Neuroimmunology Branch Repository

Multiple Sclerosis Clinical Trial

Official title:

NIB Repository Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01581567
• Other study ID #: 110210
• Secondary ID: 11-N-0210
• Status: Completed
• Start date: July 15, 2011

Study information

• Verified date: May 1, 2019
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

Purpose

This protocol has the following goals:

1. To enable prospective IRB review of research using human samples and data collected under other Neuroimmunology Branch (NIB) protocols

2. To enable retrospective review of samples and data from the branch s protocols that have been terminated prior to full data analysis and publication.

3. To enable continued use of human samples and data collected under NIB protocols in which some of the Investigators have previously participated.

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:

• 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

• 04-N-0071: Phase I/II Study of HTLV-I-Associated Myelopathy / Tropical Spastic Paraparesis

(HAM/TSP) Using the Humanized MiK- <=-1 Monoclonal Antibody Directed Toward the IL-2/IL-

15R <= Subunit (CD122) that Blocks IL-15 Action

-11-N-0261: Evaluation of skeletal muscle, cardiac, and diaphragm imaging biomarkers for

GSK2402968 effects in ambulatory boys with Duchenne muscular dystrophy

-14-N-0051: A Two-part Placebo-controlled study to evaluate the safety, tolerability and

preliminary efficacy of BVS857 in patients with Spinal and bulbar muscular atrophy (SBMA)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2465
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• HTLV-1 Infection
• HTLV-I Infections
• Multiple Sclerosis
• Nervous System Diseases
• Neurologic Disorders

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center, 9000 Rockville Pike	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Bielekova B, Goodwin B, Richert N, Cortese I, Kondo T, Afshar G, Gran B, Eaton J, Antel J, Frank JA, McFarland HF, Martin R. Encephalitogenic potential of the myelin basic protein peptide (amino acids 83-99) in multiple sclerosis: results of a phase II clinical trial with an altered peptide ligand. Nat Med. 2000 Oct;6(10):1167-75. Erratum in: Nat Med 2000 Dec;6(12):1412. — View Citation

Bielekova B, Martin R. Antigen-specific immunomodulation via altered peptide ligands. J Mol Med (Berl). 2001 Oct;79(10):552-65. Review. — View Citation

Bielekova B, Richert N, Howard T, Packer AN, Blevins G, Ohayon J, McFarland HF, Stürzebecher CS, Martin R. Treatment with the phosphodiesterase type-4 inhibitor rolipram fails to inhibit blood--brain barrier disruption in multiple sclerosis. Mult Scler. 2009 Oct;15(10):1206-14. doi: 10.1177/1352458509345903. Epub 2009 Sep 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Data/samples will be analyzed as approved under the 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 reposito...	Data/samples will be analyzed as approved under the 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.	ongoing

External Links

•   NIH Clinical Center Detailed Web Page