Spasms, InfantilePhase 4SLISSNCT06838559
Clinical Trial on 7-day Followed by Maintenance Therapy for 10 Weeks vs. 14-day and no Maintenance Course of Prednisolone for the Treatment of Infantile Epileptic Spasms Syndrome (IESS)
A Phase 4 study testing Short-Duration Oral Prednisolone with Extended Tapering and Standard Oral Prednisolone Regimen with Tapering in people with Spasms, Infantile and Prednisolone, run by University of Colombo at 7 sites in Sri Lanka.
Trial summary
The goal of this clinical trial is to learn if short courses (7 days) of oral prednisolone are as effective as longer courses (14 days) in treating Infantile Epileptic Spasms Syndrome (IESS) in infants. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 3 to 24 months
- Conditions the study is for
- Spasms, Infantile, Prednisolone
- What is being tested?
- Short-Duration Oral Prednisolone with Extended Tapering and Standard Oral Prednisolone Regimen with Tapering
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 7 sitesSri Lanka
- Study dates
- 1 Jan 2025to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants between ages of 3 to 24 months
- Newly confirmed diagnosis of infantile epileptic spasms syndrome made by the referring paediatrician/ paediatric neurologist based on the diagnostic criteria outlined in the recent ILAE classification and definition of epilepsy syndrome with onset in neonates and infants in 2022
- Hypsarrhythmia recorded on pre-treatment EEG. This will be those who show a BASED score of 4 or 5 in a standard EEG
Who cannot join
- Infants with tuberous sclerosis complex
- Ever treated previously for infantile epileptic spasms syndrome with steroids or other anticonvulsants
- Infants already on steroids or ACTH for any other illness
- Contraindication for the use of high dose steroids such as underlying infection, immune deficiency, hypertension etc.
- Children in critical conditions such as severe infections, congenital heart disease or requiring ventilation or care in an ICU
- Not accompanied by parent/s or parent's inability to complete follow up
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Sri Lanka7 sites
Teaching Hospital Anuradhapura
Anuradhapura, North Central Province, 50000
Lady Ridgeway Hospital for Children
Colombo, Western Province, 00800
Teaching Hospital - Karapitiya
Galle, Southern Province, 80000
Teaching Hospital - Jaffna
Jaffna, Northern Province, 40000
Colombo South Teaching Hospital
Kalubowila, Western Province, 10350
Sirimavo Bandaranayake Specialized Children's Hospital
Peradeniya, Central Province, 20400
Colombo North Teaching Hospital
Ragama, Western Province, 11010
About this study
Official title: Multicentre, Randomized, Controlled Clinical Trial on 7-day Followed by Maintenance Therapy for 10 Weeks vs. 14-day and no Maintenance Course of Prednisolone for the Treatment of Infantile Epileptic Spasms Syndrome (IESS)
The goal of this clinical trial is to learn if short courses (7 days) of oral prednisolone are as effective as longer courses (14 days) in treating Infantile Epileptic Spasms Syndrome (IESS) in infants. The main questions it aims to answer are:
- Does a 7-day course of oral prednisolone result in a similar or better reduction in spasm frequency compared to a 14-day course?
- Does the duration of treatment (7 vs. 14 days) influence relapse rates and developmental outcomes in infants with IESS?
- Researchers will compare the effects of the two treatment arms (7-day course vs. 14-day course of oral prednisolone) to see if there is a difference in efficacy and safety.
Read more
Participants will:
- Receive either a 7-day or 14-day course of oral prednisolone as part of their treatment
- Be monitored for spasm frequency and any side effects during hospital observation for the first 48 hours
- Maintain a spasm diary during the treatment period to track spasm frequency
- Return for follow-up visits at 7 days, 14 days, 28 days, 42 days, 3 months, 6 months, and 12 months to assess treatment response, relapse, and developmental outcomes
Read the detailed description
Study Title: Comparison of Short (7-Day) versus Long (14-Day) Courses of Oral Prednisolone in the Treatment of Infantile Epileptic Spasms Syndrome (IESS)
Study Overview: This is a clinical trial designed to compare the efficacy and safety of two treatment regimens using oral prednisolone for infants with Infantile Epileptic Spasms Syndrome (IESS). The study aims to evaluate the impact of treatment duration (7 days vs. 14 days) on spasm resolution, relapse rates, and developmental outcomes in infants with IESS. Participants will be randomized into two treatment arms to receive either a 7-day or 14-day course of oral prednisolone, and they will be followed for a year to assess outcomes related to spasm control, relapse, adverse effects, and long-term development.
Study Population: The study will include infants diagnosed with IESS, aged 3 to 24 months, who are receiving care at participating clinical sites. Eligibility criteria ensure the inclusion of infants with confirmed spasms, with or without known aetiology, and those who have not previously received systemic treatment for IESS.
Objectives:
- Primary Objective: To compare the effectiveness of 7-day versus 14-day oral prednisolone treatment in reducing spasm frequency in infants with IESS.
- Secondary Objectives: To evaluate the impact of treatment duration on relapse rates, developmental outcomes, and adverse effects.
- Exploratory Objectives: To assess any differences in long-term neurodevelopmental progress, including cognitive and motor development, and to compare EEG findings between treatment groups.
Methodology:
- Randomization: Participants will be randomly assigned to receive either 7 days or 14 days of oral prednisolone, with blinding for the treatment duration.
- Treatment Regimen:
- Intervention Arm (7-Day Course): Participants will receive 3 mg/kg/day of oral prednisolone for 7 days.
- Comparator Arm (14-Day Course): Participants will receive 3 mg/kg/day of oral prednisolone for 14 days.
- In both arms, after 48 hours of in-hospital treatment, participants will be monitored for side effects, and parents will be educated on medication administration and spasm monitoring.
- Adverse Event Monitoring: Adverse events will be tracked throughout the trial, with particular attention to common side effects associated with prednisolone use, including irritability, weight gain, and gastric irritation. Serious adverse events will be carefully documented and managed.
- Follow-Up: Follow-up visits will be conducted at 7 days, 14 days, 28 days, 42 days, 3 months, 6 months, and 12 months to monitor spasm control, relapse, and developmental progress. At 24 months, a comprehensive developmental assessment will be conducted to evaluate the long-term effects of the treatment.
Inclusion and Exclusion Criteria:
- Inclusion Criteria: Infants diagnosed with IESS, aged 2 to 24 months, with confirmed spasms either due to a known or unknown aetiology.
- Exclusion Criteria: Infants with a history of other significant neurological conditions, or who are contraindicated for oral prednisolone, including those with uncontrolled systemic infections, significant cardiovascular disease, or severe hypertension.
Data Collection:
Baseline Data: Clinical history, imaging (CT or MRI), and EEG results will be collected to help categorize participants into known or undetermined aetiology groups. A metabolic screening will be conducted for infants with undetermined aetiology.
- Conditions
- Spasms, Infantile, Prednisolone
- Being tested
- Short-Duration Oral Prednisolone with Extended Tapering, Standard Oral Prednisolone Regimen with Tapering
- Keywords
- Randomized controlled trial, Spasms, Infantile, Prednisolone, Infant, Electroencephalography, Child Development, Relapse, Tapering Regimen, Treatment Duration
- Medical subject headings
- Spasms, Infantile, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short-Duration Oral Prednisolone with Extended TaperingDrug
In treatment arm A, oral prednisolone will be administered in tablet form (5 mg strength) as follows: an initial phase of 10 mg four times daily (total 40 mg/day) for 7 days, followed by a 15-day tapering phase-10 mg three times daily for 5 days, 10 mg twice daily for 5 days, and 10 mg once daily for 5 days. After tapering, a prolonged low-dose maintenance phase will be implemented, where 10 mg is given once daily twice a week for an additional 10 weeks. This regimen is designed to test whether a shorter high-dose course, combined with extended low-dose maintenance, can provide equivalent control of infantile epileptic spasms syndrome while reducing the adverse effects associated with longer high-dose therapy, compared to the standard 14-day high-dose regimen (treatment arm B).
Standard Oral Prednisolone Regimen with TaperingDrug
Prednisone oral tablets, 10 mg, administered four times daily (40 mg/day) for 14 days, followed by a tapering phase over 15 days: 10 mg three times daily for 5 days, 10 mg twice daily for 5 days, and 10 mg once daily for 5 days. No further tapering will be implemented after the initial 14-day treatment period. This regimen represents the standard therapy for Infantile Spasms in Sri Lanka.
| Study group | Role | What they receive |
|---|---|---|
| treatment arm A | Experimental | The initial phase of the intervention involves administering prednisolone orally at a dosage of 10 mg, four times daily (40 mg/day) for 7 days. This will be followed by a tapering regimen over 15 days (~2 weeks) as outlined below:
10 mg three times daily - 5 days 10 mg twice daily - 5 days 10 mg daily - 5 days The second phase of the intervention begins at the end of 15 days, where a prolonged tapering of prednisolone at a low dose (<0.4 mg/kg per day) will be administered as 10 mg once daily, twice a week, for an additional 10 weeks. Receives: Drug: Short-Duration Oral Prednisolone with Extended Tapering |
| treatment arm B | Active comparator | Prednisone will be administered orally at a dose of 10 mg, four times daily (40 mg/day) for 14 days. This is the standard therapy currently given to children with IESS in Sri Lanka. This will be followed by a tapering regimen over 15 days (~2 weeks) as outlined below:
10 mg three times daily - 5 days 10 mg twice daily - 5 days 10 mg daily - 5 days No additional tapering will be implemented. Receives: Drug: Standard Oral Prednisolone Regimen with Tapering |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroclinical Remission at Day 14 and Day 28
This primary outcome measure compares the efficacy of the 7-day versus 14-day oral prednisolone regimens. Electroclinical remission is defined as (1) spasm control-no clinically recognizable spasms for a minimum of 24 consecutive hours as recorded by the caregiver-and (2) EEG remission-disappearance of hypsarrhythmia with the BASED score improved to 3 or less on a standardized 30-minute sleep EEG (with 5 minutes of wakefulness).
Measured: Assessed at 14 days and 28 days after treatment initiation.
Secondary outcomes (4)
Long-Term Spasm Control
This measure evaluates sustained spasm control by documenting the absence of any visible spasms (as observed by caregivers) for at least 72 hours on the day of assessment. It is used to compare the durability of the two treatment regimens over an extended follow-up period.
Measured: Assessed at 42 days, 3 months, 6 months, and 12 months post-treatment.
Spasm Relapse Rate and Time to Relapse
This outcome captures the relapse rate, defined as the reappearance of clinical spasms in conjunction with the return of hypsarrhythmia on EEG (BASED score of 4 or above), after initial remission. It also records the duration of spasm freedom until the first relapse, providing information on both the frequency and timing of relapse events.
Measured: Evaluated continuously over the 12-month follow-up period.
Developmental Outcome at 24 Months
Neurodevelopmental progress is assessed using the Bayley Scales of Infant and Toddler Development (3rd edition). The measure records deviations from the normative mean (100) across domains (cognition, language, motor skills, social-emotional, and adaptive behavior) and examines correlations with spasm control and relapse status between the treatment arms.
Measured: Assessed at 24 months following treatment initiation.
Evolution of Epilepsy
This outcome measure tracks the emergence or evolution of other seizure types or epilepsy syndromes beyond infantile spasms. Epilepsy is defined as the occurrence of two or more unprovoked seizures (other than spasms) in a previously spasm-free child. Comparisons between treatment groups will provide insight into long-term seizure evolution.
Measured: Assessed at 12 months post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start1 Jan 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spasms, InfantileStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized (1:1), single-blinded, multi-centre, parallel-group clinical trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colombo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jithangi Wanigasinghe, University of Colombo
- Investigators
- Jithangi Wanigasinghe, MD, MPhil, Principal investigator, Department of Paediatrics at the Faculty of Medicine, University of Colombo, Sri LankaCarukshi Arambepola, MSc, MD, Principal investigator, Department of Community Medicine, Faculty of Medicine, University of Colombo, Sri LankaShalini Sri Ranganathan, MD, PhD, Principal investigator, Department of Pharmacology, Faculty of Medicine, University of Colombo, Sri LankaNimesha Gamhewage, MD, DCH, Principal investigator, Department of Paediatrics, University of Sri Jayewardenepura, Sri Lanka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838559
- Sponsor's protocol ID
- EC-24-125
- Other IDs
- U1111-1318-1599
- Acronym
- SLISS
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2025
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Since this clinical trial involves infants, who belong to a vulnerable population, strict ethical considerations have been incorporated to ensure data confidentiality and participant protection. All collected data will remain confidential and will be stored securely in a password-protected computer and locked storage, accessible only to the investigators. There is no plan to share individual participant data (IPD).
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Randomized, Controlled Clinical Trial on 7-day Followed by Maintenance Therapy for 10 Weeks vs. 14-day and no Maintenance Course of Prednisolone for the Treatment of Infantile Epileptic Spasms Syndrome (IESS)
- ClinicalTrials.gov ID
- NCT06838559
- Acronym / sponsor ID
- SLISS / EC-24-125
- Conditions
- Spasms, Infantile, Prednisolone
- Keywords
- Randomized controlled trial, Spasms, Infantile, Prednisolone, Infant, Electroencephalography, Child Development, Relapse, Tapering Regimen
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- University of ColomboUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Feb 2025 (actual)
- 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.
The goal of this clinical trial is to learn if short courses (7 days) of oral prednisolone are as effective as longer courses (14 days) in treating Infantile Epileptic Spasms Syndrome (IESS) in infants. The main questions it aims to answer are:
- Does a 7-day course of oral prednisolone result in a similar or better reduction in spasm frequency compared to a 14-day course?
- Does the duration of treatment (7 vs. 14 days) influence relapse rates and developmental outcomes in infants with IESS?
- Researchers will compare the effects of the two treatment arms (7-day course vs. 14-day course of oral prednisolone) to see if there is a difference in efficacy and safety.
Participants will:
- Receive either a 7-day or 14-day course of oral prednisolone as part of their treatment
- Be monitored for spasm frequency and any side effects during hospital observation for the first 48 hours
- Maintain a spasm diary during the treatment period to track spasm frequency
- Return for follow-up visits at 7 days, 14 days, 28 days, 42 days, 3 months, 6 months, and 12 months to assess treatment response, relapse, and developmental outcomes
Detailed description
Study Title: Comparison of Short (7-Day) versus Long (14-Day) Courses of Oral Prednisolone in the Treatment of Infantile Epileptic Spasms Syndrome (IESS)
Study Overview: This is a clinical trial designed to compare the efficacy and safety of two treatment regimens using oral prednisolone for infants with Infantile Epileptic Spasms Syndrome (IESS). The study aims to evaluate the impact of treatment duration (7 days vs. 14 days) on spasm resolution, relapse rates, and developmental outcomes in infants with IESS. Participants will be randomized into two treatment arms to receive either a 7-day or 14-day course of oral prednisolone, and they will be followed for a year to assess outcomes related to spasm control, relapse, adverse effects, and long-term development.
Study Population: The study will include infants diagnosed with IESS, aged 3 to 24 months, who are receiving care at participating clinical sites. Eligibility criteria ensure the inclusion of infants with confirmed spasms, with or without known aetiology, and those who have not previously received systemic treatment for IESS.
Objectives:
- Primary Objective: To compare the effectiveness of 7-day versus 14-day oral prednisolone treatment in reducing spasm frequency in infants with IESS.
- Secondary Objectives: To evaluate the impact of treatment duration on relapse rates, developmental outcomes, and adverse effects.
- Exploratory Objectives: To assess any differences in long-term neurodevelopmental progress, including cognitive and motor development, and to compare EEG findings between treatment groups.
Methodology:
- Randomization: Participants will be randomly assigned to receive either 7 days or 14 days of oral prednisolone, with blinding for the treatment duration.
- Treatment Regimen:
- Intervention Arm (7-Day Course): Participants will receive 3 mg/kg/day of oral prednisolone for 7 days.
- Comparator Arm (14-Day Course): Participants will receive 3 mg/kg/day of oral prednisolone for 14 days.
- In both arms, after 48 hours of in-hospital treatment, participants will be monitored for side effects, and parents will be educated on medication administration and spasm monitoring.
- Adverse Event Monitoring: Adverse events will be tracked throughout the trial, with particular attention to common side effects associated with prednisolone use, including irritability, weight gain, and gastric irritation. Serious adverse events will be carefully documented and managed.
- Follow-Up: Follow-up visits will be conducted at 7 days, 14 days, 28 days, 42 days, 3 months, 6 months, and 12 months to monitor spasm control, relapse, and developmental progress. At 24 months, a comprehensive developmental assessment will be conducted to evaluate the long-term effects of the treatment.
Inclusion and Exclusion Criteria:
- Inclusion Criteria: Infants diagnosed with IESS, aged 2 to 24 months, with confirmed spasms either due to a known or unknown aetiology.
- Exclusion Criteria: Infants with a history of other significant neurological conditions, or who are contraindicated for oral prednisolone, including those with uncontrolled systemic infections, significant cardiovascular disease, or severe hypertension.
Data Collection:
Baseline Data: Clinical history, imaging (CT or MRI), and EEG results will be collected to help categorize participants into known or undetermined aetiology groups. A metabolic screening will be conducted for infants with undetermined aetiology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized (1:1), single-blinded, multi-centre, parallel-group clinical trial.
| Arm | Type | Receives |
|---|---|---|
| treatment arm A | Experimental | Drug: Short-Duration Oral Prednisolone with Extended TaperingThe initial phase of the intervention involves administering prednisolone orally at a dosage of 10 mg, four times daily (40 mg/day) for 7 days. This will be followed by a tapering regimen over 15 days (~2 weeks) as outlined below: 10 mg three times daily - 5 days 10 mg twice daily - 5 days 10 mg daily - 5 days The second phase of the intervention begins at the end of 15 days, where a prolonged tapering of prednisolone at a low dose (<0.4 mg/kg per day) will be administered as 10 mg once daily, twice a week, for an additional 10 weeks. |
| treatment arm B | Active comparator | Drug: Standard Oral Prednisolone Regimen with TaperingPrednisone will be administered orally at a dose of 10 mg, four times daily (40 mg/day) for 14 days. This is the standard therapy currently given to children with IESS in Sri Lanka. This will be followed by a tapering regimen over 15 days (~2 weeks) as outlined below: 10 mg three times daily - 5 days 10 mg twice daily - 5 days 10 mg daily - 5 days No additional tapering will be implemented. |
Who may qualify
- Ages
- 3 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants between ages of 3 to 24 months
- Newly confirmed diagnosis of infantile epileptic spasms syndrome made by the referring paediatrician/ paediatric neurologist based on the diagnostic criteria outlined in the recent ILAE classification and definition of epilepsy syndrome with onset in neonates and infants in 2022
- Hypsarrhythmia recorded on pre-treatment EEG. This will be those who show a BASED score of 4 or 5 in a standard EEG
Key exclusion criteria (6 listed)
- Infants with tuberous sclerosis complex
- Ever treated previously for infantile epileptic spasms syndrome with steroids or other anticonvulsants
- Infants already on steroids or ACTH for any other illness
- Contraindication for the use of high dose steroids such as underlying infection, immune deficiency, hypertension etc.
- Children in critical conditions such as severe infections, congenital heart disease or requiring ventilation or care in an ICU
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 |
|---|---|---|
| Short-Duration Oral Prednisolone with Extended TaperingIn treatment arm A, oral prednisolone will be administered in tablet form (5 mg strength) as follows: an initial phase of 10 mg four times daily (total 40 mg/day) for 7 days, followed by a 15-day tapering phase-10 mg three times daily for 5 days, 10 mg twice daily for 5 days, and 10 mg once daily for 5 days. After tapering, a prolonged low-dose maintenance phase will be implemented, where 10 mg is given once daily twice a week for an additional 10 weeks. This regimen is designed to test whether a shorter high-dose course, combined with extended low-dose maintenance, can provide equivalent control of infantile epileptic spasms syndrome while reducing the adverse effects associated with longer high-dose therapy, compared to the standard 14-day high-dose regimen (treatment arm B). | Drug | treatment arm A |
| Standard Oral Prednisolone Regimen with TaperingPrednisone oral tablets, 10 mg, administered four times daily (40 mg/day) for 14 days, followed by a tapering phase over 15 days: 10 mg three times daily for 5 days, 10 mg twice daily for 5 days, and 10 mg once daily for 5 days. No further tapering will be implemented after the initial 14-day treatment period. This regimen represents the standard therapy for Infantile Spasms in Sri Lanka. | Drug | treatment arm B |
Primary outcome
Electroclinical Remission at Day 14 and Day 28
Time frame: Assessed at 14 days and 28 days after treatment initiation.
This primary outcome measure compares the efficacy of the 7-day versus 14-day oral prednisolone regimens. Electroclinical remission is defined as (1) spasm control-no clinically recognizable spasms for a minimum of 24 consecutive hours as recorded by the caregiver-and (2) EEG remission-disappearance of hypsarrhythmia with the BASED score improved to 3 or less on a standardized 30-minute sleep EEG (with 5 minutes of wakefulness).
4 secondary outcomes
Long-Term Spasm Control
Time frame: Assessed at 42 days, 3 months, 6 months, and 12 months post-treatment.
Spasm Relapse Rate and Time to Relapse
Time frame: Evaluated continuously over the 12-month follow-up period.
Developmental Outcome at 24 Months
Time frame: Assessed at 24 months following treatment initiation.
Evolution of Epilepsy
Time frame: Assessed at 12 months post-treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: No. Since this clinical trial involves infants, who belong to a vulnerable population, strict ethical considerations have been incorporated to ensure data confidentiality and participant protection. All collected data will remain confidential and will be stored securely in a password-protected computer and locked storage, accessible only to the investigators. There is no plan to share individual participant data (IPD).
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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.
Jithangi Wanigasinghe, MD, MPhil principal investigator
Department of Paediatrics at the Faculty of Medicine, University of Colombo, Sri Lanka
Carukshi Arambepola, MSc, MD principal investigator
Department of Community Medicine, Faculty of Medicine, University of Colombo, Sri Lanka
Shalini Sri Ranganathan, MD, PhD principal investigator
Department of Pharmacology, Faculty of Medicine, University of Colombo, Sri Lanka
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Short-Duration Oral Prednisolone with Extended Tapering and Standard Oral Prednisolone Regimen with Tapering in people with Spasms, Infantile and Prednisolone, run by University of Colombo at 7 sites in Sri Lanka.
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: under way, not looking for participants, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Sri Lanka. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Electroclinical Remission at Day 14 and Day 28 (time frame: Assessed at 14 days and 28 days after treatment initiation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2025.