A pilot clinical trial of creatine and minocycline in early parkinson disease

18-month results

The NINDS NET-PD Investigators

Research output: Contribution to journalArticle

Abstract

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 anti-parkinsonian 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.

Original languageEnglish (US)
Pages (from-to)141-150
Number of pages10
JournalClinical Neuropharmacology
Volume31
Issue number3
DOIs
StatePublished - 2008

Fingerprint

Minocycline
Creatine
Parkinson Disease
Clinical Trials
Medical Futility
Secondary Parkinson Disease
Placebos
Safety
Therapeutics

Keywords

  • Clinical trial
  • Creatine
  • Futility
  • Minocycline
  • Parkinson disease

ASJC Scopus subject areas

  • Pharmacology
  • Clinical Neurology
  • Pharmacology (medical)

Cite this

A pilot clinical trial of creatine and minocycline in early parkinson disease : 18-month results. / The NINDS NET-PD Investigators.

In: Clinical Neuropharmacology, Vol. 31, No. 3, 2008, p. 141-150.

Research output: Contribution to journalArticle

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abstract = "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 anti-parkinsonian 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.",
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author = "{The NINDS NET-PD Investigators} and Karl Kieburtz and Barbara Tilley and Bernard Ravina and Galpern, {Wendy R.} and Kathleen Shannon and Caroline Tanner and Wooten, {G. Frederick} and Brad Racette and Patricia Deppen and Dewey, {Richard B.} and Burton Scott and Joanne Field and Julie Carter and Matthew Brodsky and Pamela Andrews and Bala Manyam and Jacqueline Whetteckey and Jayaraman Rao and Maureen Cook and Aminoff, {Michael J.} and Chadwick Christine and Jessie Roth and Martha Nance and Sotirios Parashos and Susan Peterson and Jeana Jaglin and Carlos Singer and Perez, {Marian A.} and Anita Blenke and Robert Hauser and Theresa McClain and Summer Wolfrath and Ted Dawson and Dawson, {Ted M} and Rajesh Pahwa and Kelly Lyons and Amy Parsons and Maureen Leehey and Jacci Bainbridge and Lisa Shulman and William Weiner and Katharine Pabst and Rodger Elble and Charlene Young and Kapil Sethi and Buff Dill and Wayne Martin and Germaine McInnes and Calabrese, {Vincent P.} and Peng Huang",
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AU - Brodsky, Matthew

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AU - Christine, Chadwick

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AU - Nance, Martha

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AU - Jaglin, Jeana

AU - Singer, Carlos

AU - Perez, Marian A.

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AU - Hauser, Robert

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AU - Parsons, Amy

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AU - Weiner, William

AU - Pabst, Katharine

AU - Elble, Rodger

AU - Young, Charlene

AU - Sethi, Kapil

AU - Dill, Buff

AU - Martin, Wayne

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AU - Calabrese, Vincent P.

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N2 - 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 anti-parkinsonian 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.

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