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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 : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Biogen

Brief Summary:
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.

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
Allocation: Randomized
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)
Masking Description: Double-blind
Primary Purpose: Treatment
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 : March 20, 2018
Estimated Primary Completion Date : July 18, 2019
Estimated Study Completion Date : July 17, 2020


Arm Intervention/treatment
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.
Drug: Natalizumab
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.
Other: Placebo
As specified in treatment arms.




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Must have focal epilepsy diagnosed on clinical grounds and as applicable supported by electroencephalogram findings [Scheffer 2017] and brain imaging. Participants with multifocal epilepsy may be included if all other entry criteria are met.
  • Must have a drug-resistant epilepsy defined as failure of adequate trials of 2 (or more) tolerated and appropriately chosen and used AEDs (whether as monotherapies or in combination) [Kwan 2010].
  • Experiences 6 or more seizures during the 6-week prospective baseline period and is not seizure free for more than 21 consecutive days during the prospective baseline period

Key Exclusion Criteria:

  • Focal aware seizures without motor signs are the only seizure type.
  • Diagnosis of generalized, combined generalized and focal, or unknown epilepsy
  • Known progressive structural CNS lesion.
  • History of seizures occurring in predominantly clustered patterns, as determined by the Investigator, over the 12 months prior to the Screening Visit (Week -6) or during the 6-week prospective baseline period, where individual seizures cannot be counted.
  • History of status epilepticus within the previous 6 months.
  • Known history or presence of non-epileptic seizures.

NOTE; Other protocol defined Inclusion/Exclusion criteria may apply


Information from the National Library of Medicine

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


Contacts
Contact: US Biogen Clinical Trial Center 866-633-4636 clinicaltrials@biogen.com
Contact: Global Biogen Clinical Trial Center clinicaltrials@biogen.com

  Show 45 Study Locations
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT03283371     History of Changes
Other Study ID Numbers: 101EP201
2017-001995-45 ( EudraCT Number )
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Biogen:
Drug Resistant Focal Epilepsy, Natalizumab, Seizure

Additional relevant MeSH terms:
Epilepsy
Seizures
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Natalizumab
Immunologic Factors
Physiological Effects of Drugs