Infantile SpasmsPhase 3NCT01828437
Addition of Pyridoxine to Prednisolone in Infantile Spasms
A Phase 3 study testing Pyridoxine plus prednisolone and Prednisolone in people with Infantile Spasms, run by Lady Hardinge Medical College at 1 site in India.
Trial summary
Infantile spasms constitute a unique age specific epilepsy syndrome of infancy, characterized by epileptic spasms often accompanied by neurodevelopmental regression and an EEG finding of hypsarrhythmia. When all 3 components are present, the eponym "West syndrome" is commonly used. Read more about this study
- Who is it for?
- Ages 3 to 36 months
- Conditions the study is for
- Infantile Spasms
- What is being tested?
- Pyridoxine plus prednisolone and Prednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteIndia
- Study dates
- Nov 2012to Mar 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age in 3months-3years.
- Presence of epileptic spasms (1 or more clusters per day) with EEG evidence of hypsarrythmia or its variants.
- -
Who cannot join
- Children with active systemic illness
- Children with evidence of active tuberculosis
- Severe Acute Malnutrition (standard deviation scores below median weight for height)
- Children with recurrent illness/chronic systemic illness
- Prior treatment of pyridoxine, steroid, or ACTH.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Addition of Pyridoxine to Prednisolone in the Treatment of Infantile Spasms: A Randomized Controlled Trial
Infantile spasms constitute a unique age specific epilepsy syndrome of infancy, characterized by epileptic spasms often accompanied by neurodevelopmental regression and an EEG finding of hypsarrhythmia. When all 3 components are present, the eponym "West syndrome" is commonly used. West syndrome is a catastrophic epileptic encephalopathy. It does not respond well to standard anti-epileptic drugs. Hormonal therapy is the mainstay in the treatment of infantile spasms. This includes adreno-cortico trophic hormone (ACTH) and oral steroids. Variable dose of prednisolone used in the treatment. Oral prednisolone used in usual dose (2mg/kg) has been shown to be less effective as compared to ACTH. High dose prednisolone (4mg/kg) has been used in the treatment of infantile spasms, which has been shown to be as effective as ACTH. Pyridoxine has been used as first line treatment in Japan, however there is paucity of data on the efficacy of combination of pyridoxine with hormonal therapy. There are no studies comparing add on pyridoxine with high prednisolone versus high dose prednisolone alone in the treatment of infantile spasms. Therefore the study has been planned to see whether the addition of pyridoxine with high dose prednisolone in the treatment of infantile spasms improves the efficacy in terms of spasm cessation.
- Conditions
- Infantile Spasms
- Being tested
- Pyridoxine plus prednisolone, Prednisolone
- Medical subject headings
- Spasms, Infantile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyridoxine plus prednisoloneDrug
PrednisoloneDrug
| Study group | Role | What they receive |
|---|---|---|
| Pyridoxine plus prednisolone | Experimental | allocated patients receive pyridoxine (30 mg/kg/day) in addition to prednisolone Receives: Drug: Pyridoxine plus prednisolone |
| Prednisolone | Active comparator | allocated patients receive prednisolone alone Receives: Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of children who achieved complete cessation spasm for at least 48 hours as per parental reports at the end of 2 weeks in both the groups.
Proportion of children who achieved complete cessation spasm for at least 48 hours as per parental reports at the end of 2 weeks in both the groups.
Measured: 2 weeks
Secondary outcomes (1)
• Proportion of children who achieved more than 50 % reduction of clinical spasms as per parental reports at the end of 2 weeks
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2013 (estimated)
- Study startNov 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infantile SpasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lady Hardinge Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Satinder Aneja, Lady Hardinge Medical College
- Investigators
- Satinder Aneja, MD, Principal investigator, Lady Hardinge Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01828437
- Sponsor's protocol ID
- PYRIPREDIS
- Status last verified
- Jan 2019
- First submitted
- 7 Apr 2013
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Kunnanayaka V, Jain P, Sharma S, Seth A, Aneja S. Addition of pyridoxine to prednisolone in the treatment of infantile spasms: A pilot, randomized controlled trial. Neurol India. 2018 Mar-Apr;66(2):385-390. doi: 10.4103/0028-3886.227281.
PubMed 29547159
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addition of Pyridoxine to Prednisolone in the Treatment of Infantile Spasms: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01828437
- Acronym / sponsor ID
- PYRIPREDIS
- Conditions
- Infantile Spasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Lady Hardinge Medical CollegeOther government
- Study start
- Nov 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 10 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Infantile spasms constitute a unique age specific epilepsy syndrome of infancy, characterized by epileptic spasms often accompanied by neurodevelopmental regression and an EEG finding of hypsarrhythmia. When all 3 components are present, the eponym "West syndrome" is commonly used. West syndrome is a catastrophic epileptic encephalopathy. It does not respond well to standard anti-epileptic drugs. Hormonal therapy is the mainstay in the treatment of infantile spasms. This includes adreno-cortico trophic hormone (ACTH) and oral steroids. Variable dose of prednisolone used in the treatment. Oral prednisolone used in usual dose (2mg/kg) has been shown to be less effective as compared to ACTH. High dose prednisolone (4mg/kg) has been used in the treatment of infantile spasms, which has been shown to be as effective as ACTH. Pyridoxine has been used as first line treatment in Japan, however there is paucity of data on the efficacy of combination of pyridoxine with hormonal therapy. There are no studies comparing add on pyridoxine with high prednisolone versus high dose prednisolone alone in the treatment of infantile spasms. Therefore the study has been planned to see whether the addition of pyridoxine with high dose prednisolone in the treatment of infantile spasms improves the efficacy in terms of spasm cessation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pyridoxine plus prednisolone | Experimental | Drug: Pyridoxine plus prednisoloneallocated patients receive pyridoxine (30 mg/kg/day) in addition to prednisolone |
| Prednisolone | Active comparator | Drug: Prednisoloneallocated patients receive prednisolone alone |
Who may qualify
- Ages
- 3 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age in 3months-3years.
- Presence of epileptic spasms (1 or more clusters per day) with EEG evidence of hypsarrythmia or its variants.
- -
Key exclusion criteria (6 listed)
- Children with active systemic illness
- Children with evidence of active tuberculosis
- Severe Acute Malnutrition (standard deviation scores below median weight for height)
- Children with recurrent illness/chronic systemic illness
- Prior treatment of pyridoxine, steroid, or ACTH.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pyridoxine plus prednisolone | Drug | Pyridoxine plus prednisolone |
| Prednisolone | Drug | Prednisolone |
Primary outcome
Proportion of children who achieved complete cessation spasm for at least 48 hours as per parental reports at the end of 2 weeks in both the groups.
Time frame: 2 weeks
Proportion of children who achieved complete cessation spasm for at least 48 hours as per parental reports at the end of 2 weeks in both the groups.
1 secondary outcome
• Proportion of children who achieved more than 50 % reduction of clinical spasms as per parental reports at the end of 2 weeks
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Derived from this study: PubMed 29547159Kunnanayaka V, Jain P, Sharma S, Seth A, Aneja S. Addition of pyridoxine to prednisolone in the treatment of infantile spasms: A pilot, randomized controlled trial. Neurol India. 2018 Mar-Apr;66(2):385-390. doi: 10.4103/0028-3886.227281.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Satinder Aneja, MD principal investigator
Lady Hardinge Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pyridoxine plus prednisolone and Prednisolone in people with Infantile Spasms, run by Lady Hardinge Medical College at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of children who achieved complete cessation spasm for at least 48 hours as per parental reports at the end of 2 weeks in both the groups. (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01828437, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2019.