Lambert-Eaton Myasthenic SyndromeNCT00994916
Treatment of Lambert-Eaton Syndrome With 3,4 Diaminopyridine
A study testing 3,4 diaminopyridine in people with Lambert-Eaton Myasthenic Syndrome, run by David Lacomis, MD.
Trial summary
The purpose of the study is to provide expanded access (compassionate use) of 3,4 diaminopyridine to patients with Lambert-Eaton myasthenic syndrome (LEMS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lambert-Eaton Myasthenic Syndrome
- What is being tested?
- 3,4 diaminopyridine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Diagnosis of LEMS
- Over 18 years old
- Medically stable
- If female and premenopausal, have a negative urine pregnancy test prior to starting the 3,4 DAP, and, if premenopausal, be willing to practice an effective form of birth control such as "double-barrier contraception" during the study
Who cannot join
- Known sensitivity to 3,4 DAP
- History of past or current seizures
- History of severe asthma
- Believed by the investigator to be unable to comply with the protocol
- Unable to provide informed consent
About this study
The purpose of the study is to provide expanded access (compassionate use) of 3,4 diaminopyridine to patients with Lambert-Eaton myasthenic syndrome (LEMS).
Read the detailed description
Up to 15 patients over the age of 18 years with a diagnosis of LEMS are eligible to enroll if they are medically stable. They may receive 3,4 diaminopyridine in addition to other treatments and standard of care investigations for LEMS under supervision of the primary investigator. Safety laboratory studies and EKGs will be obtained.
The study has been approved by the University of Pittsburgh IRB. There is a local Data-Safety Monitoring Board.
The investigator has a hold on enrolling new subjects.
- Conditions
- Lambert-Eaton Myasthenic Syndrome
- Being tested
- 3,4 diaminopyridine
- Keywords
- Lambert-Eaton myasthenic syndrome, 3,4 diaminopyridine
- Medical subject headings
- Lambert-Eaton Myasthenic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3,4 diaminopyridineDrug
3,4 diaminopyridine up to 80 mg daily in divided doses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lambert-Eaton Myasthenic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- David Lacomis, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Jacobus Pharmaceutical
- Responsible party
- Sponsor-investigator, David Lacomis, MD, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00994916
- Sponsor's protocol ID
- IRB0410047
- Status last verified
- Jul 2019
- First submitted
- 8 Oct 2009
- Last updated
- 9 Jul 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Lambert-Eaton Syndrome With 3,4 Diaminopyridine
- ClinicalTrials.gov ID
- NCT00994916
- Acronym / sponsor ID
- IRB0410047
- Conditions
- Lambert-Eaton Myasthenic Syndrome
- Keywords
- Lambert-Eaton myasthenic syndrome, 3,4 diaminopyridine
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- David Lacomis, MDUniversity, hospital or other
- Collaborators
- Jacobus Pharmaceutical
- First posted
- 14 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to provide expanded access (compassionate use) of 3,4 diaminopyridine to patients with Lambert-Eaton myasthenic syndrome (LEMS).
Detailed description
Up to 15 patients over the age of 18 years with a diagnosis of LEMS are eligible to enroll if they are medically stable. They may receive 3,4 diaminopyridine in addition to other treatments and standard of care investigations for LEMS under supervision of the primary investigator. Safety laboratory studies and EKGs will be obtained.
The study has been approved by the University of Pittsburgh IRB. There is a local Data-Safety Monitoring Board.
The investigator has a hold on enrolling new subjects.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of LEMS
- Over 18 years old
- Medically stable
- If female and premenopausal, have a negative urine pregnancy test prior to starting the 3,4 DAP, and, if premenopausal, be willing to practice an effective form of birth control such as "double-barrier contraception" during the study
Key exclusion criteria (5 listed)
- Known sensitivity to 3,4 DAP
- History of past or current seizures
- History of severe asthma
- Believed by the investigator to be unable to comply with the protocol
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3,4 diaminopyridine3,4 diaminopyridine up to 80 mg daily in divided doses | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 3,4 diaminopyridine in people with Lambert-Eaton Myasthenic Syndrome, run by David Lacomis, MD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2019.