A randomized, double-blind, futility clinical trial of creatine and minocycline in early Parkinson disease
NINDS NET-PD Investigators
Neurology · 297 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- National Institute of Neurological Disorders and Stroke
- Gobierno
- NINDS NIH HHS
- Subvenciones
- National Institute of Neurological Disorders and Stroke (U10NS044545); National Institute of Neurological Disorders and Stroke (U10NS44555); National Institute of Neurological Disorders and Stroke (U01NS043127); National Institute of Neurological Disorders and Stroke (U10 NS044481); National Institute of Neurological Disorders and Stroke (U10NS44415); National Institute of Neurological Disorders and Stroke (U01NS043128)
Según 2 financiadores declarados.
Publicación
- Publicado
- 2006-02-15 · Neurology · vol. 66 · número 5 · págs. 664–671
- Editorial
- Lippincott Williams & Wilkins
- Citado
- 453 citas · más que el 100% de estudios similares · 24.1× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 47 trabajos
- Acceso
- De pago
- Áreas de investigación
- Parkinson's Disease Mechanisms and Treatments · Nuclear Receptors and Signaling · Neurological disorders and treatments
- Palabras clave
- Parkinson's disease, creatine, minocycline, disease-modifying therapy, early-stage Parkinson's disease, placebo response, tolerability, adverse events
- MeSH
- humans, parkinson disease, creatine, minocycline, anti-bacterial agents, double-blind method, aged, middle aged, female, male, persons with disabilities
1 autor
- The NINDS NET-PD Investigators · autor de correspondencia
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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