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Safety and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02187809
Recruitment Status : Terminated (The study was terminated due to recruitment challenges)
First Posted : July 11, 2014
Results First Posted : February 15, 2017
Last Update Posted : March 27, 2017
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Dravet Syndrome Drug: Clobazam Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-site, Prospective, Open-label, Long-term, Flexible Dose, Interventional Study to Evaluate the Safety and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome
Study Start Date : March 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Clobazam

Arms and Interventions
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Arm Intervention/treatment
Experimental: Clobazam
A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally
 Drug: Clobazam
Other Name: Onfi®


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to Day 390 ]
  2. Number of Participants With Adverse Events of Special Interest as a Measure of Safety and Tolerability Based on Dose [ Time Frame: Up to Day 390 ]
  3. Columbia Suicide Severity Rating Scale (C-SSRS), Categorisation Based on Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories (1, 2, 3, 4 and 7) for Patients Aged ≥ 6 Years [ Time Frame: Baseline and from Day 0 to Day 360 ]
  4. Change in Behavioural, Neurocognitive Measures Using Vineland Adaptive Behaviour Scale (VABS) [ Time Frame: Baseline and from Day 0 to Day 360 ]

Secondary Outcome Measures :
  1. Change in Mean Weekly Number of Tonic-clonic and Clonic Seizures [ Time Frame: Baseline and from Day 0 to Day 360 and upon Study Completion/Withdrawal ]
  2. Number of Initial Treatment Responders Who Returned to Their Baseline Tonic-clonic and Clonic Seizure Rate During the Study (an Assessment of Tachyphylaxis) [ Time Frame: Baseline and from Day 0 to Day 360 ]
  3. Percentage of Initial Treatment Responders Who Returned to Their Baseline Tonic-clonic and Clonic Seizure Rate During the Study (an Assessment of Tachyphylaxis) [ Time Frame: Baseline and from Day 0 to Day 360 ]

Eligibility Criteria
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Ages Eligible for Study:   1 Year to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

The inclusion and exclusion criteria for the patients who participated in lead-in Study 14362A will be transferred from the 14362A study and for the patients who did not participate in lead-in Study 14362A the inclusion/exclusion is separately listed below.

Inclusion Criteria:

  1. The patient has a diagnosis of Dravet Syndrome supported by:

    1. onset of seizures in the first year of life

    2. history of fever-induced prolonged seizures as determined by the Investigator

      • these may include prolonged (approximately 15 minutes or longer) hemi-clonic seizures

    3. multiple seizure types which may include:

      • generalised tonic-clonic (required for inclusion)
      • clonic (required for inclusion)
      • myoclonic jerks/seizures
    4. history of normal development prior to seizure onset followed by development delay or regression after seizure onset
    5. abnormal EEG consistent with Dravet Syndrome
  2. The patient is currently receiving a stable dose of clobazam of at least 0.5 mg/kg/day (maximum 20 mg/day) for at least 3 months

Other protocol-defined inclusion and exclusion criteria may apply.

Contacts and Locations
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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): NCT02187809


Locations
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United States, California
US010
Los Angeles, California, United States
US012
Orange, California, United States
United States, Florida
US001
Orlando, Florida, United States
United States, Minnesota
US003
Rochester, Minnesota, United States
United States, Missouri
US005
Kansas City, Missouri, United States
United States, Texas
US0011
Dallas, Texas, United States
US006
Dallas, Texas, United States
United States, Washington
US004
Seattle, Washington, United States
Mexico
MX003
Guadalajara, Mexico
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
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Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
More Information
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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT02187809    
Other Study ID Numbers: 14362B
First Posted: July 11, 2014    Key Record Dates
Results First Posted: February 15, 2017
Last Update Posted: March 27, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Epilepsies, Myoclonic
Syndrome
Disease
Pathologic Processes
Epilepsy, Generalized
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epileptic Syndromes
Clobazam
 Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action