Parkinson's Disease

Parkinson's Disease

Efficacy and Safety of Amantadine HCl Extended-Release Tablets to Treat Parkinson’s Disease Patients With Levodopa-Induced Dyskinesia (ALLAY-LID I)

Purpose of the Study: The purpose of this multicenter, randomized, double-blind, parallel-group, 16-week study is to compare the efficacy and safety of two different dose levels of Amantadine Extended Release Tablets to placebo for the treatment of levodopa-induced dyskinesia in patients with Parkinson's disease.


Description: Amantadine has been used for many years as a treatment for Parkinson’s disease. It has been reported in the literature to effectively treat the motor complications of levodopa, especially dyskinesia, but it must be given two to four times a day. In this trial, the dose will be given once a day in the morning so that amantadine concentrations are maintained throughout the day for treating the levodopa-induced dyskinesia, but will be lower during the night, potentially reducing the negative impact of amantadine on sleep.


Eligibility Criteria: Men and women age 30 to 85 with idiopathic Parkinson’s disease per the UK Parkinson’s Disease Society Brain Bank criteria who have levodopa- induced, predictable peak-effect dyskinesia considered problematic and/or disabling are eligible. Participants taking stable doses of all oral anti-Parkinson’s medication, including any levodopa preparation, for 30 days should be willing to remain on the same doses throughout the trial. The subject/caregiver must demonstrate the ability to complete an accurate home diary based on training and evaluation during the screening period.


Study Status: Open to enrollment


Principal Investigator: Ariane Park, MD


Contact:
Katherine Ambrogi, BSN, RN
Phone: 614-688-6685, Fax: 614-366-6230
Email: katherine.ambrogi@osumc.edu


Sponsor: Osmotica Pharmaceutical Corp.

Efficacy and Safety of Amantadine HCl Extended-Release Tablets in Parkinson’s Disease Subjects With Levodopa-Induced Dyskinesias (ALLAY-LID II)

Purpose of the Study: The purpose of this multicenter, randomized, double-blind, parallel-group, 26-week study is to compare the efficacy and safety of two different dose levels of Amantadine Extended Release Tablets to placebo for the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease.


Description: Amantadine HCl ER has been used for many years as a treatment for Parkinson’s disease. It has been reported in the literature to effectively treat the motor complications of levodopa, especially dyskinesia, but it must be given two to four times a day. In this trial, the dose will be given once a day in the morning so that amantadine concentrations are maintained throughout the day for treating the levodopa-induced dyskinesia, but will be lower during the night, potentially reducing the negative impact of amantadine on sleep.


Eligibility Criteria: Men and women age 30 to 85 with idiopathic Parkinson’s disease per the UK Parkinson’s Disease Society Brain Bank criteria who have levodopa-induced, predictable peak-effect dyskinesia considered problematic and/or disabling. Participants taking stable doses of all oral anti-Parkinson's medication, including any levodopa preparation, for 30 days should be willing to remain on the same doses throughout the trial. The subject/caregiver must demonstrate the ability to complete an accurate home diary based on training and evaluation during the screening period.


Study Status: Recruiting


Principal Investigator: Ariane Park, MD


Contact:
Katherine Ambrogi, BSN, RN
Phone: 614-688-6685, Fax: 614-366-6230
Email: katherine.ambrogi@osumc.edu


Sponsor: Osmotica Pharmaceutical Corp.

Safety, Tolerability, and Efficacy Assessment of Isradipine for PD (STEADY-PD III) Trial

Purpose of the Study: The purpose of the STEADY-PD III trial is to determine if the drug isradipine is safe and effective in slowing the progression of Parkinson’s disease (PD) disability. Isradipine is a calcium channel blocker and has been approved by the Food and Drug Administration to treat high blood pressure. In this trial, however, researchers will test isradipine as a disease-modifying drug for PD.


Eligibility Criteria: Eligible participants must have a diagnosis of PD less than three years, be at least 30 years old at the time of diagnosis, be able to provide written informed consent, be able and willing to comply with study specific procedures, not be taking dopaminergic therapy at the time of study enrollment, not be pregnant or lactating, and not intending to become pregnant.


Status of Study: Recruiting


Principal Investigator: Ariane Park, MD


Contact:
Katherine Ambrogi, BSN, RN
Phone: 614-688-6685, Fax: 614-366-6230
Email: katherine.ambrogi@osumc.edu


Funding: National Institute of Neurological Disorders and Stroke

Huntington's Disease

Huntington's Disease

Enroll-HD: A Prospective Registry Study in a Global Huntington’s Disease Cohort

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

Alternatives for Reducing Chorea in HD (ARC-HD)

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.

Open Label Extension Study to Investigate Long-Term Safety, Tolerability and Efficacy of Pf-02545920 in Subjects With Huntington’s Disease Who Completed Study A8241021

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

Randomized, Placebo-Controlled Study of the Efficacy and Safety of PF-02545920 in Subjects With Huntington’s Disease

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

Treadmill Walking in Individuals With Dementia With Lewy Bodies and Huntington’s Disease

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

VX15/2503 Treatment for Huntington's Disease (SIGNAL)

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).
Females must be either surgically sterile, postmenopausal or nonlactating and nonpregnant. Female subjects of childbearing potential must practice a highly effective method of contraception

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

Other Conditions

Continued Access Protocol: ExAblate Transcranial MR-Guided Focused Ultrasound for the Treatment of Essential Tremors

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

A Study on the Use of the MMF07 Foot Massager and Heat Therapy Treatments for Restless Leg Syndrome

Purpose of the Study: The purpose of this study is to assess whether the MMF07 Foot Massager and/ or heat therapy may improve symptoms of restless leg syndrome (RLS). It will also assess the effect of the MMF07 Foot Massager and/or heat on quality of life and sleep in people affected by RLS.


Description of Study: Few clinical trials have looked into non-pharmacological, non-invasive treatments for restless leg syndrome, despite reports that massage, baths and vibrations can alleviate RLS symptoms. We would like to assess whether the MMF007 Foot Massager device and/or heat therapy is associated with improved severity of RLS symptoms. For this study the investigator will enroll 40 participants who have been diagnosed with RLS, and who will be followed over the course of four weeks and asked to complete two in-person study visits. In the study, the investigator is comparing the use of the MMF007 Foot Massager device and/or heat therapy to a non-treatment group to assess if the symptoms of RLS improve.


Eligibility Criteria: Men and women between 18-75 years diagnosed with RLS according to the diagnostic criteria of the International Restless Legs Syndrome Study Group who have bothersome RLS symptoms, despite best medical therapy. Participants should be stable on all RLS medication for at least four weeks prior to enrollment, have vision, and be proficient in English for compliance with testing and surveys. All women of childbearing age must be using an acceptable form of birth control, including abstinence, intrauterine device (IUD) or intrauterine system in place for at least three months prior to screening, subject or partner using barrier method (e.g., condom, diaphragm or cervical cap) with spermicide from screening through study completion; partner has a documented vasectomy > six months prior to baseline, stable hormonal contraception (with approved oral, transdermal, or depot regimen) for at least three months prior to screening.


Status of Study: Recruiting


Principal Investigator: Ariane Park, MD


Contact:
Katherine Ambrogi, BSN, RN
Phone: 614-688-6685, Fax: 614-366-6230
Email: katherine.ambrogi@osumc.edu


Sponsors: Ariane Park, MD

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