A Phase 3 interventional study of creatine and placebo in Parkinson's Disease, sponsored by University of Rochester. Terminated at 50 sites in 2 countries. Per ClinicalTrials.gov, last updated 2015-04-02.
Sponsored by University of Rochester · Phase 3, Interventional, and Treatment
The purpose of this trial is to determine if the nutritional supplement creatine slows the progression of Parkinson's disease over time.
Parkinson's disease (PD) affects nearly a million Americans, a number that will increase over the coming decades as the population ages. Symptoms of PD may include tremor, rigidity or stiffness of the limbs and trunk, slowness of movement, and impaired balance and coordination. These problems occur because as PD worsens, some of the brain cells that control body movement die.
This study will determine if creatine--an investigational compound--is able to slow the progression of PD. Creatine, a widely used dietary supplement is thought to improve exercise performance. In animal models and human studies, creatine has been shown to be well tolerated and may have some ability to protect brain cells.
In the NET-PD LS-1 study, 1,720 participants will be randomly assigned to receive either creatine or a placebo (inactive substance). Participation in this study lasts a minimum of 5 years and includes at least 9 follow-up clinic visits and at least 3 telephone calls.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 1,741 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: placebo
Drug: creatine
Creatine, a widely used dietary supplement is thought to improve exercise performance. In animal models and human studies, creatine has been shown to be well tolerated and may have some ability to protect brain cells. The study is comparing creatine 5 grams twice daily with placebo.
an inactive substance
The Global Outcome Combined Information on Change From Baseline in Schwab England Activities of Daily Living, 39-Item Parkinson's Disease Questionnaire, Ambulatory Capacity, Symbol Digit Modalities, and Modified Rankin at 5 Years.
All outcomes were coded such that higher scores indicated worse outcomes. Patients were ranked on each outcome and their ranks were summed (summed-ranks). Higher summed ranks (range, 5-4775) indicate worse outcomes. The mean summed ranks were compared by treatment group by a global statistical test (GST).
Time frame: Change from baseline to 5 YEARS
| Milestone | Placebo | Creatine |
|---|---|---|
| Started | 867 | 874 |
| Completed year 1 | 802 | 822 |
| Completed year 2 | 768 | 766 |
| Completed year 3 | 719 | 715 |
| Completed year 4 | 521 | 523 |
| Completed | 345 | 340 |
| Not completed | 522 | 534 |
| Withdrew: Withdrawal by subject | 110 | 110 |
| Withdrew: Lost to follow-up | 36 | 37 |
| Withdrew: Physician decision | 13 | 12 |
| Withdrew: Death | 31 | 40 |
| Withdrew: Protocol violation | 8 | 7 |
| Withdrew: Study was stopped | 324 | 328 |
All outcomes were coded such that higher scores indicated worse outcomes. Patients were ranked on each outcome and their ranks were summed (summed-ranks). Higher summed ranks (range, 5-4775) indicate worse outcomes. The mean summed ranks were compared by treatment group by a global statistical test (GST).
| summed-ranks | Placebo | Creatine |
|---|---|---|
| The Global Outcome Combined Information on Change From Baseline in Schwab England Activities of Daily Living, 39-Item Parkinson's Disease Questionnaire, Ambulatory Capacity, Symbol Digit Modalities, and Modified Rankin at 5 Years. | 2360 (2249 to 2470) | 2414 (2304 to 2524) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 347/867 (40%) | 687/867 (79.2%) |
| Creatine | — | 315/874 (36%) | 698/874 (79.9%) |
| Event | Placebo | Creatine |
|---|---|---|
| Deep brain stimulationSurgical and medical procedures | 27/867 | 24/874 |
| PneumoniaInfections and infestations | 18/867 | 16/874 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 16/867 | 15/874 |
| Chest painGeneral disorders | 15/867 | 14/874 |
| SyncopeNervous system disorders | 15/867 | 12/874 |
| ArthritisMusculoskeletal and connective tissue disorders | 6/867 | 13/874 |
| Hip fractureInjury, poisoning and procedural complications | 12/867 | 10/874 |
| Myocardial infarctionCardiac disorders | 8/867 | 12/874 |
| FallInjury, poisoning and procedural complications | 11/867 | 7/874 |
| Spinal column stenosisMusculoskeletal and connective tissue disorders | 11/867 | 4/874 |
| Event | Placebo | Creatine |
|---|---|---|
| OedemaGeneral disorders | 139/867 | 154/874 |
| Weight increasedInvestigations | 101/867 | 137/874 |
| PainGastrointestinal disorders | 122/867 | 121/874 |
| ConstipationGastrointestinal disorders | 107/867 | 121/874 |
| Urinary tract infectionInfections and infestations | 109/867 | 85/874 |
| Back painMusculoskeletal and connective tissue disorders | 106/867 | 105/874 |
| DepressionPsychiatric disorders | 106/867 | 100/874 |
| NauseaGastrointestinal disorders | 101/867 | 99/874 |
| InsomniaPsychiatric disorders | 101/867 | 96/874 |
| Muscle spasmsMusculoskeletal and connective tissue disorders | 53/867 | 101/874 |
| Age, Continuous(years) | Placebo | Creatine | Total |
|---|---|---|---|
| Mean | 61.5 ± 9.6 | 62.1 ± 9.7 | 61.8 ± 9.6 |
| Sex: Female, Male(Participants) | Placebo | Creatine | Total |
|---|---|---|---|
| Female | 313 | 305 | 618 |
| Male | 554 | 569 | 1123 |
| Time since diagnosis, y(years) | Placebo | Creatine | Total |
|---|---|---|---|
| Mean | 1.6 ± 1.1 | 1.5 ± 1.1 | 1.5 ± 1.1 |
| Total Unified Parkinson's Disease Rating Scale (UPDRS)(units on a scale) | Placebo | Creatine | Total |
|---|---|---|---|
| Mean | 25.9 ± 11 | 26.5 ± 11.7 | 26.2 ± 11.4 |
This study is terminated, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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