Neuroimmunology Branch Repository

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01581567
First received: April 19, 2012
Last updated: March 21, 2014
Last verified: February 2014

April 19, 2012
March 21, 2014
July 2011
Not Provided
Data samples will be analyzed as approved under original protocol and as amended with IRB approval. Data and samples that were obtained with consent for this study or with approval for future use may be analyzed on site or sent to a repository.
Not Provided
Complete list of historical versions of study NCT01581567 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Neuroimmunology Branch Repository
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.

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.
Observational
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
  • HTLV-1 Infection
  • Multiple Sclerosis
  • Neurologic Disorders
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
Not Provided
Not Provided
  • 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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01581567
110210, 11-N-0210
Not Provided
Not Provided
National Institute of Neurological Disorders and Stroke (NINDS)
Not Provided
Principal Investigator: Avindra Nath, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health Clinical Center (CC)
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP