Lambert Eaton Myasthenic Syndrome (LEMS)NCT01378546
Treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) With 3, 4 DAP
A study testing 3,4-diaminopyridine in people with Lambert Eaton Myasthenic Syndrome (LEMS), run by Louis H. Weimer, MD at 1 site in United States.
Trial summary
Lambert Eaton Myasthenic Syndrome (LEMS) is rare neurological disorder that results in muscle weakness and limited reflex activity. More than half of LEMS cases are associated with a malignancy, usually small cell lung cancer, and tend to progress more quickly than cases not coupled with malignant cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lambert Eaton Myasthenic Syndrome (LEMS)
- What is being tested?
- 3,4-diaminopyridine
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- May 2005to May 2015
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be diagnosed with LEMS or a type of CMS likely to respond to 3, 4-DAP.
- If female of childbearing age, have negative pregnancy test, and be willing to practice and effective form of birth control during the study.
- Tested and found by ECG not to have a prolonged QTc syndrome.
- Agrees to have a second ECG at the time of peak drug effect. Has understood and signed the Informed Consent.
Who cannot join
- Is known to have a sensitivity to 3, 4-DAP.
- Has a history of past or current seizures or of severe asthma, or has an epileptiform EEG.
- Is believed by the investigator to be unable to comply with the protocol.
- Is unable to give informed consent.
- No patient will be excluded based on race, ethnicity, gender, or HIV status
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Treatment of Lambert-Eaton Myasthenic Syndrome and Congenital Myasthenic Syndromes With 3, 4-Diaminopyridine
Lambert Eaton Myasthenic Syndrome (LEMS) is rare neurological disorder that results in muscle weakness and limited reflex activity. More than half of LEMS cases are associated with a malignancy, usually small cell lung cancer, and tend to progress more quickly than cases not coupled with malignant cells.
3,4diaminopyridine (3,4DAP)is a drug that has been demonstrated to be effective in treating the weakness associated with LEMS as it increases strength and improves autonomic symptoms in LEMS patients. It is not currently approved by the FDA for use in the United States. The investigators plan to use 3,4DAP to treat patients with LEMS here at the Columbia University MDA/ALS Research Center.
- Conditions
- Lambert Eaton Myasthenic Syndrome (LEMS)
- Being tested
- 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
Treatment will begin with 5mg three times a day or less.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2011 (estimated)
- Study startMay 2005
- Primary completionMay 2015 (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 Syndrome (LEMS)Studies 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
- Louis H. Weimer, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Louis H. Weimer, MD, Columbia University
- Investigators
- Louis H Weimer, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01378546
- Sponsor's protocol ID
- AAAB2528
- Status last verified
- Jul 2013
- First submitted
- 20 Jun 2011
- Last updated
- 18 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Lambert-Eaton Myasthenic Syndrome and Congenital Myasthenic Syndromes With 3, 4-Diaminopyridine
- ClinicalTrials.gov ID
- NCT01378546
- Acronym / sponsor ID
- AAAB2528
- Conditions
- Lambert Eaton Myasthenic Syndrome (LEMS)
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Louis H. Weimer, MDUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- May 2015 (estimated)
- First posted
- 22 Jun 2011 (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.
Lambert Eaton Myasthenic Syndrome (LEMS) is rare neurological disorder that results in muscle weakness and limited reflex activity. More than half of LEMS cases are associated with a malignancy, usually small cell lung cancer, and tend to progress more quickly than cases not coupled with malignant cells.
3,4diaminopyridine (3,4DAP)is a drug that has been demonstrated to be effective in treating the weakness associated with LEMS as it increases strength and improves autonomic symptoms in LEMS patients. It is not currently approved by the FDA for use in the United States. The investigators plan to use 3,4DAP to treat patients with LEMS here at the Columbia University MDA/ALS Research Center.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be diagnosed with LEMS or a type of CMS likely to respond to 3, 4-DAP.
- If female of childbearing age, have negative pregnancy test, and be willing to practice and effective form of birth control during the study.
- Tested and found by ECG not to have a prolonged QTc syndrome.
- Agrees to have a second ECG at the time of peak drug effect. Has understood and signed the Informed Consent.
Key exclusion criteria (5 listed)
- Is known to have a sensitivity to 3, 4-DAP.
- Has a history of past or current seizures or of severe asthma, or has an epileptiform EEG.
- Is believed by the investigator to be unable to comply with the protocol.
- Is unable to give informed consent.
- No patient will be excluded based on race, ethnicity, gender, or HIV status
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-diaminopyridineTreatment will begin with 5mg three times a day or less. | 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 18 Jul 2013.
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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.
Louis H Weimer, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3,4-diaminopyridine in people with Lambert Eaton Myasthenic Syndrome (LEMS), run by Louis H. Weimer, MD at 1 site in United States.
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 18 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 18 Jul 2013.