Parkinson's Disease
Purpose of the study: To measure the effects of CVN424 in Parkinson's Disease (PD) participants experiencing motor fluctuations and dyskinesia.
Eligibility inclusion criteria
- Are at least 30 years old.
- Have a confirmed diagnosis of Parkinson's Disease (PD)
- Experience clearly defined ON, OFF, and dyskinetic periods throughout the day where PD medication is either managing symptoms or waning.
- Have been on a stable dose of PD medication for at least 30 days; MOA-B inhibitors (such as selegiline, rasagiline, safinamide) must be stable for 12 weeks.
- Are able to freely move about, with or without an assistive device.
Eligibility exclusion criteria
- Diagnosis of secondary or atypical parkinsonism
- Severe or disabling dyskinesia or OFF expected to preclude successful study participation, in the opinion of the investigator.
- Any previous procedure or therapy designed to provide continuous levodopa or stimulation of dopaminergic tone (i.e. Duopa, apomorphine, subcutaneous levodopa), surgery for PD (i.e. Deep brain stimulation [DBS] or anticipation of these during the study.
- Routine use of PD on-demand medications (i.e., inhaled levodopa, apomorphine injection). Routine use defined as three (3) or more uses per week of on-demand medication is not allowed. On demand medications should only be used for medical emergencies and should be avoided on anticipated diary days, as best as possible.
Sponsor: Cerevance Beta
Purpose of the study: To test whether NEU-411 can help prevent or slow the progression of PD in LRRK2-driven participants, test the safety of NEU-411, determine how your body absorbs, breaks down and removes NEU-411 and determine how long NEU-411 stays in your blood.
Eligibility inclusion criteria
- Age between 40 -80 years.
- Have received a diagnosis of Parkinson's disease by a neurologist.
- Must test positive (LRKK2-driven) using the investigational CDx.
- A screening brain dopamine transporter single-photon emission computed tomography (DaT-SPECT) consistent with PD based on scan performed within 1 year of screening or performed and centrally interpreted during screening.
- No anticipated need for dopaminergic medication to treat PD symptoms for the duration of the trial period.
Eligibility exclusion criteria
- Parkinsonian syndromes due to a secondary etiology or that are unlikely to exhibit clinically meaningful improvement of motor symptoms from dopaminergic medications(levodopa non-responsive), including parkinsonism from encephalitis, metabolic disorders, vascular parkinsonism, drug-induced parkinsonism, multiple system atrophy, corticobasal syndrome, progressive supranuclear palsy, LB dementia.
- Known homozygous carriers of the familial PD genes such as Parkin, phosphatase and tensin homologue-induced kinase 1 (PINK1), protein deglycase-1 (DJ-1 also known as PARK7), synuclein (SNCA), and/or glucocerebrosidase (GBA).
- Participants unable to refrain from or anticipate the use of the medication classes listed prior to the first study dose administration, or anticipated need for the duration of the study.
Sponsor: Neuron23, Inc.
Purpose of the study: To develop a central repository for PD-related genomic data by individuals who consent to deposit their data and bank their residual DNA obtained through clinical genetic testing for future research use.
Eligibility inclusion criteria
- Meet Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson’s disease: probable diagnosis based on Investigator discretion.
- Willingness to undergo genetic testing and may choose to be informed of genetic test results for, at minimum, seven Parkinsons-related genes, including: GBA1, LRRK2, SNCA, VPS35, PRKN, PINK1, PARK7. Participants may choose to also receive additional findings which might be related to their PD diagnosis and/or health-related clinically actionable findings.
Eligibility exclusion criteria
- Probable diagnosis at the time of consent of an atypical parkinsonian disorder (i.e., multiple system atrophy, progressive supranuclear palsy, dementia with Lewy bodies, corticobasal syndrome), including that due to medications, metabolic disorders, encephalitis, cerebrovascular disease, or normal pressure hydrocephalus.
- Individuals who have received a blood transfusion within the past 3 months.
- Individuals who have active hematologic malignancies such as lymphoma or leukemia.
- Individuals who have had a bone marrow transplant within the past 5 years.
Sponsor: Parkinson's Foundation
Huntington's Disease
Purpose of the Study:
This is a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of Valbenazine to treat chorea in subjects with Huntington disease.
Eligibility Criteria:
- Have a clinical diagnosis of Huntington Disease (HD) with chorea
- Be able to walk, with or without the assistance of a person or device
- Subjects of childbearing potential who do not practice total abstinence must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment and follow-up periods of the study
- Be able to read and understand English
Exclusion Criteria
- Have a history of prior VMAT2 inhibitor therapy
- Have difficulty swallowing
- Are currently pregnant or breastfeeding
- Have a known history of long QT syndrome, cardiac tachyarrhythmia, left bundle-branch block, atrioventricular (AV) block, bradycardia (<60 bpm), or heart failure
- Have an unstable or serious medical or psychiatric illness
- Have a significant risk of suicidal behavior
- Have current substance dependence or substance (drug) or alcohol abuse
- If taking antidepressant therapy, be on a stable regimen
- Have received gene therapy at any time
- Have received an investigational drug within 30 days before the baseline visit or plan to use an investigational drug (other than valbenazine) during the study
- Have had a blood loss ≥550 mL or donated blood within 30 days before the baseline visit
Link:
https://clinicaltrials.gov/ct2/show/NCT04102579?term=KINECT-HD&cond=Huntington+Disease&draw=2&rank=1
Sponsor:
Neurocrine Biosciences
Status:
Recruiting
Purpose of the Study:
This is a Phase 3, open-label study to evaluate the long-term safety and tolerability of valbenazine, and to provide subjects continued access to valbenazine for the treatment of chorea associated with Huntington disease.
Eligibility Criteria:
- Have participated in in Study NBI-98854-HD3005 and: a)Study drug dosing completion of Study NBI-98854-HD3005, as demonstrated by completed study drug dosing through the end of treatment period; b) Early terminated Study NBI-98854-HD3005 for administrative reasons due to COVID-19 (eg, site closure related to COVID-19).
- Subjects of childbearing potential who do not practice total abstinence must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently while participating in the study until 30 days (females) or 90 days (males) after the last dose of the study drug.
Exclusion Criteria
- Are currently pregnant or breastfeeding
- Have difficulty swallowing
- Have a known history of long QT syndrome, cardiac tachyarrhythmia, left bundle-branch block, atrioventricular (AV) block, uncontrolled bradyarrhythmia, or heart failure
- Have an unstable or serious medical or psychiatric illness
- Have a significant risk of suicidal behavior
- Have current substance dependence or substance (drug) or alcohol abuse
- Have received gene therapy at any time
- Have received an investigational drug (other than valbenazine) within 30 days before the baseline visit or plan to use an investigational drug (other than valbenazine) during the study
- Have had a blood loss ≥550 mL or donated blood within 30 days before the baseline visit
- Have a history of severe hepatic impairment or history of protocol specified hematologic abnormalities during the course of the NBI-98854-HD3005 study
- Had a medically significant illness within 30 days before baseline, or any history of neuroleptic malignant syndrome
Link:
https://clinicaltrials.gov/ct2/show/NCT04400331?term=valbenazine&cond=Huntington+Disease&draw=2&rank=1
Sponsor:
Neurocrine Biosciences
Status:
Recruiting (Only open to patients who complete KINECT-HD)
Purpose of the Study:
This is the first study of AMT-130 in patients with early manifest HD and is designed to establish safety and proof-of-concept (PoC). CT-AMT-130-01 is a Phase I/II, randomized, multicenter, dose escalation, double-blind, imitation surgery, first-in-human (FIH) study.
Eligibility Criteria:
- Early manifest HD as defined by a UHDRS total functional capacity (TFC) score of 9 to 13 and EITHER a diagnostic classification level (DCL) of 4 OR a DCL of 3 if the subject either meets the definition of multidimensional manifest HD (UHDRS question 80) or has cognitive symptoms
- HTT gene expansion testing with the presence of ≥40 CAG repeats.
- Striatal MRI volume requirements per hemisphere: Putamen ≥2.5 cm3 (per side); Caudate ≥2.0 cm3 (per side)
- All HD concomitant medications (addressing motor, behavioral, and cognitive symptoms) stable for 3 months prior to Screening.
- Able and willing to provide written informed consent
- Able and willing to comply with all procedures and study visits
Exclusion Criteria
- Evidence of suicide risk
- Receipt of an experimental agent within 60 days or five half-lives prior to Screening or anytime over the duration of this study.
- Participation in an investigational trial or investigational paradigm (such as exercise/physical activity, cognitive therapy, brain stimulation, etc.) within 60 days prior to Screening or anytime over the duration of this study.
- Presence of an implanted deep brain stimulation device, ventriculoperitoneal or other CSF shunt, or other implanted catheter
- Any history of gene therapy, RNA or DNA targeted HD specific investigational agents, such as antisense oligonucleotides (ASO), cell transplantation or any other experimental brain surgery.
- Any contraindication to lumbar puncture or 3.0 Tesla MRI as per local guidelines.
- Brain and spinal pathology that may interfere with the surgical delivery of AMT-130 or represents a significant neurologic comorbid disorder.
- Hospitalization for any major medical or surgical procedure involving general anesthesia within 12 weeks of Screening or planned during the study.
- Current or recurrent disease, infection, or other significant concurrent medical condition or medications that could confound clinical and laboratory evaluations or could affect a subject's safety or their ability to undergo the neurosurgical procedure or comply with the procedures and study visit schedule
Link:
https://clinicaltrials.gov/ct2/show/NCT04120493?term=CT-AMT130-01&draw=2&rank=1
Sponsor:
UniQure Biopharma B.V.
Status:
Recruiting
Purpose of the Study:
This is a phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pridopidine 45 mg BID in patients with early stage HD. Eligible patients who completed the Main Study (65 to 78 weeks) will have the option to enroll into an open-label extension.
Eligibility Criteria:
- Diagnosis of HD based on clinical features and the presence of ≥36 CAG repeats in the huntingtin gene
- Diagnostic confidence level (DCL) of 4
- Adult-onset HD with onset of signs and symptoms ≥18 years of age
- Stage 1 or Stage 2 HD, defined as a UHDRS-TFC score of ≥7, at screening
Exclusion Criteria
- Use of pridopidine within 12 months before the baseline visit.
- Gene therapy at any time
- Any serious medical condition or clinically significant laboratory, or vital sign abnormality that precludes the patient's safe participation in and completion of the study e.g. significant heart disease within 12 weeks before baseline or history of certain cardiac arrhythmias
- History of epilepsy or seizures within the last 5 years
- Pregnant or breastfeeding, or intention to become pregnant during the study
Link:
https://clinicaltrials.gov/ct2/show/NCT04556656?term=PROOF-HD&cond=huntington&draw=1&rank=1
Sponsor:
Prilenia
Status:
Pending
Purpose of the Study: Enroll-HD is a longitudinal, observational, multinational study that will integrate two existing Huntington’s Disease (HD) registries, REGISTRY in Europe and COHORT in North America and Australia, while also expanding to include sites in Latin America and Asia. With no end date and annual assessments, the goal of Enroll-HD is to build a large and rich database of longitudinal clinical information and biospecimens. This database will serve as a basis for future studies aimed at developing tools and biomarkers for progression and prognosis, identifying clinically relevant phenotypic characteristics and establishing clearly defined endpoints for interventional studies.
Description of Study: The primary objective of Enroll-HD is to develop a comprehensive repository of prospective and systematically collected clinical research data (demography, clinical features, family history, genetic characteristics) and biological specimens (blood) from individuals with manifest HD, unaffected individuals known to carry the HD mutation or to be at risk of carrying the HD mutation, and control research participants (e.g., spouses, siblings or offspring of HD mutation carriers known not to carry the HD mutation). Enroll-HD is conceived as a broad-based and long-term project to maximize the efficiencies of non-clinical research and participation in clinical research. With more than 200 sites in roughly 30 countries, Enroll HD will be the largest database available for HD researchers.
Eligibility Criteria:
- Carriers: This group comprises the primary study population and consists of individuals who carry the HD gene expansion mutation.
- Controls: This group comprises the comparator study population and consists of individuals who do not carry the HD expansion mutation.
These two major categories can be further subdivided into six different subgroups of eligible individuals:
- Manifest/Motor-manifest HD: Carriers with clinical features that are regarded in the opinion of the investigator as diagnostic of HD
- Pre-Manifest/-Motor-manifest HD: Carriers without clinical features regarded as diagnostic of HD
- Genotype Unknown: This group includes a first- or second-degree relative (i.e., related by blood to a carrier) who has not undergone predictive testing for HD and therefore has an undetermined carrier status
- Genotype Negative: This group includes a first- or second-degree relative (i.e., related by blood to a carrier) who has undergone predictive testing for HD and is known not to carry the HD expansion mutation
- Family Control: Family members or individuals not related by blood to carriers (e.g., spouses, partners, caregivers)
- Community Controls: Individuals unrelated to HD carriers who did not grow up in a family affected by HD. Data collected from community controls will be used for generation of normative data for sub-studies
Status of Study: Recruiting
Principal Investigator: Sandra Kostyk, MD, PhD
Contact:
Allison Daley MS, MPH
Phone: 614-688-8672, Fax: 614-366-8672
Purpose of Study: The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of SD-809 ER in subjects switching from tetrabenazine to SD-809 ER. In addition, the safety and tolerability of long-term treatment with SD-809 ER will be assessed in “Switch” subjects as well as “Rollover” subjects completing a randomized, double-blind, placebo-controlled study of SD-809 ER.
Eligibility Criteria: Men and women age 18 and older who have been diagnosed with manifest HD, as indicated by characteristic motor exam features, and who have a documented expanded CAG repeat (≥ 37) at or before screening. Subjects must meet either of the following:
- Have successfully completed participation in the First-HD Study (SD-809-C-15) OR
- Have been receiving an FDA-approved dose of tetrabenazine that has been stable for ≥ 8 weeks before screening and is providing a therapeutic benefit for control of chorea.
Also:
Subjects have a Total Functional Capacity (TFC) score ≥ 5 at screening.
Subjects are able to swallow study medication whole.
Subjects have provided written, informed consent, or a legally authorized representative (LAR) has provided written informed consent and the subjects have provided assent.
Subjects have provided a Research Advance Directive.
Female subjects of childbearing potential agree to use an acceptable method of contraception from screening through study completion.
Subject have a reliable caregiver who interacts with them daily, oversees study drug administration, assures attendance at study visits and participates in evaluations, as required.
Subjects are able to ambulate without assistance for at least 20 yards (Note: The use of assistive devices [e.g., walker, cane] are permitted during ambulation).
Subjects have sufficient reading skills to comprehend the subject-completed rating scales.
Status of Study: Ongoing, not recruiting
Principal Investigator: Sandra Kostyk, MD, PhD
Contact:
Allison Daley, MS, MPH
Phone: 614-688-8672, Fax: 614-366-8672
email: Allison.Daley@osumc.edu
Sponsor: Auspex Pharmaceuticals, Inc.
Purpose of Study: This is a 12-month, open-label, extension study of PF-02545920 20 mg-dosed BID following study A8241021 in subjects with HD. Primary endpoints will be to assess long-term safety and tolerability of 20 mg BID of PF-02545920. Secondary endpoints will be the change from baseline in the Total Motor Score (TMS)assessment, and/or the Total maximum Chorea (TMC) assessment of the Unified Huntington Disease Rating Scale (UHDRS) after six and 12 months of treatment, and Clinical Global Impression-Improvement score after six and 12 months of treatment.
Description of Study: Subjects who were assigned to the 20 mg PF-02545920-dose group in the preceding A8241021 study will receive 20 mg PF-02545920 without any titration. All other subjects will be titrated to the 20 mg BID dose as follows: 5 mg BID for seven days, 10 mg BID for seven days, 15 mg BID for seven days, then 20 mg BID for the remainder of the treatment phase. Up to 260 subjects may take part in this open-label extension.
Eligibility Criteria: Men and women age 30 to 65 who have completed study A8241021 and have a diagnosis of HD, including ≥36 CAG repeats.
Status of Study: Recruiting
Principal Investigator: Sandra Kostyk, MD, PhD
Contact:
Allison Daley, MS, MPH
Phone: 614-688-8672, Fax: 614-366-8672
email: Allison.Daley@osumc.edu
Sponsor: Pfizer
Purpose of Study: This study is a 26-week, randomized, parallel-group, double-blind comparison of PF-02545920 5 mg, PF-02545920 20 mg and placebo-dosed BID in the treatment of motor impairment of subjects with Huntington’s disease.
Description of Study: Investigators plan to randomize approximately 260 subjects in the study. Primary endpoint is the change from baseline in the Total Motor Score (TMS) assessment of the Unified Huntington Disease Rating Scale (UHDRS) after 26 weeks of treatment. Secondary endpoints will include change from baseline in the Total Maximum Chorea (TMC) score of the UHDRS after 13 and 26 weeks of treatment and Clinical Global Impression-Improvement score after 13 and 26 weeks of treatment.
Eligibility Criteria: Men and women age 30 to 65 with CAG repeat equal to or greater than 36; total motor score equal to or greater than 10; total functional capacity equal to or greater than 7 are eligible.
Status of Study: Recruiting
Principal Investigator: Sandra Kostyk, MD, PhD
Contact:
Allison Daley, MS, MPH
Phone: 614-688-8672, Fax: 614-366-8672
email: Allison.Daley@osumc.edu
Sponsor: Pfizer
Purpose of Study: Individuals with dementia with Lewy Bodies (DLB) and Huntington’s disease (HD) experience balance and walking problems that lead to falls. Treadmill walking has demonstrated improvements in balance walking and fall risk in individuals with Parkinson’s disease (PD), suggesting that it may be beneficial for individuals with DLB and HD. In PD subjects, changes in gait parameters have been noted after only one treadmill training session. The investigators propose a pilot study to investigate the safety, feasibility and utility of trying to improve mobility and fall risk through a single session of treadmill walking in individuals with DLB and HD.
Description of Study: Several studies using HD animal models have shown that HD mice housed in enriched environments or in cages with running wheels that stimulated physical activity demonstrated a delayed onset and/or slowed decline in motor function compared to mice in non-enriched environments (van Dellen et al. 2000, 2008; Spires et al., 2004).
Evidence suggests that aerobic exercise may have neuroprotective effects and helps the elderly and individuals with neurodegenerative diseases to maintain better cognitive and motor function than those who are inactive. More specifically, there is strong evidence from animal and human trials in neurological populations (e.g., Parkinson’s disease, spinal cord injury, stroke) that treadmill training can improve walking and motor function. Immediate effects of a single-session of treadmill walking in the Parkinson’s disease population were improved overground gait measures (e.g., gait speed, stride length, double support percent, stride variability), and longer-term treadmill training studies demonstrated additional improvements in Unified Parkinson Disease Rating Scale scores, fall risk and health-related quality of life (Herman et al., 2008).
This study builds upon foundational knowledge gained in animal and other neurologic populations to determine the feasibility, safety and possible immediate benefit of treadmill walking in individuals with HD. The primary purpose of this pilot study is to investigate the safety, feasibility and utility of a single 20-minute session of treadmill walking to improve gait parameters in ambulatory individuals with DLB and HD.
Secondarily we will explore the effects of treadmill walking on mobility, fall risk, and motor coordination. Based on previous studies utilizing a single session of treadmill training in the PD population, we hypothesize that treadmill walking will improve overground spatiotemporal gait parameters (gait speed, stride length, double support percent and stride-to-stride variations in gait) in individuals with DLB and HD (Pohl et al., 2003; Frenkel-Toledo et al., 2005; Bello et al., 2008).
Eligibility Criteria: Men and women age 18 to 20 with a diagnosis of Huntington’s disease or Dementia with Lewy Bodies, the ability to ambulate 80 feet without assistance, and the ability to provide informed consent and understand directions are eligible.
Status of Study: Recruiting
Co-Principal Investigator: Sandra Kostyk, MD, PhD
Contact:
Allison Daley, MS, MPH
Phone: 614-688-8672, Fax: 614-366-8672
email: Allison.Daley@osumc.edu
Sponsor: The Ohio State University
Purpose of Study: The purpose of this study is to evaluate the safety, tolerability, PK and efficacy of VX15/2503 in subjects with late-prodromal and early-manifest Huntington's disease.
Description of Study: VX15/2503-N-131 is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study of VX15/2503 in subjects with late-prodromal and early-manifest Huntington's disease. The primary objective is to evaluate the safety and tolerability of monthly IV administration of a single dosage of VX15/2503 (or placebo). Secondary objectives include determining the effect of VX15/2503 on brain volumes (MRI), FDG-PET imaging and clinical features of HD including cognition, motor function, behavior, functional abilities and global function. Additional secondary objectives include PK / PD, immunogenicity and exploratory biomarkers.
Enrollment will involve approximately 84 individuals who are 21 years of age or older with late-prodromal (CAG-age product score [CAP score] of greater than 200 and Diagnostic Confidence Level [DCL] of 2 or 3) or early-manifest HD (Total Functional Capacity (TFC) greater than or equal to 11). The study will be divided into Cohort A and Cohort B.
Cohort A subjects will be treated for six months with either drug or placebo (1:1), and then all subjects will be treated with drug for six months, followed by three months of follow up. Treatment duration for each subject will be 12 months. Participation in Cohort A will include a screening visit, a baseline visit within 30 days of screening, 12 monthly treatment visits beginning at baseline and continuing through month 12, a follow-up safety phone call at one month and a follow-up safety visit three months after the final infusion. Cohort A subjects will participate in the study for approximately 16 months.
Cohort B subjects will be treated with drug or placebo (1:1) for 18 months, followed by three months of follow up. Treatment duration for each subject will be 18 months. (The duration of treatment may be reduced to 12 months based on the outcome of the analysis of the data from Cohort A.) Participation in Cohort B will include a screening visit, a baseline visit within 30 days of screening, 18 monthly treatment visits beginning at baseline and continuing through month 18, a follow-up safety phone call at one month and a follow-up safety visit three months after the final infusion. Cohort B subjects will participate in the study for approximately 22 months.
Eligibility Criteria: Male or female at least 21 years of age at screening.
Must fulfill one of the following criteria at screening:
- Late-prodromal HD as defined by a CAP score of greater than 200 and DCL 2 or 3,
- Early-manifest HD as defined by a TFC greater than or equal to 11. Subject must have been given a clinical diagnosis of HD
Must fulfill both of the following criteria at screening:
- Have undergone genetic testing with a known CAG repeat greater than or equal to 36
- Have no features of juvenile HD (Westphal variant).
Males must agree to use a reliable method of birth control
Subjects are willing and capable of providing informed consent for study participation and CAG genotyping (all subjects)
Subjects are capable of reading, writing and communicating effectively with others
Subjects are taking stable doses of any concomitant medications (including tetrabenazine) during the month prior to the baseline visit, and dosing must remain stable throughout the study.
Status of Study: Recruiting
Principal Investigator: Sandra Kostyk, MD, PhD
Contact:
Allison Daley, MS, MPH
Phone: 614-688-8672, Fax: 614-366-8672
email: Allison.Daley@osumc.edu
Sponsor: Vaccinex, Inc.
Collaborator: Huntington Study Group
Other Conditions
Purpose of Study: The objective of this prospective, multisite, single-arm study is to capture the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory tremor in patients with essential tremor (ET).
Description of Study: This study is evaluating a new technique for performing thalamotomy for tremor control. While current techniques have possible invasive or radiation effects, the use of ExAblate is non-invasive and without radiation. After informed consent and screening, eligible subjects will undergo an ExAblate treatment. All subjects will be followed at one day; one week; one, three, six and 12 months; and for up to five years as directed by their doctor.
Eligibility Criteria: Men and women age 22 and older with a diagnosis of essential tremor, as confirmed by clinical history and examination by a neurologist or neurosurgeon specialized in movement disorder, and significant disability from their ET despite medical treatment. Subjects should be on a stable dose of all ET medications for 30 days prior to study entry, able to communicate sensations during the ExAblate transcranial procedure, and able and willing to give informed consent and attend all study visits.
Status of Study: Recruiting
Contacts:
Phuong (Lina) Nguyen, MBA, CCRP
Phone: 614-366-6952
Email: phuong.nguyen2@osumc.edu
Amelia Hargrove
Phone: 614-366-6639
Email: amelia.hargrove@osumc.edu
Sponsor: Insightec