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Clinical Trials

 

Conditions

The following neurological conditions are at the forefront of our research studies. If you are interested in clinical research related to these areas, please contact us.

•    Acoustic neuroma
•    Amyotrophic lateral sclerosis (ALS) or Lou Gehrig's disease
•    Brain tumors
•    Diabetic neuropathy
•    Encephalitis
•    Epilepsy
•    Essential Tremor
•    Headaches
•    Memory disorders
•    Multiple sclerosis
•    Neuromuscular diseases
•    Parkinson's disease
•    Stroke
•    Tics
•    Trigeminal neuralgia

 

`Study: SYN 115-CL02
(PD Study)
PI:  David Swope, MD

 

Contact: Dharmaseeli Moses, RN,CCRC
Department Of Neurology
Loma Linda University
(909)-558-2037

 

Inclusion Criteria
1.    30-80 yrs old with diagnosis of Parkinson’s.
2.    Hoehn &Yahr stages 2-4 in OFF state and 3 in On state.
3.    Subjects should have been on 4 doses of Levadopa preparation for at least 12 months and currently experiencing end of dose “wearing off” fluctuations with at least 2.5 hrs of OFF per day.
4.    Stable anti PD medications for 4 weeks prior  to Screening.(Dopamine  agonists, COMT inhibitors and MAOB inhibitors are permitted.)
5.    75% diary concordance with trainer in 2 hour training session.
Valid 2-day practice diary preceding the baseline visit.

 

Exclusion  Criteria
1.    Secondary or atypical Parkinsonism(drug-induced, post –stroke)
2.    Apomorphine, 30 days prior to screening, current antipsychotics, acetylcholinesterase inhibitors or NMDA anatagonists.
3.    Treatment with any other investigational drug within 5 half –lives or 30 days prior to screening. Allergy to SYN 115 components.
4.    Score of <26 on MMSE.
5.    Current Major Depression, if they are on stable doses of anti-depressant for 4 weeks prior to randomization they may be enrolled.
6.    Orthostatic hypotension requiring medication out of range Labs on screening.
7.    Suicidal ideation on C-SSRS of type 4 or 5 in past 3 months.
8.    Malignant Melanoma on examination.
9.    Positive answer for a disorder on  modified Minnesota Impulsive Disorders Interview (Mmidi)

 


Study: ACADIA PD PSYCHOSIS

(PD Study)
PI:  K.Dashtipour, MD


Contact: Dharmaseeli Moses, RN,CCRC
Department Of Neurology
Loma Linda University
(909)-558-2037

 

Inclusion Criteria
1.    >40 yrs with clinical diagnosis of Idiopathic PD for 1 year.
2.    Psychotic symptoms developed after diagnosis of PD and include visual or auditory hallucinations to be present a month before screening every week.
3.    Symptoms are severe enough to warrant treatment with an antipsychotic agent documented at screening and defined as a  score of 4 or greater on either the Hallucinations(Frequency x Severity)or Delusions(Frequency x Severity) scales OR combined score of  6 or greater.
4.    At Baseline visit, must have SAPS hallucinations or Delusions global item (H7 or D13) score of ≥ 3 and a score of  ≥ 3 on at least one other non global item using the modified 9 items SAPS hallucinations and Delusions domains.
5.    Subject is on stable dose of anti-Parkinson’s medication for 1 month prior to Day 2 (Baseline)
6.    Has received stereotaxic surgery for subthalamic nucleus for DBS at least 6 months prior to Day 1(Baseline) with stable setting.

 

Exclusion  Criteria
1.    Psychotic symptoms due to toxic, metabolic or infection-induced delirium/encephalopathy, with schizophrenia, bipolar or depression.
2.    Psychotic symptoms prior to or concomitantly with diagnosis of PD including, but not limited to,schizophrenia or bipolar disorder.
3.    Atypcial or secondary PD.
4.    Ablative stereotaxic surgery (pallidotomy and thalamomotomy) to treat PD.
5.    Dementia prior to or concomitantly with PD.
6.    MMSE of < 21.
7.    Myocardial Infarction in the last 6 months.
8.    Moderate to severe CHF. Known symptoms of long QT syndrome.
9.    Has a screening and baseline ECG with Bazett’s corrected QT (QTcB) of greater than 460 msec if male or 470 msec if female.
10.    On medications that prolong long QT syndrome.
11.    Allergy or sensitivity to Pimavanserin.

 


Study: Sepracor 093-045
(Epilepsy study)
PI:  Travis Losey, MD

 

Contact: Dharmaseeli Moses, RN,CCRC
Department Of Neurology
Loma Linda University
(909)-558-2037

 

Inclusion Criteria
1.    Diagnosis of partial epilepsy (SPS with observable motor component or complex, with or without secondary generalization). Documented EEG within 5 years.
2.    Documented CT/MRI within 10 years. Mesial l temporal sclerosis is acceptable.
3.    ≥ 4 partial onset seizures during the 8 weeks prior to screening with no 28 day seizure free period. Stable treatment with 1-2 AEDs during the last 4 weeks prior to screening.
4.    Male or female aged 16-70 years old

 

Exclusion  Criteria
1.    SPS without motor component.
2.    Generalized seizures (juvenile myoclinic epilepsy  or Lennox-Gastaut syndrome). History of Pseudoseizures.
3.    Status epilepticus within 2 years prior to screening.
4.    Seizures occurring in cluster pattern.
5.    Subject on 2 of the following sodium channel blockers: phenytoin,carbamazepine, oxcarbazepine or lamotrigine.
6.    Subjects taking 2 AEDs with both in the upper dose range.
7.    Severe drug allergic reactions to carbazepine,oxcarbazepine.
8.    WBC< 2500 cells/uL. Sodium level ≤ 125mmol/L.

 


Study: BIA-2093-304
(Epilepsy study)
PI:  Travis Losey, MD


Contact: Dharmaseeli Moses, RN,CCRC
Department Of Neurology
Loma Linda University
(909)-558-2037

 

Inclusion Criteria    
1. Diagnosis of epilepsy since at least 12 months of screening.
2. At least 4 partial onset seizures -4 weeks prior to screening.
3. Currently treated with 1 or 2 AEDs in a stable dose regimen during at least 1 month prior to screening. Patients using Vigabatrin should have been on this medication for at least 1 year with no deficit in visual field identified. The device for VNS should be implanted at least 6 months before screening, parameters to be stable for at least 1 month prior to screening.
4. At Visit 2 (randomization) subjects should have at least 3 partial –onset seizures in each 4 week selection of the 8 week baseline period prior to randomization and no seizure free interval exceeding 28 consecutive days.

Exclusion  Criteria
1. SPS with no motor symptomatology. Primary Gen Seizures.
2. Status epilepticus or cluster seizures. Seizures of psychogenic in origin. Major psychiatric disorders.
3. Documented diagnosis of schizophrenia with history of at least 1 acute psychoses episode within last 2 years, suicidal attempt.
4. Currently treated with OXC.
5. Using benzodiazepines on more than an occasional basis.
6. Previous use of Eslicarbazepine acetate in a clinical study, known allergy to this drug. Hypersensative to carboxamide derivatives.
7. Currently treated with VNS, but implanted < 6 months before screening or parameters not stable for at least 1 month prior to screening.

 


Study: SP 902
(Epilepsy study)
PI:  Travis Losey, MD


Contact: Dharmaseeli Moses, RN,CCRC
Department of Neurology
 Loma Linda University
(909) 558-2037

Inclusion Criteria
1. Male or female subjects between age of 16 and 70 years of age.
2. Diagnosis of epilepsy with SPS (motor component) and/or CPS (with or without secondary generalization).
3. On stable dose of 1or 2 AEDs for at least 28 days prior to visit 1& BSL.
4. Subjects on 2 AEDs, the second AED must be ≤ 50%of the minimum recommended maintenance dose.
5. During the 8 week BSL phase the minimum requirement of seizures should be 2 partial-onset seizures (IA, IB, or IC) per 28 days. In case of SPS, only those with motor signs (IA1) will be counted.
6. Subject has < 40 partial seizures (ie IA1, IA2,IA3,IA4,IB,IC) per 28 days during the 8 week baseline phase.
7. Subject has had an EEG and a brain CT or MRI of brain consistent with diagnosis of partial onset epilepsy.


Exclusion  Criteria
1. Subjects who have previously received LCM may be considered for participation if the treatment is in single iv administration, must have occurred earlier than 28 days to screening.
2. Seizure disorder with primarily isolated auras, history of generalized seizures, cluster seizures or unclassified.
3. Status epilepticus within 12 months prior to Visit 1.
4. Seizure free period ≥28 days during the BSL phase.
5. ≥ 5 seizures of any type, including isolated aura in the 8 wk BSL.
6. Received treatment with benzodiazapines,MAOI ,barbiturates.
7. Implanted VNS.
8. Sick Sinus Syndrome without a pacemaker, second-third degree AV Block. NYHA Class III or class IV heart failure.

 


Study: SP 904
(Epilepsy study)

PI:  Travis Losey, MD


Contact: Dharmaseeli Moses, RN,CCRC
Department of Neurology
Loma Linda University
(909)-558-2037

Inclusion Criteria    
1. Subject has entered the Maintenance phase for the double-blind trial, SP 902 and either completed SP902 or met an exit criterion in SP902.
2. Subject is expected to benefit from participation in an open-label extension trial with LCM.

Exclusion  Criteria
1. Subject is receiving any investigational drugs using any experimental devices in addition to LCM.
2. Subject meets the withdrawal criteria (excluding the exit criteria) for the previous trial (SP902) or is experiencing an ongoing SAE.

 


Study: EPOC/ Protocol: CFTY720DUS01
(MS Study)
PI:  Daniel Giang, MD


Contact: Dharmaseeli Moses, RN,CCRC
Department of Neurology
Loma Linda University
(909)-558-2037

Inclusion Criteria    
1. Subjects must be diagnosed with relapsing forms of MS.
2. Subjects who agree to be assigned to a treatment group that may receive Fingolimod or DMT.
3. Male or Female Subjects aged 18-65 years.
4. EDSS score of 0.5-5 inclusive.
5. Must have received continous treatment with a single approved and indicated MS DMT for a minimum of 6 months prior to screening visit.
6. Naïve to treatment with FTY 720 (Fingolimod)    

Exclusion  Criteria
1. Hypersensitive to Fingolimod.
2. Subjects who test negative for Varicella –Zoster Virus IgG antibodies. Subjects who have received live attenuated vaccines within one month prior to screening.
3. Subjects who have received total lymphoid irradiation or bone marrow transplantation.
4. Treated with immunosuppressive medications.
5. ECG: MI within last 6 months prior to enrollment. Class III or IV NYHA heart failure.
6. Subjects receiving Class Ia  or Class III antiarrythmic drugs.
7. Mobitz   type II second degree or third degree AV Block.


Study: ACORDA

(MS Study)
PI:  Daniel Giang, MD


Contact: Dharmaseeli Moses, RN,CCRC
Department of Neurology
Loma Linda University
(909)-558-2037
    
Inclusion Criteria    
1. MS diagnosis as defined by McDonald Criteria.,18-70 years old.
2. Subjects who previously has taken Ampyra or Dalfampridine in  any formulation, must have withdrawn from the drug for at least one month prior to the screening visit.
3. Should complete the T25FW in an average of 8-45 seconds at the screening visit.

Exclusion  Criteria    
1. Has seizures, renal impairment. Active UTI within 4 weeks before screening.
2. Who has received Cyclophosphamide or Mitxantrone for MS treatment within 6 months prior to the screening visit.
3. Who has started a treatment regimen of Betaseron,Avonex,Copaxone,Rebif,Tysabri or Gilenya within 90 days prior to screening visit.
4. Who has received corticosteroids within 30 days prior to the screening visit and is expected to continue during the study.
5. Who has been administered Botulinum toxin in the lower extremities within six months prior to the screening visit.
6. Known allergy to pyridine containing substances.


Study: Cef-ALS2006
(ALS Study)
PI-Laura Nist, MD

    
Contact: Dharmaseeli Moses, RN,CCRC
Department of Neurology
Loma Linda University
(909)-558-2037

Inclusion Criteria    
1. 18 years or older.
2. Vital Capacity at least 60%predicted value for gender, height and age at screening.
3. First ALS symptoms occurred no more than 3 years prior to the screening visit.
4. Not taking Riluzole or on stable dose for at least 30 days prior to screening visit.
5. Able to undergo placement of Central venous catheter.    

Exclusion  Criteria
1. Dependence on mechanical ventilation.
2. Known allergy to ceftriaxone
3. Immune compromising illness.
4. History of antibiotic induced colitis.
5. Active biliary disease,including gall stones.
6. Active gastrointestinal disease within 30 days of the screening visit.

Study: ANS C-04-02
(ET Study)
PI-Dashtipour,MD


Contact: Dharmaseeli Moses, RN,CCRC
Department of Neurology
Loma Linda University
(909)-558-2037
    
Inclusion Criteria    
1. 18 years of age. Diagnosed with essential tremor for at least 3 years.
2. Has a disabling medical- refractory upper extremity tremor with no evidence of supraspinal CNS disease or injury.
3. Has postural or kinetic tremor severity score of at least 3 out of 4 in the extremity intended for treatment on the Fahn-Tolosa-Martin Clinical Rating Scale for Tremor.
4. Subject is willing to maintain a constant dose of anti-tremor medication or best medical management, for at least one month prior to study enrollment.   
Exclusion  Criteria
1. Not a Surgical candidate, no other neurological illness.
2. Has any condition requiring diathermy.
3. Takes anticoagulant medication.
4. Has had electrical or electromagnetic implant(e.g.cochlear prosthesis or pacemaker).
5. Has dementia with MMSE score of <24.
6. Had Botulinum toxin injections in the six months prior to enrollment.
7. Prior surgical ablation procedure.

Study: AAB-001,ELN115727
(Alzheimer's Dementia Study)
PI-Sherzai,MD


Contact: Dharmaseeli Moses, RN,CCRC
Department of Neurology
Loma Linda University
(909)-558-2037
    
Inclusion Criteria    
1. Diagnosis of Alzheimer’s disease as per NINCDS-ADRDA criteria.
2. MMSE of 16-26, inclusive.
3. Rosen Modified Hachinski Ischemic Score ≤4.
4. Lives at home with appropriate caregiver, to come with caregiver at least 5 times a week for the duration of the study.
5.  Screening visit brain MRI scan consistent with the diagnosis of AD.
6.  Adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments.
Exclusion  Criteria
1. History of or screening visit brain MRI scan indicative of any other significant abnormality.
2. Current presence of a clinically important major psychiatric disorder (eg, major depressive disorder)
3. Systemic illness, clinically evident stroke and seizures.
4. Weight greater than 120 kg (264 lb).
5. Autoimmune disease, infection within the last 30 days.
6. Immunosuppressive medications (eg, systemic corticosteroids) within the last 90 days.