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Trial record 1 of 1 for:    NCT02625090
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An Open-label Extension Study of UCB0942 in Adult Patients With Highly Drug-resistant Focal Epilepsy

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ClinicalTrials.gov Identifier: NCT02625090
Recruitment Status : Active, not recruiting
First Posted : December 9, 2015
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

Brief Summary:
The purpose of study EP0073 is to assess the long-term safety, tolerability, and efficacy during 5 years of treatment with the drug UCB0942 in patients with highly drug-resistant focal epilepsy. Also, the effects of UCB0942 on the patient's quality of life will be explored.

Condition or disease Intervention/treatment Phase
Highly Drug-resistant Focal Epilepsy Drug: UCB0942 Phase 2

Detailed Description:
For those subjects who benefit substantially from UCB0942 in the multicenter, randomized, double-blind, placebo-controlled, parallel group study EP0069, the current open-label extension study EP0073 will provide an opportunity to continue UCB0942 treatment after a careful evaluation of the individual benefit-risk balance and with close monitoring of safety, tolerability and efficacy of long-term study treatment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multicenter, Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of UCB0942 When Used as Adjunctive Therapy for Partial-onset Seizures in Adult Subjects With Highly Drug-resistant Focal Epilepsy
Actual Study Start Date : December 2015
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020


Arm Intervention/treatment
Experimental: UCB0942

UCB0942 400 mg bid or a tapered UCB0942 dose of 200 mg bid.

The Investigator will be allowed to increase or decrease the dose of UCB0942 to optimize tolerability and seizure control for each subject. Increases or decreases to the dose of UCB0942 should be made in steps not exceeding 200 mg/day per week; an exception is Taper Week 1 where a step of 800 mg/day to 500 mg/day is allowed. A faster decrease of the dose than 200 mg/day per week is allowed when it is clinically appropriate in the Investigator's medical judgment. Daily UCB0942 doses during this study may be 100 mg (50 mg bid), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid); intermediate doses will not be allowed except for tapering and titration unless agreed by the UCB Study Physician or PRA Medical Monitor. The dose of UCB0942 must always be administered as bid morning and evening doses, approximately 12 hours apart.

Drug: UCB0942
  • Active Substance: UCB0942
  • Pharmaceutical form: Film-coated tablet
  • Concentration: 25 mg, 100 mg or 200 mg
  • Route of Administration: oral




Primary Outcome Measures :
  1. Percentage of subjects with at least one treatment-emergent Adverse Events during the EP0073 study [ Time Frame: 58 months ]
  2. Percentage of subjects with at least one Serious Adverse Event during the EP0073 study [ Time Frame: 58 months ]
  3. Percentage of subjects discontinued due to treatment-emergent Adverse Events during the EP0073 study [ Time Frame: 58 months ]
  4. The 75 % Responder Rate at the end of the Evaluation Period [ Time Frame: 58 months ]
    A 75 % responder is defined as a subject with a ≥ 75 % reduction in partial-onset seizure frequency relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069.


Secondary Outcome Measures :
  1. Median partial-onset seizure frequency per 28 days over the Evaluation Period of the EP0073 study [ Time Frame: 58 months ]
  2. Median partial-onset seizure frequency per 28 days by seizure type over the Evaluation Period of the EP0073 study [ Time Frame: 58 months ]
  3. Percent reduction in partial-onset seizure frequency relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069 over the Evaluation Period of the EP0073 study [ Time Frame: 58 months ]
  4. The 50 % responder rate over the Evaluation Period of the EP0073 study [ Time Frame: 58 months ]
    A 50 % responder is defined as a subject with a ≥ 50 % reduction in partial-onset seizure frequency relative to the 2 week Prospective Outpatient Baseline Period defined in EP0069.

  5. Percentage of seizure-free days over the Evaluation Period [ Time Frame: 58 months ]
  6. Seizure-free rate over the Evaluation Period [ Time Frame: 58 months ]
  7. Changes in Quality of Life in Epilepsy 31-P (QOLIE-31-P) scores from Visit 3 (Week 2) of EP0069 through the assessment of the Evaluation Period [ Time Frame: 58 months ]
    The Quality of Life in Epilepsy 31-P (QOLIE-31-P) total score is a weighted sum of sub-scales scores related to seizures worry, overall quality of life, emotional well-being, energie/fatigue, cognitive functioning, medications effects, daily activities/social functioning.



Information from the National Library of Medicine

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

Inclusion Criteria:

  • A written Informed Consent form approved by the Independent Ethics Committee is signed and dated by the subject, after the Investigator assesses whether the subject is able to understand the potential risks and benefits of participating in the study
  • Subject must have completed Visit 13 (V13) of the Outpatient Maintenance Period of EP0069 to be eligible for enrollment into EP0073
  • In EP0069, the subject demonstrated a reduction in frequency and/or severity of seizures as compared to baseline that is considered clinically significant by the Investigator and significant by the subject
  • In EP0069, the subject experiences substantial benefit from UCB0942 with acceptable tolerability according to the subject and Investigator
  • No tolerability issues that can outweigh attained benefits, in the opinion of the Investigator
  • Female subjects of nonchildbearing potential (premenarcheal, postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, and complete hysterectomy) are eligible. Female subjects of childbearing potential are eligible if they use medically accepted contraceptive methods
  • Male subject confirms that, during the study period and for a period of 3 months after the final dose, when having sexual intercourse with a woman of childbearing potential, he will use a barrier contraceptive (eg, condom)Exclusion Criteria:
  • Subject has active suicidal ideation as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the 'Since Last Visit' version of the Columbia Suicide Severity Rating Scale. The subject should be referred immediately to a Mental Healthcare Professional and must be withdrawn from the study
  • Subject has taken other (non-Anti-Epileptic Drug) prescription, non-prescription, dietary (eg, grapefruit or passion fruit), or herbal products that are potent inducers or inhibitors of the CYP3A4 pathway for 2 weeks (or 5 half lives whichever is longer) prior to study entry
  • Subject has an abnormality in the 12-lead electrocardiography that, in the opinion of the Investigator, increases the risks associated with participating in the study. In addition, any subject with any of the following findings will be excluded:

    1. Prolonged QTc (Bazett's, machine-read) interval defined as > 450 ms for males and > 470 ms for females
    2. Bundle branch blocks and other conduction abnormalities other than mild first degree atrioventricular block (defined as PR interval >= 220 ms)
    3. Irregular rhythms other than sinus arrhythmia or occasional, rare supraventricular or rare ventricular ectopic beats
    4. In the judgment of the Investigator, T-wave configurations are not of sufficient quality for assessing QT interval duration
  • Subject has a clinically significant abnormality on echocardiography at the Entry Visit (V2) of EP0073
  • Upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >ULN total bilirubin (>=1.5xULN total bilirubin if known Gilbert's syndrome) at the EV (V2) of EP0073 (V15 of EP0069). If subject has elevations only in total bilirubin that are >ULN and <1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert's syndrome (ie, direct bilirubin <35%). For enrolled subjects with a baseline result

    • ULN for ALT, AST, ALP, or total bilirubin, a baseline diagnosis and/or the cause of any clinically meaningful elevation must be understood and recorded in the electronic Case Report form (eCRF). If subject has >ULN ALT, AST, or ALP that does not meet the exclusion limit at screening (ie, the value is
    • ULN but <=2xULN at the EV [V2] of EP0073), repeat the tests, if possible, prior to dosing to ensure there is no further ongoing clinically relevant increase. In case of a clinically relevant increase, inclusion of the subject must be discussed with the Medical Monitor

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): NCT02625090


Locations
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Belgium
Ep0073 103
Brussels, Belgium
Ep0073 101
Ghent, Belgium
Ep0073 102
Leuven, Belgium
Bulgaria
Ep0073 201
Sofia, Bulgaria
Germany
Ep0073 402
Bielefeld, Germany
Ep0073 403
Radeberg, Germany
Ep0073 405
Ravensburg, Germany
Hungary
Ep0073 601
Budapest, Hungary
Ep0073 602
Budapest, Hungary
Netherlands
Ep0073 302
Heeze, Netherlands
Spain
Ep0073 502
Barcelona, Spain
Ep0073 505
L'Hospitalet de Llobregat, Spain
Ep0073 506
Madrid, Spain
Ep0073 501
Sevilla, Spain
Ep0073 503
Valencia, Spain
Sponsors and Collaborators
UCB Biopharma S.P.R.L.
Investigators
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Study Director: UCB Cares +1 844 599 2273 (UCB)
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Responsible Party: UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier: NCT02625090    
Other Study ID Numbers: EP0073
2015-001268-20 ( EudraCT Number )
First Posted: December 9, 2015    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020
Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):
Drug-resistance
focal epilepsy
partial-onset seizures
Additional relevant MeSH terms:
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Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases