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Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy (STRIDE-PD)

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ClinicalTrials.gov Identifier: NCT00099268
Recruitment Status : Completed
First Posted : December 10, 2004
Results First Posted : March 8, 2011
Last Update Posted : April 23, 2012
Sponsor:
Collaborator:
Orion Corporation, Orion Pharma
Information provided by:
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Parkinson's Disease
Interventions Drug: Carbidopa/levodopa/entacapone
Drug: Immediate release carbidopa/levodopa
Enrollment 747
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Carbidopa/Levodopa/Entacapone Carbidopa/Levodopa
Hide Arm/Group Description Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks. Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
Period Title: Overall Study
Started 374 373
Intent-to-Treat 373 [1] 372
Completed 282 [2] 291 [3]
Not Completed 92 82
Reason Not Completed
Withdrawal by Subject             46             28
Adverse Event             19             19
Protocol Violation             9             8
Lost to Follow-up             6             4
Lack of Efficacy             5             18
Administrative problems             4             4
Death             3             1
[1]
One patient from each group discontinued without receiving a single dose of study drug.
[2]
Plus 1 death in the carbidopa/levodopa/entacapone group within 30 days of treatment discontinuation
[3]
Plus 1 death in the carbidopa/levodopa group within 30 days of treatment discontinuation
Arm/Group Title Carbidopa/Levodopa/Entacapone Carbidopa/Levodopa Total
Hide Arm/Group Description Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks. Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks. Total of all reporting groups
Overall Number of Baseline Participants 373 372 745
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 373 participants 372 participants 745 participants
60.6  (8.67) 59.8  (8.20) 60.2  (8.44)
[1]
Measure Description: Baseline numbers represent the Intent-to-treat (ITT) population. Of the 747 randomized patients, one patient in each group discontinued the study without receiving a single dose of study drug and was excluded from the ITT population.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 373 participants 372 participants 745 participants
Female
128
  34.3%
150
  40.3%
278
  37.3%
Male
245
  65.7%
222
  59.7%
467
  62.7%
1.Primary Outcome
Title Time to First Occurrence of Dyskinesia
Hide Description Dyskinesia was assessed by a blinded rater at each visit. Time to dyskinesia was defined as the visit at which the rater first answered “yes” to the following question: “In your opinion, does this patient have dyskinesia?” Time to dyskinesia was estimated by Kaplan-Meier product limit estimate that takes into consideration patients who did not experience dyskinesia by censoring them at the end of the study.
Time Frame Treatment duration for an individual patient varied between a minimum of 134 weeks for those patients recruited last and a maximum of 208 weeks for those patients recruited first
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization.
Arm/Group Title Carbidopa/Levodopa/Entacapone Carbidopa/Levodopa
Hide Arm/Group Description:
Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
Overall Number of Participants Analyzed 373 372
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: weeks
90.7
(65.3 to 104.0)
117.1
(92.1 to 132.6)
2.Secondary Outcome
Title Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score (Parts II and III)
Hide Description The UPDRS is a standardized assessment scale used to measure the patient’s disease state. It was to be completed by a blinded rater. There are 6 parts to the UPDRS. Part II (items 5-17; total score 0-52 units on the scale) measures the patient’s activities of daily living and part III (items 18-31; total score 0-56 units on the scale) measures the motor function of the patient. The total score ranges from 0 to 108 units on the scale. A higher score indicates greater disability. A negative change score indicates improvement.
Time Frame Baseline, Week 6 and Week 130
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization.
Arm/Group Title Carbidopa/Levodopa/Entacapone Carbidopa/Levodopa
Hide Arm/Group Description:
Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
Overall Number of Participants Analyzed 373 372
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change from baseline to Week 6 21.9  (11.96) 21.8  (11.24)
Change from baseline to Week 130 23.2  (13.38) 22.8  (13.21)
3.Secondary Outcome
Title Occurrence of Wearing-off
Hide Description Wearing-off is defined as a perception of loss of mobility or dexterity, usually taking place gradually over minutes (up to an hour) and usually bearing a close temporal relationship to the timing of anti-parkinsonian medications; it does not include early-morning akinesia. To ascertain its occurrence, a blinded rater questioned the patient as to whether he/she had noticed that the benefits of the study drug were wearing-off.
Time Frame Baseline to Week 134
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization. Subjects who discontinued treatment before 134 weeks without wearing-off were excluded.
Arm/Group Title Carbidopa/Levodopa/Entacapone Carbidopa/Levodopa
Hide Arm/Group Description:
Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
Overall Number of Participants Analyzed 305 333
Measure Type: Number
Unit of Measure: Participants
139 161
4.Secondary Outcome
Title Time to First Occurrence of Wearing-off
Hide Description Wearing off is defined as a perception of loss of mobility or dexterity, usually taking place gradually over minutes (up to an hour) and usually bearing a close temporal relationship to the timing of anti-parkinsonian medications; it does not include early-morning akinesia. To ascertain its occurrence, a blinded rater questioned the patient whether he/she had noticed that the benefits of the study drug wear-off. A motor complications and patient questionnaire card were provided to assist the blinded rater in determining whether a patient had experienced wearing-off.
Time Frame Baseline to end of study (134-208 weeks of treatment)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization.
Arm/Group Title Carbidopa/Levodopa/Entacapone Carbidopa/Levodopa
Hide Arm/Group Description:
Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
Overall Number of Participants Analyzed 373 372
Mean (Standard Error)
Unit of Measure: Weeks
131.7  (3.8) 129.5  (3.6)
5.Secondary Outcome
Title Occurrence of Dyskinesia
Hide Description Dyskinesia was assessed by a blinded rater at each visit. Time to dyskinesia was defined as the visit at which the rater first answered “yes” to the following question: “In your opinion, does this patient have dyskinesia?”
Time Frame Baseline to Week 208
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization. Subjects who discontinued from treatment before 134 weeks without dyskinesia were excluded.
Arm/Group Title Carbidopa/Levodopa/Entacapone Carbidopa/Levodopa
Hide Arm/Group Description:
Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
Overall Number of Participants Analyzed 307 318
Measure Type: Number
Unit of Measure: Participants
128 103
6.Secondary Outcome
Title Change From Baseline in Health-related Quality of Life Assessed Using the 39-item Parkinson's Disease Questionnaire (PDQ-39)
Hide Description The PDQ-39 instrument is used to assess quality of life in individuals with Parkinson’s disease. The questionnaire provides scores on eight scales: Mobility, activities of daily living, emotions, stigma, social support, cognition, communication, and bodily discomfort. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The total score can range from 39 to 190. A lower score indicates better quality of life. A negative change score indicates an improvement.
Time Frame Baseline to Week 156
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization.
Arm/Group Title Carbidopa/Levodopa/Entacapone Carbidopa/Levodopa
Hide Arm/Group Description:
Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
Overall Number of Participants Analyzed 201 213
Mean (Standard Deviation)
Unit of Measure: Units on a scale
4.1  (12.06) 1.8  (11.79)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Carbidopa/Levodopa/Entacapone Carbidopa/Levodopa
Hide Arm/Group Description Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks. Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
All-Cause Mortality
Carbidopa/Levodopa/Entacapone Carbidopa/Levodopa
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Carbidopa/Levodopa/Entacapone Carbidopa/Levodopa
Affected / at Risk (%) Affected / at Risk (%)
Total   91/373 (24.40%)   84/371 (22.64%) 
Blood and lymphatic system disorders     
Lymphocytosis  1  1/373 (0.27%)  0/371 (0.00%) 
Cardiac disorders     
Acute myocardial infarction  1  1/373 (0.27%)  0/371 (0.00%) 
Angina pectoris  1  2/373 (0.54%)  5/371 (1.35%) 
Angina unstable  1  1/373 (0.27%)  1/371 (0.27%) 
Aortic valve stenosis  1  0/373 (0.00%)  1/371 (0.27%) 
Atrial fibrillation  1  2/373 (0.54%)  1/371 (0.27%) 
Atrial flutter  1  1/373 (0.27%)  0/371 (0.00%) 
Bradycardia  1  0/373 (0.00%)  1/371 (0.27%) 
Cardiac arrest  1  1/373 (0.27%)  0/371 (0.00%) 
Cardiac failure  1  0/373 (0.00%)  1/371 (0.27%) 
Cardiac failure congestive  1  2/373 (0.54%)  0/371 (0.00%) 
Cardiac flutter  1  1/373 (0.27%)  0/371 (0.00%) 
Coronary artery disease  1  2/373 (0.54%)  2/371 (0.54%) 
Coronary artery stenosis  1  1/373 (0.27%)  2/371 (0.54%) 
Myocardial infarction  1  5/373 (1.34%)  0/371 (0.00%) 
Palpitations  1  1/373 (0.27%)  0/371 (0.00%) 
Supraventricular tachycardia  1  0/373 (0.00%)  1/371 (0.27%) 
Ventricular tachycardia  1  0/373 (0.00%)  1/371 (0.27%) 
Congenital, familial and genetic disorders     
Muscular dystrophy  1  1/373 (0.27%)  0/371 (0.00%) 
Vitello-intestinal duct remnant  1  0/373 (0.00%)  1/371 (0.27%) 
Ear and labyrinth disorders     
Vertigo  1  0/373 (0.00%)  1/371 (0.27%) 
Eye disorders     
Chalazion  1  1/373 (0.27%)  0/371 (0.00%) 
Eyelid ptosis  1  0/373 (0.00%)  1/371 (0.27%) 
Gastrointestinal disorders     
Abdominal adhesions  1  1/373 (0.27%)  1/371 (0.27%) 
Abdominal discomfort  1  1/373 (0.27%)  0/371 (0.00%) 
Anal fissure  1  1/373 (0.27%)  0/371 (0.00%) 
Colitis ulcerative  1  1/373 (0.27%)  0/371 (0.00%) 
Colonic obstruction  1  0/373 (0.00%)  1/371 (0.27%) 
Constipation  1  1/373 (0.27%)  0/371 (0.00%) 
Diarrhoea  1  2/373 (0.54%)  0/371 (0.00%) 
Flatulence  1  0/373 (0.00%)  1/371 (0.27%) 
Gastric ulcer perforation  1  1/373 (0.27%)  0/371 (0.00%) 
Gastrooesophageal reflux disease  1  1/373 (0.27%)  0/371 (0.00%) 
Hiatus hernia  1  0/373 (0.00%)  1/371 (0.27%) 
Inguinal hernia  1  3/373 (0.80%)  2/371 (0.54%) 
Intestinal ischaemia  1  1/373 (0.27%)  0/371 (0.00%) 
Intestinal obstruction  1  2/373 (0.54%)  0/371 (0.00%) 
Nausea  1  0/373 (0.00%)  3/371 (0.81%) 
Pancreatitis  1  1/373 (0.27%)  0/371 (0.00%) 
Peritonitis  1  0/373 (0.00%)  1/371 (0.27%) 
Small intestinal obstruction  1  0/373 (0.00%)  1/371 (0.27%) 
Vomiting  1  0/373 (0.00%)  1/371 (0.27%) 
General disorders     
Chest discomfort  1  2/373 (0.54%)  1/371 (0.27%) 
Chest pain  1  0/373 (0.00%)  2/371 (0.54%) 
General physical health deterioration  1  1/373 (0.27%)  0/371 (0.00%) 
Non-cardiac chest pain  1  0/373 (0.00%)  1/371 (0.27%) 
Oedema peripheral  1  0/373 (0.00%)  1/371 (0.27%) 
Orthostatic intolerance  1  0/373 (0.00%)  1/371 (0.27%) 
Hepatobiliary disorders     
Cholelithiasis  1  2/373 (0.54%)  0/371 (0.00%) 
Infections and infestations     
Acute sinusitis  1  0/373 (0.00%)  1/371 (0.27%) 
Appendicitis  1  1/373 (0.27%)  1/371 (0.27%) 
Arthritis bacterial  1  0/373 (0.00%)  1/371 (0.27%) 
Bronchitis  1  1/373 (0.27%)  1/371 (0.27%) 
Bursitis infective  1  1/373 (0.27%)  0/371 (0.00%) 
Campylobacter gastroenteritis  1  1/373 (0.27%)  0/371 (0.00%) 
Erysipelas  1  1/373 (0.27%)  0/371 (0.00%) 
Gastroenteritis  1  1/373 (0.27%)  1/371 (0.27%) 
Gastroenteritis viral  1  0/373 (0.00%)  1/371 (0.27%) 
Herpes zoster  1  1/373 (0.27%)  0/371 (0.00%) 
Lobar pneumonia  1  0/373 (0.00%)  1/371 (0.27%) 
Pneumonia  1  2/373 (0.54%)  0/371 (0.00%) 
Pneumonia pneumococcal  1  1/373 (0.27%)  0/371 (0.00%) 
Postoperative wound infection  1  1/373 (0.27%)  1/371 (0.27%) 
Urinary tract infection  1  1/373 (0.27%)  0/371 (0.00%) 
Viral infection  1  0/373 (0.00%)  1/371 (0.27%) 
Injury, poisoning and procedural complications     
Accident at work  1  1/373 (0.27%)  0/371 (0.00%) 
Anaesthetic complication  1  1/373 (0.27%)  0/371 (0.00%) 
Ankle fracture  1  2/373 (0.54%)  0/371 (0.00%) 
Back injury  1  1/373 (0.27%)  0/371 (0.00%) 
Clavicle fracture  1  1/373 (0.27%)  0/371 (0.00%) 
Drug administration error  1  1/373 (0.27%)  0/371 (0.00%) 
Facial bones fracture  1  0/373 (0.00%)  1/371 (0.27%) 
Fall  1  7/373 (1.88%)  7/371 (1.89%) 
Femoral neck fracture  1  1/373 (0.27%)  1/371 (0.27%) 
Fractured sacrum  1  0/373 (0.00%)  1/371 (0.27%) 
Hip fracture  1  0/373 (0.00%)  1/371 (0.27%) 
Joint sprain  1  1/373 (0.27%)  0/371 (0.00%) 
Limb traumatic amputation  1  1/373 (0.27%)  0/371 (0.00%) 
Lower limb fracture  1  0/373 (0.00%)  1/371 (0.27%) 
Medical device complication  1  1/373 (0.27%)  0/371 (0.00%) 
Meniscus lesion  1  2/373 (0.54%)  1/371 (0.27%) 
Muscle rupture  1  0/373 (0.00%)  1/371 (0.27%) 
Pelvic fracture  1  1/373 (0.27%)  0/371 (0.00%) 
Post procedural haemorrhage  1  1/373 (0.27%)  0/371 (0.00%) 
Postoperative fever  1  1/373 (0.27%)  0/371 (0.00%) 
Rib fracture  1  1/373 (0.27%)  0/371 (0.00%) 
Road traffic accident  1  2/373 (0.54%)  2/371 (0.54%) 
Scrotal haematoma  1  0/373 (0.00%)  1/371 (0.27%) 
Spinal fracture  1  1/373 (0.27%)  2/371 (0.54%) 
Stress fracture  1  0/373 (0.00%)  1/371 (0.27%) 
Tendon rupture  1  0/373 (0.00%)  1/371 (0.27%) 
Thermal burn  1  0/373 (0.00%)  1/371 (0.27%) 
Traumatic brain injury  1  0/373 (0.00%)  1/371 (0.27%) 
Wrist fracture  1  2/373 (0.54%)  0/371 (0.00%) 
Investigations     
Weight decreased  1  1/373 (0.27%)  0/371 (0.00%) 
Metabolism and nutrition disorders     
Diabetes mellitus  1  0/373 (0.00%)  1/371 (0.27%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/373 (0.27%)  3/371 (0.81%) 
Arthritis  1  0/373 (0.00%)  1/371 (0.27%) 
Back pain  1  0/373 (0.00%)  3/371 (0.81%) 
Bursa calcification  1  0/373 (0.00%)  1/371 (0.27%) 
Compartment syndrome  1  0/373 (0.00%)  1/371 (0.27%) 
Intervertebral disc degeneration  1  1/373 (0.27%)  1/371 (0.27%) 
Intervertebral disc disorder  1  1/373 (0.27%)  0/371 (0.00%) 
Intervertebral disc protrusion  1  4/373 (1.07%)  5/371 (1.35%) 
Intervertebral disc space narrowing  1  1/373 (0.27%)  0/371 (0.00%) 
Lumbar spinal stenosis  1  1/373 (0.27%)  0/371 (0.00%) 
Mobility decreased  1  1/373 (0.27%)  0/371 (0.00%) 
Muscle spasms  1  0/373 (0.00%)  1/371 (0.27%) 
Musculoskeletal chest pain  1  0/373 (0.00%)  1/371 (0.27%) 
Musculoskeletal pain  1  1/373 (0.27%)  0/371 (0.00%) 
Osteoarthritis  1  5/373 (1.34%)  2/371 (0.54%) 
Osteonecrosis  1  1/373 (0.27%)  0/371 (0.00%) 
Pain in extremity  1  1/373 (0.27%)  0/371 (0.00%) 
Spinal column stenosis  1  0/373 (0.00%)  1/371 (0.27%) 
Spinal osteoarthritis  1  1/373 (0.27%)  1/371 (0.27%) 
Spondylolisthesis  1  1/373 (0.27%)  0/371 (0.00%) 
Synovial cyst  1  1/373 (0.27%)  2/371 (0.54%) 
Torticollis  1  0/373 (0.00%)  1/371 (0.27%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
B-cell lymphoma  1  1/373 (0.27%)  0/371 (0.00%) 
Basal cell carcinoma  1  6/373 (1.61%)  5/371 (1.35%) 
Bowen's disease  1  0/373 (0.00%)  1/371 (0.27%) 
Breast cancer  1  1/373 (0.27%)  2/371 (0.54%) 
Cartilage neoplasm  1  0/373 (0.00%)  1/371 (0.27%) 
Colon adenoma  1  1/373 (0.27%)  0/371 (0.00%) 
Gastric cancer  1  0/373 (0.00%)  1/371 (0.27%) 
Leiomyosarcoma  1  1/373 (0.27%)  0/371 (0.00%) 
Lung adenocarcinoma metastatic  1  1/373 (0.27%)  0/371 (0.00%) 
Lung neoplasm malignant  1  1/373 (0.27%)  0/371 (0.00%) 
Lymphoma  1  1/373 (0.27%)  0/371 (0.00%) 
Malignant melanoma  1  0/373 (0.00%)  1/371 (0.27%) 
Metastases to bone  1  1/373 (0.27%)  0/371 (0.00%) 
Metastases to central nervous system  1  1/373 (0.27%)  0/371 (0.00%) 
Metastases to lung  1  1/373 (0.27%)  0/371 (0.00%) 
Metastases to lymph nodes  1  0/373 (0.00%)  2/371 (0.54%) 
Multiple myeloma  1  1/373 (0.27%)  0/371 (0.00%) 
Oesophageal cancer metastatic  1  1/373 (0.27%)  0/371 (0.00%) 
Ovarian cancer  1  1/373 (0.27%)  0/371 (0.00%) 
Prostate cancer  1  9/373 (2.41%)  2/371 (0.54%) 
Renal cell carcinoma  1  0/373 (0.00%)  1/371 (0.27%) 
Skin cancer  1  0/373 (0.00%)  1/371 (0.27%) 
Squamous cell carcinoma  1  2/373 (0.54%)  4/371 (1.08%) 
Uterine leiomyoma  1  0/373 (0.00%)  1/371 (0.27%) 
Uterine leiomyosarcoma  1  1/373 (0.27%)  0/371 (0.00%) 
Nervous system disorders     
Amnesia  1  1/373 (0.27%)  0/371 (0.00%) 
Autonomic nervous system imbalance  1  0/373 (0.00%)  1/371 (0.27%) 
Balance disorder  1  0/373 (0.00%)  1/371 (0.27%) 
Carotid artery stenosis  1  0/373 (0.00%)  1/371 (0.27%) 
Coma  1  0/373 (0.00%)  1/371 (0.27%) 
Depressed level of consciousness  1  1/373 (0.27%)  0/371 (0.00%) 
Dystonia  1  1/373 (0.27%)  0/371 (0.00%) 
Facial palsy  1  1/373 (0.27%)  1/371 (0.27%) 
Loss of consciousness  1  1/373 (0.27%)  2/371 (0.54%) 
Parkinson's disease  1  2/373 (0.54%)  1/371 (0.27%) 
Parkinsonism  1  2/373 (0.54%)  2/371 (0.54%) 
Restless legs syndrome  1  1/373 (0.27%)  0/371 (0.00%) 
Ruptured cerebral aneurysm  1  1/373 (0.27%)  0/371 (0.00%) 
Sciatica  1  2/373 (0.54%)  0/371 (0.00%) 
Spinal claudication  1  1/373 (0.27%)  0/371 (0.00%) 
Stupor  1  0/373 (0.00%)  1/371 (0.27%) 
Subarachnoid haemorrhage  1  1/373 (0.27%)  2/371 (0.54%) 
Sudden onset of sleep  1  1/373 (0.27%)  2/371 (0.54%) 
Syncope  1  0/373 (0.00%)  1/371 (0.27%) 
Transient ischaemic attack  1  0/373 (0.00%)  1/371 (0.27%) 
Tremor  1  1/373 (0.27%)  0/371 (0.00%) 
Psychiatric disorders     
Delirium  1  1/373 (0.27%)  0/371 (0.00%) 
Depression  1  1/373 (0.27%)  0/371 (0.00%) 
Disorientation  1  1/373 (0.27%)  0/371 (0.00%) 
Hallucination  1  1/373 (0.27%)  0/371 (0.00%) 
Hallucination, visual  1  1/373 (0.27%)  0/371 (0.00%) 
Hypersexuality  1  1/373 (0.27%)  0/371 (0.00%) 
Mental status changes  1  0/373 (0.00%)  2/371 (0.54%) 
Rapid eye movements sleep abnormal  1  1/373 (0.27%)  1/371 (0.27%) 
Stress  1  1/373 (0.27%)  0/371 (0.00%) 
Renal and urinary disorders     
Urinary fistula  1  1/373 (0.27%)  0/371 (0.00%) 
Urinary retention  1  2/373 (0.54%)  0/371 (0.00%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  1/373 (0.27%)  0/371 (0.00%) 
Ovarian cyst  1  0/373 (0.00%)  1/371 (0.27%) 
Prostatitis  1  1/373 (0.27%)  0/371 (0.00%) 
Uterine prolapse  1  1/373 (0.27%)  0/371 (0.00%) 
Vaginal prolapse  1  0/373 (0.00%)  1/371 (0.27%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome  1  0/373 (0.00%)  1/371 (0.27%) 
Asthma  1  0/373 (0.00%)  1/371 (0.27%) 
Dyspnoea  1  2/373 (0.54%)  3/371 (0.81%) 
Pharyngeal hypoaesthesia  1  1/373 (0.27%)  0/371 (0.00%) 
Pneumonia aspiration  1  1/373 (0.27%)  0/371 (0.00%) 
Pulmonary embolism  1  1/373 (0.27%)  0/371 (0.00%) 
Skin and subcutaneous tissue disorders     
Precancerous skin lesion  1  1/373 (0.27%)  0/371 (0.00%) 
Vascular disorders     
Aortic aneurysm  1  0/373 (0.00%)  1/371 (0.27%) 
Circulatory collapse  1  0/373 (0.00%)  2/371 (0.54%) 
Deep vein thrombosis  1  1/373 (0.27%)  0/371 (0.00%) 
Orthostatic hypotension  1  1/373 (0.27%)  2/371 (0.54%) 
Peripheral ischaemia  1  1/373 (0.27%)  0/371 (0.00%) 
Phlebitis superficial  1  1/373 (0.27%)  0/371 (0.00%) 
Subclavian artery stenosis  1  1/373 (0.27%)  0/371 (0.00%) 
Thrombosis  1  1/373 (0.27%)  1/371 (0.27%) 
Varicose vein  1  0/373 (0.00%)  1/371 (0.27%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Carbidopa/Levodopa/Entacapone Carbidopa/Levodopa
Affected / at Risk (%) Affected / at Risk (%)
Total   310/373 (83.11%)   291/371 (78.44%) 
Gastrointestinal disorders     
Constipation  1  50/373 (13.40%)  44/371 (11.86%) 
Diarrhoea  1  65/373 (17.43%)  28/371 (7.55%) 
Dry mouth  1  19/373 (5.09%)  13/371 (3.50%) 
Dyspepsia  1  14/373 (3.75%)  20/371 (5.39%) 
Nausea  1  114/373 (30.56%)  70/371 (18.87%) 
Vomiting  1  22/373 (5.90%)  9/371 (2.43%) 
General disorders     
Fatigue  1  40/373 (10.72%)  42/371 (11.32%) 
Oedema peripheral  1  27/373 (7.24%)  34/371 (9.16%) 
Infections and infestations     
Bronchitis  1  20/373 (5.36%)  20/371 (5.39%) 
Nasopharyngitis  1  34/373 (9.12%)  43/371 (11.59%) 
Upper respiratory tract infection  1  19/373 (5.09%)  17/371 (4.58%) 
Urinary tract infection  1  20/373 (5.36%)  24/371 (6.47%) 
Injury, poisoning and procedural complications     
Fall  1  28/373 (7.51%)  36/371 (9.70%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  38/373 (10.19%)  43/371 (11.59%) 
Back pain  1  47/373 (12.60%)  53/371 (14.29%) 
Muscle spasms  1  20/373 (5.36%)  21/371 (5.66%) 
Pain in extremity  1  37/373 (9.92%)  32/371 (8.63%) 
Nervous system disorders     
Dizziness  1  59/373 (15.82%)  46/371 (12.40%) 
Dyskinesia  1  21/373 (5.63%)  10/371 (2.70%) 
Headache  1  37/373 (9.92%)  26/371 (7.01%) 
Somnolence  1  37/373 (9.92%)  28/371 (7.55%) 
Tremor  1  11/373 (2.95%)  26/371 (7.01%) 
Psychiatric disorders     
Abnormal dreams  1  25/373 (6.70%)  17/371 (4.58%) 
Anxiety  1  37/373 (9.92%)  27/371 (7.28%) 
Depression  1  57/373 (15.28%)  51/371 (13.75%) 
Insomnia  1  47/373 (12.60%)  53/371 (14.29%) 
Skin and subcutaneous tissue disorders     
Rash  1  13/373 (3.49%)  19/371 (5.12%) 
Vascular disorders     
Hypertension  1  19/373 (5.09%)  27/371 (7.28%) 
Orthostatic hypotension  1  19/373 (5.09%)  11/371 (2.96%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862 778-8300
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00099268     History of Changes
Other Study ID Numbers: CELC200A2401
First Submitted: December 10, 2004
First Posted: December 10, 2004
Results First Submitted: December 15, 2010
Results First Posted: March 8, 2011
Last Update Posted: April 23, 2012