Trial Outcomes & Findings for Carbidopa/Levodopa/Entacapone Versus Immediate Release (IR) Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing Off (NCT NCT00642356)
NCT ID: NCT00642356
Last Updated: 2011-02-18
Results Overview
The QWOQ-9 is a self-rated questionnaire used to assess motor and non-motor symptoms of Parkinson's disease. The 4 non-motor symptoms are each measured on a five item (0-4) Likert scale, reflecting the severity of the item from "not present" to "very severe". The range of possible score values of the non-motor subscale of the QWOQ-9 is 0 to 16. A higher score indicates greater disability. A negative change score indicates improvement.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
14 participants
Primary outcome timeframe
Baseline to 15 minutes prior to 2nd dose at Week 8
Results posted on
2011-02-18
Participant Flow
Participant milestones
| Measure |
Carbidopa/Levodopa/Entacapone
Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study.
|
Immediate Release Carbidopa/Levodopa
Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
|
Overall Study
COMPLETED
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Carbidopa/Levodopa/Entacapone
Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study.
|
Immediate Release Carbidopa/Levodopa
Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
3
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
Baseline Characteristics
Carbidopa/Levodopa/Entacapone Versus Immediate Release (IR) Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing Off
Baseline characteristics by cohort
| Measure |
Carbidopa/Levodopa/Entacapone
n=7 Participants
Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study.
|
Immediate Release Carbidopa/Levodopa
n=7 Participants
Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Customized
>= 65 years
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 15 minutes prior to 2nd dose at Week 8Population: All subjects that were assessed for efficacy
The QWOQ-9 is a self-rated questionnaire used to assess motor and non-motor symptoms of Parkinson's disease. The 4 non-motor symptoms are each measured on a five item (0-4) Likert scale, reflecting the severity of the item from "not present" to "very severe". The range of possible score values of the non-motor subscale of the QWOQ-9 is 0 to 16. A higher score indicates greater disability. A negative change score indicates improvement.
Outcome measures
| Measure |
Carbidopa/Levodopa/Entacapone
n=7 Participants
Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study.
|
Immediate Release Carbidopa/Levodopa
n=5 Participants
Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.
|
|---|---|---|
|
Change From Baseline on the Non-motor Score of the Quantitative Wearing-Off Questionnaire 9 Item (QWOQ-9)
|
-0.9 Units on a scale
Standard Deviation 0.90
|
-0.2 Units on a scale
Standard Deviation 2.49
|
SECONDARY outcome
Timeframe: Baseline to 15 minutes prior to 2nd dose at Week 8Population: All subjects that were assessed for efficacy
The QWOQ-9 is a self-rated questionnaire used to assess motor and non-motor symptoms of Parkinson's disease. The 5 motor symptoms are each measured on a five item (0-4) Likert scale, reflecting the severity of the item from "not present" to "very severe". The range of possible score values of the motor subscale of the QWOQ-9 is 0 to 20. A higher score indicates greater disability. A negative change score indicates improvement.
Outcome measures
| Measure |
Carbidopa/Levodopa/Entacapone
n=6 Participants
Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study.
|
Immediate Release Carbidopa/Levodopa
n=5 Participants
Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.
|
|---|---|---|
|
Change From Baseline on the Motor Score of the Quantitative Wearing-Off Questionnaire 9 Item (QWOQ-9)
|
-1.2 Units on a scale
Standard Deviation 2.23
|
0.0 Units on a scale
Standard Deviation 2.00
|
Adverse Events
Carbidopa/Levodopa/Entacapone
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Immediate Release Carbidopa/Levodopa
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Carbidopa/Levodopa/Entacapone
n=7 participants at risk
Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study.
|
Immediate Release Carbidopa/Levodopa
n=7 participants at risk
Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.
|
|---|---|---|
|
General disorders
Nervousness
|
14.3%
1/7
|
0.00%
0/7
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
1/7
|
0.00%
0/7
|
|
Gastrointestinal disorders
Nausea
|
28.6%
2/7
|
0.00%
0/7
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7
|
0.00%
0/7
|
|
General disorders
Fatigue
|
14.3%
1/7
|
0.00%
0/7
|
|
General disorders
Oedema
|
14.3%
1/7
|
0.00%
0/7
|
|
Infections and infestations
Urinary tract infection
|
14.3%
1/7
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/7
|
14.3%
1/7
|
|
Injury, poisoning and procedural complications
Fall
|
14.3%
1/7
|
14.3%
1/7
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/7
|
14.3%
1/7
|
|
Investigations
Urine colour abnormal
|
14.3%
1/7
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
1/7
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/7
|
14.3%
1/7
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
14.3%
1/7
|
0.00%
0/7
|
|
Nervous system disorders
Disturbance in attention
|
14.3%
1/7
|
0.00%
0/7
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7
|
0.00%
0/7
|
|
Nervous system disorders
Headache
|
14.3%
1/7
|
0.00%
0/7
|
|
Nervous system disorders
Somnolence
|
0.00%
0/7
|
14.3%
1/7
|
|
Psychiatric disorders
Anxiety
|
14.3%
1/7
|
0.00%
0/7
|
|
Renal and urinary disorders
Pollakiuria
|
14.3%
1/7
|
14.3%
1/7
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.3%
1/7
|
0.00%
0/7
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862 778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER