Contact us at (800) USC-CARE (800-872-2273)

Clinical Trials and Research Projects

Clinical Trials and Research Projects2019-02-06T12:01:50+00:00

Our research group is committed to the pursuit of basic and clinical knowledge that can advance treatments and care for individuals with multiple sclerosis. Toward these goals, we are conducting clinical trials and basic science studies for MS patients, described below.

The following are clinical trials currently open for enrollment:

  • Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis in Anti-JCV Antibody Negative Patients
  • MS Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus Copaxone
  • Exploratory Study to Assess Clinical Response to Gilenya® (Fingolimod) in Relapsing Remitting Hispanic Multiple Sclerosis Forms
  • Assessing Induction of Type II (M2) Monocytes/Macrophages in Patients Receiving Gilenya
  • Ampyra in Female Sexual Function
  • Hispanic Ancestry Multiple Sclerosis Registry at USC

For information about any of these trials, you may contact the individuals who are listed with each trial or study below, or you may contact us at (800) USC-CARE (800-872-2273).

Studies currently open for enrollment:

  • Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis in Anti-JCV Antibody Negative Patients
  • MS Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus Copaxone
  • Exploratory Study to Assess Clinical Response to Gilenya® (Fingolimod) in Relapsing Remitting Hispanic Multiple Sclerosis Forms
  • Assessing Induction of Type II (M2) Monocytes/Macrophages in Patients Receiving Gilenya
  • Ampyra in Female Sexual Function
  • Hispanic Ancestry Multiple Sclerosis Registry at USC

Ongoing studies:

  • An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab
  • John Cunningham Virus (JCV) Antibody Study of Multiple Sclerosis (MS) Patients With Relapsing Forms of MS Receiving Treatment With Tysabri

 

Study of myMS in Participants With a Diagnosis of Multiple Sclerosis

This is a pilot study looking at the feasibility of a mobile application (app) to collect
data from active tasks (questionnaires, 6Mapp™, COGapp™, VISapp™), clinical magnetic
resonance imaging information and conduct genome-wide association studies in subjects with
multiple sclerosis. Participants will be self-referred to this study from different sources;
patient advocacy groups, social media tools, clinicaltrials.gov, and flyers.

For information about this clinical trial here at USC or to see if you qualify, contact Jose Aparicio by phone at (323) 442-6833 for more information.

Inclusion Criteria:

– Males or females participants with access to an iPhone 5 and above.

– Participants willing to provide electronic consent.

– Age 18 and above.

– A diagnosis of MS (Polman, 2010), with dissemination in time and space. CIS
participants will be included if they fulfil 3 of the 4 MRI criteria for dissemination
in space as per Polman et al. 2010.

– EDSS of between 0 and 8.0

Exclusion Criteria:

– Under 18 years of age

– Participants who do not consent to participate.

– Participants participating in ongoing MS clinical trials with non-approved drugs.

– Any concurrent illness, disability or clinically significant abnormality (including
laboratory tests) that may prevent the subject from safely completing the assessments
required by the protocol.

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Active, not recruiting

Canadian Multicenter Observational Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Participants

The primary objective of the study is to evaluate the impact of early treatment with Tysabri
in Relapsing Remitting Multiple Sclerosis (RRMS) participants on their quality of life (QoL)
as measured by Multiple Sclerosis Impact Scale-29 (MSIS-29) over 2 years. The secondary
objectives of the study are: to evaluate the impact of early treatment with Tysabri in RRMS
participants over 2 years on the following: annualized relapse rate (ARR), Expanded
Disability Status Scale (EDSS), work productivity, quality of life (QoL) by EuroQol
5-Dimension questionnaire (EQ-5D), QoL by Subject Global Assessment of Wellbeing visual
analog scale (VAS) and to evaluate clinical disease-free status (relapses, EDSS) over 2
years.

For information about this clinical trial here at USC or to see if you qualify, contact Jose Aparicio by phone at (323) 442-6833 for more information.

Key Inclusion Criteria:

– Ability to understand the purpose and risks of the study and provide signed and dated
informed consent.

– Documented diagnosis of Relapsing Multiple Sclerosis (McDonald 2010 Criteria).

– Must have an Expanded Disability Status Scale (EDSS) score from 0 to 4.0, inclusive.

– Must satisfy the approved therapeutic indications for Tysabri as per Product
Monograph.

– Must either be treatment naïve or have been treated with disease modifying therapy
DMT(s) (such as, but not limited to, Avonex, Betaseron, Rebif, Copaxone, Extavia,
Tecfidera and/or Gilenya) for ≤5 years total prior to date of informed consent.

– Decision to treat with Tysabri must precede enrollment.

Key Exclusion Criteria:

– Any prior treatment with Tysabri.

– Contraindications to treatment with Tysabri as described in the Product Monograph.

– History of progressive multifocal leukoencephalopathy (PML) or other opportunistic
infections, or an increased risk for such infections.

– History of diagnosis of Primary Progressive Multiple Sclerosis [PPMS] and/or Secondary
Progressive Multiple Sclerosis [SPMS].

– Receiving immunomodulatory or immunosuppressive therapy.

– Prior history of immunosuppressive use (mitoxantrone, azathioprine, methotrexate,
cyclophosphamide, mycophenolate, cladribine, rituximab).

– Immunocompromised at the time of enrollment.

– Known active malignancies (subjects with cutaneous basal cell carcinoma that has been
completely excised prior to study entry remain eligible).

– Women breastfeeding, pregnant, or planning to become pregnant; women who are not
post-menopausal or surgically sterile who are unwilling to practice contraception.

– Inability to comply with study requirements.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

MS Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus Copaxone

The purpose of this study was to demonstrate that at least one dose (0.5 mg followed by 0.25
mg) of fingolimod is superior to glatiramer acetate 20 mg SC in reducing the ARR up to 12
months in patients with relapsing-remitting MS

For information about this clinical trial here at USC or to see if you qualify, contact Jose Aparicio by phone at (323) 442-6833 for more information.

Inclusion criteria:

– Written informed consent must be obtained before any assessment is performed

– Male and female patients 18 to 65 years of age, inclusive.

– Patients with RRMS, as defined by 2010 revised McDonald criteria.

– Patients must be neurologically stable with no onset of relapse within 30 days of
randomization

– Patients with at least 1 documented relapse during the previous year or 2 documented
relapses during the previous 2 years before randomization.

– Patients with an EDSS score of 0 to 6, inclusive, at Screening. A score of 6.0
indicates unilateral assistance (cane or crutch) required to walk at least 100 meters
with or without resting.

Exclusion criteria:

– Patients with a history of malignancy of any organ system (other than cutaneous basal
cell carcinoma) in the last 5 years that do not have confirmation of absence of a
malignancy prior to randomization

– Patients with an active chronic disease (or stable but treated with immune therapy) of
the immune system other than MS (e.g., rheumatoid arthritis, scleroderma, Sjogren’s
syndrome, Crohn’s disease, ulcerative colitis) or with a known immunodeficiency
syndrome (HIV-antibody positive, AIDS, hereditary immune deficiency, drug-induced
immune deficiency).

– Patients who have been treated with:

– High-dose intravenous (IV) immunoglobulin (Ig) within 4 weeks before randomization

– Immunosuppressive/chemotherapeutic medications (e.g., azathioprine, cyclophosphamide,
methotrexate) within 6 months before randomization

– Natalizumab within 2 months before randomization

– Previous treatment with lymphocyte-depleting therapies (e.g., rituximab, alemtuzumab,
ofatumumab, ocrelizumab, or cladribine) within 1 year before randomization Previous
treatment with mitoxantrone within 6 months before randomization

– Use of teriflunomide within 3.5 months prior to randomization, except if active
washout (with either cholestyramine or activated charcoal) was done. In that case,
plasma levels are required to be measured and be below 0.02 mg/L before randomization.

No washout period is necessary for patients treated with dimethyl fumarate, interferon
(IFN) beta, or glatiramer acetate.

Patients being treated with dimethyl fumarate, glatiramer acetate, or IFN beta at the
Screening visit can continue drug intake up to the day before Day 1 of this study (i.e.,
there is no need for a washout period).

– Patients who have been treated with systemic corticosteroids or adrenocorticotropic
hormones in the past 30 days prior to the screening magnetic resonance imaging (MRI)
procedure.

– Patients with uncontrolled diabetes mellitus (glycosylated hemoglobin >9%) or with
diabetic neuropathy.

– Patients with a diagnosis of macular edema during Screening (patients with a history
of macular edema will be allowed to enter the study provided that they do not have
macular edema at Screening).

– Patients with severe active bacterial, viral, or fungal infections.

– Patients without acceptable evidence of immunity to varicella zoster virus (VZV) at
randomization.

– Patients who have received any live or live-attenuated vaccines (including VZV, herpes
simplex, or measles) within 1 month before randomization.

– Patients who have received total lymphoid irradiation or bone marrow transplantation.

– Patients with any unstable medical/psychiatric condition, as assessed by the primary
treating physician at each site.

– Patients who in the last 6 months experienced any of the following cardiovascular
conditions or findings in the screening electrocardiogram (ECG): myocardial
infarction, unstable angina, stroke, transient ischemic attack or decompensated heart
failure requiring hospitalization or Class III/IV heart failure.

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Exploratory Study to Assess Clinical Response to Gilenya® (Fingolimod) in Hispanics With RRMS

Gilenya (fingolimod) is approved for multiple sclerosis. However, it is unclear of its
clinical effect in the Hispanics with MS given that clinical studies had limited
representation of this population. It is also unclear if Gilenya would be as effective in
individuals with disease predominantly affecting the optic nerve and spinal cord (OSMS)
commonly seen in Asian populations.

Objectives: To compare the clinical response of Gilenya® (fingolimod) in relapsing remitting
OSMS and MS of Hispanic descent using ancestral markers as a biomarker of treatment response
and clinical disease state.

For information about this clinical trial here at USC or to see if you qualify, contact Jose Aparicio by phone at (323) 442-6833 for more information.

Inclusion Criteria:

– Clinically definite multiple sclerosis defined by McDonald Criteria (8) with a score
of 0 to 5.5 on the Expanded Disability Status Scale (EDSS)(9). Inclusion will also be
determined by PI if clinically indicated. Relapsing remitting form of MS.

– Between 18-65 years of age (This age range is selected so as to capture the vast
majority of patients who are seen in the clinics with a confirmed diagnosed of MS.
This age range also allows for exclusion of co-morbid conditions that may be
associated with aging as well as pediatric cases where their disease characteristics
have been shown to be different).

– Ability to understand and sign the IRB-approved informed consent form prior to the
performance of any study-specific procedures and is willing to comply with the
required scheduling and assessments of the protocol.

– Women of childbearing potential must have a negative urine pregnancy test at the
Screening Visit and must be willing to practice a reliable birth-control method.

– Patient must be willing to discontinue and remain free from concomitant
immunosuppressive or additional immunomodulatory treatment (including IFNβ1a, 1b,
natalizumab and GA) for the duration of the study.

– Willing to answer a series of questions about disease, ancestry, residence history,
socioeconomic status and ethnic background.

– Willing to donate 50cc of blood for genetic admixture and immunological testing on
three occasions (O months, 6 months, 12 months).

– Willing to undergo MRI as standard of care at a 1.5 Tesla magnet strength at least.

Exclusion Criteria:

– Inability to understand nature of the study.

– Lack of a definite diagnosis of Multiple Sclerosis such as clinical isolated syndrome
will be excluded.

– NMO Antibody positive.

– Primary progressive or secondary progressive MS.

– Inability to undergo an MRI study or receive contrast agent and GFR<30. - Considered by the Investigator to be immunocompromised, based on medical history, physical examination, or laboratory testing or due to prior immunosuppressive treatment. - Lack of Varicella immunity. - History of, or available abnormal laboratory results indicative of, any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric (including major depression), renal, and/or other major disease. - History of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible). - Known history of human immunodeficiency virus infection, hematological malignancy, or organ transplantation, history of severe allergic or anaphylactic reactions or known drug hypersensitivity. - Prior treatment history with the interferons, glatiramer acetate or natalizumab will be acceptable after drug clearance of 1 month. 1 month has been selected due to clinical experience of possible disease breakthrough if longer period is performed. [/fusion_toggle][/fusion_accordion] [/fusion_builder_column][fusion_builder_column row_column_index="2_3" type="1_1" background_position="left top" background_color="" border_size="" border_color="" border_style="solid" spacing="yes" background_image="" background_repeat="no-repeat" padding="" margin_top="0px" margin_bottom="0px" class="" id="" animation_type="" animation_speed="0.3" animation_direction="left" hide_on_mobile="no" center_content="no" min_height="none"]Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Completed

Assessing Induction of Type II (M2) Monocytes/Macrophages in Patients Receiving Gilenya.

In this study we wish to test the hypothesis that continuous Gilenya treatment alters immune
homeostasis in favor of an anti-inflammatory type II monocyte and macrophage (M2) phenotype
in the circulation of patients with relapsing-remitting Multiple Sclerosis (MS). In this
study we will determine the change in ratio of M2 (type II, alternatively activated) versus
M1 (type I, classically activated) monocytes and macrophages in a cohort of patients that
have received continuous Gilenya treatment for 0, 1, 3, 6 or 12 months. We will also assess
changes in cell surface expression of the M1 marker CCR7 and the M2 markers CD206 or CD301 by
monocytes and macrophages using FACS analysis of whole blood, and assess the tyrosine
phosphorylation of the signal transducer and activator of transcription STAT-1 (pTyr-STAT1),
which is critical for the activation of M1 myeloid cells. We will assess correlates with
changes in M1 and M2 cytokine expression assessing possible mechanisms of action of Gilenya
on myeloid lineage cells.

For information about this clinical trial here at USC or to see if you qualify, contact Jose Aparicio by phone at (323) 442-6833 for more information.

Inclusion Criteria:

– Patients must qualify to receive treatment with Gilenya, according to the University
of Southern California, Department of Neurology, MS Group, Gilenya Prescribing
Process.

– Clinically definite Multiple Sclerosis defined by the revised McDonald criteria
(Polman et al., 2005, Polman et al., 2010) of the relapsing-remitting form with an
Expanded Disability Status Scale (EDSS) score of 0 to 5.5.

– Ability to understand and sign this study-specific institutional review board-approved
informed consent form.

– Willing to donate ~50mls of blood for immunological testing on up to five occasions.

Exclusion Criteria:

– Patient does not qualify to receive treatment with Gilenya, according to the USC,
Department of Neurology, MS Group, Gilenya Prescribing Process.

– Inability to understand nature of the study.

– Treatment with any of the following within 30 days of commencing treatment with
Gilenya: Avonex, Betaseron, Rebif, Copaxone, Natalizumab, Rituximab, Mitoxantrone,
Cyclophosphamide, Cyclosporine, Azathioprine, Methotrexate or any other
immunomodulatory, immunosuppressant or immune homeostasis altering drug.

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Completed

An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab

This open-label, rater-blinded extension study enrolled participants who had
relapsing-remitting multiple sclerosis (RRMS) and who participated in one of three prior
Genzyme-sponsored studies of alemtuzumab (CAMMS223 [NCT00050778], CAMMS323 [NCT00530348] also
known as CARE-MS I, or CAMMS324 [NCT00548405] also known as CARE-MS II). The purposes of this
study were:

1. To examine the long term safety and efficacy of alemtuzumab treatment in participants
who received alemtuzumab as their study treatment in one of the prior studies.

2. To examine the safety and efficacy of initial alemtuzumab treatment in this study for
participants who received Rebif® (interferon beta-1a) as their study treatment in one of
the prior studies.

3. To determine the safety and efficacy of additional “as needed” alemtuzumab treatment
courses. This applied both to participants who received alemtuzumab for the first time
in one of the prior studies or for the first time in this extension study.

For information about this clinical trial here at USC or to see if you qualify, contact Jose Aparicio by phone at (323) 442-6833 for more information.

Inclusion Criteria:

– 1.Received alemtuzumab in CAMMS323 or CAMMS324, completed the 2-year study period, and
had not subsequently received disease modifying treatments (other than glatiramer
acetate or interferon beta); or

– 2.Received Rebif® in CAMMS323 or CAMMS324, completed the 2-year study period, and had
not subsequently received alternative disease modifying treatments (other than
glatiramer acetate or another interferon beta); or

– 3.Participated in CAMMS223.

– NOTE: Criteria 1 and 2 above meant that participants who enrolled in CAMMS323 or
CAMMS324 but did not complete the 2-year study period or went on to receive non-study
drug DMTs after randomization were not eligible for inclusion in the Extension Study.
Participants who enrolled in CAMMS324 after participation in CAMMS223 must meet
criteria 1 or 2 to be eligible for inclusion in the Extension Study.

Exclusion Criteria:

– Any alemtuzumab participant from CAMMS223, CAMMS323, or CAMMS324 who had received
alemtuzumab off-label (ie, outside of one of the prior Genzyme-sponsored studies), or
was participating in any other investigational study, unless approved by Genzyme. In
addition, these participants must be screened for disqualifying safety concerns before
receiving alemtuzumab retreatment.

– Any Rebif® participants from CAMMS223, CAMMS323, or CAMMS324 who met any of the
following criteria. In addition, these participants must be screened for disqualifying
safety concerns before receiving alemtuzumab treatment. a) Did not wish to receive
alemtuzumab; b) Ongoing participation in any other investigational study, unless
approved by Genzyme; c) Had received alemtuzumab off-label (ie, outside of one of the
prior Genzyme-sponsored studies); d) Known bleeding disorder or therapeutic
anticoagulation; e) Diagnosis of idiopathic thrombocytopenia purpura or other
autoimmune hematologic abnormality; f) History of malignancy, except basal cell skin
carcinoma; g) Intolerance of pulsed corticosteroids, especially a history of steroid
psychosis h) Significant Autoimmune disorder (other than MS); i) Major psychiatric
disorder or epileptic seizures not adequately controlled by treatment; j) Active
infection or high risk for infection k) Unwilling to use a reliable and acceptable
contraceptive method during and for at least 6 months following each alemtuzumab
treatment cycle (fertile participants only).

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Completed

JC Virus Antibody Study of Participants With Relapsing Forms of MS Receiving Treatment With Natalizumab

The primary objective of this study is to demonstrate that the incidence of progressive
multifocal Leukoencephalopathy (PML) in natalizumab-treated participants who do not have
detectable antibodies to John Cunningham virus (JCV) (antibody negative) is lower than in
participants who have detectable antibodies to JCV (antibody positive).

The secondary objectives of this study are to: Estimate the incidence of PML in
natalizumab-treated participants who are anti-JCV antibody negative and anti-JCV antibody
positive, based on a meta-analysis of data obtained from this study and other data sources;
Define the prevalence of anti-JCV antibody in relapsing multiple sclerosis (MS) participants
receiving natalizumab within the TYSABRI Outreach: United Commitment to Health (TOUCH)
Prescribing Program; Determine changes in anti-JCV antibody status over time.

For information about this clinical trial here at USC or to see if you qualify, contact Jose Aparicio by phone at (323) 442-6833 for more information.

Key Inclusion Criteria:

– Relapsing MS patients receiving commercial natalizumab

– Patients receiving natalizumab and their prescribers must be enrolled in the TOUCH
Prescribing Program.

– Patients with suspected or confirmed PML who are at or referred to a participating
STRATIFY-2 site may enroll into STRATIFY-2 for purposes of PML sample collection.

Key Exclusion Criteria:

– Patients may participate in any other clinical trial or study sponsored by Biogen Idec ;
however, if the anti-JCV antibody test is included in the other clinical study and that
study is performing a longitudinal analysis of those samples, the patient should withdraw
from STRATIFY-2.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Completed

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