Trial · NCT07483632
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | TP Cohort A and OLE Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and AEs Leading to Treatment Discontinuation | Cohort A: From first dose of study drug up to end of follow-up (up to Week 104), OLE: Baseline (Week 96) up to the end of OLE period (up to Week 196) | |
| Primary | TP Cohort B: Annualized Relapse Rate (ARR) Through Week 96 | Baseline (Day 1) up to Week 96 | |
| Secondary | TP Cohorts A and B: Maximum Observed Concentration at Steady State (Cmax,ss) of Monomethyl Fumarate (MMF) | Predose and at multiple timepoints post dose up to Week 96 | |
| Secondary | TP Cohorts A and B: Minimum Observed Concentration at Steady State (Cmin,ss) of MMF | Predose and at multiple timepoints post dose up to Week 96 | |
| Secondary | TP Cohorts A and B: Cmax,ss of 2-Hydroxyethyl Succinimide (HES) | Predose and at multiple timepoints post dose up to Week 96 | |
| Secondary | TP Cohorts A and B: Cmin,ss of HES | Predose and at multiple timepoints post dose up to Week 96 | |
| Secondary | TP Cohorts A, B and OLE Period: Number of Participants with Potentially Clinically Serious (PCS) Change from Baseline in Vital Sign Parameters | Cohorts A and B: Baseline up to Week 96, OLE: Baseline (Week 96) up to Week 196 | |
| Secondary | TP Cohorts A, B and OLE Period: Number of Participants With Change From Baseline in Clinically Relevant Electrocardiogram (ECG) Abnormalities | Cohorts A and B: Baseline up to Week 96, OLE: Baseline (Week 96) up to Week 196 | |
| Secondary | TP Cohorts A, B and OLE Period: Number of Participants with PCS Change from Baseline in Clinical Laboratory Parameters | Cohorts A and B: Baseline up to Week 96, OLE: Baseline (Week 96) up to Week 196 | |
| Secondary | TP Cohorts A, B and OLE Period: Change From Baseline in Height | Cohorts A and B: Baseline up to Week 104, OLE: Baseline (Week 96) up to Week 196 | |
| Secondary | TP Cohorts A, B and OLE Period: Change From Baseline in Weight | Cohorts A and B: Baseline up to Week 104, OLE: Baseline (Week 96) up to Week 196 | |
| Secondary | TP Cohorts A, B and OLE Period: Change From Baseline in Tanner Score | Cohorts A and B: Baseline up to Week 96, OLE: Baseline (Week 96) up to Week 196 | Assessment of Tanner stage will be performed by a healthcare professional experienced with this assessment. Tanner score ranges from Stage 1 (childhood) to Stage 5 (full physical maturity). Information regarding Tanner staging will be collected for all male participants with bone age \< 16 years and for female participants who are premenarche and have a bone age of \< 16 years and will be stopped once the participant's bone age reaches ≥ 16 years or once the participant is postmenarche. |
| Secondary | TP Cohorts A, B and OLE Period: Change From Baseline in Bone Age | Cohorts A and B: Baseline up to Week 96, OLE: Baseline (Week 96) up to Week 196 | |
| Secondary | TP Cohorts A, B and OLE Period: Number of Participants with Change From Baseline in Endocrine Tests | Cohorts A and B: Baseline up to Week 96, OLE: Baseline (Week 96) up to Week 196 | Endocrine parameters to be tested will include insulin-like growth factor 1, and insulin-like growth factor binding protein for both females and males; follicle stimulating hormone (FSH), luteinizing hormone (LH), and estradiol (E-2) for females; and testosterone, FSH, and LH for males. All endocrine tests will stop being performed once the participant has reached a bone age of ≥ 16 years or the participant is postmenarche. |
| Secondary | TP Cohorts A, B and OLE Period: Change From Baseline in Depression Monitored Using the Children's Depression Rating Scale for Participants <18 Years or the Hamilton Rating Scale for Depression (HAMD-17) for Participants ≥18 Years | Cohorts A and B: Baseline up to Week 96, OLE: Baseline (Week 96) up to Week 196 | |
| Secondary | TP Cohorts A, B and OLE Period: Change From Baseline in Depression Monitored Using the Columbia Suicide Severity Rating Scale (C-SSRS) | Cohorts A and B: Baseline up to Week 96, OLE: Baseline (Week 96) up to Week 196 | The C-SSRS is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assesses whether participant experiences any of the following 1. completed suicide, 2. suicide attempt (response of "yes" on "actual attempt"), 3. preparatory acts toward imminent suicidal behavior ("yes" on "aborted attempt", "interrupted attempt", "preparatory acts or behavior"), 4. any suicidal behavior or ideation, suicidal ideation ("yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent"), 5. self-injurious behavior, no suicidal intent ("yes" on "has participant engaged in non-suicidal self-injurious behavior"). |
| Secondary | TP Cohort B: Change From Baseline in Annualized Rate of New/Newly Enlarging (N/NE) T2 Hyperintense Lesions Through Week 96 | Baseline (Day 1) up to Week 96 | |
| Secondary | TP Cohort B: Time to First Relapse | Baseline (Day 1) up to Week 96 | |
| Secondary | TP Cohort B: Percentage of Participants Free of Relapse up to Week 96 | Baseline (Day 1) up to Week 96 | |
| Secondary | TP Cohort B and OLE Period: Change From Baseline in Expanded Disability Status Scale (EDSS) Score | Cohort B: Baseline up to Week 96, OLE: Baseline (Week 96) up to Week 196 | The EDSS is a method of quantifying disability and monitoring changes in the level of disability over time. EDSS score ranges from 0 (normal neurological exam) to 10 (death from MS) with higher scores indicating more disability. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT07483632/registered