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

NCT00558337 | Completed Phase 2 DMC

• 1 other identifier: OS353-CTP 01
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 9

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.

Conditions

Parkinson's Disease

Keywords

Treatment of Parkinson's Disease

Outcome Measures

Primary Outcomes (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

  every half hour for the first 8 hours after dosing

Secondary Outcomes (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)

  over the course of the study

Study Arms (2)

A

ACTIVE COMPARATOR

Drug: levodopa-carbidopa

B

ACTIVE COMPARATOR

Drug: levodopa-carbidopa

Interventions

levodopa-carbidopa DRUG

novel levodopa/carbidopa formulation or a reference levodopa/carbidopa formulation

A; B

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Osmotica Pharmaceutical US LLC: lead

Study Sites (9)

Fundacion Alfredo Thomson

Buenos Aires, Argentina

Location

Hospital Posadas

Buenos Aires, Argentina

Location

Hospital Ramos Mejía

Buenos Aires, Argentina

Location

Hospital Sirio Libanés

Buenos Aires, Argentina

Location

Instituto Frenopático

Buenos Aires, Argentina

Location

nstituto INEBA

Buenos Aires, Argentina

Location

Policlínica Bancaria

Buenos Aires, Argentina

Location

Fundación Rosarina de Neuro-Rehabilitación

Rosario, Argentina

Location

Hospital San Bernardo

Salta, Argentina

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

carbidopa, levodopa drug combination

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Gustavo Fischbein, M.D.

  Osmotica Pharmaceutical Argentina S.A.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 12, 2007
• First Posted: November 14, 2007
• Study Start: November 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: January 14, 2009

Record last verified: 2009-01

Locations

AR (9)