G35
Conditions
Interventions
Group 1: This study has one arm in which each MS patient receives all placebo formulations in randomised order.
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Disease/Illness Diagnosis of MS according to 2017 McDonald criteria, including both relapsing and progressive disease course. Health Participants must be able to swallow the oral formulations and to accept the study procedures. This conclusion is based on medical history, physical examination, and all other appropriate diagnostic procedures. Compliance Participants understand and are willing, able, and likely to comply with examination procedures and restrictions. Consent Participants are capable of understanding the examination procedures, participant obligations as well as risks and benefits of participation in this study and have given written informed consent.
Exclusion criteria
Exclusion criteria: Disease/Illness Significant impairment of swallowing solids and liquids as a consequence of chronic illness (e.g. cerebral palsy), acute illness (e.g. sepsis, respiratory distress, gastroenteritis, or respiratory tract infection), or oral deformation, as assessed by the investigator. Dysphagia with relevant risk for aspiration as judged by the investigator Intolerance History of hypersensitivity to any of the ingredients present in any of the oral placebo formulations. Pre- and Concomitant Medication Recent initiation or dose increase of any drug that causes nausea, fatigue, or palsy within four weeks of study participation. Nutrition Patients, who have eaten 1 hour before the examination and who feel sick because of the food.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to investigate the acceptability of different oral placebo formulations in patients with multiple sclerosis (MS). Acceptability is investigated and evaluated as follows: The deglutition process and the patient’s reactions will be thoroughly observed and documented by a trained investigator. Palatability will be assessed by a second investigator. In addition, the patient will rate the swallowability and palatability of the different formulations by a five-point scale after administration of the oral formulations. Afterwards the patient will rank the different formulations according to his/her preference. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives of this study are: • To investigate the swallowability and palatability of different oral placebo formulations in patients with MS as assessed by the investigator • To investigate the swallowability and palatability of different oral placebo formulations in patients with MS, based on questionnaires answered by the patient • To investigate the acceptability, swallowability, and palatability of different oral placebo formulations in two patient subgroups of differing MS disability levels (Expanded Disability Status Scale [EDSS] score <4 and =4) • To investigate patient preference by ranking the different oral placebo formulations (from 1-best to 4-worst) • To compare patient and investigator assessment of palatability • To identify any possible problem that could occur during deglutition • To identify the percentage of patients who inhaled or coughed during ingestion of any of the oral placebo formulations • To investigate the safety of the different formulations | — |
Countries
Germany
Contacts
Public ContactViviane Klingmann
Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie, Universitätsklinikum Düsseldorf
Outcome results
None listed