A randomised double blind trial of add-on flunarizine to prevent the cognitive deterioration associated with infantile spasms

ISRCTN	ISRCTN36757519
DOI	https://doi.org/10.1186/ISRCTN36757519
Secondary identifying numbers	MCT-53573

Submission date: 01/09/2005
Registration date: 01/09/2005
Last edited: 08/09/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Lionel Carmant
Scientific

Service de Neurologie
Hôpital Sainte-Justine
3175 Chemin de la Côte Ste-Catherine
Montréal, Quebec
H3T 1C5
Canada

Phone	+1 514 345 4931 (6106)
Email	lionel.carmant@umontreal.ca

Study information

Study design	Randomised double blind trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	To determine whether infants and children receiving the Infantile Spasms (IS) standard therapy as well as Flunarizine will have an improved developmental outcome as compared to that of children receiving the same treatment with a placebo.
Ethics approval(s)	Ethics approval received from the Hôpital Sainte-Justine, Comité d'éthique de la recherche on the 15th July 2004.
Health condition(s) or problem(s) studied	Infantile Spasms (IS)
Intervention	All infants and children will receive initial IS conventional therapy, consisting of Vigabatrin (VGB) administration (as well as vitamin B6), followed after a two week period by Adrenocorticotropic Hormone (ACTH - Synacthen) treatment, if no IS cessation or amelioration occurs. Moreover, if the infants or children's' IS still do not respond to the latter hormone, they may be treated with Topiramate. Besides the standard IS treatment, Flunarizine or placebo will be administered from the onset of the study for a total of six months in order to determine its efficacy in preventing or ameliorating the mental deterioration associated with IS. After this time, all treatment will be ceased. Following cessation of treatment, the neurological and neuro-psychological status of infants and children will still be followed for an additional one and one half year period to determine their long-term response to Flunarizine (and to placebo) and to assess their mental development.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Flunarizine, vigabatrin, synacthen, topiramate
Primary outcome measure	Intelligence Quotient (IQ) scores are evaluated with Bayley scales at time 0 and 24 months.
Secondary outcome measures	1. Autistic behaviour 2. Longitudinal development and pattern of developmental progress in infants and children 3. Occurrence of IS
Overall study start date	01/04/2002
Completion date	31/03/2006

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	3 Months
Upper age limit	18 Months
Sex	All
Target number of participants	80
Key inclusion criteria	1. Children aged 3 - 18 months, either sex, with new onset infantile spasms 2. Electroencephalogram (EEG) showing hypsarrhythmia or modified hypsarrhythmia 3. Children not receiving treatment for infantile spasms at the time of the initial visit, i.e. vigabatrin or synacthen 4. Parents or legal guardian agree to sign the consent form
Key exclusion criteria	1. Age under 3 months or over 18 months at onset of spasms 2. Degenerative neurological disorder because their relentless course toward a poor outcome regardless of therapeutic interventions would limit the possibility of generalising our findings to all children with infantile spasms 3. Pre-existing medical condition where steroids would be contraindicated 4. Families unable to comply with follow-up visits or agree to informed consent
Date of first enrolment	01/04/2002
Date of final enrolment	31/03/2006

Locations

Countries of recruitment

Canada

Study participating centre

Service de Neurologie

Montréal, Quebec
H3T 1C5
Canada

Sponsor information

Hôpital Sainte-Justine (Montréal) (Canada)
Not defined

3175 chemin Côte Ste-Catherine
Montréal, Quebec
H3T 1C5
Canada

"ROR"	https://ror.org/01gv74p78

Funders

Funder type

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-53573)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan