An observational study in Autoimmune Encephalitis Associated With Anti-CAPR2 Antibodies, sponsored by Hospices Civils de Lyon. Recruiting at 1 site in France. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-02-07.
Sponsored by Hospices Civils de Lyon · Observational
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Among 22 studies in Autoimmune Diseases of the Nervous System by Hospices Civils de Lyon — 8 open to participants now, 11 under way, none of them phase 3. Autoimmune Diseases of the Nervous System · Hospices Civils de Lyon.
Among the 22 studies in Autoimmune Diseases of the Nervous System by Hospices Civils de Lyon, this one is the 18th largest by planned enrollment of the 21 observational ones that give a count, is one of 3 that started in 2023, is one of 21 observational ones, reaches primary completion later than 4 of the 10 other live ones, and was the 18th registered.
123 studies on the registry are indexed under Autoimmune Diseases of the Nervous System; 59 are open to participants now.
Browse Autoimmune Diseases of the Nervous System studies →8 of the 22 studies in Autoimmune Diseases of the Nervous System by Hospices Civils de Lyon are open now, in 1 country. Recruiting first, the newest first:
Hospices Civils de Lyon · Sites in France
Ages 18+
Hospices Civils de Lyon · Sites in France
Hospices Civils de Lyon · Sites in France
Ages 18+
Hospices Civils de Lyon · Sites in France
Hospices Civils de Lyon · Sites in France
Ages 18+
By country, each count listing its studies:
Of the 44 Autoimmune Diseases of the Nervous System studies recruiting now, 27 (61%) set no upper age limit and 11 (25%) stop at 75 or younger; 15 take children under 18; 9 take healthy volunteers.
This study: 18 Years to 100 Years · all sexes · no healthy volunteers.
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22 studies; the count open now beside each. This study's row is marked.
First in 2017; this study’s year is marked. 3 started in 2023.
This study's planned enrollment of 27 is below the median of 160 across 57 observational studies indexed under Autoimmune Diseases of the Nervous System.
Median enrollment 3,500 across the 1 interventional studies, 50 across the 21 observational. Of the 8 that completed or were terminated, 0 (0%) have results posted.
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Hospices Civils de Lyon is the lead sponsor of 1,867 studies on the registry; 448 are open to participants now.
1 of the studies in Autoimmune Diseases of the Nervous System by Hospices Civils de Lyon that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07158229Hospices Civils de LyonLong-term Impact of NMDAR Encephalitis, Level 3 | 2026-11-21 |
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Among the 22 studies in Autoimmune Diseases of the Nervous System by Hospices Civils de Lyon, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Anti-CASPR2 limbic encephalitis (CASPR2-LE) is a rare neurological disorder primarily affecting males over the age of 50. It is mediated by an autoimmune antibody response in the central nervous system (CNS) against the cellular adhesion molecule contactin-associated protein-like 2 (CASPR2). This protein plays an important role in the trafficking of KV1 channels under the myelin sheath in the juxtaparanodal region of myelinated axons. It is mostly present in the neurons of the limbic system, basal ganglia, and other motor related and sensation areas (Qin, Yang, Zhu, Wang, \& Shan, 2021). This distribution explains the diverse clinical manifestations of the disease, primarily characterized by cognitive impairment. Other manifestations include cerebellar ataxia, hyperkinetic movement disorders (HMDs), seizures, and neuropathic pain, which all typically develop around 10.4 months after onset. At last visit, memory impairment is seen in 69% of the patients, cerebellar ataxia in 42% of the patients, and functional dependency in 25% of the patients. Even though most patients' symptoms improve with immune-active treatments, up to 69% of them have long-term memory impairments due to damage to hippocampal structures (Benoit et al., 2023). Research has primarily focused on understanding the disease's clinical features, underlying mechanisms, and potential treatment options. On the other hand, it is shown that MRIs performed at baseline show signal changes in the hippocampus in 62-71% of the patients, and these changes are subject to variations in subsequent follow-up scans, that differ widely among patients as mentioned before (Bien et al., 2017). And since the dynamics of hippocampal volume changes and its association with the development of hippocampal atrophy and long-term cognitive impairment are not well studied yet in CASPR2-LE, we primarily aim to examine the longitudinal changes of hippocampal volume in anti-CASPR2 Limbic Encephalitis (CASPR2-LE) patients to examine whether it correlates to the development of anterograde amnesia and hippocampal atrophy on follow-up.
Patients will be included from the from the database of the French Reference Centre for Paraneoplastic Neurological Syndromes and Autoimmune Encephalitis (Lyon, France)
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Exclusion Criteria:
Other: Retrospective evaluation of specific brain MRI features
Other: Retrospective evaluation of specific brain MRI features
* Brain MRI changes in the acute stage, i.e. \< 3 months from symptoms onset, including abnormal signal intensity, altered diffusion and/or contrast enhancement in the hippocampus (unilateral/bilateral), abnormal signal intensity in basal ganglia, insula, and/or perisylvian cortex, presence of global brain atrophy, presence of hippocampal atrophy and/or MTS, hippocampal volumetry * Brain MRI changes after acute phase resolution (\> 6 months after symptoms onset) including abnormal signal intensity in the hippocampus (unilateral/bilateral), presence of global brain atrophy, presence of hippocampal atrophy and/or MTS, hippocampal volumetry
Functional independance
Defined by a modified Rankin Scale (mRS) score ≤2
Time frame: 12 months after first treatment
Started Oct 2023 (actual). Primary completion is estimated for Jun 2024, 8 months after the start.
Of 28 observational studies under Autoimmune Diseases of the Nervous System, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 17. This study's planned 8 months is below that.
How these figures are worked out, and which studies are left out of them.
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