Parkinson DiseasePhase 2NCT00037830
GM1 Ganglioside Effects on Parkinson's Disease
A Phase 2 study testing GM1 ganglioside in people with Parkinson Disease, run by Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 39 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- GM1 ganglioside
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 1999to Jun 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 39 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- Mini Mental State Exam score > 25.
- Beck Depression Inventory score < 10.
- Signed informed consent.
Who cannot join
- 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.
Show all 34Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Parkinson's Disease Research Unit, Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: The Study of GM1 Ganglioside, A Potential New Parkinson's Disease Medication
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- GM1 ganglioside, Placebo
- Keywords
- Parkinson's disease, PD, GM1 Ganglioside, Sygen
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GM1 gangliosideDrug
Also called Sygen
100 mg twice per day by subcutaneous injection
PlaceboDrug
Twice per day subcutaneous injection, equal volume as active drug
| Study group | Role | What they receive |
|---|---|---|
| Early-Start Group | Active comparator | Subjects were randomized to receive GM1 ganglioside for 24 weeks. Receives: Drug: GM1 ganglioside |
| Delayed-Start Group | Placebo comparator | Subjects were randomized to receive placebo for 24 weeks. Receives: Drug: Placebo |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to Week 120
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2002 (estimated)
- Study startNov 1999
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jay S. Schneider, Ph.D., Principal investigator, Parkinson's Disease Research Unit, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00037830
- Sponsor's protocol ID
- R01NS038681
- Other IDs
- R01NS038681
- Status last verified
- Dec 2012
- First submitted
- 22 May 2002
- Last updated
- 21 Dec 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of GM1 Ganglioside, A Potential New Parkinson's Disease Medication
- ClinicalTrials.gov ID
- NCT00037830
- Acronym / sponsor ID
- R01NS038681
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's disease, PD, GM1 Ganglioside, Sygen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Nov 1999
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 23 May 2002 (estimated)
- Results
- Posted 9 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Early-Start Group | Active comparator | Drug: GM1 gangliosideSubjects were randomized to receive GM1 ganglioside for 24 weeks. |
| Delayed-Start Group | Placebo comparator | Drug: PlaceboSubjects 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. |
Who may qualify
- Ages
- 39 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (34 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GM1 gangliosideAlso: Sygen100 mg twice per day by subcutaneous injection | Drug | Early-Start Group |
| PlaceboTwice per day subcutaneous injection, equal volume as active drug | Drug | Delayed-Start Group |
Primary outcome
Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From Baseline to Week 24 Assessed Off Medication.
Time frame: 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.
Time frame: 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.
6 secondary outcomes
Change From Baseline to Week 24 in Total Unified Parkinson's Disease Rating Scale (UPDRS)Score Assessed Off Medication
Time frame: Baseline to Week 24
Change in Total UPDRS Score From Baseline to Week 120 Assessed Off Medication
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Week 96
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jay S. Schneider, Ph.D. principal investigator
Parkinson's Disease Research Unit, Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GM1 ganglioside in people with Parkinson Disease, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From Baseline to Week 24 Assessed Off Medication. (time frame: Baseline to Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2012.