© 2016 by Pmdi.org 

FOLLOW US:

  • Facebook Social Icon
  • LinkedIn Social Icon

Current Drug Studies

If you suffer from Parkinson's disease and experience motor fluctuations, You may be eligible to participate in a research drug study conducted at the Parkinson's & Movement Disorder Institute.

For more information please contact our study staff at (714) 378-5021 
Kyowa 6002-014 (Istradefylline)

 

The purpose of the study is to assess the safety and effectiveness of an investigational treatment, Istradefylline, for Parkinson’s Disease (PD) patients with motor fluctuations and dyskinesia. Patients who meet the following criteria could be eligible to participate:
 

•       Male or female, 30 years of age or older at the time of enrollment

•       Diagnosed with idiopathic PD

•       Treatment with levodopa therapy for at least 1 year

•       Taking total daily levodopa dosage of at least 400 mg plus at least 1 adjunctive medication approved to treat PD (Dopamine Agonist, COMT or MAO-B)

•       Patients who have documented end-of-dose wearing-off and who have experienced
levodopa-induced dyskinesia;

Participation would last about 14 weeks.  Enrolled patients may be compensated for travel and meals

 

Steady PD III Isradipine (NIH/NINDS)

To establish efficacy of isradipine to slow progression of Parkinson disease (PD) disability as determined by the change in the total Unified Parkinson Disease Rating Scale (UPDRS) score in the active treatment arm versus placebo between the baseline and 36 months

  • Patients with early idiopathic PD (presence of two out of three cardinal manifestations of PD). If tremor is not present, patients must have unilateral onset and persistent asymmetry of the symptoms.

  • Age equal or greater than 30 years at the time of diagnosis of PD

  • Hoehn and Yahr stage less than or equal to 2

  • Diagnosis of PD less than 3 years.

  • Currently NOT receiving dopaminergic (levodopa, dopamine agonist or MAO-B inhibitors) therapy and NOT projected to require PD symptomatic therapy for at least 6 months from the baseline visit.

  • Use of amantadine and/or anticholinergics will be allowed. The dosage must be stable for 12 weeks prior to the baseline visit and throughout the duration of the study.

Participations would last about 32 months

 

Cynapsus Therapeutics Inc. CTH-300/301

 

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy, Safety and Tolerability of APL-130277 in Levodopa Responsive Patients with Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes), CTH-300 12Weeks

An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and  Efficacy of APL-130277 in Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (“OFF” Episodes), CTH-301 24Weeks

  • Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria

  • Male or female subjects ≥  18 years of age

  • Patients must experience at least one well defined “OFF” episode per day with a total daily “OFF” time duration of >2 hours during the waking day, based on patient self-assessment

  • Patient and/or caregiver must be trained in performing home dosing diary assessments of the motor state and must be able to recognize “ON” and “OFF” states

  Enrolled patients may be compensated for travel and meals

 

Adamas ADS-AMT-PD-304 (Amantadine HCl)

 

The purpose of the study is to evaluate the efficacy of ADS-5102 oral capsules, an extended release formulation of Amantadine, dose level 340mg, dose nightly at bedtime, for the treatment of levodopa induced dyskinesia (LID) in patients with Parkinson’s Disease (PD)
 

•       Male of female patients between 30 and 85 years of age

•       Parkinson’s disease, per UK Parkinson’s Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria

•       Stable regimen antiparkinson’s medications for at least 30 days prior to screening, including a levodopa preparation administered not less than three times daily and willing to continue regimen during study participation

•       Willing to complete 24hour PD home diary after diary training

•       Patients with “ON  with Troublesome Dyskinesia”

Participation would last about 13 weeks. Enrolled patients may be compensated for travel and meals

 

Osmotica OS-320-3005/3006  Amantadine ER

A Multicenter, Randomized, Placebo-controlled, Double-blind, 16 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson’s Disease Subjects with Levodopa-Induced Dyskinesia, OS320-3005

A Multicenter, Randomized, Placebo-controlled, Double-blind, 26 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson’s Disease Subjects with Levodopa-Induced Dyskinesia, OS320-3006

  • Have been diagnosed with idiopathic Parkinson's disease as defined by the UK Parkinson's Disease Society Brain Bank criteria.

  • Be male or female 30 to 85 years old

  • Have levodopa induced, predictable peak-effect dyskinesia that are considered by the patient to be problematic and/or disabling

  • The patient/caregiver must demonstrate the ability to complete an accurate home diary based on training and evaluation during the screening period.

 Enrolled patients may be compensated for travel and meals

Pfizer B7601005

B7601005: A Phase 1b, 2-Period, Open Label, Multicenter, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06649751 in Subjects with Parkinson`s Disease and Motor Fluctuations 8 Weeks

•    Patient must have a clinical diagnosis of idiopathic Parkinson’s disease and presence of at least 2 out of 3 cardinal characteristics (tremor, rigidity and/or bradykinesia).
•    Females of non-childbearing potential and/or male subjects between the ages of 30 and 80 years, inclusive
•    Patient must have a history of L-Dopa–responsiveness for at least 1 year prior to screening
•    Patient must have documented history of definite end of L-Dopa dose wearing OFF
•    Patient  must be willing and able to refrain from any Parkinson’s disease medication not permitted by the protocol throughout participation in the study
Patients will be admitted to Orange Coast Memorial hospital for 29 days.
Enrolled patients may be compensated for travel and meals

 

Adamas ADS-AMT-PD-302 (Amantadine HCl) OpenLabel

 

The purpose of the study is to evaluate the efficacy of ADS-5102 oral capsules, an extended release formulation of Amantadine, dose level 340mg, dose nightly at bedtime, for the treatment of levodopa induced dyskinesia (LID) in patients with Parkinson’s Disease (PD)
 

This study will be offered to patients who are described by one of the following 3 groups:

 

•      Group 1 current ADS-AMT-PD-304 patients who will immediately transition

•      Group 2 previous ADS-AMT-PD-304 patients who decided to not enter immediately  (time gap)

•      Group 3 non ADS-AMT-PD-304 with prior DBS (deep brain stimulation)

 

•       Male of female patients between 30 and 85 years of age

•       Parkinson’s disease, per UK Parkinson’s Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria

•       Stable regimen antiparkinson’s medications for at least 30 days prior to screening, including a levodopa preparation administered not less than

•       Patients with Peak dose dyskinesas

Participation would last about 100 weeks.  Enrolled patients may be compensated for travel and meals

Civitas Therapeutics, INC CVT-301-005

Protocol CVT-301-005: A Phase 3, Randomized Study Investigating the Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson’s Disease Patients With Motor Response Fluctuations (OFF Phenomena) Compared to an Observational Cohort Control

  • Patient has idiopathic PD (i.e., not induced by drugs or other diseases) as defined by fulfilling Steps 1 and 2 of the UK Brain Bank criteria, diagnosed after the age of 30 years.

  • Patient is classified as Stage 1 to 3 (in the ON state) on the modified Hoehn and Yahr scale for staging of PD severity.

  • Patient has experienced motor fluctuations for a minimum of 2 hours of average daily OFF time per waking day (excluding early morning OFF time) by self-report and confirmed by the PD Diary (on 3 consecutive days) during the screening period.

  • Patient must be stable on oral LD-containing therapy for at least 2 weeks prior to SV1 with a LD/dopamine decarboxylase inhibitor (DDI)-containing regimen, which must include doses at least 4 times during the waking day and a total daily LD dose of ≤1600 mg (exclusive of PRN LD-containing medications).

  • Patient must be able to perform a spirometry maneuver in the ON and OFF states, and must have a screening FEV1 ≥50% of predicted and an FEV1/FVC ratio >60% in the ON state at screening.

Participations would last about 12 months.  Enrolled patients may be compensated for travel and meals