Trial · NCT05919407
Pyridostigmine and Amifampridine for Myasthenia Gravis
NCT05919407, Phase 3, Unknown, Leiden University Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pyridostigmine and Amifampridine for Myasthenia Gravis. Trials, record NCT05919407. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05919407
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pyridostigmine and Amifampridine for Myasthenia Gravis
- NCT number
- NCT05919407
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 24 participants, estimated
- Lead sponsor
- Leiden University Medical Center
- Conditions
- Myasthenia Gravis
- Interventions
- Pyridostigmine, Amifampridine (base) with modified release, Placebo, Placebo
- First posted
- 2023-06-26
- Last updated
- 2023-06-26
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | A clinically relevant change in Myasthenia Gravis Impairment Index (MGII) compared to placebo. | Assessed on Day 1, Day 5, Day 12, Day 19, Day 26 and Day 33 (cross-over), | |
| Secondary | Change on 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) compared to placebo | Assessed on Day 5, Day 12, Day 19, Day 26 and Day 33 (cross-over), | |
| Secondary | Change on the 15-item revised version of the Myasthenia Gravis Quality of Life questionnaire (MG-QoL15r) compared to placebo | Assessed on Day 1, Day 5, Day 12, Day 19, Day 26 and Day 33 (cross-over), | |
| Secondary | A clinically relevant change (≥2 points change) on the Myasthenia Gravis Activities of Daily Living (MG-ADL) score compared to placebo. | Assessed on Day 1, Day 5, Day 12, Day 19, Day 26 and Day 33 (cross-over), | |
| Secondary | A clinically relevant change (≥3 points change) on the Quantitative Myasthenia Gravis (QMG) score compared to placebo. | Assessed on Day 1, Day 5, Day 12, Day 19, Day 26 and Day 33 (cross-over), | |
| Secondary | Number of patients not able to complete first wash-out period due to an increase in myasthenic symptoms. | Assessed on Day 1 (crossover) | |
| Secondary | Number of times escape medication is used (including effect on symptoms) | Assessed on Day 1, Day 5 and Day 12 (cross-over), | |
| Secondary | Trough concentrations of pyridostigmine and amifampridine | Assessed on Day 1, Day 5, Day 12, Day 19, Day 26 and Day 33 (cross-over), | |
| Secondary | Peak Plasma Concentration (Cmax) | Assessed on Day 19, Day 26 and Day 33 (cross-over), | |
| Secondary | Area under the concentration-time curve (AUC0-8) | Assessed on Day 19, Day 26 and Day 33 (cross-over), |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05919407
GET https://conductscience.org/api/trials/v1/NCT05919407/registered