A randomized, double-blind, futility clinical trial of creatine and minocycline in early Parkinson disease
Abstract
BACKGROUND: Creatine and minocycline were prioritized for testing in Phase II clinical trials based on a systematic evaluation of potentially disease modifying compounds for Parkinson disease (PD). OBJECTIVE: To test whether creatine and minocycline alter the course of early PD relative to a predetermined futility threshold for progression of PD in a randomized, double-blind, Phase II futility clinical trial. Agents that do not perform better than the futility threshold are rejected as futile and are not considered for further study. METHODS: Participants had a diagnosis of PD within 5 years, but did not require medications for the management of symptoms. The primary outcome was the change in the total Unified Parkinson's Disease Rating Scale (UPDRS) score from baseline to either the time when there was sufficient disability to warrant symptomatic therapy for PD or 12 months, whichever came first. Subjects were randomized 1:1:1 to receive creatine 10 g/day, minocycline 200 mg/day, or matching placebo. The futility threshold was set as a 30% reduction in UPDRS progression based on the placebo/tocopherol arm of the Deprenyl And Tocopherol Antioxidative Therapy Of Parkinsonism (DATATOP) trial. p values < or = 0.1 indicate futility. RESULTS: Two hundred subjects were randomized to the three groups. Neither creatine (p = 0.96) nor minocycline (p = 0.66) could be rejected as futile based on the DATATOP futility threshold. The rate of progression for the calibration placebo group fell outside the 95% CI for the DATATOP historical control. In a sensitivity analysis, based on the threshold derived from the calibration placebo group, again neither drug could be rejected as futile. Tolerability was 91% in the creatine group and 77% in the minocycline group. Common adverse events included upper respiratory symptoms (26%), joint pain (19%), and nausea (17%). CONCLUSIONS: Both creatine and minocycline should be considered for definitive Phase III trials to determine if they alter the long term progression of Parkinson disease (PD). Additional factors must be weighed before selecting agents for Phase III trials, including safety, tolerability, activity, cost, and availability of these two agents in comparison with other agents currently in development for PD.
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In a randomized, double-blind, Phase II futility clinical trial in early PD, creatine reduced UPDRS scores and could not be rejected as futile based on the 30% DATATOP futility threshold.
“Creatine was shown to reduce the UPDRS scores, and could not be rejected as futile based on the 30% DATATOP futility threshold.”
From Mitochondrial Approaches for Neuroprotection (2008) · cites this paper as [130]
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- Authors
- The NINDS NET-PD Investigators
- Corresponding author
- The NINDS NET-PD Investigators
- Venue
- Neurology
- Published
- 2006-03-14
- Volume
- 66
- Issue
- 5
- Pages
- 664-671
- ISSN
- 0028-3878 (ISSN-L)
- 1526-632X
- OpenAlex
- W2358364508
- Cited by
- 453
- References
- 45
- Citations by year
- 2026: 16 · 2025: 8 · 2024: 18 · 2023: 16 · 2022: 15 · 2021: 15 · 2020: 40 · 2019: 10 · 2018: 11 · 2017: 20 · 2016: 23 · 2015: 17 · 2014: 27 · 2013: 21 · 2012: 31
- FWCI
- 26.68
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Neurology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institute of Neurological Disorders and Stroke (U10NS044545, U10NS044481, U10NS44555, U10NS044555, U10NS044415, U10NS44415, U01NS043127, U01NS043128)
- Topics
- Health Sciences › Medicine › Neurology › Parkinson's Disease Mechanisms and Treatments
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Nuclear Receptors and Signaling
- Health Sciences › Medicine › Neurology › Neurological disorders and treatments
- Keywords
- Parkinson's disease, creatine, minocycline, disease-modifying therapy, early-stage Parkinson's disease, placebo response, tolerability, adverse events
- MeSH terms
- Aged, Anti-Bacterial Agents, Creatine, Double-Blind Method, Female, Persons with Disabilities, Disabled Persons, Humans, Male, Middle Aged, Minocycline, Parkinson Disease
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Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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