Safety and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome
NCT02187809 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3
Last updated 2017-03-27
Summary
To investigate the long-term safety and tolerability of clobazam when administered for 1 year as adjunctive therapy in paediatric patients aged ≥1 to ≤16 years with Dravet Syndrome.
Conditions
Interventions
- DRUG
-
Clobazam
Sponsors & Collaborators
-
H. Lundbeck A/S
lead INDUSTRY
Principal Investigators
-
Email contact via H. Lundbeck A/S · [email protected]
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 1 Year
- Max Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-03-31
- Primary Completion
- 2015-10-31
- Completion
- 2015-10-31
Countries
- United States
- Mexico
Study Locations
More Related Trials
-
The Pharmacokinetics of Cannabidiol (CBD) and Its Effects in Children With Severe Epilepsy
NCT02910297 ·Status: WITHDRAWN
-
GWPCARE2 A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome
NCT02224703 ·Status: COMPLETED ·Phase: PHASE3
-
Phase 1b Study of Tizanidine in Pediatric Patients With Cerebral Palsy
NCT01405950 ·Status: TERMINATED ·Phase: PHASE1
-
The Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in Children With Severe Epilepsy
NCT02815540 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Clonazepam in Children Status Epilepticus
NCT04287361 ·Status: COMPLETED
-
A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) in Children and Young Adults With Dravet Syndrome
NCT02682927 ·Status: COMPLETED ·Phase: PHASE3
-
Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Participants With Inadequately Controlled Dravet Syndrome
NCT02318563 ·Status: WITHDRAWN ·Phase: PHASE3
-
A Randomized, Controlled Trial of Ganaxolone in Patients With Infantile Spasms
NCT00441896 ·Status: COMPLETED ·Phase: PHASE2
-
Compassionate Use of Stiripentol in Dravet Syndrome
NCT01835314 ·Status: NO_LONGER_AVAILABLE
-
Single Dose of Clonazepam Versus Intermiittent Diazepam for Febrile Seizures Prevention
NCT04364321 ·Status: UNKNOWN ·Phase: NA
-
NB-001 in Children and Adolescents With 22q11 Deletion Syndrome
NCT05290493 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase 2 Study of Radiprodil in Subjects With Drug-resistant Infantile Spasms (IS)
NCT02829827 ·Status: TERMINATED ·Phase: PHASE2
-
Predictors of Drug Resistant Epilepsy Among Pediatric Patients
NCT07241754 ·Status: NOT_YET_RECRUITING
-
Oral Baclofen Pharmacokinetics and Pharmacodynamics in Children With Spasticity
NCT00607542 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Open-label Extension to Protocol 1042-0500
NCT00442104 ·Status: TERMINATED ·Phase: PHASE2
-
A Multicenter Study of the Efficacy and Safety of Xyrem With an Open- Label Pharmacokinetic Evaluation and Safety Extension in Pediatric Subjects With Narcolepsy With Cataplexy
NCT02221869 ·Status: COMPLETED ·Phase: PHASE3
-
Gadopiclenol Pharmacokinetics, Safety and Efficacy in Children < 2 Years of Age
NCT05590884 ·Status: COMPLETED ·Phase: PHASE2
-
Continued Anticonvulsants After Resolution of Neonatal Seizures: a Patient-centered Comparative Effectiveness Study
NCT02789176 ·Status: COMPLETED
-
A Study to Assess the Safety and Tolerability of ZX008 in Children and Young Adults With Dravet Syndrome or Lennox Gastaut Syndrome Currently Taking Cannabidiol
NCT03467113 ·Status: COMPLETED ·Phase: PHASE1
-
An Open-Label Study to Investigate the Safety of Single and Multiple Ascending Doses in Children and Adolescents With Dravet Syndrome
NCT04442295 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Treatment Resistant Epilepsy and N-Acetyl Cysteine
NCT02054949 ·Status: WITHDRAWN ·Phase: NA
-
A Study to Test if TEV-50717 is Safe and Effective in Relieving Abnormal Involuntary Movements in Cerebral Palsy
NCT04200352 ·Status: TERMINATED ·Phase: PHASE3
-
Topiramate in Neonates Receiving Whole Body Cooling for Hypoxic Ischemic Encephalopathy
NCT01765218 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
A Novel Approach to Infantile Spasms
NCT03347526 ·Status: SUSPENDED ·Phase: PHASE3
-
Phase II Randomized Study of Early Surgery Vs Multiple Sequential Antiepileptic Drug Therapy for Infantile Spasms Refractory to Standard Treatment
NCT00004758 ·Status: COMPLETED ·Phase: PHASE2