Comparing Different Levodopa/Carbidopa/Entacapone Treatment Regimens

NCT01296464 | Completed Phase 2

• 1 other identifier: 2939136
• Study Type: interventional
• Target: 27
• Locations: 2 countries
• Sites: 5

Brief Summary

The primary objective is to assess the effect of a single dose of two experimental levodopa/carbidopa/entacapone (L/C/E) treatment regimens versus standard L/C/E treatment regimen in Parkinson's disease (PD) patients with end-of-dose motor fluctuations in terms of duration of motor response after the first morning dose of levodopa. The secondary objective is to evaluate the safety of the L/C/E treatment regimens in patients with PD.

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease; Motor response; Wearing-off

Outcome Measures

Primary Outcomes (1)

• Duration of motor response by UPDRS III

  Statistical method for the primary comparison will be analysis of variance (ANOVA) with the following grouping factors: treatment, sequence, subject, and period. Differences between Stalevo and treatment regimen A will be evaluated using orthogonal contrasts with 5% significance level.

  20 minute intervals

Study Arms (2)

Stalevo

EXPERIMENTAL

levodopa/carbidopa/entacapone

Drug: Carbidopa

Placebo

PLACEBO COMPARATOR

Drug: Carbidopa

Interventions

Carbidopa DRUG

Capsules

Placebo; Stalevo

Eligibility Criteria

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

You may qualify if:

• Written informed consent (IC) obtained.
• Male or female patients with idiopathic PD according to the United Kingdom brain bank criteria with end-of-dose motor fluctuations
• Hoehn and Yahr stage 2-4 performed during the "ON" state.
• Duration of response between 1.5 and 4 hours (based on medical history) to the patient's first morning dose of levodopa/dopa decarboxylase inhibitor (DDCI) with or without entacapone.
• Treatment with 3-8 daily doses of levodopa/DDCI with or without entacapone with a total daily levodopa dose in the range of 300-1200 mg. One evening dose of controlled-release formulation of levodopa/DDCI is allowed provided that it is included in the total of 3-8 daily doses of levodopa/DDCI mentioned above.
• Unchanged levodopa/DDCI with or without entacapone and other antiparkinsonian medication(dopamine agonists, monoamine oxidase \[MAO\] B inhibitor, amantadine and/or anticholinergics with approved doses), if any, for at least 6 weeks prior to the screening visit.
• Age of 30 years or above

You may not qualify if:

• Secondary or atypical parkinsonism.
• Use of tolcapone within 6 weeks prior to the first treatment period.
• Previous tolerability problems with entacapone or tolcapone.
• Concomitant treatment with apomorphine, MAO-A inhibitors or nonselective MAO inhibitors.
• Concomitant treatment with drugs having antidopaminergic action including alpha-methyldopa, reserpine and antipsychotic drugs (also D2 receptor blocking antiemetics except domperidone). As an exception, an evening dose of an atypical antipsychotic is allowed.
• Use of any iron preparations.
• Intensity of dyskinesias which would, in the opinion of the investigator, interfere with the interpretation of motor part (part III of the Unified Parkinson's Disease Rating Scale (UPDRS III) scoring during the levodopa challenge test.
• Currently active hallucinations.
• Severe orthostatic hypotension as judged by the investigator.
• Mini-Mental State Examination (MMSE) score \< 26
• History of neuroleptic malignant syndrome (NMS) and/or non-traumatic rhabdomyolysis.
• Past or current treatment with deep brain stimulation (DBS) or other surgical treatment for PD.
• Treatment with levodopa or dopamine agonist infusion or injection
• Active malignancy, narrow-angle glaucoma or pheochromocytoma.
• Clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, neurological or psychiatric disorder or any other major concurrent illness that in the opinion of the investigator would interfere with the interpretation of the study results or constitute a health risk for the subject if he/she takes part into the study.

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead

Study Sites (5)

Kanta-Hämeen keskussairaala

Hämeenlinna, 13530, Finland

Location

ODL Terveys Oy (ODL)

Oulu, 90100, Finland

Location

Porin Lääkäritalo

Pori, 28100, Finland

Location

Länssjukhuset Ryhov, Medicin/Neurologmottagningen

Jönköping, SE-55185, Sweden

Location

Karolinska Universitetssjukhuset Solna, Neurologkliniken

Stockholm, SE-171 76, Sweden

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Carbidopa

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Methyldopa; Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Hydrazines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Vilho Myllylä, Prof

  Oulu Deaconess Instutute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2011
• First Posted: February 15, 2011
• Study Start: February 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: September 12, 2011

Record last verified: 2011-09

Locations

FI (3); SE (2)