Lennox-Gastaut SyndromeEarly Phase 1NCT02632149
Trial to Assess Vagus Nerve Stimulation Therapy in Children With Lennox-Gastaut Syndrome
A Early Phase 1 study testing PINS Vagus Nerve Stimulator in people with Lennox-Gastaut Syndrome, run by Beijing Pins Medical Co., Ltd at 5 sites in China.
Trial summary
The purpose of this study is to evaluate the clinical effectiveness of PINS vagus nerve stimulatior in children with Lennox-Gastaut Syndrome. Read more about this study
- Who is it for?
- Ages 3 to 14 years
- Conditions the study is for
- Lennox-Gastaut Syndrome
- What is being tested?
- PINS Vagus Nerve Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 5 sitesChina
- Study dates
- Oct 2016to Oct 2017
- Phase
- Early Phase 1
- 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 3 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 3-14 year
- Lennox - Gastaut syndrome diagnostic standard
- Regular drug treatment is invalid
- Antiepileptic drug stability in recent 3 months
- Good health except epilepsy
- Patients or his(her) familyscould understand this method and sign the informed consent
- Patients with good compliance and could complete postoperative follow-up.
Who cannot join
- Results of MRI remind epilepsy caused by intracranial space-occupying lesions
- Had epileptic foci excision surgery or corpus callosum
- The vagus nerve lesion and damage
- Tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma， mental disease，peptic ulcer，diabetes Type 1，bad health etc, and other surgical contraindication
- Participated in other clinical drug test subjects within three months
- The researchers think that is not suitable for participants'
Trial locations and contacts
5 sites in 1 country.
Luming Ph Li contact
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Shujun Xu, 0531-82169114
- Not yet recruiting
JiNing First People's Hospital
Jining, Shandong, 272002
Changdi Zhao
- Not yet recruiting
Linyi People's Hospital
Linyi, Shandong, 276005
Chang MD Fei
- Not yet recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
Peng Sun, 0532-96166
- Not yet recruiting
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000
Guotai Tang
About this study
Official title: The Clinical Research on PINS Vagus Nerve Stimulator for Treatment of Lennox-Gastaut in Children
The purpose of this study is to evaluate the clinical effectiveness of PINS vagus nerve stimulatior in children with Lennox-Gastaut Syndrome.
- Conditions
- Lennox-Gastaut Syndrome
- Being tested
- PINS Vagus Nerve Stimulator
- Keywords
- PINS Vagus Nerve Stimulator
- Medical subject headings
- Lennox Gastaut Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PINS Vagus Nerve StimulatorDevice
| Study group | Role | What they receive |
|---|---|---|
| Vagus nerve Stimulation is on | Experimental | Not described Receives: Device: PINS Vagus Nerve Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in seizure frequency from baseline to the seizure count evaluation period 6 month
Measured: 6 month of stimulation
Secondary outcomes (3)
Changes in seizure frequency from baseline to the seizure count evaluation period
Measured: 1,3,6,months of stimulation
Change from Baseline in the Engel and McHugh description
Measured: At 1,3,6 months
Overall WISC Score in Patients from Baseline
Measured: Mean change from baseline WISC Overall Score at 1,3,6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startOct 2016
- Primary completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lennox-Gastaut SyndromeStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Pins Medical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Qilu Hospital of Shandong University, Qingdao University, Linyi People's Hospital, Yantai Yuhuangding Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02632149
- Sponsor's protocol ID
- PINS-017
- Status last verified
- Oct 2016
- First submitted
- 13 Dec 2015
- Last updated
- 11 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Research on PINS Vagus Nerve Stimulator for Treatment of Lennox-Gastaut in Children
- ClinicalTrials.gov ID
- NCT02632149
- Acronym / sponsor ID
- PINS-017
- Conditions
- Lennox-Gastaut Syndrome
- Keywords
- PINS Vagus Nerve Stimulator
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Beijing Pins Medical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Qilu Hospital of Shandong University, Qingdao University, Linyi People's Hospital, Yantai Yuhuangding Hospital
- Study start
- Oct 2016
- Primary completion
- Oct 2017 (estimated)
- First posted
- 16 Dec 2015 (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.
The purpose of this study is to evaluate the clinical effectiveness of PINS vagus nerve stimulatior in children with Lennox-Gastaut Syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vagus nerve Stimulation is on | Experimental | Device: PINS Vagus Nerve Stimulator |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age 3-14 year
- Lennox - Gastaut syndrome diagnostic standard
- Regular drug treatment is invalid
- Antiepileptic drug stability in recent 3 months
- Good health except epilepsy
Key exclusion criteria (6 listed)
- Results of MRI remind epilepsy caused by intracranial space-occupying lesions
- Had epileptic foci excision surgery or corpus callosum
- The vagus nerve lesion and damage
- Tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma， mental disease，peptic ulcer，diabetes Type 1，bad health etc, and other surgical contraindication
- Participated in other clinical drug test subjects within three months
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 |
|---|---|---|
| PINS Vagus Nerve Stimulator | Device | Vagus nerve Stimulation is on |
Primary outcome
Changes in seizure frequency from baseline to the seizure count evaluation period 6 month
Time frame: 6 month of stimulation
3 secondary outcomes
Changes in seizure frequency from baseline to the seizure count evaluation period
Time frame: 1,3,6,months of stimulation
Change from Baseline in the Engel and McHugh description
Time frame: At 1,3,6 months
Overall WISC Score in Patients from Baseline
Time frame: Mean change from baseline WISC Overall Score at 1,3,6months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2016.
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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.
Luming Ph Li contact
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing PINS Vagus Nerve Stimulator in people with Lennox-Gastaut Syndrome, run by Beijing Pins Medical Co., Ltd at 5 sites in China.
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 7 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: status not confirmed, as of the sponsor's last update on 11 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Contact Fumin Ph D Jia (+86 010-59361265, pins_medical@163.con), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in seizure frequency from baseline to the seizure count evaluation period 6 month (time frame: 6 month of stimulation). 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 11 Oct 2016.