Who is sponsoring NCT01377922?

NCT01377922 is sponsored by Catalyst Pharmaceuticals, Inc..

What drugs are being tested in NCT01377922?

Interventions in NCT01377922: Amifampridine Phosphate, Placebo.

What condition does NCT01377922 study?

NCT01377922 studies Lambert Eaton Myasthenic Syndrome.

Is NCT01377922 still recruiting?

NCT01377922 is currently completed. Last updated 3 January 2018.

Are results published for NCT01377922?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-01-03 · How we verify

NCT01377922

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase 3, Double-blind, Placebo-controlled, Randomized Discontinuation Study Followed by Open-label Extension Evaluating Efficacy and Safety of Amifampridine Phosphate in Patients With Lambert-Eaton Myasthenic Syndrome (LEMS)

Completed Phase 3 Results posted Last updated 3 January 2018

What this trial tests

Phase 3 trial testing Amifampridine Phosphate in Lambert Eaton Myasthenic Syndrome in 38 participants. Completed in 1 July 2016.

Timeline

1 June 2011

Primary endpoint
1 July 2016

1 July 2016

Quick facts

Lead sponsor	Catalyst Pharmaceuticals, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	38
Start date	1 June 2011
Primary completion	1 July 2016
Estimated completion	1 July 2016
Sites	14 locations across United States, France, Germany, Hungary, Poland, Russia, Serbia, Spain

Drugs / interventions tested

Amifampridine Phosphate — full drug profile →
Placebo

Conditions studied

Lambert Eaton Myasthenic Syndrome — all drugs for Lambert Eaton Myasthenic Syndrome →

Sponsor

Catalyst Pharmaceuticals, Inc. — full company profile →

Who can join

18 and older, any sex, with Lambert Eaton Myasthenic Syndrome. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Change From Baseline Quantitative Myasthenia Gravis (QMG) at 14 Days
Time frame: Assessment at Baseline and Day 14
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.
Change in SGI Score
Time frame: Assessment at Baseline and Day 14
Subject Global Impression (SGI) is a measure of changes in subject's perception of change in overall wellbeing. The patient is asked to use the 7-point scale below to rate their impression of the effects of the study medication during the preceding 3 days on their physical well being. 1. Terrible 2. Mostly dissatisfied 3. Mixed 4. Partially satisfied 5. Mostly satisfied 6. Pleased 7. Delighted

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Amifampridine Phosphate

Trials testing the same drug.

NCT03781479 — Controlled Trial to Evaluate Amifampridine Phosphate in Spinal Muscular Atrophy Type 3 Patients · Phase 2 · completed
NCT03579966 — Long Term Safety Study of Amifampridine Phosphate in MuSK-MG (Muscle Specific Tyrosine Kinase Myasthenia Gravis) · Phase 3 · terminated
NCT03304054 — Study to Evaluate Amifampridine Phosphate in Patients With MuSK-MG · Phase 3 · completed
NCT02189720 — Expanded Access Study Amifampridine Phosphate in Lambert-Eaton Myasthenic Syndrome (LEMS),Congenital Myasthenic Syndrome · approved for marketing

Other Catalyst Pharmaceuticals, Inc. trials

Trials by the same sponsor.

NCT03819660 — Long Term Safety of Amifampridine Phosphate in Spinal Muscular Atrophy 3 · Phase 2 · terminated
NCT03781479 — Controlled Trial to Evaluate Amifampridine Phosphate in Spinal Muscular Atrophy Type 3 Patients · Phase 2 · completed
NCT03579966 — Long Term Safety Study of Amifampridine Phosphate in MuSK-MG (Muscle Specific Tyrosine Kinase Myasthenia Gravis) · Phase 3 · terminated
NCT03304054 — Study to Evaluate Amifampridine Phosphate in Patients With MuSK-MG · Phase 3 · completed
NCT02189720 — Expanded Access Study Amifampridine Phosphate in Lambert-Eaton Myasthenic Syndrome (LEMS),Congenital Myasthenic Syndrome · approved for marketing

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01377922 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Catalyst Pharmaceuticals, Inc.
Last refreshed: 3 January 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01377922.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing