Trial · NCT05701423
A Study of End of Dose Phenomena in Subcutaneous Natalizumab Treated Multiple Sclerosis (MS) Participants
NCT05701423, Terminated, Biogen
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of End of Dose Phenomena in Subcutaneous Natalizumab Treated Multiple Sclerosis (MS) Participants. Trials, record NCT05701423. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05701423
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of End of Dose Phenomena in Subcutaneous Natalizumab Treated Multiple Sclerosis (MS) Participants
- NCT number
- NCT05701423
- Status
- Terminated
- Enrollment
- 34 participants, actual
- Lead sponsor
- Biogen
- Conditions
- Multiple Sclerosis
- Interventions
- Natalizumab
- First posted
- 2023-01-27
- Last updated
- 2024-09-19
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants who Develop End of Dose Symptoms (EOD) Under NTZ | Up to 30 weeks | |
| Secondary | Change From Baseline in Expanded Disability Status Scale (EDSS) Score | Baseline up to 30 weeks | The EDSS is used to quantify disability due to symptoms of MS and to track changes in disability status over time. Scores range from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). Higher scores indicate the worse level of disability. |
| Secondary | Change From Baseline in Fatigue Scale for Motor and Cognitive Functions (FSMC) | Baseline up to 30 weeks | Fatigue is rated using the self-administered 20-item FSMC questionnaire that includes ten questions related to motor fatigue and ten questions related to cognitive fatigue. A Likert-type 5-point scale (ranging from 'does not apply at all' to 'applies completely') produces a score between 1 and 5 for each scored question. Minimum value is 20 (no fatigue at all) and maximum value is 100 (severe fatigue). Higher scores indicate higher fatigue. |
| Secondary | Change From Baseline in Fatigue Severity Scale (FSS) | Baseline up to 30 weeks | The FSS is a self-assessment questionnaire that provides a score as a measurement of the severity of fatigue. It consists of 9 questions scored from 1 to 7, low value indicates strong disagreement with the statement, whereas a high value indicates strong agreement. A total score of 36 or more suggests the presence of fatigue. |
| Secondary | Change From Baseline in World Health Organization Quality of Life Brief Version (WHOQOL-BREF) Score | Baseline up to 30 weeks | The WHOQOL-BREF questionnaire measures quality of life across 4 domains: Physical health, psychological health, social relationships and environment. It also includes one question on overall QOL and one on general health. The WHOQOL-BREF scores correlate highly (.89 or above) with WHOQOL-100 scores, and demonstrate good discriminant validity, content validity, internal consistency and test-retest reliability. The four WHOQOL-BREF domain scores will be used as main outcome measure. The measure is calculated by summing the point values for the questions corresponding to each domain and then transforming the scores to a 0-100 point interval, higher score correspond to greater QOL. |
| Secondary | Change From Baseline in Brief Fatigue Inventory (BFI) Score | Baseline up to 30 weeks | A questionnaire will be used to measure the severity of fatigue in the past 24 hours. This 9-item self-reported questionnaire is scored on a 0-10 numerical rating scale, where 0 and 10 represent absence and the highest severity of fatigue, respectively. |
| Secondary | Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score | Baseline up to 30 weeks | MSFC has 2 components: Timed 25-foot walk (T25FW) and 9-hole peg test (9HPT) \[dominant and nondominant hands\]. The MSFC Z-score is calculated by creating Z-scores for each component of the MSFC and averaging them to create an overall composite score. MSFC Z-score = (Z25-foot-walk + Z9HPT-2)/2, where Zj refers to Z-scores of component j. A Z-score represented the number of standard deviations participant's test result was higher (Z \>0) or lower (Z \<0) than the average test result (Z = 0) from the reference population. Higher scores indicate better outcomes. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42368888 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05701423
GET https://conductscience.org/api/trials/v1/NCT05701423/registered