WHO ICTRP trial
Improving symptomatic treatment with pyridostigmine and amifampridine in…
EUCTR2021-004110-20-NL · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2021-004110-20-NL |
|---|---|
| Public title | Improving symptomatic treatment with pyridostigmine and amifampridine in patients with myasthenia gravis |
| Scientific title | Improving symptomatic treatment with pyridostigmine and amifampridine: a randomized double-blinded, placebo controlled crossover trial in patients with myasthenia gravis (IMPACT-MG) - Pyridostigmine and amifampridine for myasthenia gravis |
| Primary sponsor | Leiden University Medical Center |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): yes |
| Countries | Netherlands |
| Conditions | Myasthenia Gravis MedDRA version: 24.0 Level: LLT Classification code 10085562 Term: AChR myasthenia gravis System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] |
| Interventions | Product Name: Amifampridine Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Mestinon Product Name: Pyridostigmine Pharmaceutical Form: Tablet INN or… |
| Registration date | Dec 7, 2022 |
| Target size | 24 |
| Secondary IDs | 78666 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: