Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001781
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Safety Tolerability and Effectiveness of CGP77116 in Patients With Multiple Sclerosis MS
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Open-Label Baseline vs Treatment Trial Evaluating the Safety Tolerability and Effect on MRI Lesion and Immunology Parameters of CGP 77116 in Patients With Multiple Sclerosis Mark
Status:
COMPLETED
Status Verified Date:
2002-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Multiple sclerosis MS is a disease of the nervous system The exact cause of MS is unknown but it is believed to be an autoimmune condition Autoimmune conditions are diseases that cause the bodys immune system and natural defenses to attack healthy cells In the case of MS the immune system begins attacking myelin the cells that make up the sheath covering nerves Without myelin nerves are unable to transmit signals effectively and symptoms occur
Researchers are interested in testing the safety tolerability and effectiveness of a new therapy CGP77116 for Multiple Sclerosis MS CGP77116 is a small protein similar to the protein in myelin CGP77116 is designed to modify the immune reaction that destroys normal myelin CGP77116 is an experimental therapy meaning it has not been approved by the US Food and Drug Administration However in preliminary studies on animal it has been shown to be effective at modifying the autoimmune reaction associated with the development of MS
The purpose of this study is to assess the safety and effect of CGP77116 on disease activity in patients with Multiple Sclerosis as measured by magnetic resonance imaging MRI and immunological studies
The study is broken into three parts
I BASELINE in the first part of the study patients will undergo 6 MRIs over a 5 month period During this time patients will be evaluated based on the presence of MS lesions seen on MRI Patients whose MS lesions are highly active will be entered into the second part of the study
II TREATMENT in the second part of the study patients with active MS lesions will begin receiving CGP77116 The drug will be given by injection once a week for one month and then once a month for 8 additional months
III FOLLOW-UP in the third and final part of the study patients will undergo an MRI every 2 months for 6 months and then every 3 months for 6 additional months The results of the MRIs will be used to measure the effectiveness of CGP77116
Researchers are interested in testing the safety tolerability and effectiveness of a new therapy CGP77116 for Multiple Sclerosis MS CGP77116 is a small protein similar to the protein in myelin CGP77116 is designed to modify the immune reaction that destroys normal myelin CGP77116 is an experimental therapy meaning it has not been approved by the US Food and Drug Administration However in preliminary studies on animal it has been shown to be effective at modifying the autoimmune reaction associated with the development of MS
The purpose of this study is to assess the safety and effect of CGP77116 on disease activity in patients with Multiple Sclerosis as measured by magnetic resonance imaging MRI and immunological studies
The study is broken into three parts
I BASELINE in the first part of the study patients will undergo 6 MRIs over a 5 month period During this time patients will be evaluated based on the presence of MS lesions seen on MRI Patients whose MS lesions are highly active will be entered into the second part of the study
II TREATMENT in the second part of the study patients with active MS lesions will begin receiving CGP77116 The drug will be given by injection once a week for one month and then once a month for 8 additional months
III FOLLOW-UP in the third and final part of the study patients will undergo an MRI every 2 months for 6 months and then every 3 months for 6 additional months The results of the MRIs will be used to measure the effectiveness of CGP77116
Detailed Description:
This trial will evaluate safety tolerability and effect on cranial magnetic resonance imaging MRI and immune response of CGP 77116 in patients with the demyelinating autoimmune disease multiple sclerosis MS The purpose of the trial is to assess whether CGP 77116 modifies inflammatory disease activity as measured by MRI and immunological techniques and to facilitate dose selection for future pivotal trials in progressive and relapsing-remitting MS
CGP 77116 is an altered peptide ligand APL designed around an immunodominant epitope of human myelin basic protein MBP corresponding to amino acids 83-99 for the treatment of multiple sclerosis MS Substitution of a key T cell receptor contact residue with alanine results in a non-stimulatory peptide analogue Recent evidence suggests that a T cell-mediated immune response against immunodominant myelin protein peptides such as MBP 83-99 is involved in MS pathogenesis 1 MS results when the immune system is unable to keep autoreactive T cells from entering the central nervous system where they initiate demyelination of myelin sheaths By targeting MBP autoreactive T cells CGP 77116 may downregulate the MBP-specific immune response and lead to amelioration of MS
CGP 77116 is an altered peptide ligand APL designed around an immunodominant epitope of human myelin basic protein MBP corresponding to amino acids 83-99 for the treatment of multiple sclerosis MS Substitution of a key T cell receptor contact residue with alanine results in a non-stimulatory peptide analogue Recent evidence suggests that a T cell-mediated immune response against immunodominant myelin protein peptides such as MBP 83-99 is involved in MS pathogenesis 1 MS results when the immune system is unable to keep autoreactive T cells from entering the central nervous system where they initiate demyelination of myelin sheaths By targeting MBP autoreactive T cells CGP 77116 may downregulate the MBP-specific immune response and lead to amelioration of MS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 98-N-0069 | None | None | None |