Trial · NCT03283371
Phase 2 Efficacy, Safety, and Tolerability Study of Natalizumab in Focal Epilepsy
NCT03283371, Phase 2, Completed, Biogen; results first posted 2021-04-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 2 Efficacy, Safety, and Tolerability Study of Natalizumab in Focal Epilepsy. Trials, record NCT03283371. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03283371
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2 Efficacy, Safety, and Tolerability Study of Natalizumab in Focal Epilepsy
- NCT number
- NCT03283371
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 67 participants, actual
- Lead sponsor
- Biogen
- Conditions
- Epilepsy, Focal Seizures, Partial Seizures
- Interventions
- Natalizumab, Placebo
- First posted
- 2017-09-14
- Last updated
- 2021-12-14
- Other registries' IDs
- eudract:2017-001995-45
- Results first posted
- 2021-04-27
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Log-Transformed Seizure Frequency During Weeks 8 to 24 of Treatment | Baseline, Week 8 to Week 24 | Seizures included were focal aware seizures with motor signs, focal impaired awareness seizures and focal to bilateral tonic-clonic seizure. Focal aware seizures without motor signs were not included. Seizure clusters (where individual seizures cannot be distinguished) were counted as 1 seizure per cluster on each day that they are present. Study baseline seizure frequency (number of seizures per 28 days) was calculated based on participant's seizure diary data during prospective baseline phase. Seizure frequency (SF) at post baseline visit was calculated based on sum of the seizures reported in participant seizure diary and the number of days with non-missing SF data in participant seizure diary on or after the previous visit date. Change from Baseline are based on natural log transformation of baseline SF or SF at post baseline visit correspondingly. For log-transformation, the quantity 0.2 {ln(x+0.2)} was added to the SF at post baseline visit to account for 0 seizure count. |
| Secondary | Percentage of Responders During Weeks 8 to 24 of Treatment | Week 8 to Week 24 | Responders were defined as participants with \>=50% reduction from study baseline in seizure frequency during Weeks 8 to 24. Study baseline seizure frequency (number of seizures per 28 days) was calculated based on participants' seizure diary data during the prospective Baseline Phase (number of seizures during Baseline Phase/number of days with non-missing seizure frequency\*28). Participants who withdrew from treatment or required protocol specified modifications of antiepileptic drug (AEDs) prior to Week 24 (completion of the Placebo-controlled Phase) or death related to Epilepsy were considered as non-responders in the analysis. Seizure frequency at post baseline visit was calculated based on the sum of the seizures reported in the subject seizure diary and the number of days with non-missing seizure frequency data in the subject seizure diary on or after the previous visit date. |
| Secondary | Number of Participants Free From Seizures During Weeks 8 to 24 of Treatment | Week 8 to Week 24 | Seizure free is defined as a participant with no seizure reported and no missing diary during Weeks 8 to 24. Participants who withdrew from treatment, required modifications of AEDs prior to Week 24 (completion of the Placebo-controlled Phase), or any missing diary data during Weeks 8 to 24 of treatment were not considered as seizure free in the analysis. |
| Secondary | Percent Change From Baseline of Seizure-Free Days Change During Weeks 8 to 24 of Treatment | Baseline, Week 8, Week 12, Week 16, Week 20, Week 24 | Study baseline seizure free days (number of seizure free days per 28 days) was calculated based on the diary data during the prospective baseline Phase (Number of seizures during baseline Phase/Number of days with non-missing seizure frequency\*28). Seizure frequency at post baseline visit was calculated based on the sum of the seizures reported in the subject seizure diary and the number of days with non-missing seizure frequency data in the subject seizure diary on or after the previous visit date. |
| Secondary | Percentage of Participants With Inadequate Treatment Response During Weeks 8 to 24 of Treatment | Week 8 to Week 24 | Inadequate treatment response includes participants who withdraw from treatment due to lack of efficacy or require protocol specified modifications of antiepileptic drugs (AEDs) prior to Week 24 (completion of the placebo- controlled phase) or death related to Epilepsy. |
| Other | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From first dose up to 24 weeks after the last dose of study treatment (up to Week 68) | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal assessment such as an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, in the view of the Investigator, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a birth defect. |
| Other | Number of Participants With Clinically Significant Laboratory Abnormalities | From first dose up to 16 weeks after the last dose of study treatment (up to Week 60) | The laboratory assessments included hematology, blood chemistry, serology, urinalysis and vital signs assessment. |
| Other | Number of Participants With Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) or C-SSRS Score | Placebo-controlled Phase: Baseline, Weeks 4, 8, 12, 16, 20 and 24; Open-label Phase: Baseline, Weeks 28, 32, 36, 40, 44, 48 and 60/End of Study (EOS) | C-SSRS is a prospective assessment tool to evaluate suicidal ideation and behavior. C-SSRS score for suicidal ideation ranges from 1 to 10, where 1=Wish to be Dead; 2=Nonspecific Active Suicidal Thoughts; 3=Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; 4=Active Suicidal Ideation with Some Intent to Act, without Specific Plan; 5=Active Suicidal Ideation with Specific Plan and Intent; and for suicidal behavior ranges from 6=Preparatory Acts or Behavior, 7=Aborted Attempt, 8=Interrupted Attempt, 9=Actual Attempt (nonfatal), 10=Completed Suicide. Participants with a C-SSRS score between 1-10 are reported in this outcome measure. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Log-Transformed Seizure Frequency During Weeks 8 to 24 of Treatment | Baseline, Week 8 to Week 24 | ITT population is defined as all participants who were randomized and received any dose of study treatment. | log(seizure/28 days) | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Responders During Weeks 8 to 24 of Treatment | Week 8 to Week 24 | The ITT population is defined as all participants who were randomized and received any dose of study treatment. | percentage of responders | NUMBER |
| SECONDARY | Number of Participants Free From Seizures During Weeks 8 to 24 of Treatment | Week 8 to Week 24 | The ITT population is defined as all participants who were randomized and received any dose of study treatment. Here, number of participants analyzed signifies number of participants who were analyzed in this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent Change From Baseline of Seizure-Free Days Change During Weeks 8 to 24 of Treatment | Baseline, Week 8, Week 12, Week 16, Week 20, Week 24 | ITT population is defined as all participants who were randomized and received any dose of study treatment. Here, number analyzed signifies number of participants analyzed at specific timepoint. | percent change | MEAN |
| SECONDARY | Percentage of Participants With Inadequate Treatment Response During Weeks 8 to 24 of Treatment | Week 8 to Week 24 | The ITT population is defined as all participants who were randomized and received any dose of study treatment. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From first dose up to 24 weeks after the last dose of study treatment (up to Week 68) | The safety population is defined as all participants who were randomized and received any dose of study treatment and were used for the analysis of safety data. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With Clinically Significant Laboratory Abnormalities | From first dose up to 16 weeks after the last dose of study treatment (up to Week 60) | The safety population is defined as all participants who were randomized and received any dose of study treatment and were used for the analysis of safety data. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) or C-SSRS Score | Placebo-controlled Phase: Baseline, Weeks 4, 8, 12, 16, 20 and 24; Open-label Phase: Baseline, Weeks 28, 32, 36, 40, 44, 48 and 60/End of Study (EOS) | The safety population is defined as all participants who were randomized and received any dose of study treatment and were used for the analysis of safety data. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group62
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Log-Transformed Seizure Frequency During Weeks 8 to 24 of Treatment | Placebo (Placebo-controlled Phase) | -0.43 | Standard Error 0.162 | log(seizure/28 days) | |
| Change From Baseline in Log-Transformed Seizure Frequency During Weeks 8 to 24 of Treatment | Natalizumab 300 mg (Placebo-controlled Phase) | -0.58 | Standard Error 0.165 | log(seizure/28 days) | |
| Percentage of Responders During Weeks 8 to 24 of Treatment | Placebo (Placebo-controlled Phase) | 17.6 | percentage of responders | ||
| Percentage of Responders During Weeks 8 to 24 of Treatment | Natalizumab 300 mg (Placebo-controlled Phase) | 31.3 | percentage of responders | ||
| Number of Participants Free From Seizures During Weeks 8 to 24 of Treatment | Placebo (Placebo-controlled Phase) | 1 | Participants | ||
| Number of Participants Free From Seizures During Weeks 8 to 24 of Treatment | Natalizumab 300 mg (Placebo-controlled Phase) | 0 | Participants | ||
| Percent Change From Baseline of Seizure-Free Days Change During Weeks 8 to 24 of Treatment | Placebo (Placebo-controlled Phase) | Baseline | 16.23 | Standard Deviation 7.347 | percent change |
| Percent Change From Baseline of Seizure-Free Days Change During Weeks 8 to 24 of Treatment | Natalizumab 300 mg (Placebo-controlled Phase) | Baseline | 17.54 | Standard Deviation 7.223 | percent change |
| Percent Change From Baseline of Seizure-Free Days Change During Weeks 8 to 24 of Treatment | Placebo (Placebo-controlled Phase) | Week 8 | 4.33 | Standard Deviation 50.740 | percent change |
| Percent Change From Baseline of Seizure-Free Days Change During Weeks 8 to 24 of Treatment | Natalizumab 300 mg (Placebo-controlled Phase) | Week 8 | 39.23 | Standard Deviation 130.988 | percent change |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 results by groupParticipant flow28
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Placebo-controlled | STARTED | Placebo (Placebo-controlled Phase) | 34 | |
| Placebo-controlled | STARTED | Natalizumab 300 mg (Placebo-controlled Phase) | 33 | |
| Placebo-controlled | STARTED | Placebo to Natalizumab 300 mg (Open-label Phase) | 0 | |
| Placebo-controlled | STARTED | Natalizumab 300 mg to Natalizumab 300 mg (Open-label Phase) | 0 | |
| Placebo-controlled | Number of Participants Dosed | Placebo (Placebo-controlled Phase) | 34 | |
| Placebo-controlled | Number of Participants Dosed | Natalizumab 300 mg (Placebo-controlled Phase) | 32 | |
| Placebo-controlled | Number of Participants Dosed | Placebo to Natalizumab 300 mg (Open-label Phase) | 0 | |
| Placebo-controlled | Number of Participants Dosed | Natalizumab 300 mg to Natalizumab 300 mg (Open-label Phase) | 0 | |
| Placebo-controlled | COMPLETED | Placebo (Placebo-controlled Phase) | 31 | |
| Placebo-controlled | COMPLETED | Natalizumab 300 mg (Placebo-controlled Phase) | 30 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 participant flowAdverse events120
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Placebo (Placebo-controlled Phase) | 0 | 34 | |
| other | Anaemia | Blood and lymphatic system disorders | Natalizumab 300 mg (Placebo- Controlled Phase) | 2 | 32 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo to Natalizumab 300 mg (Open-label Phase) | 0 | 31 | |
| other | Anaemia | Blood and lymphatic system disorders | Natalizumab 300 mg to Natalizumab 300 mg (Open-label Phase) | 0 | 30 | |
| other | Vision blurred | Eye disorders | Placebo (Placebo-controlled Phase) | 1 | 34 | |
| other | Vision blurred | Eye disorders | Natalizumab 300 mg (Placebo- Controlled Phase) | 2 | 32 | |
| other | Vision blurred | Eye disorders | Placebo to Natalizumab 300 mg (Open-label Phase) | 0 | 31 | |
| other | Vision blurred | Eye disorders | Natalizumab 300 mg to Natalizumab 300 mg (Open-label Phase) | 0 | 30 | |
| other | Nausea | Gastrointestinal disorders | Placebo (Placebo-controlled Phase) | 1 | 34 | |
| other | Nausea | Gastrointestinal disorders | Natalizumab 300 mg (Placebo- Controlled Phase) | 3 | 32 |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo (Placebo-controlled Phase) | 0 | 34 |
| Total, all-cause mortality | Natalizumab 300 mg (Placebo- Controlled Phase) | 0 | 32 |
| Total, all-cause mortality | Placebo to Natalizumab 300 mg (Open-label Phase) | 0 | 31 |
| Total, all-cause mortality | Natalizumab 300 mg to Natalizumab 300 mg (Open-label Phase) | 0 | 30 |
| Total, other adverse events | Placebo (Placebo-controlled Phase) | 15 | 34 |
| Total, other adverse events | Natalizumab 300 mg (Placebo- Controlled Phase) | 17 | 32 |
| Total, other adverse events | Placebo to Natalizumab 300 mg (Open-label Phase) | 13 | 31 |
| Total, other adverse events | Natalizumab 300 mg to Natalizumab 300 mg (Open-label Phase) | 9 | 30 |
| Total, serious adverse events | Placebo (Placebo-controlled Phase) | 1 | 34 |
| Total, serious adverse events | Natalizumab 300 mg (Placebo- Controlled Phase) | 1 | 32 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34521687 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Natalizumab 300 mg (Placebo-controlled Phase) vs Placebo (Placebo-controlled Phase): Number of Participants Free From Seizures During Weeks 8 to 24 of Treatment |
Source Trial comparisons
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/NCT03283371
GET https://conductscience.org/api/trials/v1/NCT03283371/results?page=2