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Prednisolone Versus Vigabatrin in the First-line Treatment of Infantile Spasms (PREDVGB)

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ClinicalTrials.gov Identifier: NCT02299115
Recruitment Status : Recruiting
First Posted : November 24, 2014
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
Carter Snead, The Hospital for Sick Children

Brief Summary:
Infantile Spasms, is an rare age-specific epilepsy of early infancy. A 2012 American Academy Neurology/ Child Neurology Society practice parameter update on the medical treatment of infantile spasms concluded: adrenocorticotrophic hormone or vigabatrin may be offered for short-term treatment of infantile spasms. There was insufficient evidence to recommend the use of prednisolone, dexamethasone, and methylprednisolone. The cost of ACTH and the side effects of vigabatrin have led to the consideration of alternative medications to treat infantile spasms. The United Kingdom Infantile Spasms Study (UKISS) in 2004, comparing the efficacy of intramuscular synthetic ACTH to high dose oral prednisolone, showed a response rate of 74% for ACTH and 70% for prednisolone. Since the UKISS paper was published, many institutions in the United States and Australia have used oral prednisolone instead of ACTH, partly due to the exorbitant cost of intramuscular ACTH but also its ease of use and better adverse event profile compared to ACTH. Prednisolone and vigabatrin are both oral medications, which can be initiated promptly upon diagnosis of infantile spasms, expediting treatment and shortening treatment lag time. Because the UKISS trial is the only Class 3 study providing evidence for oral prednisolone in the first-line treatment of infantile spasms, further prospective studies are needed.

Condition or disease Intervention/treatment Phase
Infantile Spasms Drug: Prednisolone Drug: Vigabatrin Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prednisolone vs. Vigabatrin in the First-line Treatment of Infantile Spasms
Actual Study Start Date : September 5, 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : March 2021


Arm Intervention/treatment
Experimental: Prednisolone
Single center, prospective, observational, open trial using high-dose oral prednisolone as first-line treatment for newly diagnosed Infantile Spasms (non-Tuberous Sclerosis)
Drug: Prednisolone
Corticosteroid
Other Name: pms-prednisolone

Active Comparator: Vigabatrin
Retrospective controls composed of our cohort of non-Tuberous Sclerosis Infantile Spasms patients from January 2010- September 2013 who received Vigabatrin as first-line treatment.
Drug: Vigabatrin
Antiepileptic
Other Name: Sabril




Primary Outcome Measures :
  1. Resolution of Infantile spasms and Hypsarrhythmia [ Time Frame: 14 days ]

    Clinical response: cessation of spasms: no reported spasms for at least 48 hours including day 14 of the trial.

    EEG response: complete resolution of hypsarrhythmia or modified hypsarrhythmia pattern, on follow up EEG at approximately 2 weeks of the trial.



Secondary Outcome Measures :
  1. Clinical or EEG relapse of Infantile Spasms [ Time Frame: 6 months ]

    Clinical relapse: any spasm occurring after 2 weeks up to and including final clinical assessment at approximately 5 months (+/- 2weeks) post-treatment in an infant who had cessation of spasms.

    EEG Relapse: recurrence of hypsarrhythmia/modified hypsarrhythmia pattern after one previous EEG showing resolution of hypsarrhythmia


  2. Seizure outcome at final follow up (presence or absence of any seizure types at final follow up as assessed by seizure diary and on history at final follow up visit) [ Time Frame: 6 months ]
    Clinical assessment of the presence or absence of any seizure types at final follow up as assessed by seizure diary and on history at final follow up visit.

  3. Time to cessation of Infantile spasms [ Time Frame: 14 days ]
    Length of time in days to achieve cessation of Infantile spasms

  4. Time to relapse [ Time Frame: 6 months ]
    Length of time (in days) from the initial resolution of Infantile spasms to the relapse of Infantile spasms



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Ages Eligible for Study:   2 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Inclusion criteria:

  1. Age 2-24 months
  2. Clinical spasms
  3. Initial EEG with hypsarrhythmia or modified hypsarrhythmia

The inclusion criteria do not quantify the initial severity or frequency of infantile spasms. Infantile spasms is a unique epileptic disorder characterized by clusters of brief infantile spasms, where each one lasts a few seconds and cluster may last minutes. The diagnosis of infantile spasms and response to medication depends on the presence or absence of these events and the frequency of infantile spasms has not been used to determine medication efficacy in previous studies. A seizure diary will be used to quantify the seizure burden, however efficacy will depend on complete resolution of clinical spasms and resolution of hypsarrhythmia on EEG -

Exclusion Criteria:

  1. Age <2months or older than 24 months
  2. Tuberous sclerosis (if known at the time of enrolment)
  3. Previous treatment (within 28 days) with VGB or hormonal treatments
  4. Contraindications to hormonal therapy: This includes untreated systemic fungal infections, known hypersensitivity to prednisolone or other corticosteroids, or to any of the non-medicinal ingredients present in the solution. Active or latent tuberculosis, ocular herpes simplex, hypothyroidism, hepatic cirrhosis, nonspecific ulcerative colitis, abscess or other pyogenic infection, fresh intestinal anastomoses, active or latent peptic ulcer, renal insufficiency, hypertension, osteoporosis, cardiac disease, thromboembolic disorders and diabetes mellitus. All patients with cardiac risk factors will receive an electrocardiogram (ECG), chest xray (CXR) and cardiology referral if indicated. Patients diagnosed with cardiac disorders will be excluded from the study since high dose steroids may exacerbate arrhythmias.
  5. Inability of parents or guardians to give consent
  6. Enrolment in a concurrent treatment trial that might affect outcome measures of this trial -

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): NCT02299115


Contacts
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Contact: Cristina Go, MD 416-813-7353 cristina.go@sickkids.ca

Locations
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Canada, Ontario
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G1X8
Contact: Cristina Go, MD    416-813-7353    cristina.go@sickkids.ca   
Principal Investigator: Carter Snead, MD         
Sub-Investigator: Kevin C Jones, MD         
Sub-Investigator: Blathnaid McCoy, MD         
Sub-Investigator: Ayako Ochi, MD         
Sub-Investigator: Jennifer Boyd, RN,MSCN         
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Carter Snead, MD The Hospital for Sick Children

Publications:

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Responsible Party: Carter Snead, Staff Neurologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02299115     History of Changes
Other Study ID Numbers: 1000045463
First Posted: November 24, 2014    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Carter Snead, The Hospital for Sick Children:
Vigabatrin
Prednisolone
Additional relevant MeSH terms:
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Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Spasm
Spasms, Infantile
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Epilepsy, Generalized
Epilepsy
Brain Diseases
Central Nervous System Diseases
Epileptic Syndromes
Vigabatrin
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents