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WithdrawnNCT02174094Updated Sep 24, 2015

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

A Phase 3 interventional study of Clobazam and Placebo in Dravet Syndrome, sponsored by H. Lundbeck A/S. Withdrawn at 9 sites in 2 countries. Open to participants aged 1 Year to 16 Years. Per ClinicalTrials.gov, last updated 2015-09-24.

Sponsored by H. Lundbeck A/S · Phase 3, Interventional, and Treatment

Why this study was withdrawn
The study was terminated due to recruitment challenges
Phase
Phase 3
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
1 Year to 16 Years
Sex
All
01

Study summary

The purpose of this study is to investigate the effect on the frequency of tonic-clonic and clonic seizures of clobazam as adjunctive therapy compared to placebo after 16 weeks of treatment in paediatric patients aged ≥1 to ≤16 years with Dravet Syndrome.

02

Conditions studied

  • Dravet Syndrome
03

In context

Epilepsies, Myoclonic

87 studies on the registry are indexed under Epilepsies, Myoclonic; 23 are open to participants now.

Browse Epilepsies, Myoclonic studies →

Lead sponsor

H. Lundbeck A/S is the lead sponsor of 218 studies on the registry; 10 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 10 (30%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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:

    • generalised tonic-clonic (required for inclusion)
    • clonic (required for inclusion)
    • 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 2. The patient has a history of approximately 2 tonic-clonic or clonic seizures in 2 weeks 3. The patient is treated with at least 1 but no more than 3 antiepileptic drugs (AEDs) [Vagal Nerve Stimulator (VNS) and ketogenic diet will not be considered an AED] 4. Patient has at least 2 seizures during the Baseline Period of either 2 or 4 weeks

Exclusion criteria

Exclusion Criteria:

  1. The patient is taking stiripentol, verapamil, or felbatol. If patients have taken these drugs in the past, they need to have been off drug for 5 half-lives
  2. The patient is taking a sodium channel blocker including, but not limited to, phenytoin, fosphenytoin, carbamazepine, oxcarbamazepine, lamotrigine, lacosamide, and rufinamide. If patients have taken these drugs in the past, they need to have been off drug for 5 half-lives
  3. The patient is on cannabidiol, medical marijuana, or any drug that contains cannabinoids
  4. The patient has received chronic treatment (≥2 weeks for any indication) with a benzodiazepine within at least 5 half-lives prior to screening. Rescue therapy for prolonged seizures is allowed
  5. The patient has received clobazam within 3 months prior to the Screening Visit. If the patient has received clobazam in the past, discontinuation must not have been for adverse events or lack of efficacy

Other protocol-defined inclusion and exclusion criteria may apply.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Clobazam

    Clobazam - 1.0, 1.5 or 2.0 mg/kg/day (maximum 60 or 80 mg/day) twice daily (BID); Clobazam oral suspension 2.5 mg/mL, clobazam scored tablets 10 mg, orally

    Drug: Clobazam

  • Placebo comparator
    Placebo

    Placebo to clobazam oral suspension 2.5 mg/mL and placebo to clobazam scored tablets 10 mg, orally

    Drug: Placebo

Interventions

  • DrugClobazam

    Also known as: Onfi®

  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. Percent change from baseline to study completion/withdrawal in seizure rate for combined tonic-clonic and clonic seizure rates, based upon a calculation of seizure frequency determined from daily seizure diary counts

    Time frame: Baseline and from week 0 to week 16

Secondary outcomes

  1. Percent change from baseline to study completion/withdrawal in seizure rate for combined tonic-clonic and clonic seizure rates, based upon a calculation of seizure frequency determined from daily seizure diary counts during 4 weeks of maintenance

    Time frame: Baseline and from week 4 to week 16

  2. Percent change in seizure rate for myoclonic seizures determined from daily seizure diary counts

    Time frame: Baseline and from week 0 to week 16

  3. Percent change in seizure rate for atypical absence seizures determined from daily seizure diary counts

    Time frame: Baseline and from week 0 to week 16

  4. Percent change in seizure rate for complex partial seizures determined from daily seizure diary counts

    Time frame: Baseline and from week 0 to week 16

  5. Percent change in seizure rate for all seizure types determined from daily seizure diary counts

    Time frame: Baseline and from week 0 to week 16

  6. 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 week 0 to week 16

  7. 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 week 0 to week 16

  8. Percent change in seizure rate for myoclonic seizures determined from video EEG

    Time frame: Baseline and from week 0 to week 16

  9. Percent change in seizure rate for atypical absence seizures determined from video EEG

    Time frame: Baseline and from week 0 to week 16

  10. Change in Symptom and Seizure Activity Scale (Investigator and Parent/caregiver versions)

    Time frame: Baseline and from week 0 to week 16

  11. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Time frame: Up to Week 32

  12. 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 week 0 to week 16

  13. Number of Participants with Adverse Events of special interest as a Measure of Safety and Tolerability based on dose

    Time frame: Baseline and Week 32

  14. Change in Vineland Adaptive Behaviour Scale (VABS) - all adaptive behavior sub-domains and maladaptive behaviors

    Time frame: Baseline and from week 0 to week 16

07

Study locations

9 sites
  • US010
    Los Angeles, California, United States
  • US001
    Orlando, Florida, United States
  • US003
    Rochester, Minnesota, United States
  • US005
    Kansas City, Missouri, United States
  • US006
    Dallas,, Texas, United States
  • US0011
    Dallas, Texas, United States
  • US002
    Houston, Texas, United States
  • US004
    Seattle, Washington, United States
  • MX003
    Guadalajara, Mexico
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02174094
Lead sponsor
H. Lundbeck A/S
Responsible party
Sponsor
First posted
Jun 25, 2014
Start date
Mar 2015
Primary completion
Aug 2015
Completion
Aug 2015
Last update
Sep 24, 2015

Study contacts

Email contact via H. Lundbeck A/S
study director · LundbeckClinicalTrials@lundbeck.com

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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