Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001995-45 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary efficacy objective of the study is to determine if adjunctive therapy of natalizumab 300 mg intravenous (IV) every 4 weeks reduces the frequency of seizures in adult participants with drug-resistant focal epilepsy. The secondary efficacy objective is to assess the effects of natalizumab versus placebo in drug-resistant focal epilepsy on additional measures of seizure frequency.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Natalizumab 300 mg | Experimental | Participants will undergo a prospective baseline period of 6 weeks (Weeks -6 to 0) followed by placebo controlled phase to receive natalizumab 300 mg intravenous (IV) infusion every 4 weeks from Week 0 to Week 24. Participants will continue to receive natalizumab 300 mg IV infusion every 4 weeks for up to an additional 24 weeks in open label phase. |
|
| Placebo | Placebo Comparator | Participants will undergo a prospective baseline period of 6 weeks (Weeks -6 to 0) followed by placebo controlled phase to receive natalizumab matching placebo intravenous (IV) infusion every 4 weeks from Week 0 to Week 24. Participants will then receive natalizumab 300 mg IV infusion every 4 weeks for 24 weeks in open label phase. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Natalizumab | Drug | As specified in the treatment arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Log-Transformed Seizure Frequency During Weeks 8 to 24 of Treatment | 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. | Baseline, Week 8 to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Responders During Weeks 8 to 24 of Treatment | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. |
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE; Other protocol defined Inclusion/Exclusion criteria may apply
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | 35294 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34521687 | Derived | French JA, Cole AJ, Faught E, Theodore WH, Vezzani A, Liow K, Halford JJ, Armstrong R, Szaflarski JP, Hubbard S, Patel J, Chen K, Feng W, Rizzo M, Elkins J, Knafler G, Parkerson KA; OPUS Study Group. Safety and Efficacy of Natalizumab as Adjunctive Therapy for People With Drug-Resistant Epilepsy: A Phase 2 Study. Neurology. 2021 Nov 2;97(18):e1757-e1767. doi: 10.1212/WNL.0000000000012766. Epub 2021 Sep 14. |
Not provided
Not provided
A total 67 participants with drug-resistant focal epilepsy were enrolled and randomized in this study. Of which, 66 participants received at least one dose of study drug.
Participants were enrolled at 31 investigational sites in United States from 20 March 2018 to 18 Nov 2020.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo (Placebo-controlled Phase) | Participants received natalizumab-matching placebo intravenous (IV) infusion every 4 weeks in Placebo-controlled Phase for up to Week 24. |
| FG001 | Natalizumab 300 mg (Placebo-controlled Phase) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Placebo-controlled |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 30, 2018 | Dec 24, 2020 |
Not provided
Not provided
This is a 6-month randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of natalizumab as adjunctive therapy in the treatment of adult subjects with drug-resistant focal epilepsy. The placebo-controlled phase is followed by a 6-month open-label phase during which all subjects receive natalizumab.
Not provided
Not provided
Double-blind
| Placebo | Other | As specified in treatment arms. |
|
| Week 8 to Week 24 |
| Number of Participants Free From Seizures During Weeks 8 to 24 of Treatment | 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. | Week 8 to Week 24 |
| Percent Change From Baseline of Seizure-Free Days Change During Weeks 8 to 24 of Treatment | 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. | Baseline, Week 8, Week 12, Week 16, Week 20, Week 24 |
| Percentage of Participants With Inadequate Treatment Response During Weeks 8 to 24 of Treatment | 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. | Week 8 to Week 24 |
| From first dose up to 24 weeks after the last dose of study treatment (up to Week 68) |
| Number of Participants With Clinically Significant Laboratory Abnormalities | The laboratory assessments included hematology, blood chemistry, serology, urinalysis and vital signs assessment. | From first dose up to 16 weeks after the last dose of study treatment (up to Week 60) |
| Number of Participants With Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) or C-SSRS Score | 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. | 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) |
| Phoenix |
| Arizona |
| 85004 |
| United States |
| Research Site | Phoenix | Arizona | 85054 | United States |
| Research Site | San Diego | California | 92103 | United States |
| Research Site | Santa Monica | California | 90404 | United States |
| Research Site | Washington D.C. | District of Columbia | 20037 | United States |
| Research Site | Jacksonville | Florida | 32209 | United States |
| Research Site | Maitland | Florida | 32751 | United States |
| Research Site | Orlando | Florida | 32803 | United States |
| Research Site | Tallahassee | Florida | 32308 | United States |
| Research Site | Tampa | Florida | 33606 | United States |
| Research Site | Honolulu | Hawaii | 96817 | United States |
| Research Site | Chicago | Illinois | 60612 | United States |
| Research Site | Bethesda | Maryland | 20817 | United States |
| Research Site | Chevy Chase | Maryland | 20815 | United States |
| Research Site | Boston | Massachusetts | 02111 | United States |
| Research Site | Boston | Massachusetts | 02115 | United States |
| Research Site | Saginaw | Michigan | 48602 | United States |
| Research Site | St Louis | Missouri | 63110 | United States |
| Research Site | Camden | New Jersey | 08103 | United States |
| Research Site | Rochester | New York | 14642 | United States |
| Research Site | Syracuse | New York | 13210 | United States |
| Research Site | The Bronx | New York | 10467 | United States |
| Research Site | Asheville | North Carolina | 28806 | United States |
| Research Site | Chapel Hill | North Carolina | 27514 | United States |
| Research Site | Durham | North Carolina | 27705 | United States |
| Research Site | Akron | Ohio | 44320 | United States |
| Research Site | Philadelphia | Pennsylvania | 19104 | United States |
| Research Site | Charleston | South Carolina | 29425 | United States |
| Research Site | Dallas | Texas | 75390 | United States |
| Research Site | Renton | Washington | 98055 | United States |
Participants received natalizumab 300 mg IV infusion every 4 weeks in Placebo-controlled Phase for up to Week 24.
| FG002 | Placebo to Natalizumab 300 mg (Open-label Phase) | Participants who received natalizumab-matching placebo in Placebo-controlled Phase, received natalizumab 300 mg IV infusion every 4 weeks in Open-label Phase for up to Week 48. |
| FG003 | Natalizumab 300 mg to Natalizumab 300 mg (Open-label Phase) | Participants who received natalizumab 300 mg in Placebo-controlled Phase, continued to receive natalizumab 300 mg IV infusion every 4 weeks in Open-label Phase for up to Week 48. |
| Number of Participants Dosed |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Open-label Phase |
|
|
The Intent to Treat (ITT) population is defined as all participants who were randomized and received any dose of study treatment. Ethnicity was not collected in this study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo (Placebo-controlled Phase) | Participants received natalizumab-matching placebo IV infusion every 4 weeks in Placebo-controlled Phase for up to Week 24. |
| BG001 | Natalizumab 300 mg (Placebo-controlled Phase) | Participants received natalizumab 300 mg IV infusion every 4 weeks in Placebo-controlled Phase for up to Week 24. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Log-Transformed Seizure Frequency During Weeks 8 to 24 of Treatment | 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. | ITT population is defined as all participants who were randomized and received any dose of study treatment. | Posted | Least Squares Mean | Standard Error | log(seizure/28 days) | Baseline, Week 8 to Week 24 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Responders During Weeks 8 to 24 of Treatment | 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. | The ITT population is defined as all participants who were randomized and received any dose of study treatment. | Posted | Number | percentage of responders | Week 8 to Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Free From Seizures During Weeks 8 to 24 of Treatment | 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. | 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. | Posted | Count of Participants | Participants | Week 8 to Week 24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline of Seizure-Free Days Change During Weeks 8 to 24 of Treatment | 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. | 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. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 8, Week 12, Week 16, Week 20, Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Inadequate Treatment Response During Weeks 8 to 24 of Treatment | 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. | The ITT population is defined as all participants who were randomized and received any dose of study treatment. | Posted | Number | percentage of participants | Week 8 to Week 24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | 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. | Posted | Count of Participants | Participants | From first dose up to 24 weeks after the last dose of study treatment (up to Week 68) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Clinically Significant Laboratory Abnormalities | The laboratory assessments included hematology, blood chemistry, serology, urinalysis and vital signs assessment. | 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. | Posted | Count of Participants | Participants | From first dose up to 16 weeks after the last dose of study treatment (up to Week 60) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) or C-SSRS Score | 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. | 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. | Posted | Count of Participants | Participants | 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) |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo (Placebo-controlled Phase) | Participants received natalizumab-matching placebo IV infusion every 4 weeks in Placebo-controlled Phase for up to Week 24. | 0 | 34 | 1 | 34 | 15 | 34 |
| EG001 | Natalizumab 300 mg (Placebo- Controlled Phase) | Participants received natalizumab 300 mg IV infusion every 4 weeks in Placebo-controlled Phase for up to Week 24. | 0 | 32 | 1 | 32 | 17 | 32 |
| EG002 | Placebo to Natalizumab 300 mg (Open-label Phase) | Participants who received natalizumab-matching placebo in Placebo-controlled Phase, received natalizumab 300 mg IV infusion every 4 weeks in Open-label Phase for up to Week 48. | 0 | 31 | 3 | 31 | 13 | 31 |
| EG003 | Natalizumab 300 mg to Natalizumab 300 mg (Open-label Phase) | Participants who received natalizumab 300 mg in Placebo-controlled Phase, continued to receive natalizumab 300 mg IV infusion every 4 weeks in Open-label Phase for up to Week 48. | 0 | 30 | 2 | 30 | 9 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seizure | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Seizure cluster | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| US Biogen Clinical Trial Center | Biogen | 866-633-4636 | clinicaltrials@biogen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 7, 2020 | Dec 24, 2020 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069442 | Natalizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Withdrawal by Subject |
|
| Other |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
| OG002 | Placebo to Natalizumab 300 mg (Open-label Phase) | Participants who received natalizumab-matching placebo in Placebo-controlled Phase, received natalizumab 300 mg IV infusion every 4 weeks in Open-label Phase for up to Week 48. |
| OG003 | Natalizumab 300 mg to Natalizumab 300 mg (Open-label Phase) | Participants who received natalizumab 300 mg in Placebo-controlled Phase, continued to receive natalizumab 300 mg IV infusion every 4 weeks in Open-label Phase for up to Week 48. |
|
|
| Natalizumab 300 mg to Natalizumab 300 mg (Open-label Phase) |
Participants who received natalizumab 300 mg in Placebo-controlled Phase, continued to receive natalizumab 300 mg IV infusion every 4 weeks in Open-label Phase for up to Week 48. |
|
|
| OG002 | Placebo to Natalizumab 300 mg (Open-label Phase) | Participants who received natalizumab-matching placebo in Placebo-controlled Phase, received natalizumab 300 mg IV infusion every 4 weeks in Open-label Phase for up to Week 48. |
| OG003 | Natalizumab 300 mg to Natalizumab 300 mg (Open-label Phase) | Participants who received natalizumab 300 mg in Placebo-controlled Phase, continued to receive natalizumab 300 mg IV infusion every 4 weeks in Open-label Phase for up to Week 48. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|