short term nerve conduction in patients with immune-mediated neuropathies will be explored
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with immune neuropathies
Key inclusion criteria (3 listed)
- immune neuropathy
- age above 18 y
- IVIg treatment
Key exclusion criteria (1 listed)
- no IVIg treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical Improvement
Time frame: 6 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2014.
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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.
Helmar C. Lehmann, PD Dr. med. principal investigator
PI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Guillain-Barre Syndrome and CIDP, run by University of Cologne at 1 site in Germany.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 12 Dec 2014. 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 Germany. 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.
Are results available for this study?
Results are not available in the source record.
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?
Clinical Improvement (time frame: 6 Months). 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 Dec 2014.