EpilepsyNICOPETNCT03268369
PET Study of the Nicotinic System in Epilepsy
A study testing MRI of the brain, PET scan [18F]F-A-85380 and PET scan [18F]FDG in people with Epilepsy, run by Fabienne PICARD.
Trial summary
Mutations in neuronal nicotinic acetylcholine receptors (nAChRs) have been identified in the autosomal dominant nocturnal frontal lobe epilepsy (ADNFLE). Despite the demonstration of a gain of function of the mutated receptors, the precise mechanisms leading to this nocturnal epilepsy are still unknown. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- MRI of the brain, PET scan [18F]F-A-85380 and PET scan [18F]FDG
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Nov 2015
- 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 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- males
- 18-60 years old
- non-smokers
Who cannot join
- smoking during the past twelve months
- contraindications to MRI
- brain lesions on MRI (including hippocampal atrophy)
- neurological disorder (other than epilepsy) or psychiatric disorder
- neoplasia or coronary disease
- blood test showing : creatinine clearance < 50 ml/min, or platelet < 100 G/l, or leucocytes < 3.8 G/l, or ALT or AST > 2 x upper standard, or gamma-GT > 3 x upper standard, or albumin < 35 g/l or > 48 g/l .
- patients only : nuclear imaging during the past twelve months
- healthy volunteers only : ionising radiation exam during the past five years
About this study
Mutations in neuronal nicotinic acetylcholine receptors (nAChRs) have been identified in the autosomal dominant nocturnal frontal lobe epilepsy (ADNFLE). Despite the demonstration of a gain of function of the mutated receptors, the precise mechanisms leading to this nocturnal epilepsy are still unknown. In 2006 the investigators studied the nAChR cerebral distribution in a group of patients with ADNFLE carrying a nAChR mutation, by a PET-scan using [18F]-F-A-85380, a ligand with a high affinity and specificity for alpha4beta2 nicotinic receptors. The study showed a different pattern of brain distribution of the radiotracer in the ADNFLE patients when compared to a group of control subjects, with a significant increase of nicotinic receptor density in the patients in mesencephalon and cerebellum (Picard et al., Brain 2006). Based on the known biochemical and cellular circuits in the brainstem, these results suggest that the nAChR density increase in mesencephalon is involved in the pathophysiology of ADNFLE through the role of brainstem ascending cholinergic systems in arousal. The follow-up step consists of extending this examination to other forms of epilepsy, in order to verify the specificity of the hyperfixation pattern for ADNFLE, and search for a potential involvement of nicotinic receptors in other forms of epilepsy. The investigators aim to study 5 groups of subjects: control subjects (Group 1, 20 subjects); patients with a non lesional partial epilepsy and a predominance of diurnal seizures (Group 2, 12 subjects); patients with an idiopathic generalized epilepsy (Group 3, 12 subjects); patients with nocturnal frontal lobe epilepsy (Group 4, 3 subjects) and epileptic patients with vagal nerve stimulation (Group 5, 1 subject). For each patient, a cerebral MRI, [18F]- fluorodeoxyglucose (FDG) PET/CT and [18F]-F-A-85380 PET/CT examinations are planned. The investigators will perform data analyses on volume of distribution (Vt) parametric images which will be based on the ratio of brain tissue to unchanged F-A-85380 plasma at equilibrium. Statistical parametric mapping (SPM2) will be used to further study the parametric PET images. This study is primarily dedicated to demonstrate that the pattern of hyperfixation that was obtained in ADNFLE patients is specific for this disorder and does not constitute a common pattern to various forms of epilepsy. The investigators will also search for a possible involvement of the nAChRs in other forms of epilepsy.
- Conditions
- Epilepsy
- Being tested
- MRI of the brain, PET scan [18F]F-A-85380, PET scan [18F]FDG
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI of the brainRadiation
to eliminate a structural intra-cerebral lesion
PET scan [18F]F-A-85380Radiation
exam performed after iv injection of 200 MBq [18F]F-A-85380
PET scan [18F]FDGRadiation
exam performed after iv injection of 200 MBq [18F]FDG
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Not described Receives: Radiation: MRI of the brain; Radiation: PET scan [18F]F-A-85380; Radiation: PET scan [18F]FDG |
| Non lesional diurnal partial epilepsy | Experimental | Not described Receives: Radiation: MRI of the brain; Radiation: PET scan [18F]F-A-85380; Radiation: PET scan [18F]FDG |
| Idiopathic generalized epilepsy | Experimental | Not described Receives: Radiation: MRI of the brain; Radiation: PET scan [18F]F-A-85380; Radiation: PET scan [18F]FDG |
| Nocturnal frontal lobe epilepsy | Experimental | Not described Receives: Radiation: MRI of the brain; Radiation: PET scan [18F]F-A-85380; Radiation: PET scan [18F]FDG |
| Epileptic patients with Vagus Nerve Stimulation (VNS) | Experimental | Not described Receives: Radiation: PET scan [18F]F-A-85380; Radiation: PET scan [18F]FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the cerebral distribution of the neuronal nicotinic acetylcholine receptors (nAChR) in the 5 groups of individuals by means of voxelwise and regional 18F-FA binding potential measurements
Parametric 18F-FA and 18F-FDG binding potential measurements will be compared between the different groups of patients with epilepsy and the control group in order to find specific changes in the cerebral distribution of the nicotinic receptors in the different types of epilepsy, by using a voxel-wise (SPM) and a volume of interest (VOI) analysis.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study startFeb 2012
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fabienne PICARD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fabienne PICARD, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03268369
- Sponsor's protocol ID
- 10-041
- Acronym
- NICOPET
- Status last verified
- Aug 2017
- First submitted
- 24 Aug 2017
- Last updated
- 31 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Picard F, Bruel D, Servent D, Saba W, Fruchart-Gaillard C, Schollhorn-Peyronneau MA, Roumenov D, Brodtkorb E, Zuberi S, Gambardella A, Steinborn B, Hufnagel A, Valette H, Bottlaender M. Alteration of the in vivo nicotinic receptor density in ADNFLE patients: a PET study. Brain. 2006 Aug;129(Pt 8):2047-60. doi: 10.1093/brain/awl156. Epub 2006 Jun 30.
PubMed 16815873
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Study of the Nicotinic System in Epilepsy
- ClinicalTrials.gov ID
- NCT03268369
- Acronym / sponsor ID
- NICOPET / 10-041
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Fabienne PICARDUniversity, hospital or other
- Study start
- Feb 2012 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 31 Aug 2017 (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.
Mutations in neuronal nicotinic acetylcholine receptors (nAChRs) have been identified in the autosomal dominant nocturnal frontal lobe epilepsy (ADNFLE). Despite the demonstration of a gain of function of the mutated receptors, the precise mechanisms leading to this nocturnal epilepsy are still unknown. In 2006 the investigators studied the nAChR cerebral distribution in a group of patients with ADNFLE carrying a nAChR mutation, by a PET-scan using [18F]-F-A-85380, a ligand with a high affinity and specificity for alpha4beta2 nicotinic receptors. The study showed a different pattern of brain distribution of the radiotracer in the ADNFLE patients when compared to a group of control subjects, with a significant increase of nicotinic receptor density in the patients in mesencephalon and cerebellum (Picard et al., Brain 2006). Based on the known biochemical and cellular circuits in the brainstem, these results suggest that the nAChR density increase in mesencephalon is involved in the pathophysiology of ADNFLE through the role of brainstem ascending cholinergic systems in arousal. The follow-up step consists of extending this examination to other forms of epilepsy, in order to verify the specificity of the hyperfixation pattern for ADNFLE, and search for a potential involvement of nicotinic receptors in other forms of epilepsy. The investigators aim to study 5 groups of subjects: control subjects (Group 1, 20 subjects); patients with a non lesional partial epilepsy and a predominance of diurnal seizures (Group 2, 12 subjects); patients with an idiopathic generalized epilepsy (Group 3, 12 subjects); patients with nocturnal frontal lobe epilepsy (Group 4, 3 subjects) and epileptic patients with vagal nerve stimulation (Group 5, 1 subject). For each patient, a cerebral MRI, [18F]- fluorodeoxyglucose (FDG) PET/CT and [18F]-F-A-85380 PET/CT examinations are planned. The investigators will perform data analyses on volume of distribution (Vt) parametric images which will be based on the ratio of brain tissue to unchanged F-A-85380 plasma at equilibrium. Statistical parametric mapping (SPM2) will be used to further study the parametric PET images. This study is primarily dedicated to demonstrate that the pattern of hyperfixation that was obtained in ADNFLE patients is specific for this disorder and does not constitute a common pattern to various forms of epilepsy. The investigators will also search for a possible involvement of the nAChRs in other forms of epilepsy.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Radiation: MRI of the brain, Radiation: PET scan [18F]F-A-85380, Radiation: PET scan [18F]FDG |
| Non lesional diurnal partial epilepsy | Experimental | Radiation: MRI of the brain, Radiation: PET scan [18F]F-A-85380, Radiation: PET scan [18F]FDG |
| Idiopathic generalized epilepsy | Experimental | Radiation: MRI of the brain, Radiation: PET scan [18F]F-A-85380, Radiation: PET scan [18F]FDG |
| Nocturnal frontal lobe epilepsy | Experimental | Radiation: MRI of the brain, Radiation: PET scan [18F]F-A-85380, Radiation: PET scan [18F]FDG |
| Epileptic patients with Vagus Nerve Stimulation (VNS) | Experimental | Radiation: PET scan [18F]F-A-85380, Radiation: PET scan [18F]FDG |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- males
- 18-60 years old
- non-smokers
Key exclusion criteria (8 listed)
- smoking during the past twelve months
- contraindications to MRI
- brain lesions on MRI (including hippocampal atrophy)
- neurological disorder (other than epilepsy) or psychiatric disorder
- neoplasia or coronary disease
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 |
|---|---|---|
| MRI of the brainto eliminate a structural intra-cerebral lesion | Radiation | Control group, Idiopathic generalized epilepsy, Nocturnal frontal lobe epilepsy, Non lesional diurnal partial epilepsy |
| PET scan [18F]F-A-85380exam performed after iv injection of 200 MBq [18F]F-A-85380 | Radiation | Control group, Epileptic patients with Vagus Nerve Stimulation (VNS), Idiopathic generalized epilepsy, Nocturnal frontal lobe epilepsy, Non lesional diurnal partial epilepsy |
| PET scan [18F]FDGexam performed after iv injection of 200 MBq [18F]FDG | Radiation | Control group, Epileptic patients with Vagus Nerve Stimulation (VNS), Idiopathic generalized epilepsy, Nocturnal frontal lobe epilepsy, Non lesional diurnal partial epilepsy |
Primary outcome
Comparison of the cerebral distribution of the neuronal nicotinic acetylcholine receptors (nAChR) in the 5 groups of individuals by means of voxelwise and regional 18F-FA binding potential measurements
Time frame: 1 month
Parametric 18F-FA and 18F-FDG binding potential measurements will be compared between the different groups of patients with epilepsy and the control group in order to find specific changes in the cerebral distribution of the nicotinic receptors in the different types of epilepsy, by using a voxel-wise (SPM) and a volume of interest (VOI) analysis.
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 31 Aug 2017.
- Background: PubMed 16815873Picard F, Bruel D, Servent D, Saba W, Fruchart-Gaillard C, Schollhorn-Peyronneau MA, Roumenov D, Brodtkorb E, Zuberi S, Gambardella A, Steinborn B, Hufnagel A, Valette H, Bottlaender M. Alteration of the in vivo nicotinic receptor density in ADNFLE patients: a PET study. Brain. 2006 Aug;129(Pt 8):2047-60. doi: 10.1093/brain/awl156. Epub 2006 Jun 30.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing MRI of the brain, PET scan [18F]F-A-85380 and PET scan [18F]FDG in people with Epilepsy, run by Fabienne PICARD.
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 3 inclusion and 8 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 31 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Comparison of the cerebral distribution of the neuronal nicotinic acetylcholine receptors (nAChR) in the 5 groups of individuals by means of voxelwise and regional 18F-FA binding potential measurements (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03268369, which also lists 1 linked publication.
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 31 Aug 2017.