NeurocysticercosisPhase 3NCT02243644
Effects of 2 Different Duration of Albendazole Therapy in Patients With Neurocysticercosis in Brain ≤ 5 Lesions on CT
A Phase 3 study testing 7 days of albendazole 15 mg/kg/day and 28 days of albendazole 15 mg/kg/day in people with Neurocysticercosis, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
Comparing the effect of two different duration of same drug albendazole in patients with Neurocysticercosis less than or equal to 5 lesions on CT head at the end of 6 months. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Neurocysticercosis
- What is being tested?
- 7 days of albendazole 15 mg/kg/day and 28 days of albendazole 15 mg/kg/day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2014to Oct 2015
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 2-18 years.
- Number of parenchymal lesions: upto 5*
- Stages of cysticerci at which albendazole treatment is effective
- Vesicular stage
- Colloid vesicular stage
- Granular nodular stage
Who cannot join
- Cysticercotic encephalitis
- Calcified cyst
- Hydrocephalus
- Intraventricular cyst
- Subarachnoid cyst
- Ophthalmic Cysticercosis
Show all 11Show fewer
- No of cysts >5
- Known allergy to benzimidazole class of compound which includes anaphylaxis, hypotension, severe skin reactions .
- Features of raised ICT (papilloedema, hyperventilation, hypertension, tonic posturing, B/L 6th nerve palsy, features of midline shift on CT/MRI)
- Critically sick (respiratory failure, cardiovascular instability)
- Already received albendazole or praziquantel or steroid therapy
Trial locations and contacts
1 site in 1 country.
India1 site
sheffali Gulati
New Delhi, National Capital Territory of Delhi, 110029
About this study
Official title: A Clinical Trial to Study the Effects of Two Different Duration of Same Drug Albendazole in Patients With Neurocysticercosis in Brain ≤ 5 Lesions on CT Scan Head at the End of 6 Months
Comparing the effect of two different duration of same drug albendazole in patients with Neurocysticercosis less than or equal to 5 lesions on CT head at the end of 6 months.
Read the detailed description
The trial will be comparing the effectiveness of short and long duration of albendazole ie 7 and 28 days therapy in patients with parenchymal neurocysticercosis in terms of complete resolution or calcification of cyst on CT head at the end of 6 months after starting albendazole
- Conditions
- Neurocysticercosis
- Being tested
- 7 days of albendazole 15 mg/kg/day, 28 days of albendazole 15 mg/kg/day
- Keywords
- parenchymal neurocysticercosis upto five lesions
- Medical subject headings
- Neurocysticercosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7 days of albendazole 15 mg/kg/dayDrug
Also called Zentel, Bandy
group A will receive 7 days of oral albendazole 15 mg/kg/day
28 days of albendazole 15 mg/kg/dayDrug
Also called Zentel, Bandy
group B will receive 28 days of oral albendazole 15 mg/kg/day
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | 7 days of albendazole 15 mg/kg/day Receives: Drug: 7 days of albendazole 15 mg/kg/day |
| Group B | Active comparator | 28 days of albendazole 15 mg/kg/day Receives: Drug: 28 days of albendazole 15 mg/kg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cyst resolved/ calcified completely after therapy. Resolution or calcification of cyst assessed on CT head at the end of 6 months after starting albendazole
A randomized open labeled control clinical trial to compare the radiological outcome of 7 days versus 28 days albendazole therapy along with steroid in patients with parenchymal neurocysticercosis with lesion load < 5
Measured: 1 year
Secondary outcomes (3)
Frequency of seizure occurrence
A randomized open labeled control clinical trial to compare the radiological outcome of 7 days versus 28 days albendazole therapy along with steroid in patients with parenchymal neurocysticercosis with lesion load < 5
Measured: 1 year
Frequency of occurrence of other symptoms attributable to Neurocysticercosis
A randomized open labeled control clinical trial to compare the radiological outcome of 7 days versus 28 days albendazole therapy along with steroid in patients with parenchymal neurocysticercosis with lesion load < 5
Measured: 1 year
Frequency of occurrence of side effects of albendazole
A randomized open labeled control clinical trial to compare the radiological outcome of 7 days versus 28 days albendazole therapy along with steroid in patients with parenchymal neurocysticercosis with lesion load < 5
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2014 (estimated)
- Study startMar 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurocysticercosisStudies 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
- 97 participants (actual)
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, MD, Principal investigator, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243644
- Sponsor's protocol ID
- IESC/T-320/02.08.2013
- Status last verified
- Dec 2015
- First submitted
- 5 May 2014
- Last updated
- 1 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Study the Effects of Two Different Duration of Same Drug Albendazole in Patients With Neurocysticercosis in Brain ≤ 5 Lesions on CT Scan Head at the End of 6 Months
- ClinicalTrials.gov ID
- NCT02243644
- Acronym / sponsor ID
- IESC/T-320/02.08.2013
- Conditions
- Neurocysticercosis
- Keywords
- parenchymal neurocysticercosis upto five lesions
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 18 Sep 2014 (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.
Comparing the effect of two different duration of same drug albendazole in patients with Neurocysticercosis less than or equal to 5 lesions on CT head at the end of 6 months.
Detailed description
The trial will be comparing the effectiveness of short and long duration of albendazole ie 7 and 28 days therapy in patients with parenchymal neurocysticercosis in terms of complete resolution or calcification of cyst on CT head at the end of 6 months after starting albendazole
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: 7 days of albendazole 15 mg/kg/day7 days of albendazole 15 mg/kg/day |
| Group B | Active comparator | Drug: 28 days of albendazole 15 mg/kg/day28 days of albendazole 15 mg/kg/day |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age 2-18 years.
- Number of parenchymal lesions: upto 5*
- Stages of cysticerci at which albendazole treatment is effective
- Vesicular stage
- Colloid vesicular stage
Key exclusion criteria (11 listed)
- Cysticercotic encephalitis
- Calcified cyst
- Hydrocephalus
- Intraventricular cyst
- Subarachnoid cyst
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 |
|---|---|---|
| 7 days of albendazole 15 mg/kg/dayAlso: Zentel, Bandygroup A will receive 7 days of oral albendazole 15 mg/kg/day | Drug | Group A |
| 28 days of albendazole 15 mg/kg/dayAlso: Zentel, Bandygroup B will receive 28 days of oral albendazole 15 mg/kg/day | Drug | Group B |
Primary outcome
Number of cyst resolved/ calcified completely after therapy. Resolution or calcification of cyst assessed on CT head at the end of 6 months after starting albendazole
Time frame: 1 year
A randomized open labeled control clinical trial to compare the radiological outcome of 7 days versus 28 days albendazole therapy along with steroid in patients with parenchymal neurocysticercosis with lesion load < 5
3 secondary outcomes
Frequency of seizure occurrence
Time frame: 1 year
Frequency of occurrence of other symptoms attributable to Neurocysticercosis
Time frame: 1 year
Frequency of occurrence of side effects of albendazole
Time frame: 1 year
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 1 Jan 2016.
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The Impact of Medical TV Drama in Improving Literacy on Neurocysticercosis
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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, MD principal investigator
All India Institute of Medical Sciences
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 7 days of albendazole 15 mg/kg/day and 28 days of albendazole 15 mg/kg/day in people with Neurocysticercosis, run by All India Institute of Medical Sciences 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 6 inclusion and 11 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 1 Jan 2016. 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?
Number of cyst resolved/ calcified completely after therapy. Resolution or calcification of cyst assessed on CT head at the end of 6 months after starting albendazole (time frame: 1 year). 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 1 Jan 2016.