Ketogenic DietPhase 2/3NCT05279118
Ketogenic Diet vs ACTH for the Treatment of Children With West Syndrome
A Phase 2/3 study testing Ketogenic diet and ACTH in people with Ketogenic Diet and West Syndrome, run by All India Institute of Medical Sciences at 2 sites in India.
Trial summary
Children with West syndrome are prone to refractory seizures with poor neurocognitive outcome overall. The current standard of care consists of treatment with ACTH, but the grade of evidence is not high and not much RCTs are available. Read more about this study
- Who is it for?
- Ages 6 months to 2 years
- Conditions the study is for
- Ketogenic Diet, West Syndrome, Infantile Spasm
- What is being tested?
- Ketogenic diet and ACTH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesIndia
- Study dates
- 18 Apr 2022to 28 Jul 2024
- Phase
- Phase 2/3
- 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 6 months to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children, aged 6 month - 2 years with electroclinical diagnosis of west syndrome
Who cannot join
- Already on ACTH, prednisolone vigabatrin or KD therapy > 5days
- Tuberous sclerosis
- Vitamin trial responsiveness
- Known Pre-existing contraindications for KD (IEM, Porphyria etc.)
- Chronic systemic illness (Ex: Chronic kidney disease, congenital heart diseases etc)
Trial locations and contacts
2 sites in 1 country.
India2 sites
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
AIIMS
New Delhi, 110049
About this study
Official title: Comparison of Efficacy of Ketogenic Diet and ACTH Therapy Among Children With West Syndrome: A Pilot Randomized Control Trial
Children with West syndrome are prone to refractory seizures with poor neurocognitive outcome overall. The current standard of care consists of treatment with ACTH, but the grade of evidence is not high and not much RCTs are available. Ketogenic diet is an effective and well tolerated treatment option in drug refractory epilepsy and also in refractory west syndrome. In view of minimal side effects, better cost parameters and ability to continue for a longer duration our study aiims to investigate the efficacy of ketogenic diet as a first line therapy in comparison to ACTH therapy. Children with west syndrome after satisfying the inclusion and exclusion criteria will be randomised into the two treatment arms and primary response will be noted at the end of 6 weeks of therapy in terms of mean percentage of spasm reduction.
Read the detailed description
- Consecutive children with West Syndrome (clinical spasm with EEG correlate) will be screened in the study centre for eligibility, and after applying inclusion and exclusion criteria they will be worked up for etiology.
- History will be taken and clinical examination will be done and if either are suggestive of any underlying etiology specific investigations will be performed as indicated (Ex. Neurocutaneous markers in tuberous sclerosis).
- If there are no other etiological pointers available from history and examination or if there is any history suggestive of adverse perinatal events, MRI brain with epilepsy protocol will be done.
- If MRI is not suggestive of structural etiology they will be given a vitamin trial(pyridoxine 30mg/kg/day, pyridoxal phosphate- 20mg/kg/day, biotin 10mg/day and folinic acid 15mg/day) for a period of 10 days for response. Those who respond to Vitamin trial will be excluded from the study.
- Written informed consent will be taken from legal guardians who are willing to participate in the study. Their anti-epileptic drugs will be optimised. Inappropriate AEDs like phenytoin, phenobarbitone and carbamazepine will be discontinued and replaced with valproate/levetiracetam and clonazepam in adequate doses and will be made in tablet form.
- There will be an observation period of 2 weeks where the participants will be sensitised about proper counting of spasms and the mean no. of spasms per week of the 2nd week will form the baseline and they will be randomised into two groups as mentioned above during the same period with no further changes in AEDs till the duration of completion of primary objective. Those who require hiking/titrating of AEDs during the initial period of 6 weeks plus run in period of 2 weeks will be treated as deviates and excluded from the study.
- DASII will be administered by child psychologist and will be repeated at 3 months and at 6 months of followup wherever feasible.
- Appropriate screening for Tuberculosis as per unit protocol (Mantoux and CXR screening) will be done if going to the ACTH therapy arm.
- Workup for ketogenic diet will also be done ECG, RFT, LFT, CBC, Lipid profile, Urine calcium creatinine ratio and USG KUB for nephrocalcinosis if going to the KD arm
Group 1 ACTH arm:
- Children randomised into ACTH arm will be started on high dose regimen(45)(46) of 150U/m2 or 6U/kg of ACTH.
- This high dose will be continued for 2 weeks following which they will be slowly tapered over remaining 4 weeks, for a total treatment duration of 6 weeks.
- EEG will be done at 6 weeks and 3 months of therapy in case of clinical spasm cessation and wherever clinically indicated
- First followup will be at 6 weeks of treatment initiation, then at 8 weeks and from then on once a month for a minimum period of 3 months (+/- 7 days) upto 6 months(+/- 7 days) wherever feasible.
- Those who have had complete electroclinical spasm cessation will be continued of oral AEDs.
- Those who have <50% spasm reduction rate will be shifted to KD.
- Those who have >/=50% spasm reduction rate will be given trial of other oral AEDs as per protocol.
- The overall spasm reduction will be calculated from the mean number of spasms from the observation period week and the mean number of spasms from the 6th week of therapy. Adverse effects will be noted down in their seizure diary.
- For sustained electroclinical cessation those who had complete electroclinical response will be rechecked at the end of 3 months (+/- 7 days) upto 6 months(+/- 7 days) wherever feasible.
- Compliance rate, adverse events, >50% spasm reduction rate, clinical spasm cessation rate, complete electroclinical spasm cessation rate will also be calculated from patient seizure log and EEG correlate.
- RBS and BP monitoring to be done twice weekly
Group 2 KD arm:
- Children randomised into this arm will be admitted in ward and initiated on Ketogenic diet under supervision.
- KD will be initiated in a ratio of 2:1 and then hiked to 2.5:1 in the next day and subsequently to 3:on day 3. Urine ketones will be checked daily using ketone dipsticks.
- For better assurance of ketosis and tolerance the indigenous KD will be supplemented with readymade formula for the initial period of 4 weeks and then shifted to complete indigenous KD gradually over 1 week.
- If ketosis is not achieved by day 5 of starting KD, the ratio will be hiked to a maximum of 4:1 from day 6.
- Patient will be discharged as soon as the desired ratio of KD is achieved, and the parents are adequately motivated and confident. Telephonic contacts will be made in regular intervals to further ensure compliance at home.
- Those children who are unable to tolerate taking adequate ketogenic diet therapy requiring discontinuation of therapy, will be considered as deviates.
- The overall spasm reduction will be calculated from the mean number of spasms from the observation period week and the mean number of spasms from the 4th week of therapy.
- Failure of KD: Children with response rate if not >50% spasm reduction by 6 weeks or no electroclinical cessation of spasm by 3 months, will be considered to have failed KD and shifted to standard ACTH therapy as per protocol.
- KD will be continued if there is more than 50% spasm reduction.
- EEG will be done at 6 weeks and 3 months of therapy in case of clinical spasm cessation and wherever clinically indicated
- First followup will be at 6 weeks of treatment initiation,8weeks and then once monthly for a minimum period of 3 months and 6 months wherever feasible. For sustained electroclinical cessation those who had complete electroclinical response will be rechecked at the end of 3 months (+/- 7 days) upto 6 months(+/- 7 days) wherever feasible.
- Compliance rate, adverse events, >50% spasm reduction rate, clinical spasm cessation rate, complete electroclinical spasm cessation rate will also be calculated from patient seizure log and EEG correlate. .
- Formula based KD would be supplied to the patient free of cost. But the company will play no part in the study design, conduct, data collection or analysis
- Conditions
- Ketogenic Diet, West Syndrome, Infantile Spasm, ACTH
- Being tested
- Ketogenic diet, ACTH
- Keywords
- Ketogenic diet, West Syndrome, Infantile Spasm, ACTH
- Medical subject headings
- Spasms, Infantile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic dietDietary supplement
Also called Diet therapy
Children who have consented to the study and have been randomised to ketogenic diet arm will get ketogenic diet under supervision while starting with rapid hiking of lipid to carbohydrate ratio and primary response will be assessed at 6 weeks. Ketogenic diet ratio will be hiked quickly upto a maximum of 4:!. The duration of ketogenic diet can be extended beyond the period of study based on response and parental choice. A minimum period of 6 weeks of diet therapy will be undertaken baring any undue adverse effects when the primary outcome will be assessed
ACTHDrug
Also called Hormonal therapy
ACTH is the current standard therapy for children with west syndrome. Those who have been randomised to this arm will be started on high dose ACTH for 2 weeks followed by gradual tapering over remaining 4 weeks and primary response documented at 6 weeks of therapy. The high dose ACTh is 150U/m2 or 6U/kg dose administered IM daily for two weeks. After this the doses will be tapered gradually and ACTH will be stopped by 4 weeks for a total treatment duration of strictly 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic diet arm | Experimental | Children who have consented to the study and have been randomised to ketogenic diet arm will get ketogenic diet under supervision while starting with rapid hiking of lipid to carbohydrate ratio and primary response will be assessed at 6 weeks. Ketogenic diet ratio will be hiked quickly upto a maximum of 4:!. The duration of ketogenic diet can be extended beyond the period of study based on response and parental choice. A minimum period of 6 weeks of diet therapy will be undertaken baring any undue adverse effects when the primary outcome will be assessed Receives: Dietary Supplement: Ketogenic diet |
| ACTH arm | Active comparator | ACTH is the current standard therapy for children with west syndrome. Those who have been randomised to this arm will be started on high dose ACTH for 2 weeks followed by gradual tapering over remaining 4 weeks and primary response documented at 6 weeks of therapy. The high dose ACTh is 150U/m2 or 6U/kg dose administered IM daily for two weeks. After this the doses will be tapered gradually and ACTH will be stopped by 4 weeks for a total treatment duration of strictly 6 weeks. Receives: Drug: ACTH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean percentage reduction of spam (Baseline mean weekly spasm rate - mean weekly spasm rate on 6th week of therapy/Baseline mean weekly spasm rate * 100) is compared in both arms
Mean percentage reduction of spam (Baseline mean weekly spasm rate - mean weekly spasm rate on 6th week of therapy/Baseline mean weekly spasm rate * 100) is compared in both arms
Measured: From baseline to 6 weeks of therapy
Secondary outcomes (7)
To compare complete spasm cessation rate in KD arm vs ACTH arm
Percentage of children with clinical spasm cessation at 6 weeks of therapy
Measured: Percentage of children with clinical spasm cessation at 6 weeks of therapy
To compare >50% spasm reduction rate in KD arm vs ACTH arm
Percentage of children with >50% spasm reduction at the end of 6 weeks and 3months of therapy (wherever feasible at 6 months)
Measured: Percentage of children with >50% spasm reduction at the end of 6 weeks and 3months of therapy (wherever feasible at 6 months)
To compare electroclinical spasm To compare electroclinical spasm cessation rate in KD arm vs ACTH arm at 6 weeks
Percentage of children with clinical spasm cessation at 6 weeks of therapy
Measured: Percentage of children with clinical spasm cessation at 6 weeks of therapy
To compare sustained electroclinical cessation rate in KD arm vs ACTH arm at 3 months
Percentage of children with primary electroclinical spasm cessation who sustain the remission at 3months of therapy(wherever feasible at 6 months)
Measured: Percentage of children with primary electroclinical spasm cessation who sustain the remission at 3months of therapy(wherever feasible at 6 months)
To compare the compliance rate in KD arm vs ACTH arm at 6 weeks
Percentage of children with compliance of greater than >80% of doses of ACTH in the 6 weeks of therapy compared with percentage of children with score of >80% in KD compliance questionnaire (score of >/=18 out of 25)
Measured: Percentage of children with compliance of greater than >80% of doses of ACTH in the 6 weeks of therapy compared with percentage of children with score of >80% in KD compliance questionnaire (score of >/=18 out of 25)
To compare the adverse effect profile in KD arm vs ACTH arm at 6 weeks and 3 months
Description of adverse effects in each groups with proportion of CTCAE grade 3 and above in each groups at 3months of therapy (wherever feasible at 6 months)
Measured: Description of adverse effects in each groups with proportion of CTCAE grade 3 and above in each groups at 3months of therapy (wherever feasible at 6 months)
To compare neurodevelopmental outcome in KD arm vs ACTH arm using DASII at 3 months
Percentage improvement in Motor and Mental developmental quotients of children in both groups at 3 months of therapy (wherever feasible at 6 months)
Measured: Percentage improvement in Motor and Mental developmental quotients of children in both groups at 3 months of therapy (wherever feasible at 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start18 Apr 2022
- Primary completionJul 2024 (estimated)
- Study completion28 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ketogenic DietStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- pilot randomized RCT
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheffali Gulati, All India Institute of Medical Sciences
- Investigators
- Sheffali Gulati, Principal investigator, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279118
- Sponsor's protocol ID
- IECPG-19/27.1.2022,RT/24.2.22
- Other IDs
- No.3/2/June2022/PG-Thesis
- Status last verified
- Jun 2024
- First submitted
- 3 Mar 2022
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Ketogenic Diet and ACTH Therapy Among Children With West Syndrome: A Pilot Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05279118
- Acronym / sponsor ID
- IECPG-19/27.1.2022,RT/24.2.22
- Conditions
- Ketogenic Diet, West Syndrome, Infantile Spasm, ACTH
- Keywords
- Ketogenic diet, West Syndrome, Infantile Spasm, ACTH
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- 28 Jul 2024 (estimated)
- First posted
- 15 Mar 2022 (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.
Children with West syndrome are prone to refractory seizures with poor neurocognitive outcome overall. The current standard of care consists of treatment with ACTH, but the grade of evidence is not high and not much RCTs are available. Ketogenic diet is an effective and well tolerated treatment option in drug refractory epilepsy and also in refractory west syndrome. In view of minimal side effects, better cost parameters and ability to continue for a longer duration our study aiims to investigate the efficacy of ketogenic diet as a first line therapy in comparison to ACTH therapy. Children with west syndrome after satisfying the inclusion and exclusion criteria will be randomised into the two treatment arms and primary response will be noted at the end of 6 weeks of therapy in terms of mean percentage of spasm reduction.
Detailed description
- Consecutive children with West Syndrome (clinical spasm with EEG correlate) will be screened in the study centre for eligibility, and after applying inclusion and exclusion criteria they will be worked up for etiology.
- History will be taken and clinical examination will be done and if either are suggestive of any underlying etiology specific investigations will be performed as indicated (Ex. Neurocutaneous markers in tuberous sclerosis).
- If there are no other etiological pointers available from history and examination or if there is any history suggestive of adverse perinatal events, MRI brain with epilepsy protocol will be done.
- If MRI is not suggestive of structural etiology they will be given a vitamin trial(pyridoxine 30mg/kg/day, pyridoxal phosphate- 20mg/kg/day, biotin 10mg/day and folinic acid 15mg/day) for a period of 10 days for response. Those who respond to Vitamin trial will be excluded from the study.
- Written informed consent will be taken from legal guardians who are willing to participate in the study. Their anti-epileptic drugs will be optimised. Inappropriate AEDs like phenytoin, phenobarbitone and carbamazepine will be discontinued and replaced with valproate/levetiracetam and clonazepam in adequate doses and will be made in tablet form.
- There will be an observation period of 2 weeks where the participants will be sensitised about proper counting of spasms and the mean no. of spasms per week of the 2nd week will form the baseline and they will be randomised into two groups as mentioned above during the same period with no further changes in AEDs till the duration of completion of primary objective. Those who require hiking/titrating of AEDs during the initial period of 6 weeks plus run in period of 2 weeks will be treated as deviates and excluded from the study.
- DASII will be administered by child psychologist and will be repeated at 3 months and at 6 months of followup wherever feasible.
- Appropriate screening for Tuberculosis as per unit protocol (Mantoux and CXR screening) will be done if going to the ACTH therapy arm.
- Workup for ketogenic diet will also be done ECG, RFT, LFT, CBC, Lipid profile, Urine calcium creatinine ratio and USG KUB for nephrocalcinosis if going to the KD arm
Group 1 ACTH arm:
- Children randomised into ACTH arm will be started on high dose regimen(45)(46) of 150U/m2 or 6U/kg of ACTH.
- This high dose will be continued for 2 weeks following which they will be slowly tapered over remaining 4 weeks, for a total treatment duration of 6 weeks.
- EEG will be done at 6 weeks and 3 months of therapy in case of clinical spasm cessation and wherever clinically indicated
- First followup will be at 6 weeks of treatment initiation, then at 8 weeks and from then on once a month for a minimum period of 3 months (+/- 7 days) upto 6 months(+/- 7 days) wherever feasible.
- Those who have had complete electroclinical spasm cessation will be continued of oral AEDs.
- Those who have <50% spasm reduction rate will be shifted to KD.
- Those who have >/=50% spasm reduction rate will be given trial of other oral AEDs as per protocol.
- The overall spasm reduction will be calculated from the mean number of spasms from the observation period week and the mean number of spasms from the 6th week of therapy. Adverse effects will be noted down in their seizure diary.
- For sustained electroclinical cessation those who had complete electroclinical response will be rechecked at the end of 3 months (+/- 7 days) upto 6 months(+/- 7 days) wherever feasible.
- Compliance rate, adverse events, >50% spasm reduction rate, clinical spasm cessation rate, complete electroclinical spasm cessation rate will also be calculated from patient seizure log and EEG correlate.
- RBS and BP monitoring to be done twice weekly
Group 2 KD arm:
- Children randomised into this arm will be admitted in ward and initiated on Ketogenic diet under supervision.
- KD will be initiated in a ratio of 2:1 and then hiked to 2.5:1 in the next day and subsequently to 3:on day 3. Urine ketones will be checked daily using ketone dipsticks.
- For better assurance of ketosis and tolerance the indigenous KD will be supplemented with readymade formula for the initial period of 4 weeks and then shifted to complete indigenous KD gradually over 1 week.
- If ketosis is not achieved by day 5 of starting KD, the ratio will be hiked to a maximum of 4:1 from day 6.
- Patient will be discharged as soon as the desired ratio of KD is achieved, and the parents are adequately motivated and confident. Telephonic contacts will be made in regular intervals to further ensure compliance at home.
- Those children who are unable to tolerate taking adequate ketogenic diet therapy requiring discontinuation of therapy, will be considered as deviates.
- The overall spasm reduction will be calculated from the mean number of spasms from the observation period week and the mean number of spasms from the 4th week of therapy.
- Failure of KD: Children with response rate if not >50% spasm reduction by 6 weeks or no electroclinical cessation of spasm by 3 months, will be considered to have failed KD and shifted to standard ACTH therapy as per protocol.
- KD will be continued if there is more than 50% spasm reduction.
- EEG will be done at 6 weeks and 3 months of therapy in case of clinical spasm cessation and wherever clinically indicated
- First followup will be at 6 weeks of treatment initiation,8weeks and then once monthly for a minimum period of 3 months and 6 months wherever feasible. For sustained electroclinical cessation those who had complete electroclinical response will be rechecked at the end of 3 months (+/- 7 days) upto 6 months(+/- 7 days) wherever feasible.
- Compliance rate, adverse events, >50% spasm reduction rate, clinical spasm cessation rate, complete electroclinical spasm cessation rate will also be calculated from patient seizure log and EEG correlate. .
- Formula based KD would be supplied to the patient free of cost. But the company will play no part in the study design, conduct, data collection or analysis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- pilot randomized RCT
| Arm | Type | Receives |
|---|---|---|
| Ketogenic diet arm | Experimental | Dietary Supplement: Ketogenic dietChildren who have consented to the study and have been randomised to ketogenic diet arm will get ketogenic diet under supervision while starting with rapid hiking of lipid to carbohydrate ratio and primary response will be assessed at 6 weeks. Ketogenic diet ratio will be hiked quickly upto a maximum of 4:!. The duration of ketogenic diet can be extended beyond the period of study based on response and parental choice. A minimum period of 6 weeks of diet therapy will be undertaken baring any undue adverse effects when the primary outcome will be assessed |
| ACTH arm | Active comparator | Drug: ACTHACTH is the current standard therapy for children with west syndrome. Those who have been randomised to this arm will be started on high dose ACTH for 2 weeks followed by gradual tapering over remaining 4 weeks and primary response documented at 6 weeks of therapy. The high dose ACTh is 150U/m2 or 6U/kg dose administered IM daily for two weeks. After this the doses will be tapered gradually and ACTH will be stopped by 4 weeks for a total treatment duration of strictly 6 weeks. |
Who may qualify
- Ages
- 6 months to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children, aged 6 month - 2 years with electroclinical diagnosis of west syndrome
Key exclusion criteria (5 listed)
- Already on ACTH, prednisolone vigabatrin or KD therapy > 5days
- Tuberous sclerosis
- Vitamin trial responsiveness
- Known Pre-existing contraindications for KD (IEM, Porphyria etc.)
- Chronic systemic illness (Ex: Chronic kidney disease, congenital heart diseases etc)
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 |
|---|---|---|
| Ketogenic dietAlso: Diet therapyChildren who have consented to the study and have been randomised to ketogenic diet arm will get ketogenic diet under supervision while starting with rapid hiking of lipid to carbohydrate ratio and primary response will be assessed at 6 weeks. Ketogenic diet ratio will be hiked quickly upto a maximum of 4:!. The duration of ketogenic diet can be extended beyond the period of study based on response and parental choice. A minimum period of 6 weeks of diet therapy will be undertaken baring any undue adverse effects when the primary outcome will be assessed | Dietary supplement | Ketogenic diet arm |
| ACTHAlso: Hormonal therapyACTH is the current standard therapy for children with west syndrome. Those who have been randomised to this arm will be started on high dose ACTH for 2 weeks followed by gradual tapering over remaining 4 weeks and primary response documented at 6 weeks of therapy. The high dose ACTh is 150U/m2 or 6U/kg dose administered IM daily for two weeks. After this the doses will be tapered gradually and ACTH will be stopped by 4 weeks for a total treatment duration of strictly 6 weeks. | Drug | ACTH arm |
Primary outcome
Mean percentage reduction of spam (Baseline mean weekly spasm rate - mean weekly spasm rate on 6th week of therapy/Baseline mean weekly spasm rate * 100) is compared in both arms
Time frame: From baseline to 6 weeks of therapy
Mean percentage reduction of spam (Baseline mean weekly spasm rate - mean weekly spasm rate on 6th week of therapy/Baseline mean weekly spasm rate * 100) is compared in both arms
7 secondary outcomes
To compare complete spasm cessation rate in KD arm vs ACTH arm
Time frame: Percentage of children with clinical spasm cessation at 6 weeks of therapy
To compare >50% spasm reduction rate in KD arm vs ACTH arm
Time frame: Percentage of children with >50% spasm reduction at the end of 6 weeks and 3months of therapy (wherever feasible at 6 months)
To compare electroclinical spasm To compare electroclinical spasm cessation rate in KD arm vs ACTH arm at 6 weeks
Time frame: Percentage of children with clinical spasm cessation at 6 weeks of therapy
To compare sustained electroclinical cessation rate in KD arm vs ACTH arm at 3 months
Time frame: Percentage of children with primary electroclinical spasm cessation who sustain the remission at 3months of therapy(wherever feasible at 6 months)
To compare the compliance rate in KD arm vs ACTH arm at 6 weeks
Time frame: Percentage of children with compliance of greater than >80% of doses of ACTH in the 6 weeks of therapy compared with percentage of children with score of >80% in KD compliance questionnaire (score of >/=18 out of 25)
To compare the adverse effect profile in KD arm vs ACTH arm at 6 weeks and 3 months
Time frame: Description of adverse effects in each groups with proportion of CTCAE grade 3 and above in each groups at 3months of therapy (wherever feasible at 6 months)
To compare neurodevelopmental outcome in KD arm vs ACTH arm using DASII at 3 months
Time frame: Percentage improvement in Motor and Mental developmental quotients of children in both groups at 3 months of therapy (wherever feasible at 6 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Sheffali Gulati principal investigator
All India Institute of Medical Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ketogenic diet and ACTH in people with Ketogenic Diet and West Syndrome, run by All India Institute of Medical Sciences at 2 sites 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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
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?
Mean percentage reduction of spam (Baseline mean weekly spasm rate - mean weekly spasm rate on 6th week of therapy/Baseline mean weekly spasm rate * 100) is compared in both arms (time frame: From baseline to 6 weeks of therapy). 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 25 Jun 2024.