Trial · NCT05919407
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| 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), | |
| Secondary | Time of maximum concentration (Tmax) | Assessed on Day 19, Day 26 and Day 33 (cross-over), | |
| Secondary | Serum half-life (T1/2) | Assessed on Day 19, Day 26 and Day 33 (cross-over), | |
| Secondary | Trough concentration (Ctrough) | Assessed on Day 19, Day 26 and Day 33 (cross-over), | |
| Secondary | Dose-response between serum concentrations of amifampridine and hand grip strength as measured with hand-held dynamometer. | Assessed on Day 19, Day 26 and Day 33 (cross-over), | |
| Secondary | Utility as assessed by the 5-level EQ-5D (EQ-5D-5L) | Assessed on Day 1, Day 5, Day 12, Day 19, Day 26 and Day 33 | |
| Secondary | Healthcare use as assessed by the adapted iMCQ (iMTA Medical Consumption Questionnaire) | Assessed on Day 1 | The iMCQ is adapted by omitting the modules on medication and travel. The recall period for the iMCQ is set to 12 months. |
| Secondary | Productivity as assessed by the adapted iPCQ (iMTA Productivity Cost Questionnaire) | Assessed on Day 1 | The recall period for the iPCQ is set to 3 months. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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