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| Sponsors and Collaborators: |
University of California, Davis Jacobus Pharmaceutical |
| Information provided by: | University of California, Davis |
| ClinicalTrials.gov Identifier: | NCT00704925 |
Purpose
A new drug called 3,4-Diaminopyridine (3,4-DAP) is currently under investigation for treatment of the symptoms of Lambert-Eaton Myasthenic Syndrome. 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 (FDA)and the drug manufacturer, this is not a formal study of drug in Lambert-Eaton Syndrome.
If you decide to 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 2-3 months as permitted. Blood will be drawn (approximately 1 tablespoon) at every clinic visit to assess your liver/kidney 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 3,4 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.
You will be required to keep a diary of the dosage taken. During therapy your doctor will instruct you to stop taking 3,4 DAP for a period of time. You will need to report any return of symptoms that occur. If the symptoms return as a result of being off of 3, 4 DAP, you will have demonstrated that the medication is still needed. This will be done once during the study.
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 mg/day is the maximum dosage allowed.
| Condition | Intervention |
|
Lambert Eaton Myasthenic Syndrome |
Drug: 3, 4 DAP |
| ChemIDplus related topics: | 3,4-Diaminopyridine |
| Study Type: | Expanded Access |
| Official Title: | Treatment of Lambert-Eaton Syndrome With 3, 4-Diaminopyridine |
| Study Start Date: | January 2000 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
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 6 months as permitted. Subjects will be asked to temporarily stop study drug to determine if there is a return of symptoms and need for continued treatment with 3, 4 DAP. 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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Janelle Butters, RN | 916-734-6276 | janelle.butters@ucdmc.ucdavis.edu |
| United States, California | |||||
| University of California, Davis | Recruiting | ||||
| Sacramento, California, United States, 95827 | |||||
| Contact: Janelle Butters, RN 916-734-6276 janelle.butters@ucdmc.ucdavis.edu | |||||
| Contact: Molly Lindsay 916-734-6312 molly.lindsay@ucdmc.ucdavis.edu | |||||
| Principal Investigator: David Richman, MD | |||||
| University of California, Davis |
| Jacobus Pharmaceutical |
| Principal Investigator: | David Richman, MD | University of California, Davis |
More Information
| Responsible Party: | University of California, Davis ( David Richman, MD ) |
| Study ID Numbers: | 200311036 |
| First Received: | June 23, 2008 |
| Last Updated: | June 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00704925 |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
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