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Randomized Controlled Trial
. 2023 Dec:117:105907.
doi: 10.1016/j.parkreldis.2023.105907. Epub 2023 Oct 31.

Randomized controlled trial of KW-6356 monotherapy in patients with early untreated Parkinson's disease

Tetsuya Maeda  1 , Takashi Kimura  2 , Kenichiro Sugiyama  3 , Kana Yamada  4 , Ren Hiraiwa  5 , Masato Nishi  6 , Nobutaka Hattori  7 ; 6356-002 study group
Collaborators, Affiliations
Free article
Randomized Controlled Trial

Randomized controlled trial of KW-6356 monotherapy in patients with early untreated Parkinson's disease

Tetsuya Maeda et al. Parkinsonism Relat Disord. 2023 Dec.
Free article

Abstract

Introduction: KW-6356 is a novel selective adenosine A2A receptor antagonist/inverse agonist. We evaluated the efficacy and safety of KW-6356 as monotherapy in patients with early, untreated Parkinson's disease (PD).

Methods: This was a randomized, placebo-controlled, double-blind study conducted in Japan to investigate the efficacy and safety of once-daily KW-6356 (3 or 6 mg/day) orally administered as monotherapy for 12 weeks in patients with early PD (NCT02939391). The primary endpoint was the least squares means of change from baseline in the MDS-UPDRS Part III total score.

Results: Overall, 168 patients were randomized and treated (KW-6356 3 mg/day n = 55; 6 mg/day n = 58, placebo n = 55); Week 12 completion rates were >90% per group. LS mean [95% CI] changes from baseline to Week 12 in MDS-UPDRS Part III total scores were -5.37 [-7.25, -3.48] for 3 mg/day, -4.76 [-6.55, -2.96] for 6 mg/day and -3.14 [-4.97, -1.30] for placebo. Changes from baseline were larger for both KW-6356 groups than for the placebo group at all time points. Secondary endpoints supported the primary findings with larger changes in MDS-UPDRS Part II, Parts II + III, and Total scores in the KW-6356 groups than in the placebo group. Treatment was well-tolerated; the most common treatment-emergent adverse events with KW-6356 were constipation (n = 4 [7.3%] and n = 6 [10.3%] in the 3 and 6 mg/day groups, respectively) followed by nasopharyngitis (n = 4 [7.3%] and n = 5 [8.6%] in the 3 and 6 mg/day groups, respectively).

Conclusion: KW-6356 monotherapy is well tolerated and more effective than placebo in patients with early, untreated PD.

Keywords: Adenosine; Adenosine antagonist; KW-6356; Monotherapy; Parkinson's disease.

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Conflict of interest statement

Declaration of competing interest Tetsuya Maeda was the responsible medical officer for the study and reports receiving personal fees from Kyowa Kirin Co., Ltd. Takashi Kimura was a study investigator and Nobutaka Hattori was the coordinating investigator; both report receiving personal fees from Kyowa Kirin Co., Ltd. Kenichiro Sugiyama, Kana Yamada, Ren Hiraiwa and Masato Nishi are employed by Kyowa Kirin Co., Ltd.

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