Parkinson Disease
Conditions
Keywords
Parkinson's disease, PD, GM1 Ganglioside, Sygen
Brief summary
The purpose of this trial is to examine the short term effects (24 Weeks) of GM1 on Parkinson's disease (PD) symptoms, as well as the effects of long-term treatment (120 Weeks) with GM1 on disease progression, and to examine the extent to which GM1 treatment influences the underlying disease process in PD.
Detailed description
The study is designed to further examine the extent to which GM1 ganglioside can improve symptoms, delay disease progression, and, perhaps, partially restore damaged brain cells in PD patients. GM1 ganglioside is a chemical that is normally found in the brain and is a normal part of the outer covering or membrane of nerve cells. This study will compare the effectiveness of GM1 to standard PD treatment. In addition to studying clinical measures of motor and cognitive functioning, the investigators will use PET (positron emission tomography) scanning to image the brain and the dopamine nerve endings in a subgroup of patients. Patients with mild to moderate idiopathic PD will be divided into 2 groups. One group will receive GM1 for 24 weeks and the other will receive placebo. At the end of this 24 week period, all patients will enter into a 96 week treatment period in which all patients will receive GM1. In parallel, a group of standard-of-care patients with mild to moderate PD will be monitored over a 1 to 2 year period to assess the natural progression of PD. These patients will receive the same clinical evaluations as the treatment group subjects but they will not receive the experimental medication.
Interventions
DRUGGM1 ganglioside
100 mg twice per day by subcutaneous injection
DRUGPlacebo
Twice per day subcutaneous injection, equal volume as active drug
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
39 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Btwn ages of 39-85 yrs old. * Females: at least 2 years post-menopausal; surgically sterile; or negative pregnancy test by quantitative serum ßHCG, & follow a reliable method of birth control for at least 2 months prior to entry, agree both to follow a reliable method of birth control, & to desist from breast feeding during, & for 1 month following, the study drug administration. * Dx of idiopathic PD 6 months prior to screening. The diagnosis requires: the presence of at least 2 of the 4 cardinal clinical manifestations of the disease, tremor, rigidity, bradykinesia, and disturbances of posture or gait, & at least 1 must be rigidity or bradykinesia. * Modified Hoehn and Yahr Staging between 1 and 3 as rated during an off period of at least 12 hours. * Unified Parkinson's Disease Rating Scale motor component score between 10 and 40 as rated during an off period of at least 12 hours and a score of 6 or greater during on period. * Antiparkinsonian treatments: stable treatment of l-dopa/carbidopa and/or dopamine agonist for at least 3 months prior to Screening. * Mini Mental State Exam score \> 25. * Beck Depression Inventory score \< 10. * Signed informed consent.
Exclusion criteria
* Abrupt onset of Parkinsonism. * Failure of Parkinsonian symptoms to have responded to l-dopa. * Motor symptoms (such as peak dose dyskinesias (UPDRS score \> 3), & random on-off phenomenon, other than end-of-dose wearing-off, persistently fluctuating over a 6 month or longer period, in response to l-dopa. * Hx of findings of any movement disorder other than idiopathic PD. * A tremor score on the UPDRS motor scale of \>5. Tremor score greater than 3 in an individual limb. * High-dose vitamin E therapy (more than 1000 I.U./day) any time during the period starting 3 months prior baseline. * Transient ischemic attack any time during the period starting 6 months prior baseline. * Hx of 2 or more strokes. Hx of any stroke that resulted in motor deficit, movement disorder, ataxia, cognitive impairment, or a hemi-inattention syndrome. Any stroke with residua at the time of, or within 6 months preceding, study entry. * Previous cerebral infarction, including lacunar infarction, in any area subserving motor function. * Binswanger's disease or hx of hypertensive encephalopathy. * Hx of encephalitis. * Hx of extended exposure to any known neurotoxin that may cause parkinsonism, or chronic or sufficient use or consumption of any non-medicinal substance that could cause risk of developing a movement disorder or disturbance of posture or gait. * Use of the following drugs within 6 months prior to screening: neuroleptics, metoclopramide, clozapine, flunarizine, alpha-methyldopa. * Patients actively taking a medicine that is known to compete with the imaging agent for binding sites on the dopamine terminals. * Hx of medication or drug use that may have caused atypical parkinsonism or history of Substance Use Disorder. * Hx of a metabolic disorder that resulted or could have resulted in movement disorder or disturbance of posture or gait. * Any disease or condition that resulted or could have resulted in a movement disorder or disturbance of posture or gait. * Hx of intracranial hemorrhage, intracranial neoplasm, significant head trauma with loss of consciousness \>24 hrs or other structural brain disease. * Hx or clinical findings suggestive of progressive supranuclear palsy or multiple system atrophy. * Acquired cognitive impairment reasonably possibly due to any cause other than idiopathic PD. * Hx of a hereditary disorder associated with a movement disorder. * Normal or low pressure hydrocephalus. * Any ill-defined neuropathic disease, myelopathy, myopathy or other medical disorder or physical condition by history or clinical examination that could be expected to interfere with the diagnosis, treatment or assessment of PD, or with any of the study assessments. * Hx of Guillain-Barré syndrome, chronic idiopathic polyneuropathy, or relapsing polyneuropathy. * Hx of Axis I or Axis II major psychiatric disorder. * Significant cardiac, pulmonary, hepatic, gastrointestinal, or renal disease. * Any condition that could alter the distribution, accumulation, metabolism, or excretion of the study medication; or result in a life expectancy of less than 2 years. * Any primarily non-neurologic medical condition with a significant risk of secondarily causing neurologic dysfunction. * Myocardial infarction within 6 months prior to screening. * Presence of any medical condition or laboratory test abnormality or use of any licit or illicit substance which could cause unwarranted risk from participation in the study or result in worsening in the patient's medical condition during participation in study. Presence of any of the following laboratory test abnormalities are unwarranted risk: serum transaminase greater than twice the upper limit of normal;serum creatinine greater than 2.0 mg/dl in a man or greater than 1.7 mg/dl in a woman. * Hx of a life-threatening allergic or immune-mediated reaction. * Previous use of any ganglioside preparation. * Use of any experimental drug in the period starting 60 days before Baseline. * Hx of stereotaxic brain surgery for PD.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From Baseline to Week 24 Assessed Off Medication. | Baseline to Week 24 | The Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) motor scores assess 14 symptoms some of which separately assess symptoms in different body parts (e.g. right arm, left arm, right leg, left leg) and each symptom is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 108. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis. |
| Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Scores From Baseline to Week 120 Assessed Off Medication. | Baseline to Week 120 | The Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) motor scores assess 14 symptoms some of which separately assess symptoms in different body parts (e.g. right arm, left arm, right leg, left leg) and each symptom is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 108. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From Baseline to Week 24 Assessed Off Medication. | Baseline to Week 24 | The Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) motor scores assess 14 symptoms some of which separately assess symptoms in different body parts (e.g. right arm, left arm, right leg, left leg) and each symptom is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 108. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis. |
| Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From Baseline to Week 48 Assessed Off Medication. | Baseline to Week 48 | The Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) motor scores assess 14 symptoms some of which separately assess symptoms in different body parts (e.g. right arm, left arm, right leg, left leg) and each symptom is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 108. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis. |
| Change From Baseline to Week 24 in Total Unified Parkinson's Disease Rating Scale (UPDRS)Score Assessed Off Medication | Baseline to Week 24 | The total Unified Parkinson's Disease Rating Scale (UPDRS) score is derived from Part I (Mentation, Behavior and Mood), Part II (Activities of Daily Living) and Part III (Motor Examination). Part I assesses 4 functions; Part II assesses 13 activities of daily living; Part III assesses 14 motor symptoms. Each item is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 176. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis. |
| Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From Baseline to Week 96 Assessed Off Medication. | Baseline to Week 96 | The Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) motor scores assess 14 symptoms some of which separately assess symptoms in different body parts (e.g. right arm, left arm, right leg, left leg) and each symptom is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 108. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis. |
| Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From Baseline to Week 72 Assessed Off Medication. | Baseline to Week 72 | The Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) motor scores assess 14 symptoms some of which separately assess symptoms in different body parts (e.g. right arm, left arm, right leg, left leg) and each symptom is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 108. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis. |
| Change in Total UPDRS Score From Baseline to Week 120 Assessed Off Medication | Baseline to Week 120 | The total Unified Parkinson's Disease Rating Scale (UPDRS) score is derived from Part I (Mentation, Behavior and Mood), Part II (Activities of Daily Living) and Part III (Motor Examination). Part I assesses 4 functions; Part II assesses 13 activities of daily living; Part III assesses 14 motor symptoms. Each item is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 176. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis. |
Countries
United States
Participant flow
Recruitment details
Seventy-seven PD patients were recruited from all across the US for this single center, double-blind, delayed start trial of GM1. Seventeen subjects participated in the comparison group. Enrollment for the study began Nov 1999 and was completed in Jan 2006. Subjects were seen at the Parkinson's Disease Research Unit at Thomas Jefferson University.
Participants by arm
| Arm | Count |
|---|---|
| Early-Start Group Phase I: Thirty nine subjects were randomized to receive GM1 for 24 weeks. | 39 |
| Delayed-Start Group Phase I: Thiry eight subjects were randomized to receive placebo for 24 weeks. | 38 |
| Comparison Group This group of PD patients who received standard of care were followed for one to two years to provide comparative information about natural disease progression. This group was not statistically compared to the treatment groups since this group was not randomized. | 17 |
| Total | 94 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 | 0 |
| Overall Study | Protocol Violation | 2 | 2 | 0 |
| Overall Study | Unrelated Medical Problem | 2 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 5 | 1 |
Baseline characteristics
| Characteristic | Total | Early-Start Group | Delayed-Start Group | Comparison Group |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 29 Participants | 12 Participants | 9 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 65 Participants | 27 Participants | 29 Participants | 9 Participants |
| Age Continuous | 59.5 years STANDARD_DEVIATION 9.6 | 59.7 years STANDARD_DEVIATION 8.4 | 57.7 years STANDARD_DEVIATION 8.7 | 61.1 years STANDARD_DEVIATION 11.8 |
| Region of Enrollment United States | 94 participants | 39 participants | 38 participants | 17 participants |
| Sex: Female, Male Female | 22 Participants | 10 Participants | 9 Participants | 3 Participants |
| Sex: Female, Male Male | 72 Participants | 29 Participants | 29 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 39 / 39 | 38 / 38 | 0 / 17 |
| serious Total, serious adverse events | 2 / 39 | 1 / 38 | 0 / 17 |
Outcome results
Primary
Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From Baseline to Week 24 Assessed Off Medication.
The Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) motor scores assess 14 symptoms some of which separately assess symptoms in different body parts (e.g. right arm, left arm, right leg, left leg) and each symptom is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 108. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.
Time frame: Baseline to Week 24
Population: Analysis was per protocol. Two subjects randomized to the Early-Start group withdrew from the study shortly after starting. The comparison group was not compared statistically to the treatment group since they were not randomized.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early-Start Group | Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From Baseline to Week 24 Assessed Off Medication. | -3.57 Scores on a scale | Standard Error 0.503 |
| Delayed-Start Group | Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From Baseline to Week 24 Assessed Off Medication. | 1.85 Scores on a scale | Standard Error 0.497 |
Comparison: The null hypothesis for Phase I was that at week 24, there is no difference between UPDRS motor scores in placebo vs. GM1-treated subjects.p-value: <0.0001t-test, 2 sided
Primary
Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Scores From Baseline to Week 120 Assessed Off Medication.
The Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) motor scores assess 14 symptoms some of which separately assess symptoms in different body parts (e.g. right arm, left arm, right leg, left leg) and each symptom is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 108. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.
Time frame: Baseline to Week 120
Population: Analysis was per protocol. Two subjects randomized to the Early-Start group withdrew from the study shortly after starting. The comparison group was not compared statistically to the treatment group since they were not randomized.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early-Start Group | Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Scores From Baseline to Week 120 Assessed Off Medication. | -1.80 Scores on a scale | Standard Error 1.117 |
| Delayed-Start Group | Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Scores From Baseline to Week 120 Assessed Off Medication. | 1.53 Scores on a scale | Standard Error 1.092 |
Comparison: The null hypothesis for Phase II is that long-term use of GM1 does not affect the progression of PD symptoms and that there is no benefit to early start of GM1 use.p-value: 0.0368t-test, 2 sided
Secondary
Change From Baseline to Week 24 in Total Unified Parkinson's Disease Rating Scale (UPDRS)Score Assessed Off Medication
The total Unified Parkinson's Disease Rating Scale (UPDRS) score is derived from Part I (Mentation, Behavior and Mood), Part II (Activities of Daily Living) and Part III (Motor Examination). Part I assesses 4 functions; Part II assesses 13 activities of daily living; Part III assesses 14 motor symptoms. Each item is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 176. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.
Time frame: Baseline to Week 24
Population: Analysis was per protocol. Two subjects randomized to the Early-Start group withdrew from the study shortly after starting. The comparison group was not compared statistically to the treatment group since they were not randomized.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early-Start Group | Change From Baseline to Week 24 in Total Unified Parkinson's Disease Rating Scale (UPDRS)Score Assessed Off Medication | -5.31 Scores on a scale | Standard Error 0.84 |
| Delayed-Start Group | Change From Baseline to Week 24 in Total Unified Parkinson's Disease Rating Scale (UPDRS)Score Assessed Off Medication | 1.88 Scores on a scale | Standard Error 0.83 |
p-value: <0.0001t-test, 2 sided
Secondary
Change in Total UPDRS Score From Baseline to Week 120 Assessed Off Medication
The total Unified Parkinson's Disease Rating Scale (UPDRS) score is derived from Part I (Mentation, Behavior and Mood), Part II (Activities of Daily Living) and Part III (Motor Examination). Part I assesses 4 functions; Part II assesses 13 activities of daily living; Part III assesses 14 motor symptoms. Each item is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 176. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.
Time frame: Baseline to Week 120
Population: Analysis was per protocol. Two subjects randomized to the Early-Start group withdrew from the study shortly after starting. The comparison group was not compared statistically to the treatment group since they were not randomized.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early-Start Group | Change in Total UPDRS Score From Baseline to Week 120 Assessed Off Medication | -1.01 Scores on a scale | Standard Error 1.764 |
| Delayed-Start Group | Change in Total UPDRS Score From Baseline to Week 120 Assessed Off Medication | 3.56 Scores on a scale | Standard Error 1.726 |
p-value: 0.131t-test, 2 sided
Secondary
Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From Baseline to Week 24 Assessed Off Medication.
The Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) motor scores assess 14 symptoms some of which separately assess symptoms in different body parts (e.g. right arm, left arm, right leg, left leg) and each symptom is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 108. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.
Time frame: Baseline to Week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early-Start Group | Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From Baseline to Week 24 Assessed Off Medication. | 2.28 Scores on a scale | Standard Error 0.866 |
Comparison: Analysis was paired sample t-test on change from baseline.p-value: <0.05t-test, 2 sided
Secondary
Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From Baseline to Week 48 Assessed Off Medication.
The Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) motor scores assess 14 symptoms some of which separately assess symptoms in different body parts (e.g. right arm, left arm, right leg, left leg) and each symptom is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 108. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.
Time frame: Baseline to Week 48
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early-Start Group | Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From Baseline to Week 48 Assessed Off Medication. | 4.41 Scores on a scale | Standard Error 1.434 |
p-value: <0.01t-test, 2 sided
Secondary
Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From Baseline to Week 72 Assessed Off Medication.
The Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) motor scores assess 14 symptoms some of which separately assess symptoms in different body parts (e.g. right arm, left arm, right leg, left leg) and each symptom is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 108. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.
Time frame: Baseline to Week 72
Population: Number of subjects enrolled at this time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early-Start Group | Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From Baseline to Week 72 Assessed Off Medication. | 5.95 Scores on a scale | Standard Error 1.22 |
p-value: <0.01t-test, 2 sided
Secondary
Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From Baseline to Week 96 Assessed Off Medication.
The Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) motor scores assess 14 symptoms some of which separately assess symptoms in different body parts (e.g. right arm, left arm, right leg, left leg) and each symptom is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 108. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.
Time frame: Baseline to Week 96
Population: Number of subjects enrolled at this time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early-Start Group | Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From Baseline to Week 96 Assessed Off Medication. | 7.81 Scores on scale | Standard Error 2.014 |
p-value: <0.01t-test, 2 sided
Post Hoc
Estimated Change in Points Per Week on Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score Assessed Off Medication
Unified Parkinson's Disease Rating Scale (UPDRS) A four part scale used to assess the severity of Parkinson's disease symptoms. Part I contains questions concerning the patient's mentation, behavior and mood. Part II asks questions about the patient's ability to perform activities of daily living. Part III is the motor examination of the patient's symptoms ranging in scores from 0 to 4 with 0 equaling either normal or absence of symptoms. The minimum score on this section is 0 and the maximum is 108. Part IV asks the patient questions about any complications of therapy they have experienced within the past week. However, for this study the total UPDRS included Parts I, II, and III. A higher the score on the scale indicates more severe symptoms.
Time frame: Week 6 to Week 24
Population: Analysis was per protocol. Two subjects randomized to the Early-Start group withdrew from the study shortly after starting. The comparison group was not compared statistically to the treatment group since they were not randomized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early-Start Group | Estimated Change in Points Per Week on Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score Assessed Off Medication | 0.04 Scores on a scale | Standard Error 0.03 |
| Delayed-Start Group | Estimated Change in Points Per Week on Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score Assessed Off Medication | 0.08 Scores on a scale | Standard Error 0.03 |
p-value: 0.1903estimate of slope of change over time
p-value: 0.0063estimate slope of change over time
Post Hoc
Estimated Rate of Change in Unified Parkinson's Disease Rating Scale (UPDRS)Motor Scores Assessed Off Medication
Time frame: Week 36 to Week 120
Population: Analysis was per protocol. Two subjects randomized to the Early-Start group withdrew from the study shortly after starting. The comparison group was not compared statistically to the treatment group since they were not randomized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early-Start Group | Estimated Rate of Change in Unified Parkinson's Disease Rating Scale (UPDRS)Motor Scores Assessed Off Medication | 0.02 Scores on a scale | Standard Error 0.01 |
| Delayed-Start Group | Estimated Rate of Change in Unified Parkinson's Disease Rating Scale (UPDRS)Motor Scores Assessed Off Medication | 0.04 Scores on a scale | Standard Error 0.01 |
p-value: 0.0502estimate of slope of change over time
p-value: 0.0003estimate slope of change over time