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NCT01377922 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Lambert-eaton Myasthenic Syndrome, sponsored by Catalyst Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
38
Enrollment target
14
Study locations

NCT01377922: Completed Phase 3 study of Lambert-eaton Myasthenic Syndrome, sponsored by Catalyst Pharmaceuticals.

NCT01377922 is a Phase 3 study of Lambert-eaton Myasthenic Syndrome that has completed, run by Catalyst Pharmaceuticals. The registered enrollment target is 38 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). The trial reports 14 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01377922, a Phase 3 study of Lambert-eaton Myasthenic Syndrome, has completed, sponsored by Catalyst Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
38 participants
Enrollment target
14
Study locations

Study Summary

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

Primary Outcome

The QMG is a physician-rated test including 13 assessments, including facial strength, swallowing, grip strength, and duration of time that limbs can be maintained in outstretched positions. Each of the 13 items is scored from 0 (none) to 3 (severe). The total score can range from 0 to 39. Increased QMG total score correlates to worsening symptoms of 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
Catalyst Pharmaceuticals

10 total trials

What the finished NCT01377922 record still lists

NCT01377922 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).

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.

NCT01377922 lists 14 locations in 7 states (Other, California, Alabama).

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.

What interventions are being tested in trial NCT01377922?

The interventions under investigation include: Placebo (DRUG), Amifampridine Phosphate (DRUG).

Who is sponsoring clinical trial NCT01377922?

This trial is sponsored by Catalyst Pharmaceuticals, which has 10 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for Lambert-eaton Myasthenic Syndrome

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01377922's enrollment target sits among peer trials

38 1900th of 2000 higher than 100 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01377922, the US trial registry maintained by the National Library of Medicine. NCT01377922 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.