Efficacy, Safety, and Pharmacokinetics/Pharmacodynamic Study of L-Dopa/Carbidopa To Treat Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00558337
Recruitment Status : Completed
First Posted : November 14, 2007
Last Update Posted : January 14, 2009
Information provided by:
Osmotica Pharmaceutical US LLC

Brief Summary:
Determine if a novel levodopa/carbidopa formulation results in a better clinical response on Parkinson's Disease patients compared to the reference formulation of levodopa/carbidopa in terms of motor complications, onset of action and response duration.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: levodopa-carbidopa Phase 2

Detailed Description:
Primary objective is to demonstrate a better clinical response profile of novel levodopa/carbidopa formulation vs. the reference formulation of levodopa/carbidopa in patients with Parkinson's Disease as judged by motor performance and to describe pharmacokinetic profile for the novel formulation compared to the reference.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: An Efficacy, Safety, and Pharmacokinetics/Pharmacodynamic Relationship Study of L-Dopa/Carbidopa in a Novel Release Formulation in Parkinson's Disease Patients
Study Start Date : November 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: A Drug: levodopa-carbidopa
novel levodopa/carbidopa formulation or a reference levodopa/carbidopa formulation
Active Comparator: B Drug: levodopa-carbidopa
novel levodopa/carbidopa formulation or a reference levodopa/carbidopa formulation

Primary Outcome Measures :
  1. Evidence of a novel levodopa/carbidopa formulation providing a better clinical profile than reference levodopa/carbidopa formulation using Unified Parkinson's Disease Rating Scale (UPDRS III) and patient's diary cards [ Time Frame: every half hour for the first 8 hours after dosing ]

Secondary Outcome Measures :
  1. Other measurements to be used for demonstrating clinical profile is UPDRS II and IV, Clinical Global Impression Scale (CGI)/Patient's Global Improvement Scale (PGI), and the Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: over the course of the study ]

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical diagnostic of Parkinson's Disease, with a Hoehn and Yahr Staging within 2-4, and L-Dopa therapy complications
  • at least 2years of L-Dopa therapy
  • Patients with the ability to differentiate between "ON" and "OFF" periods
  • Patients who have been receiving stable doses of L-Dopa between 600 and 1600 mg/day, for at least 2 months prior to the screening visit using a dosing regimen not higher that 5 times a day, and not expected in the investigator's opinion to need any dose modifications over the duration of the study
  • Patients presenting a score of at least 2 in the UPDRS IVa, item 32 and/or a score of at least 2 in the UPDRS IVb, item 39, at screening and randomization visits based on clinical records for the first visit and daily diary cards at randomization time.
  • Willing and able to understand and sign Informed Consent form

Exclusion Criteria:

  • Patients with a diagnosis of any known secondary Parkinsonian syndrome, (vascular, toxin or drug-induced, metabolic or infectious, etc) or other neurodegenerative disorder with parkinsonism (Progressive Supranuclear Palsy, Corticobasal Degeneration, Multiple System Atrophy, etc).
  • Patients receiving other concomitant anti-Parkinsonian pharmacological therapies affecting L-dopa or dopamine metabolisom (COMT inhibitors or MAO inhibitors)
  • Subjects who have undergone prior functional neurosurgical treatment for PD (ablation or Deep Brain Stimulation).
  • Patient with a L-dopa dosage regimen greater than 5 times a day which is not able to be adapted to a q.i.d. regimen.
  • Patients having received L-dopa / Decarboxylase inhibitors therapy for less than 2 years.
  • Patients needing nightly doses of L-dopa / Decarboxylase inhibitors apart from the four daily doses.
  • Any medical condition or past medical history that, in the investigator's judgment, would increase the risk of exposure to L-dopa / Carbidopa or interfere with the evaluation of the study objectives.
  • Patients with unstable or clinically significant known medical illness; such as cardiac, pulmonary, kidney, hepatic and/or gastrointestinal disease that would, in the investigator's judgment, interfere with the safe course of the study.
  • Cognitive impaired patients, as determined by a score of lesser than 26 on the Mini-Mental Score Status Examination. (MMSE < 26).
  • Alcohol or illegal drugs abuse.
  • Pregnant or lactating patients.
  • Hypersensitivity to any of the investigational drugs, based on known allergies to drugs of the same class.
  • Patients having taken any research drugs over the last 30 days prior to the beginning of the study.
  • Blood donation, or blood products, or participation to a clinical trial with serial blood withdrawals, within twelve weeks prior to the start of the trial, or intention to donate blood or blood products within three months following the study completion.
  • Patients who have received some of the following medications with an anticipation of no more than 7 treatment-drug elimination half-lives of entry time: Dopamine D2 receptor antagonists , isoniazid, anti-epileptic drugs, IMAO A or B, pyridoxine, ferrous salts or methyldopa.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00558337

Fundacion Alfredo Thomson
Buenos Aires, Argentina
Hospital Posadas
Buenos Aires, Argentina
Hospital Ramos Mejía
Buenos Aires, Argentina
Hospital Sirio Libanés
Buenos Aires, Argentina
Instituto Frenopático
Buenos Aires, Argentina
nstituto INEBA
Buenos Aires, Argentina
Policlínica Bancaria
Buenos Aires, Argentina
Fundación Rosarina de Neuro-Rehabilitación
Rosario, Argentina
Hospital San Bernardo
Salta, Argentina
Sponsors and Collaborators
Osmotica Pharmaceutical US LLC
Study Director: Gustavo Fischbein, M.D. Osmotica Pharmaceutical Argentina S.A.

Responsible Party: Gustavo Fischbein, Osmotica Pharmaceutical Argentina Identifier: NCT00558337     History of Changes
Other Study ID Numbers: OS353-CTP 01
First Posted: November 14, 2007    Key Record Dates
Last Update Posted: January 14, 2009
Last Verified: January 2009

Keywords provided by Osmotica Pharmaceutical US LLC:
Treatment of Parkinson's Disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Carbidopa, levodopa drug combination
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors
Adjuvants, Immunologic
Immunologic Factors
Dopamine Agonists