NCT02187809

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_3

Geographic Reach
2 countries

9 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

February 15, 2017

Completed
Last Updated

March 27, 2017

Status Verified

February 1, 2017

Enrollment Period

7 months

First QC Date

July 9, 2014

Results QC Date

October 28, 2016

Last Update Submit

February 22, 2017

Conditions

Dravet Syndrome

Outcome Measures

Primary Outcomes (4)

  • Number of Participants With Adverse Events as a Measure of Safety and Tolerability

    Up to Day 390

  • Number of Participants With Adverse Events of Special Interest as a Measure of Safety and Tolerability Based on Dose

    Up to Day 390

  • 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

    Baseline and from Day 0 to Day 360

  • Change in Behavioural, Neurocognitive Measures Using Vineland Adaptive Behaviour Scale (VABS)

    Baseline and from Day 0 to Day 360

Secondary Outcomes (3)

  • Change in Mean Weekly Number of Tonic-clonic and Clonic Seizures

    Baseline and from Day 0 to Day 360 and upon Study Completion/Withdrawal

  • Number of Initial Treatment Responders Who Returned to Their Baseline Tonic-clonic and Clonic Seizure Rate During the Study (an Assessment of Tachyphylaxis)

    Baseline and from Day 0 to Day 360

  • Percentage of Initial Treatment Responders Who Returned to Their Baseline Tonic-clonic and Clonic Seizure Rate During the Study (an Assessment of Tachyphylaxis)

    Baseline and from Day 0 to Day 360

Study Arms (1)

Clobazam

EXPERIMENTAL

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

Interventions

ClobazamDRUG
Also known as: Onfi®
Clobazam

Eligibility Criteria

Age1 Year - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may not qualify if:

  • The patient has a diagnosis of Dravet Syndrome supported by:
  • onset of seizures in the first year of life
  • history of fever-induced prolonged seizures as determined by the Investigator
  • these may include prolonged (approximately 15 minutes or longer) hemi-clonic seizures
  • multiple seizure types which may include:
  • myoclonic jerks/seizures
  • history of normal development prior to seizure onset followed by development delay or regression after seizure onset
  • abnormal EEG consistent with Dravet Syndrome
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

US010

Los Angeles, California, United States

Location

US012

Orange, California, United States

Location

US001

Orlando, Florida, United States

Location

US003

Rochester, Minnesota, United States

Location

US005

Kansas City, Missouri, United States

Location

US0011

Dallas, Texas, United States

Location

US006

Dallas, Texas, United States

Location

US004

Seattle, Washington, United States

Location

MX003

Guadalajara, Mexico

Location

MeSH Terms

Conditions

Epilepsies, Myoclonic

Interventions

Clobazam

Condition Hierarchy (Ancestors)

Epilepsy, GeneralizedEpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEpileptic Syndromes

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Limitations and Caveats

Early termination leading to small numbers of subjects treated and no analysis. One patient was treated for 33 days.

Results Point of Contact

Title
H. Lundbeck
Organization
H. Lundbeck A/S
LundbeckClinicalTrials@Lundbeck.com

Study Officials

  • Email contact via H. Lundbeck A/S

    LundbeckClinicalTrials@lundbeck.com

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2014

First Posted

July 11, 2014

Study Start

March 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

March 27, 2017

Results First Posted

February 15, 2017

Record last verified: 2017-02

Locations

ME(1)US(8)