USF Department of Neurology’s Clinical Trials

  • Ataxia & Movement Disorders

    FA – ALCAR – Currently Enrolling

    The purpose of this study is to learn how treatment with acetyl-L-carnitine (ALCAR) will affect the hearts of patients with Friedreich's Ataxia as well as how it may affect other symptoms of Friedreich's Ataxia such as difficulties with balance, walking, or upper arm function.

     For more information please visit the website at https://clinicaltrials.gov/ct2/show/NCT01921868

    To enroll in this study at USF please contact Jessica Shaw at 813-974-1414

    FA – Reata – Currently Enrolling

    This 2-part study will evaluate the efficacy, safety, and pharmacodynamics of omaveloxolone (RTA 408) in the treatment of patients with Friedreich's ataxia.

    For more information please visit the website at: https://clinicaltrials.gov/ct2/show/NCT02255435

    To enroll in this study at USF please contact Jessica Shaw at 813-974-1414

    FA – COMS – Currently Enrolling

    This is a long-term study of the natural progression of disease in Friedreich’s Ataxia (FA)

     

    To enroll in this study at USF please contact Jessica Shaw at 813-974-1414

    Retrotope RTMOTION – Ongoing Not Enrolling

    This is a study of a wearable gait device detecting movement in 3D in patients with movement disorders.

     

    To enroll in this study at USF please contact Jessica Shaw at 813-974-1414

    SCA - IVIG 2014 – Currently Enrolling

    The purpose of this study is to learn how Intravenous Immune Globulin (IVIG) will affect Spinocerebellar Ataxia (SCA) symptoms and how it will affect motor and nervous system function in participants Subtypes of SCA to be examined will include SCA types 1, 2, 3, 6, 10 and 11.

    For more information please visit the website at:

    https://clinicaltrials.gov/ct2/show/NCT02287064

    To enroll in this study at USF please contact Jessica Shaw at 813-974-1414

    FA - Gait and Balance – Currently Enrolling

    The purpose of this study is to assess gait and balance changes in Friedreich’s ataxia patients over the course of 12 months and correlate these changes to clinical measures of ataxia.

     

    To enroll in this study at USF please contact Jessica Shaw at 813-974-1414

    PSP - BMS CN002-003 – Currently Enrolling

    The goal of this study is to evaluate the safety and tolerability of multiple doses of BMS-986168 in patients with PSP.

    For more information please visit the website at:

    https://clinicaltrials.gov/ct2/show/NCT02460094

    To enroll in this study at USF please contact Jessica Shaw at 813-974-1414

    SCA - BHV4157-201 (Biohaven) – Start-up/Pending

    The purpose of this study is to compare the efficacy of BHV-4157 versus placebo on ataxia symptoms in subjects with spinocerebellar ataxia (SCA).

    For more information please visit the website at:

    https://clinicaltrials.gov/ct2/show/NCT02460094

    To enroll in this study at USF please contact Jessica Shaw at 813-974-1414

    PSP - Abbvie M15-562 – Start-uo/Pending

    The purpose of this study is to assess the efficacy and long term safety and tolerability of ABBV-8E12 for up to 52 weeks in subjects with progressive supranuclear palsy (PSP).

     

    To enroll in this study at USF please contact Jessica Shaw at 813-974-1414

    ET - Cavion ET – Start-up/Pending

    Pending

     

    To enroll in this study at USF please contact Jessica Shaw at 813-974-1414

    FA - EPI743-16-003 (new PM) – Start-up/Pending

    Pending

     

    To enroll in this study at USF please contact Jessica Shaw at 813-974-1414

    FA - RT001-005 (Extension) – Start-up/Pending

    Pending

     

    To enroll in this study at USF please contact Jessica Shaw at 813-974-1414

  • Huntington’s Disease

    Enroll HD Enroll HD is an observational study for families effected by Huntington’s Disease. This study monitors how the disease materializes and changes over time in different individuals. This study is open to people with HD, as well as, those who are at-risk. The Enroll HD study is intended to speed up discoveries and develop new therapies for Huntington’s Disease. For more information on this study please visit the Enroll-HD’s website at: www.enroll-hd.org To enroll in this study at USF please contact Clinical Coordinator Kelly Elliott at (813)974-0527
    Legato The Legato-HD trial evaluates the effect of the varying dosages of the investigational drug Laquinimod after a 12 month period of administration. The investigational drug, Laquinimod, is being studied to gage its effects on symptoms of HD, including abnormal movement, memory issues, and emotional conditions. For more information on this study please visit the Legato Huntington Study Group’s website at: http://huntingtonstudygroup.org/current-clinical-trials/legato-hd-trial/ To enroll in this study at USF please contact Clinical Coordinator Kelly Elliott at (813)974-0527
  • Multiple Sclerosis

    ARISE Currently Enrolling 2016-2017 The ARISE clinical trial is evaluating the safety and efficacy of an investigational drug to determine its effects on daytime sleepiness, tiredness, fatigue, and routine functioning in people with Idiopathic Hypersomnia and Narcolepsy without cataplexy. For more information on this study please visit the website at: http://www.arisestudies.com/index.html To enroll in this study at USF please contact Angela Aungst at (813)974-6378
    Chords Currently Enrolling 2016-2017 The purpose of the clinical trial CHORDS is to evaluate the effectiveness and safety of the investigational drug Ocrelizumab in patients with relapsing remitting multiple sclerosis who have had a suboptimal response to an adequate course of disease-modifying treatments. For more information on this study please visit the website at: http://www.gene.com/media/press-releases/14609/2015-10-08/genentechs-ocrelizumab-first-investigati To enroll in this study please contact Angela Aungst at (813)974-6378
    COMB Currently Enrolling 2016-2017 The purpose of this study is to compare the efficacy and safety of Ofatumumab and Teriflunomide in patients with relapsing multiple sclerosis. To enroll in this study please contact Angela Aungst at (813)974-6378
    LEM-COG Currently Enrolling 2016-2017 This clinical trial is a prospective 24 month observational study to evaluate neurocognitive function and safety in patient with relapsing MS who are initiating LEMTRADA treatment in routine clinical practice. To enroll in this study please contact Angela Aungst at (813)974-6378
    SunPharma Currently Enrolling 2016-2017 This clinical trial is a placebo-controlled randomized withdrawal evaluation of the efficacy and safety of Baclofen ER Capsules in subjects with spasticity due to MS. For more information on this study please visit the Sun Pharmaceutical website at: http://www.sunpharma.com/ To enroll in this study please contact Angela Aungst at (813)974-6378
    ML29972 Currently Enrolling 2016-2017 This trial is an open-label, multicenter, expanded access program for Ocrelizumab in patients with primary progressive multiple sclerosis. For more information on this study please visit the website at: https://clinicaltrials.gov/ct2/show/NCT02807285 To enroll in this study please contact Angela Aungst at (813)974-6378
    ENDORSE Ongoing – Not Currently Enrolling This trial is a dose-blind study to determine the long-term safety and efficacy of two doses of BG00012 Monotherapy in subjects with relapsing-remitting Multiple Sclerosis. For more information on this study please visit the website at: https://clinicaltrials.gov/ct2/show/NCT00835770 For more information please call Angela Aungst at (813)974-6378
    EFFECT Ongoing This clinical study is characterizing real-world clinical outcomes in patients with relapsing-remitting MS treated with disease modifying therapies (Tecfidera, Copaxone, Aubagio,or Gilenya) For more information please call Angela Aungst at (813)974-6378
    ESTEEM Ongoing This study is collecting information in safety and documenting the drug utilization of Tecfidera (Dimethyl Fumarate) when used in routine medical practice in the treatment of MS. For more information on this study please visit the website at: https://clinicaltrials.gov/ct2/show/NCT02047097 For more information please call Angela Aungst at (813)974-6378
    EXPAND Ongoing – Not Currently Enrolling This clinical trial is a treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive MS. For more information on this study please visit the website at: www.novartis.com/news/media-releases/novartis-announces-positive-phase-iii-results-showing-efficacy-baf312-patients For more information please call Angela Aungst at (813)974-6378
    OPERA Ongoing – Not Currently Enrolling This is a group study to evaluate the efficacy and safety of Ocrelizumab in comparison to interferon Beta-1A (Rebif) in patients with relapsing MS. For more information on this study please visit the website at: https://clinicaltrials.gov/ct2/show/NCT01412333 For more information please call Angela Aungst at (813)974-6378
    OPERA II Ongoing Parallel group study to evaluate the efficacy and safety of Ocrelizumab in comparison to interferon Beta-1A (Rebif) in patients with relapsing MS. For more information please call Angela Aungst at (813)974-6378
    PROCLAIM Ongoing An open-label study to access the effects of BG00012 on Lymphocyte subsets in subjects with relapsing-remitting MS. For more information on this study please visit the website at: https://clinicaltrials.gov/ct2/show/NCT00686959 For more information please call Angela Aungst at (813)974-6378
    Protract Ongoing This is a retrospective study and a patient real-world clinical, neurological, tolerability, and safety outcomes for Tecfidera and Rebif. For more information please call Angela Aungst at (813)974-6378
    SunPharma This is a clinical evaluation of the safety of Baclofen ER Capsules (GRS) when administered once daily to subjects with spasticity due to MS. For more information on this study please visit the website at: http://www.sunpharma.com/ For more information please call Angela Aungst at (813)974-6378
    TOPAZ This is a long-term follow-up study for MS patients who have completed the alemtuzumab Extension Study (CAMMS03409) For more information on this study please visit the website at: https://clinicaltrials.gov/ct2/show/NCT02167945 For more information please call Angela Aungst at (813)974-6378
    Veloce This is a phase IIIb, study to evaluate the effects of Orcelizumab on immune responses in patients with relapsing forms of MS. For more information please call Angela Aungst at (813)974-6378
  • Parkinson’s Disease

    Biotie

    This clinical trial to an adjunctive medication to reduce end of dose wearing off in PD patients (Tozadenant). Placebo controlled with Open Label Extension

    For more information please visit the website at: www.biotie.com

    To enroll in this study at USF please contact Claudia Rocha at 813-396-0757

    Civitas

    This clinical trial to an adjunctive medication to reduce end of dose wearing off in PD patients (Inhaled Levodopa). Open Label Extension trial

     

    To enroll in this study at USF please contact Claudia Rocha at 813-396-0757

    Cynapsus

    This clinical trial to an adjunctive medication to reduce end of dose wearing off in PD patients (Sublingual ApoMorphine).Open Label Extension trial.

    For more information please visit the website at: www.sunovion.com

    To enroll in this study at USF please contact Claudia Rocha at 813-396-0757

    Intec

    This clinical trial to evaluate the efficacy of an Accordion Pill style medication with less doses and reduce OFF time. Placebo controlled with Open Label Extension

     

    To enroll in this study at USF please contact Claudia Rocha at 813-396-0757

    Pfizer

    This clinical trial aims to reduce OFF time and reduce Sinemet dosing. Placebo Controlled with an Open Label Extension

    For more information please visit the website at: www.pfizer.com

    To enroll in this study at USF please contact Claudia Rocha at 813-396-0757

    Pfizer

    This clinical trial is for Early PD patients on MAOB medication. Placebo Controlled.

     

    To enroll in this study at USF please contact Claudia Rocha at 813-396-0757

    MJFF

    Observational trial for people of Ashkenzani Jewish Decent or first degree relatives with PD

    For more information please visit the website at: www.michaeljfox.org

    To enroll in this study at USF please contact Claudia Rocha at 813-396-0757

    Lundbeck

    Medication to control Orthostatic Hypotension in Parkinson's Disease patients. Placebo Controlled

    For more information please visit the website at: www.lundbeck.com

    To enroll in this study at USF please contact Claudia Rocha at 813-396-0757

    NIH

    Early PD patients within 3 years diagnosis currently not on treatment. Placebo Controlled.

     

    To enroll in this study at USF please contact Claudia Rocha at 813-396-0757

    Impax

    This trial is to assess the Pharmacokeinetics in patients with Advanced Parkinson's Disease

    For more information please visit the website at: www.impaxpharma.com

    To enroll in this study at USF please contact Claudia Rocha at 813-396-0757

    Neuroderm

    Sinemet delivered through a subcutaneous infusion as an adjunct to oral Sinemet

    For more information please visit the website at www.neuroder.com

    To enroll in this study at USF please contact Claudia Rocha at 813-396-0757

    Sunovion

    Medication to control halluncinations in patients with Advanced Parkinson's Disease. Placebo controlled

    For more information please visit the website at www.sunovion.com

    To enroll in this study at USF please contact Claudia Rocha at 813-396-0757

    PD and ED - Sagene2014 – Currently Enrolling

    The purpose of this study is to see if selegiline and tadalafil (generic for Cialis®) results in an improvement in Erectile dysfunction (ED) in male patients with Parkinson's disease (PD) and moderate ED. Male PD patients who have an incomplete response to tadalafil alone will be given both medications to see if the addition of selegiline improves ED symptoms more than tadalafil alone. It is common practice for a medical doctor to prescribe these two drugs to a patient like you. However, there have been no studies conducted to examine the effects of these medications when taken together.

    For more information please visit the website at: https://clinicaltrials.gov/ct2/show/NCT02225548

    To enroll in this study at USF please contact Jessica Shaw at 813-974-1414

    PD - Emory-LRRK2 – Currently Enrolling

     

     

    To enroll in this study at USF please contact Jessica Shaw at 813-974-1414

    PD - B7601011 (Pfizer Early PD) – Currently Enrolling

    This study is intended to evaluate the effect of PF-06649751 on safety and efficacy in a population of patients with early stage Parkinson’s disease.

     

    To enroll in this study at USF please contact Jessica Shaw at 813-974-1414

    PSP - BMS CN002-004 (extension) – On-going Currently Not Enrolling

    The goal of this study is to evaluate long-term safety and pharmacokinetics during multiple IV infusions of BMS-986168 in PSP patients. In addition to demonstrating multiple dose long-term safety and tolerability, BMS-986168 is expected to lower free eTau concentrations in the CSF of these patients. This study will also evaluate the progression of PSP patients treated with BMS-986168 on pharmacodynamic (PD) endpoints as well as clinical, magnetic resonance imaging (MRI), and eye tracking assessments.

    For more information please visit the website at:

    https://clinicaltrials.gov/ct2/show/NCT02658916

    To enroll in this study at USF please contact Jessica Shaw at 813-974-1414

  • Stroke

    ACTIsSIMA
    currently enrolling

    This study is being conducted to determine the safety and efficacy of a cell suspension of SB623 cells administered by injection into the brain around the area of a stroke. This is a one-time administration during a single surgery for patients that have had an ischemic stroke and have chronic motor deficits.

    For more information on this study and to take the eligibility questionnaire please visit the website at: http://stemcellstudy.ucsf.edu

    To enroll in this study at USF please contact Tara McTigue at (813)259-0826

    RESPECT-ESUS
    currently enrolling

    The purpose of this study is to test the safety and effectiveness of the anticoagulant dabigatran etexilate (Pradaxa®) taken twice daily compared to aspirin [acetylsalicylic acid (Acetylsalicylsäure 100 mg HEXAL®)] which is taken once daily for the prevention of stroke recurrence in subjects with “embolic stroke of undetermined source” (ESUS).

    For more information on this study please visit this website: https://clinicaltrials.gov/ct2/show/NCT02239120

    To enroll in this study at USF please contact Tara McTigue at (813)259-0826