Clinical trials: Skull
Cerebrospinal Fluid Leak
Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery
The objective of the study is to clinically assess the safety and effectiveness of LIQOSEAL® as a means of reducing intra- as well as post-operative CSF leakage in patients undergoing elective cranial intradural surgery with a…
- Trial name
- ENCASE-II (NCT04086550)
- Testing
- LIQOSEAL, DuraSeal, Adherus
- Where
- 17 sites in United States, Austria and 5 more
- Volunteers
- 228 people
- Sponsor
- Polyganics BV
Intracranial Hypertension, Abnormality of Intracranial Pressure
Validation of Non-Invasive Intracranial Pressure (ICP) Monitoring Device
For purposes of validation, this study compares intracranial pressure measurements obtained with a novel self-calibrating, non-invasive, intracranial pressure measuring (ICP) device, with the values obtained from (a) patients in…
- Trial name
- NCT03865576
- Testing
- Non-invasive ICP measurement
- Where
- 4 sites in United States
- Volunteers
- 80 people
- Sponsor
- Boston Neurosciences
NMOSD, Neuromyelitis Optica Spectrum Disorders
Efficacy, Safety, PK, PD, and ADA of Eculizumab in Chinese Adults With NMOSD
The primary objective of this study is to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of Eculizumab in Chinese Adults with Neuromyelitis Optica Spectrum Disorders (NMOSD).
- Trial name
- ECU-NMO-304 (NCT06724809)
- Testing
- eculizumab
- Where
- 7 sites in China
- Volunteers
- 21 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Leber's Hereditary Optic Neuropathy (LHON)
Study to Assess the Efficacy and Safety of Raxone in LHON Patients
LEROS is an open-label interventional Phase IV study, designed to further assess the efficacy and safety of Raxone® in the long-term treatment of LHON patients.
- Trial name
- LEROS (NCT02774005)
- Testing
- Idebenone
- Where
- 29 sites in United States, Austria and 8 more
- Volunteers
- 199 people
- Sponsor
- Santhera Pharmaceuticals
Neuromyelitis Optica (NMO), NMO Spectrum Disorder (NMOSD)
Efficacy and Safety Study of Satralizumab (SA237) as Add-on Therapy to Treat Participants With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)
The objective of this study is to evaluate the efficacy, safety, pharmacodynamic, pharmacokinetic, and immunogenic profiles of satralizumab, compared with placebo, in addition to baseline immunosuppressive treatment in…
- Trial name
- NCT02028884
- Testing
- Satralizumab, Baseline Treatment
- Where
- 40 sites in United States, France and 9 more
- Volunteers
- 85 people
- Sponsor
- Hoffmann-La Roche
Leber Congenital Amaurosis 10, Blindness
A Study to Evaluate Efficacy, Safety, Tolerability and Exposure After a Repeat-dose of Sepofarsen (QR-110) in LCA10 (ILLUMINATE)
The purpose of this double-masked, randomized, controlled, multiple-dose study is to evaluate the efficacy, safety, tolerability and systemic exposure of sepofarsen (QR-110) administered via intravitreal injection in subjects…
- Conditions
- Leber Congenital Amaurosis 10, Blindness, Leber Congenital Amaurosis, Vision Disorders
- Trial name
- ILLUMINATE (NCT03913143)
- Testing
- sepofarsen
- Where
- 14 sites in United States, Belgium and 7 more
- Volunteers
- 36 people
- Sponsor
- ProQR Therapeutics
Inherited Mitochondrial Disease, Including Leigh Syndrome
Open-Label, Dose-Escalating Study Assessing Safety, Tolerability, Efficacy, of RP103 in Mitochondrial Disease
To evaluate safety, tolerability and efficacy of cysteamine bitartrate delayed-release capsules (RP103) administered at a target maintenance dose of 1.3 g/m²/day in two divided doses, every 12 hours, for up to 6 months in…
- Trial name
- MITO-001 (NCT02023866)
- Testing
- Cysteamine Bitartrate
- Where
- 5 sites in United States
- Volunteers
- 36 people
- Sponsor
- Amgen
Major Depressive Disorder
Cranial Electrotherapy Stimulation for the Treatment of Major Depressive Disorder in Adults
This study is designed to evaluate the safety and efficacy of the Fisher Wallace Stimulator FW-200 to deliver Cranial Electrotherapy Stimulation (CES) for the treatment of moderate to severe Major Depressive Disorder (MDD) in…
- Trial name
- CES-MDD (NCT05384041)
- Testing
- Fisher Wallace Cranial Electrotherapy Stimulator (Active Device)
- Where
- United States
- Volunteers
- 255 people
- Sponsor
- Fisher Wallace Laboratories
Leber's Hereditary Optic Neuropathy
Emergency Administration of EPI-743 to a Single Patient With Leber's Hereditary Optic Neuropathy [LHON]
Expanded access Protocol to treat LHON subjects with EPI743
- Trial name
- NCT02300753
- Testing
- EPI-743
- Where
- United States
- Sponsor
- Edison Pharmaceuticals Inc
Mitochondrial Diseases, Mitochondrial DNA tRNALeu(UUR) m.3243A<G Mutation
The KHENEREXT Study
This is an open-label, multi-centre study in subjects with a genetically confirmed mitochondrial deoxyribonucleic acid (DNA) transfer ribonucleic acid (tRNA)Leu(UUR) m.3243A>G mutation who completed study KH176-202.
- Conditions
- Mitochondrial Diseases, Mitochondrial DNA tRNALeu(UUR) m.3243A<G Mutation, Maternally Inherited Diabetes and Deafness (MIDD), Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke Like Episodes (MELAS)
- Trial name
- NCT04604548
- Testing
- Oral administration of 100 mg KH176 twice daily
- Where
- 4 sites in Denmark, Germany and 2 more
- Volunteers
- 11 people
- Sponsor
- Khondrion BV
Plagiocephaly, Brachycephaly
Cranial Remolding Orthosis Registry
A registry of infants fitted with a cranial remolding orthosis.
- Conditions
- Plagiocephaly, Brachycephaly, Asymmetric Head
- Trial name
- NCT06762691
- Testing
- MyCRO Band, Traditional CRO
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- Otto Bock HealthCare LP
Progressive Supranuclear Palsy(PSP), Dementia With Lewy Bodies (DLB)
Digital Health Technologies for Progressive Supranuclear Palsy and Dementia With Lewy Bodies
Progressive supranuclear palsy (PSP), mild cognitive impairment with Lewy bodies (MCI-LB), and Dementia with Lewy Bodies (DLB) are severe neurodegenerative diseases that cause significant motor impairment impacting daily…
- Conditions
- Progressive Supranuclear Palsy(PSP), Dementia With Lewy Bodies (DLB), PSP, Lewy Body Dementia (LBD)
- Trial name
- NCT07240805
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- BioSensics
Autosomal Dominant Optic Atrophy, Optic Atrophy, Autosomal Dominant
Natural History of Autosomal Dominant Optic Atrophy (ADOA), Caused by OPA1 Mutation
The purpose of this study is to characterize the disease progression of confirmed OPA1 mutation-associated autosomal dominant optic atrophy (ADOA) by evaluating the changes in ocular structural and functional outcomes.
- Conditions
- Autosomal Dominant Optic Atrophy, Optic Atrophy, Autosomal Dominant, Optic Atrophies, Hereditary, Kjer Optic Atrophy
- Trial name
- NCT06140329
- Where
- 7 sites in United States, Australia and 4 more
- Volunteers
- 1 people
- Sponsor
- PYC Therapeutics
Trigeminal Neuralgia
An Efficacy and Safety Study of Basimglurant (NOE-101) in Patients With Trigeminal Neuralgia.
Trigeminal neuralgia (TN), also called "tic douloureux", is the most common form of craniofacial neuropathic pain and is considered the cause of one of the most painful afflictions known in medical practice.
- Trial name
- NCT05217628
- Testing
- Basimglurant
- Where
- 34 sites in United States, Denmark and 6 more
- Volunteers
- 166 people
- Sponsor
- Noema Pharma AG
Wolfram Syndrome
AMX0035 in Adult Patients With Wolfram Syndrome
This study is an open label Phase II study to evaluate the safety and efficacy of AMX0035 in adults with Wolfram syndrome.
- Trial name
- NCT05676034
- Testing
- AMX0035
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Amylyx Pharmaceuticals Inc.
Intracranial Aneurysm
Pipeline Flex With SHield Technology Embolization - An International MulticEnter ObservationaL Post Market StuDy
This is a prospective, single-arm, multi-center post-market observational study assessing the performance of the Pipeline™ Flex Embolization Device with Shield Technology™ in subjects undergoing treatment for intracranial…
- Trial name
- SHIELD (NCT02719522)
- Testing
- Pipeline™ Flex Embolization Device with Shield Technology™
- Where
- 21 sites in Australia, Denmark and 9 more
- Volunteers
- 205 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
Progressive Supranuclear Palsy
GV1001 Subcutaneous(SC) for the Treatment of Progressive Supranuclear Palsy (PSP)
The study will be conducted by the Sponsor to evaluate the efficacy and safety of GV1001 (0.56 mg and 1.12 mg) administered subcutaneously as a treatment for Progressive Supranuclear Palsy, (PSP).
- Trial name
- NCT05819658
- Testing
- GV1001 0.56mg, GV1001 1.12mg
- Where
- 5 sites in South Korea
- Volunteers
- 78 people
- Sponsor
- GemVax & Kael
Malaria
A Community Setting Study of Malaria After Systematic Treatment of Symptomatic Carriers of P. Falciparum With COA566 (Coartem®)
This study assessed the impact of the systematic detection by Rapid Diagnostic Test (RDT) and treatment of asymptomatic carriers of malaria parasites (P.
- Trial name
- NCT01256658
- Testing
- COA566
- Where
- 3 sites in Burkina Faso
- Volunteers
- 14,075 people
- Sponsor
- Novartis
Age-Related Macular Degeneration
Study of Safety and Efficacy of Brolucizumab 6 mg Dosed Every 4 Weeks Compared to Aflibercept 2 mg Dosed Every 4 Weeks in Patients With Retinal Fluid Despite Frequent Anti-VEGF Injections
This clinical study was designed to compare the safety and efficacy of brolucizumab 6 mg dosed every 4 weeks to aflibercept 2 mg dosed every 4 weeks in those neovascular age-related macular degeneration (nAMD) patients with…
- Trial name
- MERLIN (NCT03710564)
- Testing
- Brolucizumab, Aflibercept
- Where
- 61 sites in United States, Puerto Rico
- Volunteers
- 535 people
- Sponsor
- Novartis Pharmaceuticals
Leber Hereditary Optic Neuropathy
RESCUE and REVERSE Long-term Follow-up
The goal of this clinical trial is to assess the long-term safety and efficacy of GS010, a gene therapy, and assess the quality of life in subjects with LHON due to the G11778A ND4 mitochondrial mutation and who were treated in…
- Trial name
- RESTORE (NCT03406104)
- Testing
- GS010
- Where
- 7 sites in United States, France and 3 more
- Volunteers
- 62 people
- Sponsor
- GenSight Biologics