A pilot clinical trial of creatine and minocycline in early Parkinson disease: 18-month results.
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.
National Institute of Neurological Disorders and Stroke/National Institutes of Health, Room 2225, 6001 Executive Blvd, Bethesda, MD 20892, USA.
D000978:Antiparkinson Agents / Q000627:therapeutic use*; D003401:Creatine / Q000627:therapeutic use*; D004185:Disability Evaluation; D018450:Disease Progression; D005500:Follow-Up Studies; D006801:Humans; D008911:Minocycline / Q000627:therapeutic use*; D010300:Parkinson Disease / Q000188:drug therapy* / Q000503:physiopathology; D010865:Pilot Projects; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000978:Antiparkinson Agents; D008911:Minocycline; D003401:Creatine