Lambert Eaton Myasthenic Syndrome3 4-DAPNCT01825395
Use of 3,4-Diaminopyridine in the Treatment of Lambert-Eaton Syndrome
A study testing 3, 4-Diaminopyridine in people with Lambert Eaton Myasthenic Syndrome, run by University of Colorado, Denver at 1 site in United States.
Trial summary
To learn more about the effect of 3, 4-Diaminopyridine (3,4-DAP) on patient diagnosed 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
- 1 siteUnited States
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older,
- Diagnosed with LEMS,
- If female, have a negative pregnancy test, and
- If premenopausal, be willing to practice an effective form of birth control during the study,
- Tested and found by ECG not to have a prolonged QT syndrome,
- Agree 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,
- cardiac arrhythmia,
- hepatic, renal or hematologic disease, or
- severe asthma,
- Is believed by the investigator to be unable to comply with the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of 3,4-Diaminopyridine(3 4-DAP)in the Treatment of Lambert-Eaton Syndrome (LEMS)
To learn more about the effect of 3, 4-Diaminopyridine (3,4-DAP) on patient diagnosed with Lambert-Eaton myasthenic syndrome (LEMS).
- Conditions
- Lambert Eaton Myasthenic Syndrome
- 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (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.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven P Ringel, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825395
- Sponsor's protocol ID
- 04-0567
- Acronym
- 3 4-DAP
- Status last verified
- Sep 2021
- First submitted
- 22 Mar 2013
- Last updated
- 6 Oct 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of 3,4-Diaminopyridine(3 4-DAP)in the Treatment of Lambert-Eaton Syndrome (LEMS)
- ClinicalTrials.gov ID
- NCT01825395
- Acronym / sponsor ID
- 3 4-DAP / 04-0567
- Conditions
- Lambert Eaton Myasthenic Syndrome
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- First posted
- 5 Apr 2013 (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.
To learn more about the effect of 3, 4-Diaminopyridine (3,4-DAP) on patient diagnosed with Lambert-Eaton myasthenic syndrome (LEMS).
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years or older,
- Diagnosed with LEMS,
- If female, have a negative pregnancy test, and
- If premenopausal, be willing to practice an effective form of birth control during the study,
- Tested and found by ECG not to have a prolonged QT syndrome,
Key exclusion criteria (7 listed)
- Is known to have a sensitivity to 3, 4-DAP,
- Has a history of:
- Is believed by the investigator to be unable to comply with the protocol.
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-Diaminopyridine | 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 6 Oct 2021.
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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.
Steven P Ringel, MD principal investigator
University of Colorado, Denver
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, run by University of Colorado, Denver 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 7 inclusion and 7 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 6 Oct 2021. 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 6 Oct 2021.