A pilot clinical trial of creatine and minocycline in early Parkinson disease: 18-month results
NINDS NET-PD Investigators
Clinical neuropharmacology · 131 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 NS044555); National Institute of Neurological Disorders and Stroke (P50NS038377); National Institute of Neurological Disorders and Stroke (U10NS044415); National Institute of Neurological Disorders and Stroke (U10NS44415); National Institute of Neurological Disorders and Stroke (U01NS043128)
Según 2 financiadores declarados.
Publicación
- Publicado
- 2008-05-01 · Clin Neuropharmacol · vol. 31 · número 3 · págs. 141–150
- Editorial
- Lippincott Williams & Wilkins
- Citado
- 174 citas · más que el 96% de estudios similares · 5.7× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 20 trabajos
- Acceso
- Acceso abierto (copia en repositorio)
- Áreas de investigación
- Parkinson's Disease Mechanisms and Treatments · Nuclear Receptors and Signaling · Neurological Disorders and Treatments
- Palabras clave
- Parkinson's disease, creatine, minocycline, neuroprotection, early-stage Parkinson's disease, antiparkinsonian therapy, treatment safety, drug tolerability, treatment discontinuation, disability progression
- MeSH
- humans, parkinson disease, disease progression, creatine, minocycline, antiparkinson agents, disability evaluation, treatment outcome, severity of illness index, follow-up studies, pilot projects
1 autor
- Ninds Net-Pd Investigators🇺🇸 · autor de correspondenciaNational Institutes of Health; National Institute of Neurological Disorders and Stroke
Resumen
El texto original del estudio, en el idioma en que se publicó.
Objective
To report an 18-month follow-up on creatine and minocycline futility study, the Neuroprotective Exploratory Trials in Parkinson Disease, Futility Study 1 (NET-PD FS-1).
Background
The NET-PD FS-1 futility study on creatine and minocycline found neither agent futile in slowing down the progression of disability in Parkinson disease (PD) at 12 months using the prespecified futility threshold. An additional 6 months of follow-up aimed to assess safety and potential interactions of the study interventions with antiparkinsonian therapy.
Methods
Additional 6 months of follow-up in randomized, blinded phase II trial of creatine (dosage, 10 g/d) and minocycline (dosage, 200 mg/d) in subjects with early PD.
Results
By 18 months, symptomatic treatment of PD symptoms was required in 61% of creatine, 62% of minocycline, and 60% of placebo-treated subjects. Study treatment was prematurely discontinued in 9%, 23%, and 6% of subjects in the creatine, minocycline, and placebo arms, respectively. Creatine and minocycline did not seem to adversely influence the response to symptomatic therapy nor increase adverse events.
Conclusions
Data from this small, 18-month phase II trial of creatine and minocycline do not demonstrate safety concerns that would preclude a large, phase III efficacy trial, although the decreased tolerability of minocycline is a concern.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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