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Levetiracetam Versus Topiramate as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures

Information source: UCB Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy

Intervention: Levetiracetam (Drug); Topiramate (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Korea UCB Co., Ltd.

Official(s) and/or principal investigator(s):
UCB Clinical Trial Call Center, Study Director, Affiliation: 1 877 822 9493 (UCB)

Summary

To assess the long-term effects of levetiracetam on retention rate in subjects with refractory partial onset seizure that are not fully controlled with 1 to 3 concomitant antiepileptic drugs, compared to topiramate as add-on therapy during 52 weeks.

Clinical Details

Official title: A Randomized, Open-label, Parallel Group, Multi-center, Comparative, Phase IV Trial of Levetiracetam (LEV) Versus Topiramate (TPM) as Adjunctive Therapy to Evaluate Efficacy and Safety in Adult Subjects With Refractory Partial Onset Seizures

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of subjects continuing the allocated investigational treatment from the first study treatment intake to week 52, after the beginning of investigational treatment with levetiracetam compared to topiramate

Secondary outcome:

Number of subjects with at least one adverse event reported during the trial period from baseline to week 52

Time from the first study treatment intake to drug discontinuation due to adverse event (AE)

Mean percent reduction in the weekly partial onset seizure (POS) frequency from baseline during the total treatment period from baseline to week 52

Responders defined as number of subjects with at least 50% reduction in the weekly POS frequency from baseline during the total treatment period from baseline to week 52

Eligibility

Minimum age: 16 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female subjects from 16 to 80 years, inclusive. Subjects under 20 years may

only be included where legally permitted and ethically accepted

- Subjects with refractory epilepsy with partial onset seizure classifiable according

to the International League Against Epilepsy (ILAE).

- Subjects having at least 2 partial onset seizures whether or not secondarily

generalized during the 8 weeks historical baseline preceding V1 according to ILAE classification

- Subjects having at least 1 partial onset seizures whether or not secondarily

generalized per 4 weeks preceding V2 according to ILAE classification

- Subjects with each interval of partial onset seizures less than 6 weeks during entire

12 weeks (8 weeks preceding V1 and 4 weeks preceding V2)

- Subjects being uncontrolled while treated by 1 to 3 permitted concomitant AEDs.

- Permitted concomitant AEDs having been stable and at optimal dosage for the subject

from at least 4 week before V1 and during 4 weeks preceding V2 and expected to be kept stable during the Treatment Period. Exclusion Criteria:

- Subjects presenting any generalized epilepsies classified as type II according to the

ILAE classification (ref to publication from 1981)

- Subjects suffering from epilepsies and syndromes undetermined whether focal or

generalized (classification III according to the ILAE classification)

- Subjects suffering from special syndromes (classification IV according to the ILAE

classification)

- History or occurring only in clusters (too frequently or indistinctly separated to be

reliably counted) before V2.

- Presence of exclusively type IA non-motor seizures.

- History or presence of status epilepticus within last 3 months preceding V1 or during

Baseline

- History or presence of known pseudo-seizures

- Subjects who are currently on vigabatrin. (Subjects who received vigabatrin in the

past and have a normal visual field test are allowed.)

- Subject taking 1 or more of the following medications on a regular basis within 28

days prior to Visit 1: antipsychotics drugs, and psychostimulant (amphetamine derivatives)

Locations and Contacts

14, Busan, Korea, Republic of

21, Busan, Korea, Republic of

9, Busan, Korea, Republic of

12, Daegu, Korea, Republic of

13, Daegu, Korea, Republic of

10, Daejeon, Korea, Republic of

25, Daejeon, Korea, Republic of

15, Gwangju, Korea, Republic of

7, Incheon, Korea, Republic of

19, Kyunggi-do, Korea, Republic of

23, Kyunggi-Do, Korea, Republic of

24, Kyunggi-Do, Korea, Republic of

8, Pusan, Korea, Republic of

11, Seongnam-si, Korea, Republic of

1, Seoul, Korea, Republic of

16, Seoul, Korea, Republic of

17, Seoul, Korea, Republic of

18, Seoul, Korea, Republic of

2, Seoul, Korea, Republic of

3, Seoul, Korea, Republic of

4, Seoul, Korea, Republic of

5, Seoul, Korea, Republic of

6, Seoul, Korea, Republic of

22, Ulsan, Korea, Republic of

Additional Information

Starting date: November 2010
Last updated: May 29, 2015

Page last updated: August 23, 2015

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