Trials / Terminated
TerminatedNCT05701423
A Study of End of Dose Phenomena in Subcutaneous Natalizumab Treated Multiple Sclerosis (MS) Participants
End of Dose Phenomena in Subcutaneous Natalizumab Treated MS Patients
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 34 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to better understand the pathophysiological background of end-of-dose symptoms (EOD) and thereby determine the percentage of participants who develop EOD under natalizumab (NTZ) as an example of interval therapy in MS and to detect specific changes through multimodal analyses, including radiological, blood and digital health measurements, that may be used as potential biomarkers in the future to map EOD.
Detailed description
Participants will additionally be offered to record daily activity and sleep patterns as well as heart rate for the duration of the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Natalizumab | Administered as specified in the treatment arm. |
Timeline
- Start date
- 2023-02-08
- Primary completion
- 2024-07-31
- Completion
- 2024-07-31
- First posted
- 2023-01-27
- Last updated
- 2024-09-19
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT05701423. Inclusion in this directory is not an endorsement.