Neuroimmunology Branch Repository
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Neurology, Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Immunology / Infectious Diseases, Neurology, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 12/16/2018 |
| Start Date: | July 15, 2011 |
NIB Repository Protocol
Background:
- Information and samples collected from participants in medical research studies can be
useful even after the original study is complete. Researchers can use the information and
samples to learn more about multiple sclerosis or other immune system disorders. They can
also be used for research into other disorders. Researchers would like to get permission to
use samples collected from older studies to launch new lines of research.
Objectives:
- To look at information and samples from earlier National Institutes of Health
Neuroimmunology Branch studies.
Eligibility:
- People who provided samples and medical information for earlier studies.
Design:
- Researchers will contact people who took part in earlier studies. Researchers will ask
if they can study previously collected data and samples.
- Data and samples may include physical exam data and psychological test results. Imaging
study results are included. Preserved samples of body fluids and tissues may be studied.
These include blood and urine samples.
- No new treatment will be provided as part of this research study.
- Information and samples collected from participants in medical research studies can be
useful even after the original study is complete. Researchers can use the information and
samples to learn more about multiple sclerosis or other immune system disorders. They can
also be used for research into other disorders. Researchers would like to get permission to
use samples collected from older studies to launch new lines of research.
Objectives:
- To look at information and samples from earlier National Institutes of Health
Neuroimmunology Branch studies.
Eligibility:
- People who provided samples and medical information for earlier studies.
Design:
- Researchers will contact people who took part in earlier studies. Researchers will ask
if they can study previously collected data and samples.
- Data and samples may include physical exam data and psychological test results. Imaging
study results are included. Preserved samples of body fluids and tissues may be studied.
These include blood and urine samples.
- No new treatment will be provided as part of this research study.
Purpose
The purpose of this protocol is to enable prospective IRB review of research using human
samples and data collected under other Neuroimmunology Branch (NIB) protocols and to enable
retrospective review of samples and data from the branch s protocols that have been
terminated prior to full data analysis and publication.
Subjects
Subjects who previously participated in NIH protocols for whom we have samples or data whose
wishes regarding use of their samples/data for research other than that specified in the
initial protocol is not known, or where we would like to use their samples or data for
purposes other than those they have consented for may be enrolled in this protocol if they
are able to be contacted and consent to additional use of their samples or data.
Study Methods
Data and Sample Ascension
Data and samples may include but are not limited to demographic and personal health
information, psychological or psychiatric testing, blood, urine, cerebrospinal fluid (CSF) or
other body fluids or tissues, results of medical and/or physiological evaluation, and medical
imaging.
Data and samples will enter this protocol from the following terminated IRB-approved
protocols under which all human subject enrollment and participation is complete including:
- 01-N-0089 (Rolipram): Safety, tolerability and effects of Rolipram on inflammatory
activity in the central nervous system in multiple sclerosis. A phase II, open label
crossover trial using MRI as an outcome measure.
- 98-N-0069 (APL): Double-blind, randomized, parallel-group, baseline vs. treatment trial
evaluating the safety, tolerability and effect on MRI lesion and immunology parameters
of low vs. high dose CGP 77116 in patients with MS.
- 97-N-0148 (IFG): A 48 week phase II Pilot study of tolerability and effect/efficacy of
subcutaneously administered CEP-151 (rhIGF, Myotrophin) in Multiple Sclerosis (MS)
patients.
- 94-N-0173 (Anti-tac in HAM/TSP): Monoclonal anti-tac antibody immunotherapy of
HTLV-I-associated myelopathy/tropical spastic paraparesis (HAM/TSP).
- 98-N-0160 (Avonex in HAM/TSP): Combined Virological and Immunological Evaluation of
Treatment of Patients with Early HTLV-1 Associated Myleopathy with Recombinant Human
Inteferon-beta1 a.
- 99-N-0169 (Daclizumab/IFN-beta for MS): Effect of the Humanized Monoclonal Antibody
Against the Interleukin-2 Receptor Alpha Subunit (IL-2Ra; Zenapax ) on Inflammatory
Activity in the Central Nervous System (CNS) in Multiple Sclerosis (MS) in a
Baseline-to-Treatment, Cross-Over, MRI-Controlled Single-Center Phase I/II Trial.
- 04-N-0019 (Daclizumab monotherapy for MS): ZAP MS Zenapax[R] (daclizumab) Administered
to Patients with Multiple Sclerosis: Effect of intravenously administered humanized
monoclonal antibody against the interleukin-2 receptor alpha subunit (daclizumab) on
inflammatory activity in the central nervous system in multiple sclerosis patients in a
baseline-to-treatment, cross-over, MRI-controlled single-centre phase II trial.
- 05-N-0039 (3T Cortical imaging): An Exploratory Study on Detection of Cortical Damage in
Patients with Multiple Sclerosis Using Magnetic Resonance Imaging.
- 06-N-0154 (7T): An Exploratory Study on Detection of Cortical and White Matter Damage in
Patients with Multiple Sclerosis Using Magnetic Resonance Imaging at 7 Tesla.
- 07-N-0014 (Cognitive MRI): The use of Magnetic Resonance Imaging to investigate cortical
damage in Patients with Multiple Sclerosis and correlation with Cognitive Dysfunction.
- 02-N-N196 (Stem Cells): Immunological mechanisms of immune ablation and autologous
hematopoietic stem cell transplantation in secondary progressive multiple sclerosis.
- 07-N-0092 (PET): PET Evaluation of brain peripheral benzodiazepine receptors using
[11C]PBR28 in patients with multiple sclerosis (MS).
- 76-N-0021: Clinical, immunological and virological assessment of patients with multiple
sclerosis.
- 81-N-0184: Immunogenetic studies of the human cellular immune response
- 15-N-0117: A Phase I Study of Oral Guanabenz for Multiple Sclerosis
- 15-N-0183: Anakinra, a recombinant human IL-1 receptor antagonist for neuroinflammation
in HIV-1 infection
The purpose of this protocol is to enable prospective IRB review of research using human
samples and data collected under other Neuroimmunology Branch (NIB) protocols and to enable
retrospective review of samples and data from the branch s protocols that have been
terminated prior to full data analysis and publication.
Subjects
Subjects who previously participated in NIH protocols for whom we have samples or data whose
wishes regarding use of their samples/data for research other than that specified in the
initial protocol is not known, or where we would like to use their samples or data for
purposes other than those they have consented for may be enrolled in this protocol if they
are able to be contacted and consent to additional use of their samples or data.
Study Methods
Data and Sample Ascension
Data and samples may include but are not limited to demographic and personal health
information, psychological or psychiatric testing, blood, urine, cerebrospinal fluid (CSF) or
other body fluids or tissues, results of medical and/or physiological evaluation, and medical
imaging.
Data and samples will enter this protocol from the following terminated IRB-approved
protocols under which all human subject enrollment and participation is complete including:
- 01-N-0089 (Rolipram): Safety, tolerability and effects of Rolipram on inflammatory
activity in the central nervous system in multiple sclerosis. A phase II, open label
crossover trial using MRI as an outcome measure.
- 98-N-0069 (APL): Double-blind, randomized, parallel-group, baseline vs. treatment trial
evaluating the safety, tolerability and effect on MRI lesion and immunology parameters
of low vs. high dose CGP 77116 in patients with MS.
- 97-N-0148 (IFG): A 48 week phase II Pilot study of tolerability and effect/efficacy of
subcutaneously administered CEP-151 (rhIGF, Myotrophin) in Multiple Sclerosis (MS)
patients.
- 94-N-0173 (Anti-tac in HAM/TSP): Monoclonal anti-tac antibody immunotherapy of
HTLV-I-associated myelopathy/tropical spastic paraparesis (HAM/TSP).
- 98-N-0160 (Avonex in HAM/TSP): Combined Virological and Immunological Evaluation of
Treatment of Patients with Early HTLV-1 Associated Myleopathy with Recombinant Human
Inteferon-beta1 a.
- 99-N-0169 (Daclizumab/IFN-beta for MS): Effect of the Humanized Monoclonal Antibody
Against the Interleukin-2 Receptor Alpha Subunit (IL-2Ra; Zenapax ) on Inflammatory
Activity in the Central Nervous System (CNS) in Multiple Sclerosis (MS) in a
Baseline-to-Treatment, Cross-Over, MRI-Controlled Single-Center Phase I/II Trial.
- 04-N-0019 (Daclizumab monotherapy for MS): ZAP MS Zenapax[R] (daclizumab) Administered
to Patients with Multiple Sclerosis: Effect of intravenously administered humanized
monoclonal antibody against the interleukin-2 receptor alpha subunit (daclizumab) on
inflammatory activity in the central nervous system in multiple sclerosis patients in a
baseline-to-treatment, cross-over, MRI-controlled single-centre phase II trial.
- 05-N-0039 (3T Cortical imaging): An Exploratory Study on Detection of Cortical Damage in
Patients with Multiple Sclerosis Using Magnetic Resonance Imaging.
- 06-N-0154 (7T): An Exploratory Study on Detection of Cortical and White Matter Damage in
Patients with Multiple Sclerosis Using Magnetic Resonance Imaging at 7 Tesla.
- 07-N-0014 (Cognitive MRI): The use of Magnetic Resonance Imaging to investigate cortical
damage in Patients with Multiple Sclerosis and correlation with Cognitive Dysfunction.
- 02-N-N196 (Stem Cells): Immunological mechanisms of immune ablation and autologous
hematopoietic stem cell transplantation in secondary progressive multiple sclerosis.
- 07-N-0092 (PET): PET Evaluation of brain peripheral benzodiazepine receptors using
[11C]PBR28 in patients with multiple sclerosis (MS).
- 76-N-0021: Clinical, immunological and virological assessment of patients with multiple
sclerosis.
- 81-N-0184: Immunogenetic studies of the human cellular immune response
- 15-N-0117: A Phase I Study of Oral Guanabenz for Multiple Sclerosis
- 15-N-0183: Anakinra, a recombinant human IL-1 receptor antagonist for neuroinflammation
in HIV-1 infection
- Subjects who previously participated in NIH protocols for whom we have samples or data
whose wishes regarding use of their samples/data for research other than that
specified in the initial protocol is not known, or where we would like to use their
samples or data for purposes other than those they have consented for may be enrolled
in this protocol if they are able to be contacted and consent to additional use of
their samples or data.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Click here to add this to my saved trials
