Use of 3,4-Diaminopyridine in the Treatment of Lambert-Ea... | NCT01825395

Studies
Use of 3,4-Diaminopyridine in the Treatment of Lambert-Eaton Syndrome

NCT01825395

Sponsor

University of Colorado, Denver

Status

Approved for marketing

Last Update Posted

Oct 6, 2021Actual

Enrollment

Not provided

Phase

Not provided

Conditions

Lambert Eaton Myasthenic Syndrome

Interventions

3, 4-Diaminopyridine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Approved for marketing

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Mar 22, 2013

First Submission Date that Met QC Criteria

Apr 4, 2013

First Posted Date

Apr 5, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 28, 2021

Last Update Posted Date

Oct 6, 2021Actual

Design Module

Study Type

Expanded Access

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
3, 4-Diaminopyridine	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Is known to have a sensitivity to 3, 4-DAP,
Has a history of:
1. past or current seizures,
2. cardiac arrhythmia,
3. hepatic, renal or hematologic disease, or
4. severe asthma,
Is believed by the investigator to be unable to comply with the protocol.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Steven P Ringel, MD	University of Colorado, Denver	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Colorado		Aurora	Colorado	80045	United States

Condition Browse Module

MeSH Terms

ID	Term
D015624	Lambert-Eaton Myasthenic Syndrome

Ancestor Terms

ID	Term
D009157	Myasthenia Gravis
D020361	Paraneoplastic Syndromes, Nervous System
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided