WHO ICTRP trial

Is treatment with the painkiller paracetamol safe in patients with spinal…

EUCTR2018-002295-40-DK · EU Clinical Trials Register · Authorised

Key facts

Trial ID EUCTR2018-002295-40-DK
Public title Is treatment with the painkiller paracetamol safe in patients with spinal muscular atrophy and cerebral palsy?
Scientific title Pharmacokinetics and safety of treatment with paracetamol in children and adults with spinal muscular atrophy and cerebral palsy - Paracetamol study in patients with low muscle mass
Primary sponsor Copenhagen Neuromuscular Center
Registry EU Clinical Trials Register
Recruitment status Authorised
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes
Countries Denmark
Conditions Spinal muscular atrophy type II (SMA II) Cerebral palsy (CP);Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Interventions Pharmaceutical Form: Oral suspension INN or Proposed INN: Paracetamol Other descriptive name: PARACETAMOL Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 24-
Registration date Nov 7, 2018
Target size 24
Secondary IDs 08-06-2018-paracet
Registry page clinicaltrialsregister.eu

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