Epilepsy IntractableCIDRENCT04763070
Ciprofloxacin in Drug-resistant Epilepsy
A study testing Ciprofloxacin Oral Product in people with Epilepsy Intractable, run by Mazandaran University of Medical Sciences at 1 site in Iran.
Trial summary
This study aims to investigate the effect of a short-term prescription of ciprofloxacin on intestinal microbial pattern and seizure frequency of patients with drug-resistant epilepsy. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Epilepsy Intractable
- What is being tested?
- Ciprofloxacin Oral Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteIran
- Study dates
- 1 Oct 2020to 1 Jun 2021
- Phase
- Interventional
- 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 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Drug-resistant epilepsy with frequency of at least 2 seizure/Week
- Acceptance of patients or his/her guardian (Signing informed consent)
Who cannot join
- Hypersensitivity to ciprofloxacin or other fluoroquinolones
- History of tendon, renal, hepatic or cerebrovascular disease, organ transplantation or myasthenia gravis
- Usage of medications with interaction to ciprofloxacin
- No reliable contraception
- Pregnancy or breastfeeding
- Being under treatment with corticosteroid
Show all 10Show fewer
- Usage of antibiotics in recent 2 months or need to use it during the study
- Patients who are candidate for epilepsy surgery or other nonmedical treatments
- Change in anti-seizure medications (ASMs) during recent month
- Patients who will need changes in ASMs dose during study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Ciprofloxacin on Seizure Frequency in Patients With Drug-resistant Epilepsy
This study aims to investigate the effect of a short-term prescription of ciprofloxacin on intestinal microbial pattern and seizure frequency of patients with drug-resistant epilepsy.
- Conditions
- Epilepsy Intractable
- Being tested
- Ciprofloxacin Oral Product
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciprofloxacin Oral ProductDrug
The first stool sample will be taken before treatment and the second one will be taken in day 5 to 7 after treatment initiation. Treatment includes ciprofloxacin tablet 500mg twice a day for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Ciprofloxacin | Other | Not described Receives: Drug: Ciprofloxacin Oral Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in seizure frequency registered in questionnaire
Comparison of seizure frequency in 4th week with the frequency at the start of the study.
Measured: 4 weeks
Changes in quantity of microbial DNA extracted from stool samples by AccuPrep Stool DNA extraction Kit
Comparison of quantity of extracted microbial DNA in stool sample taken at day5-7 with the sample taken at the start of the study
Measured: 7 days
Changes in microbial burden of stool samples using Absolute real time polymerase chain reaction (PCR)
Comparison of microbial burden of stool samples taken at day5-7 with the sample taken at the start of the study
Measured: 7 days
Secondary outcomes (1)
Changes in seizure frequency registered in questionnaire
Comparison of seizure frequency in 12th week with the frequency at the start of the study
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Oct 2020
- Primary completion1 Apr 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy IntractableStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mazandaran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nasim Tabrizi, Mazandaran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763070
- Sponsor's protocol ID
- 5210
- Acronym
- CIDRE
- Status last verified
- Jun 2021
- First submitted
- 16 Feb 2021
- Last updated
- 7 Jun 2021
- 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 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ciprofloxacin on Seizure Frequency in Patients With Drug-resistant Epilepsy
- ClinicalTrials.gov ID
- NCT04763070
- Acronym / sponsor ID
- CIDRE / 5210
- Conditions
- Epilepsy Intractable
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Mazandaran University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 21 Feb 2021 (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.
This study aims to investigate the effect of a short-term prescription of ciprofloxacin on intestinal microbial pattern and seizure frequency of patients with drug-resistant epilepsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ciprofloxacin | Other | Drug: Ciprofloxacin Oral Product |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Drug-resistant epilepsy with frequency of at least 2 seizure/Week
- Acceptance of patients or his/her guardian (Signing informed consent)
Key exclusion criteria (10 listed)
- Hypersensitivity to ciprofloxacin or other fluoroquinolones
- History of tendon, renal, hepatic or cerebrovascular disease, organ transplantation or myasthenia gravis
- Usage of medications with interaction to ciprofloxacin
- No reliable contraception
- Pregnancy or breastfeeding
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 |
|---|---|---|
| Ciprofloxacin Oral ProductThe first stool sample will be taken before treatment and the second one will be taken in day 5 to 7 after treatment initiation. Treatment includes ciprofloxacin tablet 500mg twice a day for 5 days. | Drug | Ciprofloxacin |
Primary outcome
Changes in seizure frequency registered in questionnaire
Time frame: 4 weeks
Comparison of seizure frequency in 4th week with the frequency at the start of the study.
Changes in quantity of microbial DNA extracted from stool samples by AccuPrep Stool DNA extraction Kit
Time frame: 7 days
Comparison of quantity of extracted microbial DNA in stool sample taken at day5-7 with the sample taken at the start of the study
Changes in microbial burden of stool samples using Absolute real time polymerase chain reaction (PCR)
Time frame: 7 days
Comparison of microbial burden of stool samples taken at day5-7 with the sample taken at the start of the study
1 secondary outcome
Changes in seizure frequency registered in questionnaire
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
- 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.
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 study testing Ciprofloxacin Oral Product in people with Epilepsy Intractable, run by Mazandaran University of Medical Sciences at 1 site in Iran.
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 10 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 7 Jun 2021. 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 Iran. 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.
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?
Changes in seizure frequency registered in questionnaire (time frame: 4 weeks). The study lists 3 primary outcomes in all. 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 7 Jun 2021.