Ignite Creation Date:
2024-05-05 @ 7:38 PM
Last Modification Date:
2024-10-26 @ 9:51 AM
Study NCT ID:
NCT00704925
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2019-10-30
First Post:
2008-06-23
Brief Title:
Treatment of Lambert-Eaton Syndrome With 34 DAP
Sponsor:
David P Richman MD
Organization:
University of California Davis
Study Overview
Official Title:
Treatment of Lambert-Eaton Syndrome With 3 4-Diaminopyridine
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A new drug called 34-Diaminopyridine 34-DAP is currently under investigation for treatment of the symptoms of Lambert-Eaton Myasthenic Syndrome LEMS This is an expanded access trial which means that although data from this study will be collected and reported to the US Food and Drug Administration FDAand the drug manufacturer this is not a formal study of drug in LEMS
If you decide volunteer you will be evaluated by a neurologist to determine your eligibility to receive 3 4-DAP by a review of your medical history medication regimen the medications you are taking and a neurological examination If you are a female of child-bearing potential a serum pregnancy test will be done to ensure that you are not pregnant Once it is determined that this treatment is appropriate for your care you will begin taking 3 4 DAP by mouth in slowly increasing doses Treatment will begin with 5mg three times a day as clinically needed and if tolerated You will be monitored for strength and side effects by routine clinic visits at initial intervals of once a month increasing to intervals of every 12 months as permitted Blood will be drawn approximately 1 tablespoon at every clinic visit or as often as the investigator deems necessary to assess your liverkidney function and blood counts You will have an EKG a test to see how your heart is functioning at your first study visit after 6 months of taking 34 DAP and again every 2 years Treatment will be continued indefinitely if a good clinical response is achieved This study is planned to last indefinitely
The dosage of 3 4DAP is individually adjusted The usual range is 10-15 mg 3-4 times per day for the full effect and will increase by 50 every two weeks to 10-15 mg three to six times a day as needed and if tolerated Dosages above the full effect level will not provide an additional benefit and should not be used 3 4 DAP is a convulsant causes seizures A total of 100 mgday is the maximum dosage allowed
If you decide volunteer you will be evaluated by a neurologist to determine your eligibility to receive 3 4-DAP by a review of your medical history medication regimen the medications you are taking and a neurological examination If you are a female of child-bearing potential a serum pregnancy test will be done to ensure that you are not pregnant Once it is determined that this treatment is appropriate for your care you will begin taking 3 4 DAP by mouth in slowly increasing doses Treatment will begin with 5mg three times a day as clinically needed and if tolerated You will be monitored for strength and side effects by routine clinic visits at initial intervals of once a month increasing to intervals of every 12 months as permitted Blood will be drawn approximately 1 tablespoon at every clinic visit or as often as the investigator deems necessary to assess your liverkidney function and blood counts You will have an EKG a test to see how your heart is functioning at your first study visit after 6 months of taking 34 DAP and again every 2 years Treatment will be continued indefinitely if a good clinical response is achieved This study is planned to last indefinitely
The dosage of 3 4DAP is individually adjusted The usual range is 10-15 mg 3-4 times per day for the full effect and will increase by 50 every two weeks to 10-15 mg three to six times a day as needed and if tolerated Dosages above the full effect level will not provide an additional benefit and should not be used 3 4 DAP is a convulsant causes seizures A total of 100 mgday is the maximum dosage allowed
Detailed Description:
Patients with clinically-confirmed LEMS will receive 3 4-DAP by mouth in slowly increasing doses Treatment will begin with 5 mg three times a day and will increase by 50 every two weeks to 10-15 mg three to six times a day as clinically needed and if tolerated Patients will be monitored for strength and side effects via routine out-patient clinic visits at initial intervals of 1 month increasing to intervals of 12 months as permitted Results of treatment and adverse events will be reported to the FDA Treatment will be continued indefinitely if a good clinical response is achieved and side effects are tolerable
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