Phase 2 Efficacy, Safety, and Tolerability Study of Natalizumab in Focal Epilepsy (OPUS)
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|ClinicalTrials.gov Identifier: NCT03283371|
Recruitment Status : Recruiting
First Posted : September 14, 2017
Last Update Posted : August 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy, Focal Seizures, Partial Seizures||Drug: Natalizumab Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||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.|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Exploring the Efficacy, Safety, and Tolerability of Natalizumab (BG00002) as Adjunctive Therapy in Adult Subjects With Drug-Resistant Focal Epilepsy|
|Actual Study Start Date :||January 17, 2018|
|Estimated Primary Completion Date :||July 17, 2019|
|Estimated Study Completion Date :||July 17, 2020|
Experimental: Natalizumab 300 mg
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.
As specified in the treatment arm.
Other Name: Tysabri
Placebo Comparator: Placebo
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.
As specified in treatment arms.
- Change from Baseline in Log-Transformed Seizure Frequency during Weeks 8 to 24 of Treatment [ Time Frame: Week 8 to Week 24 ]
Seizures included in efficacy analyses are focal aware seizures (previously termed "simple partial seizures") with motor signs, focal impaired awareness seizures (previously termed "complex partial seizures"), and focal to bilateral tonic-clonic seizures (previously termed "partial onset with secondary generalization"). Focal aware seizures without motor signs will not be included.
Seizure clusters (where individual seizures cannot be distinguished) will be counted as 1 seizure per cluster on each day that they are present.
- Percentage of Responders [ Time Frame: Week 8 to Week 24 ]Responders were defined as participants with a ≥50% reduction from Baseline in seizure frequency (number of seizures per 28 days) during Weeks 8 to 24 of treatment.
- Percentage of Participants Free from Seizures [ Time Frame: Week 8 to Week 24 ]Proportion of subjects free from seizures during Weeks 8 to 24 of treatment.
- Percentage of Seizure-Free Days Gained [ Time Frame: Week 8 to Week 24 ]Seizure free days gained will be standardized over 28 days during weeks 8 to 24 of treatment compared with baseline.
- Percentage of Participants with Inadequate Treatment Response [ Time Frame: Week 8 to Week 24 ]Inadequate treatment response will be defined as either modification of anti-epileptic drugs (AEDs) after Week 12 of the placebo-controlled phase due to lack of improvement or ongoing seizures or discontinuation of study treatment after the 8-week active run-in period due to lack of efficacy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03283371
|Contact: US Biogen Clinical Trial Centeremail@example.com|
|Contact: Global Biogen Clinical Trial Centerfirstname.lastname@example.org|
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|Study Director:||Medical Director||Biogen|