Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01NS038681 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early-Start Group | Active Comparator | Subjects were randomized to receive GM1 ganglioside for 24 weeks. |
|
| Delayed-Start Group | Placebo Comparator | Subjects were randomized to receive placebo for 24 weeks. |
|
| Comparison Group | No Intervention | A separate group of Parkinson's disease patients who received standard of care were followed for one to two years to provide comparative information about natural disease progression. This comparison group was not compared statistically to the treatment groups since they were not randomized. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GM1 ganglioside | Drug | 100 mg twice per day by subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Week 24 |
| 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. | Baseline to Week 120 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jay S. Schneider, Ph.D. | Parkinson's Disease Research Unit, Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkinson's Disease Research Unit, Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Early-Start Group | Phase I: Thirty nine subjects were randomized to receive GM1 for 24 weeks. |
| FG001 | Delayed-Start Group | Phase I: Thiry eight subjects were randomized to receive placebo for 24 weeks. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Early-Start Group | Phase I: Thirty nine subjects were randomized to receive GM1 for 24 weeks. |
| BG001 | Delayed-Start Group | Phase I: Thiry eight subjects were randomized to receive placebo for 24 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline to Week 24 |
|
Adverse events were collected for 2 and a half years beginning at baseline.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Early-Start Group | Phase I: Thirty nine subjects were randomized to receive GM1 for 24 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe weakness L>R BLC LE's | General disorders | Asthenia | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jay Schneider | Thomas Jefferson University | 215-503-0370 | jay.schneider@jefferson.edu |
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005677 | G(M1) Ganglioside |
| ID | Term |
|---|---|
| D005732 | Gangliosides |
| D020384 | Acidic Glycosphingolipids |
| D006028 | Glycosphingolipids |
| D006017 | Glycolipids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Twice per day subcutaneous injection, equal volume as active drug |
|
| Baseline to Week 24 |
| 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. | Baseline to Week 120 |
| 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. | Baseline to Week 24 |
| 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. | Baseline to Week 48 |
| 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. | Baseline to Week 72 |
| 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. | Baseline to Week 96 |
| Protocol Violation |
|
| Unrelated Medical Problem |
|
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Group that was randomized to receive GM1 ganglioside 24 weeks |
| OG001 | Delayed-Start Group | Group that was randomized to receive placebo for 24 weeks |
|
|
|
| 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. | 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. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline to Week 120 |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Error | Scores on a scale | Week 6 to Week 24 |
|
|
|
|
| Post-Hoc | Estimated Rate of Change in Unified Parkinson's Disease Rating Scale (UPDRS)Motor Scores Assessed Off Medication | 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. | Posted | Mean | Standard Error | Scores on a scale | Week 36 to Week 120 |
|
|
|
|
| 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. | 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. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline to Week 24 |
|
|
|
|
| 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. | 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. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline to Week 120 |
|
|
|
|
| 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. | Posted | Mean | Standard Error | Scores on a scale | Baseline to Week 24 |
|
|
|
|
| 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. | Posted | Mean | Standard Error | Scores on a scale | Baseline to Week 48 |
|
|
|
|
| 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. | Number of subjects enrolled at this time point. | Posted | Mean | Standard Error | Scores on a scale | Baseline to Week 72 |
|
|
|
|
| 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. | Number of subjects enrolled at this time point. | Posted | Mean | Standard Error | Scores on scale | Baseline to Week 96 |
|
|
|
|
| 2 |
| 39 |
| 39 |
| 39 |
| EG001 | Delayed-Start Group | Phase I: Thiry eight subjects were randomized to receive placebo for 24 weeks. | 1 | 38 | 38 | 38 |
| EG002 | 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. | 0 | 17 | 0 | 17 |
| CT Scan showed an Ulcerating Mass Fungating in Stomach | Injury, poisoning and procedural complications | Anastomotic ulcer | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | Muscle spams | Non-systematic Assessment |
|
| Muscle pain | Musculoskeletal and connective tissue disorders | Myalgia | Non-systematic Assessment |
|
| Increase frequency of dyskinesias | Nervous system disorders | Dyskinesia | Non-systematic Assessment |
|
| Uncontrollable shaking | Nervous system disorders | Tremor | Non-systematic Assessment |
|
| Laproscopic Removal of Stomal Tumor in Stomach | Surgical and medical procedures | Tumor excision | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Injection site nodule | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Injection site haematoma | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Injection site urticaria | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Injection site induration | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Injection site exfoliation | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Eosinophil count increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Crystal urine present | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Alkaline amniotransferase increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Aspartate amnotransferase increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Parkinsonism | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dyskinesia | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Paresthesia | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Freezing phenomenon | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Vivid dreams | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D006001 |
| Glycoconjugates |
| D002241 | Carbohydrates |
| D008055 | Lipids |
| D013107 | Sphingolipids |
| D008563 | Membrane Lipids |
random intercept model and a variance components covariance structure
| 0.0063 |
| 95 |
| No |
| Superiority or Other |
random intercept model and a variance components covariance structure
| 0.0003 |
| 95 |
| No |
| Superiority or Other |