ACT-128800. Phase IIb dose finding and safety trial exploring an oral selective S1P1 receptor modulator (possibly less cardiac and pulmonary side effects compared to Fingolimod).

Inclusion:

• McDonald RRMS, age 18-55 inclusive, EDSS 0-5.5 inclusive
• 1 attack in last 12 months OR 2 attacks in last 24 months OR 1+ Gad lesion on screening MRI
• No MS attack or high dose steroids in the last 30 days

Exclusion:

• Primary progressive MS
• treatment in the last 30 days with steroids, B-blocker, diltiazem, verapamil, digoxin
• IFN, GA, cyclosporine, sirolimus, cellcept, TPE, live vaccines in last 3 months
• imuran, methotrexate, NTZ, IVIG, daclizumab in last 6 months
• cytoxan, mitoxantrone, cladribine, Rituxan or alemtuzeumab EVER
• negative vericella-zoster antibody test
• history of cancer (except excised basal or squamous cell skin lesions)
• history of poorly controlled DM, MI in last 6 months, valvular dz, heart failure, COPD

Coordinator/s: Melissa Wilson (614)293-6468 and Jamie McGowan (614)247-6856

 

Accelerated Cure Project (ACP-001)- A Longitudinal, Case-Control Study to Collect Medical and Epidemiological Data and Blood

Inclusion:

• A patient with at least 1 CNS event (MS, TM, ADEM, ON or NMO) OR a blood relative of a patient with a CNS event can serve as a Case subject
• Any person without a history or family history of a CNS event can serve as a control subject

Exclusion:

• history of marrow transplant
• evidence of neuro diseases other than those in inclusion

Coordinator/s: Jamie McGowan (614)247-6856

 

Novartis (PPMS)- A double-blind, randomized, multicenter, placebo controlled, parallel-group study comparing the efficacy and safety of 1.25mg FTY720 administered orally once daily versus placebo

Inclusion:

• PPMS- McDonald’s criteria (2005 revised)
  • 1 yr of disease progression plus two of the following: Positive brain MRI, Positive Spinal cord MRI, Positive CSF
• Ages 25-65, inclusive, EDSS 3.5-6.0, Pyramidal FSS ≥ 2, Timed 25 foot walk< 30 seconds
• Evidence of progression of disability in the 2 yrs prior to Screening (documented in EDSS scores)
• First MS symptom onset between 2 and 10 years prior to baseline visit

Exclusion:

• history or presence of malignancy
• have received total lymphoid irridation or bone marrow transplantation
• have been treated with: systemic corticosteroids or ACTH within 3 months prior, interferon-beta or glatiramer acetate within 3 months
• immunosuppressive medications, immunoglobulins and/or monoclonal antibodies within 6 months
  

Coordinator/s: Lisa Hafer (614)293-7877

 

Estriol- combination treatment with oral Estriol in combination with injectable Copaxone is efficacious as compared to Copaxone alone in RRMS over 24 month trial period.

Inclusion:

• Females age 18-50,EDSS 0.0-4.5
• Active RRMS defined by either:
  • A. at least two clearly identified relapses within 24 months prior tostudy entry, OR
  • B. at least one relapse within 24 months prior to study entry AND have a history of at least one gadolinium enhancing lesion on a T1brain or cord. MRI done at least 3 months before or 3 months after the clinical relapse.
• Pts that are on Copaxone less than 2 months are eligible, patients that are on greater than 2 months need to wash off for 3 months for eligibility

Exclusion:

• females who are or plan to be pregnant during 24 months of study, 3 months after completion or are w/in 6 months post partum
• subjects must not be on oral contraceptives (OCP), hormone replacement therapy (HRT), progesterone IUDs or other hormones during
• screening and during the 24 month enrollment period.
• patients who smoke at any time during screening or during the 24 month enrollment period.

Coordinator/s: Lisa Hafer (614)293-7877

 

Exercise and cognition in MS

Cross sectional evaluation of MS patients’ exercise and cognitive status. 15 minute research MRI, computerized neuropsych test, wear a pedometer for a week, participation in 1 structured interview.

Inclusion: any ambulatory MS patient.

(Dr. Prakash, Contact lab manager Gabriel (614)292-9568)

Rebif+Cellcept- combination of Cell Cept with Rebif . Up-regulation of the MxA gene following the administration of Rebif® will be used as a surrogate marker of interferon bioactivity.

Inclusion:

• age of 18 to 65, inclusive
• Any patient who is eligible for interferon therapy
  • this includes RRMS and CIS patients

Exclusion:

• participation in a clinical trial or received another investigational therapy in the last 9 days.
• Previous or current use of CellCept including use in any type of solid organ transplantation.
• Subject has received corticosteroids within 30 days prior to screening.
• Subject has received cyclophosphamide or mitoxantrone ever.
• Subject has received Imuran or methotrexate in the last 3 months.
• Subject has received tysabri in the last 3 months

Coordinator/s: Lisa Hafer (614)293-7877

 

Improving MS fatigue with Tysabri- the objectives of this study are 1) To determine whether fatigued MS patients exhibit increased cerebral activation (as measured on functional MRI) compared to non-fatigued MS patients during a sustained cognitive task. 2) To determine if natalizumab (Tysabri) objectively improves cognitive fatigue in MS patients (as measured of functional MRI) by a cognitive task before and after drug treatment.

Patients will undergo computerized neuropsychological assessments and functional MRI scans on three occasions over the course of one year (baseline, 6 months and 12 months)

Inclusion:

• R-handed, RRMS (McDonald’s) patients
• disease duration < 5 years
• age < 55
• EDSS < 5.5
• patient has be about to start tysabri, a decision made by the clinician independent of whether they are going to do a trial or not

Exclusion:

• either treatment naïve or have been off other disease modifying therapies for 1 month
• relapse free and without exposure to corticosteroids for at least 6 months.

Coordinator/s: Lisa Hafer (614)293-7877