Infantile SpasmsPhase 2/3NCT01549288
Trial of the Modified Atkins Diet in Infantile Spasms Refractory to Hormonal Therapy
A Phase 2/3 study testing modified Atkins diet and no dietetic input in people with Infantile Spasms, run by Lady Hardinge Medical College at 1 site in India.
Trial summary
Infantile spasms comprise an infantile epileptic encephalopathy characterized by hypsarrhythmia on EEG, and frequent neurodevelopmental regression. Unfortunately the treatment of this disorder remains difficult. Read more about this study
- Who is it for?
- Ages 9 to 36 months
- Conditions the study is for
- Infantile Spasms
- What is being tested?
- modified Atkins diet and no dietetic input
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2012to Dec 2013
- 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 9 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age 9 months to 3 years
- Presence of epileptic spasms in clusters in child 9 months to < 3years of age, with electroencephalographic evidence of hypsarrhythmia or its variants), persisting, at least one cluster per day, despite treatment with either oral corticosteroids or adrenocorticotrophic hormone (ACTH) and one additional anticonvulsant (valproate/benzodiazepine/vigabatrin/topiramate/zonisamide/ levetiracetam) for at least 4 weeks.
Who cannot join
- Children with known or suspected inborn error of metabolism, Patients with clinical suspicion of metabolic disorder as evidenced by 2 or more of the following:
- a history of parental consanguinity,
- prior affected siblings,
- unexplained vomiting,
- intermittent worsening of symptoms,
- recurrent episodes of lethargy,
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- altered sensorium, or
- ataxia,
- hepatosplenomegaly on examination
- With or without 2 or more of the following biochemical abnormalities:
- High blood ammonia (> 80mmol/L),
- High arterial lactate (> 2 mmol/L),
- metabolic acidosis (pH < 7.2),
- hypoglycaemia (blood sugar < 40 mg/dl),
- abnormal urinary aminoacidogram,
- presence of reducing sugars or ketones in urine, and
- positive results on urine neurometabolic screening tests. In such patients, blood tandem mass spectrometry or urine gas chromatography mass spectroscopy (GCMS) will be obtained to look for inborn error of metabolism.
- Children with renal, pulmonary, cardiac or hepatic dysfunction
- Severe malnutrition (weight for length and height for age less than 3 SD for mean as per WHO growth charts),
- Children from families who lack motivation will also be excluded as it might affect the compliance.
Trial locations and contacts
1 site in 1 country.
India1 site
Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital
New Delhi, National Capital Territory of Delhi, 110001
About this study
Official title: Evaluation of the Modified Atkins Diet in Children With Infantile Spasms Refractory to Hormonal Therapy: a Randomized Controlled Trial
Infantile spasms comprise an infantile epileptic encephalopathy characterized by hypsarrhythmia on EEG, and frequent neurodevelopmental regression. Unfortunately the treatment of this disorder remains difficult. The first-line options which include hormonal therapy, i.e., adrenocorticotropic hormone (ACTH) or oral corticosteroids, and vigabatrin are effective in 60-70% of the patients. Hormonal therapy is considered the best available treatment. Vigabatrin being expensive and of limited availability is not a feasible option for most patients in our setting. Also, these are however associated with significant side effects, and high relapse rates. Newer drugs such as topiramate, zonisamide, and levetiracetam have also been evaluated; however these drugs are less effective than ACTH. The ketogenic diet (KD) is a high fat, low carbohydrate diet. It has been used for treatment of intractable childhood epilepsy. The KD has also been shown to be effective for intractable infantile spasms; often after ACTH and vigabatrin have failed.
The modified Atkins diet is a non-pharmacologic therapy for intractable childhood epilepsy that was designed to be a less restrictive alternative to the traditional ketogenic diet. This diet is started on an outpatient basis without a fast, allows unlimited protein and fat, and does not restrict calories or fluids. Preliminary data have shown efficacy in refractory infantile spasms. This diet is also ideal for resource-constraint settings with paucity of trained dieticians. Hence this study has been planned to evaluate the efficacy and tolerability of the modified Atkins diet in children with infantile spasms refractory to hormonal treatment in a randomized controlled trial.
- Conditions
- Infantile Spasms
- Being tested
- modified Atkins diet, no dietetic input
- Medical subject headings
- Spasms, Infantile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified Atkins dietBehavioural
Carbohydrate restricted to 10 g/day (18-36 months) and 5 g/day (9-18 months), fat intake encouraged, proteins unrestricted
no dietetic inputOther
continuation of anti-epileptic medication without any dietetic input
| Study group | Role | What they receive |
|---|---|---|
| modified Atkins diet | Experimental | Not described Receives: Behavioral: modified Atkins diet |
| control arm | Other | the control arm continues the anti-epileptic drugs without any added dietetic input Receives: Other: no dietetic input |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of children who achieved spasm freedom as per parental reports at 4 weeks
Measured: 4 weeks
Secondary outcomes (1)
Proportion of children who achieved >50% reduction of clinical spasm, as per parental reports at 4 weeks
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionOct 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01549288
- Sponsor's protocol ID
- RADIS
- Status last verified
- Apr 2013
- First submitted
- 6 Mar 2012
- Last updated
- 9 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Modified Atkins Diet in Children With Infantile Spasms Refractory to Hormonal Therapy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01549288
- Acronym / sponsor ID
- RADIS
- Conditions
- Infantile Spasms
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lady Hardinge Medical CollegeOther government
- Study start
- Feb 2012
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 9 Mar 2012 (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 comprise an infantile epileptic encephalopathy characterized by hypsarrhythmia on EEG, and frequent neurodevelopmental regression. Unfortunately the treatment of this disorder remains difficult. The first-line options which include hormonal therapy, i.e., adrenocorticotropic hormone (ACTH) or oral corticosteroids, and vigabatrin are effective in 60-70% of the patients. Hormonal therapy is considered the best available treatment. Vigabatrin being expensive and of limited availability is not a feasible option for most patients in our setting. Also, these are however associated with significant side effects, and high relapse rates. Newer drugs such as topiramate, zonisamide, and levetiracetam have also been evaluated; however these drugs are less effective than ACTH. The ketogenic diet (KD) is a high fat, low carbohydrate diet. It has been used for treatment of intractable childhood epilepsy. The KD has also been shown to be effective for intractable infantile spasms; often after ACTH and vigabatrin have failed.
The modified Atkins diet is a non-pharmacologic therapy for intractable childhood epilepsy that was designed to be a less restrictive alternative to the traditional ketogenic diet. This diet is started on an outpatient basis without a fast, allows unlimited protein and fat, and does not restrict calories or fluids. Preliminary data have shown efficacy in refractory infantile spasms. This diet is also ideal for resource-constraint settings with paucity of trained dieticians. Hence this study has been planned to evaluate the efficacy and tolerability of the modified Atkins diet in children with infantile spasms refractory to hormonal treatment in a randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| modified Atkins diet | Experimental | Behavioral: modified Atkins diet |
| control arm | Other | Other: no dietetic inputthe control arm continues the anti-epileptic drugs without any added dietetic input |
Who may qualify
- Ages
- 9 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- age 9 months to 3 years
- Presence of epileptic spasms in clusters in child 9 months to < 3years of age, with electroencephalographic evidence of hypsarrhythmia or its variants), persisting, at least one cluster per day, despite treatment with either oral corticosteroids or adrenocorticotrophic hormone (ACTH) and one additional anticonvulsant (valproate/benzodiazepine/vigabatrin/topiramate/zonisamide/ levetiracetam) for at least 4 weeks.
Key exclusion criteria (20 listed)
- Children with known or suspected inborn error of metabolism, Patients with clinical suspicion of metabolic disorder as evidenced by 2 or more of the following:
- With or without 2 or more of the following biochemical abnormalities:
- Children with renal, pulmonary, cardiac or hepatic dysfunction
- Severe malnutrition (weight for length and height for age less than 3 SD for mean as per WHO growth charts),
- Children from families who lack motivation will also be excluded as it might affect the compliance.
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 |
|---|---|---|
| modified Atkins dietCarbohydrate restricted to 10 g/day (18-36 months) and 5 g/day (9-18 months), fat intake encouraged, proteins unrestricted | Behavioural | modified Atkins diet |
| no dietetic inputcontinuation of anti-epileptic medication without any dietetic input | Other | control arm |
Primary outcome
Proportion of children who achieved spasm freedom as per parental reports at 4 weeks
Time frame: 4 weeks
1 secondary outcome
Proportion of children who achieved >50% reduction of clinical spasm, as per parental reports at 4 weeks
Time frame: 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 modified Atkins diet and no dietetic input 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 2 inclusion and 20 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: withdrawn, as of the sponsor's last update on 9 Apr 2013. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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 spasm freedom as per parental reports at 4 weeks (time frame: 4 weeks). 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 9 Apr 2013.