EUCTR2016-002879-96-Outside-EU/EEA
Active, not recruiting
Phase 1
An open-label, multicenter, long-term, follow-up study in Japan to evaluate the safety, tolerability, and efficacy of adjunctive treatment with oral L059 (levetiracetam) in epilepsy subjects with generalized tonic-clonic (GTC) seizures
CB Japan Co. Ltd.0 sites46 target enrollmentJuly 25, 2016
ConditionsEpilepsyGeneralized Tonic-Clonic SeizuresMedDRA version: 19.0Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 19.0Level: LLTClassification code 10062448Term: Generalized tonic-clonic seizureSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- EpilepsyGeneralized Tonic-Clonic Seizures
- Sponsor
- CB Japan Co. Ltd.
- Enrollment
- 46
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion Criteria:
- •\- The subject in Japan has completed either of the studies N01159 or N01363 or has discontinued the N01159 study due to lack of efficacy.
- •\- The subject who is judged to benefit from continued treatment with Levetiracetam by the investigators
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 14
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 29
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 1
Exclusion Criteria
- •Subjects with multiple protocol deviations during N01159 or N01363, such as missing laboratory data, and low or noncompliance with the study medication, and who the investigator considers not to have the potential to have deviations stopped are ineligible
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
A Long-Term Follow-Up Study of Haemophilia B Patients Who Have Undergone Gene TherapyHaemophilia BMedDRA version: 20.0Level: LLTClassification code 10018939Term: Haemophilia B (Factor IX)System Organ Class: 100000004850Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]EUCTR2017-005080-40-GBFreeline Therapeutics Limited50
Active, not recruiting
Phase 1
Evaluation of long-term safety, tolerability and efficacy of GLPG0634 treatment in subjects with rheumatoid arthritis regarding subject’s disability, fatigue, and quality of lifeEUCTR2012-003655-11-DEGalapagos NV739
Active, not recruiting
Phase 1
Evaluation of long-term safety, tolerability and efficacy of GLPG0634 treatment in subjects with rheumatoid arthritis regarding subject’s disability, fatigue, and quality of lifeModerately to severely active rheumatoid arthritisMedDRA version: 23.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]EUCTR2012-003655-11-BEGalapagos NV739
Active, not recruiting
Phase 1
Evaluation of long-term safety, tolerability and efficacy of GLPG0634 treatment in subjects with rheumatoid arthritis regarding subject’s disability, fatigue, and quality of lifeEUCTR2012-003655-11-LVGalapagos NV739
Active, not recruiting
Phase 1
Evaluation of long-term safety, tolerability and efficacy of GLPG0634 treatment in subjects with rheumatoid arthritis regarding subject’s disability, fatigue, and quality of lifeEUCTR2012-003655-11-HUGalapagos NV739