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COMPLETED Phase 3

A Phase 3 Study of Amifampridine Phosphate in Patients With Lambert Eaton Myasthenic Syndrome (LEMS)

NCT01377922 · View on ClinicalTrials.gov ↗

Study Summary

A Phase 3 study to evaluate the efficacy and safety of Amifampridine Phosphate in patients with Lambert-Eaton Myasthenic Syndrome (LEMS).

Interventions

  • DRUG Placebo
  • DRUG Amifampridine Phosphate

Study Locations (14)

Other

  • — Lyon
  • — Berlin
  • — Pécs
  • — Warsaw
  • — Moscow
  • — Belgrade
  • — Madrid

California

  • — Los Angeles
  • — Palo Alto

Alabama

  • — Birmingham

Arizona

  • — Scottsdale

Kansas

  • — Kansas City

New York

  • — New York

Bavaria

  • — Munich

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2011-06
Est. Completion 2016-07
Phase Phase 3

Sponsor

Catalyst Pharmaceuticals

6 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01377922

The ClinicalTrials.gov registry entry for NCT01377922 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Catalyst Pharmaceuticals, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Lambert Eaton Myasthenic Syndrome appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01377922 reports 14 study locations spanning 7 distinct geographic areas — top geographies include Other, California, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01377922 about?

NCT01377922 is a clinical study titled "A Phase 3 Study of Amifampridine Phosphate in Patients With Lambert Eaton Myasthenic Syndrome (LEMS)". A Phase 3 study to evaluate the efficacy and safety of Amifampridine Phosphate in patients with Lambert-Eaton Myasthenic Syndrome (LEMS).

What is the current status of trial NCT01377922?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 38 participants. The study started on 2011-06. Estimated completion is 2016-07.

What conditions does trial NCT01377922 study?

This clinical trial studies the following conditions: Lambert Eaton Myasthenic Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01377922?

The interventions under investigation include: Placebo (DRUG), Amifampridine Phosphate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01377922?

This trial is sponsored by Catalyst Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01377922 being conducted?

This trial has 14 study locations across Alabama, Arizona, California, Kansas, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial