Evidence map›Paper›PMID 35241003›Full record

ArticleBMC neurology2022

Evaluating the impact of adjunctive istradefylline on the cumulative dose of levodopa-containing medications in Parkinson's disease: study protocol for the ISTRA ADJUST PD randomized, controlled study.

Taku Hatano, Osamu Kano, Renpei Sengoku, Asako Yoritaka, Keisuke Suzuki, Noriko Nishikawa, Yohei Mukai, Kyoichi Nomura, Norihito Yoshida, Morinobu Seki and 16 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC neurology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 32% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors at 20 institutions in 1 country.

Taku HatanoDepartment of Neurology, Faculty of Medicine, Juntendo University, 2-1-1 Hongo, Bunkyo-ku, 113-8421, Tokyo, Japan. thatano@juntendo.ac.jp.ORCID http://orcid.org/0000-0002-6808-0444
Osamu KanoDepartment of Neurology, Faculty of Medicine, Toho University, 6-11-1 Omorinishi, Ota-ku, Tokyo, 143-8541, Japan.
Renpei SengokuDepartment of Neurology, Jikei University Daisan Hospital, 4-11-1 Izumihoncho, Komae, Tokyo, 201-0003, Japan.
Asako YoritakaDepartment of Neurology, Juntendo University Koshigaya Hospital, 560 Fukuroyama, Koshigaya-shi, Saitama, 343-0032, Japan.
Keisuke SuzukiDepartment of Neurology, Dokkyo Medical University Hospital, 880 Oaza Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi, 321-0293, Japan.
Noriko NishikawaDepartment of Neurology, Faculty of Medicine, Juntendo University, 2-1-1 Hongo, Bunkyo-ku, 113-8421, Tokyo, Japan.
Yohei MukaiDepartment of Neurology, National Center of Neurology and Psychiatry, 4-1-1 Ogawahigashi-cho, Kodaira-shi, Tokyo, 187-8551, Japan.
Kyoichi NomuraDepartment of Neurology, Saitama Medical Center, Kawagoe-shi, Saitama, 350-8550, Japan.
Norihito YoshidaDepartment of Neurology, Saitama Medical Center, Kawagoe-shi, Saitama, 350-8550, Japan.
Morinobu SekiDepartment of Neurology, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.
Miho Kawabe MatsukawaDepartment of Neurology, Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo, 173-0015, Japan.
Hiroo TerashiDepartment of Neurology, Tokyo Medical University Hospital, 6-7-1 Nishi-shinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan.
Katsuo KimuraDepartment of Neurology, Yokohama City University Medical Center, 4-57 Urafune-cho, Minami-ku, Yokohama-shi, Kanagawa, 232-0024, Japan.
Jun TashiroSapporo Parkinson MS Neurological Clinic, Dai 27 Big Sapporo-kita Sky Building 12F, 7-6 Kita-7 jo Nishi-5 chome, Kita-ku, Sapporo-shi, Hokkaido, 060-0807, Japan.
Shigeki HiranoDepartment of Neurology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, 260-8670, Japan.
Hidetomo MurakamiDepartment of Neurology, The Jikei University Hospital, 3-19-18 Nishishinbashi, Minato-ku, Tokyo, 105-8471, Japan.
Hideto JokiDepartment of Neurology and Stroke Medicine, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.
Tsuyoshi UchiyamaDepartment of Neurology, Seirei Hamamatsu General Hospital, 2-12-12 Sumiyoshi, Naka-ku, Hamamatsu-shi, Shizuoka, 430-8558, Japan.
Hideki ShimuraDepartment of Neurology, Juntendo Tokyo Koto Geriatric Medical Center, 3-3-20 Shinsuna, Koto-ku, Tokyo, 136-0075, Japan.
Kotaro OgakiDepartment of Neurology, Juntendo University Urayasu Hospital, 2-1-1 Tomioka, Urayasu-shi, Chiba, 279-0021, Japan.
Jiro FukaeDepartment of Neurology, Juntendo University Nerima Hospital, 3-1-10 Takano-dai, Nerima-ku, Tokyo, 177-8521, Japan.
Yoshio TsuboiDepartment of Neurology, Fukuoka University School of Medicine, 7-45-1 Nanakuma, Johnan-ku, Fukuoka, 814-0180, Japan.
Kazushi TakahashiDepartment of Neurology, Tokyo Metropolitan Neurological Hospital, Musashidai 2-6-1, Fuchu-shi, Tokyo, 183-0042, Japan.
Toshimasa YamamotoDepartment of Neurology, Saitama Medical University Hospital, Saitama Medical University, 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, 350-0495, Japan.
Naotake YanagisawaMedical Technology Innovation Center, Juntendo University and Juntendo Clinical Research and Trial Center, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan.
Hiroshi NagayamaDepartment of Neurology, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8602, Japan.
Juntendo University · JPSocial Insurance Saitama Chuo Hospital · JPChiba University · JPDokkyo Medical University · JPDokkyo Medical University Saitama Medical Center · JPFukuoka University · JPJuntendo University Nerima Hospital · JPJuntendo University Urayasu Hospital · JPKeio University Hospital · JPKoto Hospital · JPNational Center of Neurology and Psychiatry · JPNippon Medical School · JPSaitama Medical University Hospital · JPSeirei Hamamatsu General Hospital · JPThe Jikei University Hospital · JPToho University · JPTokyo Medical University · JPTokyo Metropolitan Geriatric Hospital · JPTokyo Metropolitan Neurological Hospital · JPYokohama City University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLevodopa remains the most effective symptomatic treatment for Parkinson's disease (PD) more than 50 years after its clinical introduction. However, the onset of motor complications can limit pharmacological intervention with levodopa, which can be a challenge when treating PD patients. Clinical data suggest using the lowest possible levodopa dose to balance the risk/benefit. Istradefylline, an adenosine A

methodsThis 37-week, multicenter, randomized, open-label, parallel-group controlled study in PD patients aged 30-84 years who are experiencing the wearing-off phenomenon despite receiving levodopa-containing medications ≥ 3 times daily (daily dose 300-400 mg) began in February 2019 and will continue until February 2022. Enrollment is planned to attain 100 evaluable patients for the efficacy analyses. Patients will receive adjunctive istradefylline (20 mg/day, increasing to 40 mg/day) or the control in a 1:1 ratio, stratified by age, levodopa equivalent dose, and presence/absence of dyskinesia. During the study, the levodopa dose will be increased according to symptom severity. The primary study endpoint is the comparison of the cumulative additional dose of levodopa-containing medications during the treatment period between the adjunctive istradefylline and control groups. Secondary endpoints include changes in efficacy rating scales and safety outcomes. DISCUSSION: This study aims to clarify whether adjunctive istradefylline can reduce the cumulative additional dose of levodopa-containing medications in PD patients experiencing the wearing-off phenomenon, and lower the risk of levodopa-associated complications. It is anticipated that data from ISTRA ADJUST PD will help inform future clinical decision-making for patients with PD in the real-world setting.

trial registrationJapan Registry of Clinical Trials, jRCTs031180248 ; registered 12 March 2019.

Indexed as

LevodopaParkinson DiseaseAdenosine A2 Receptor AntagonistsAdultAgedAged, 80 and overAntiparkinson AgentsHumansMiddle AgedMulticenter Studies as TopicPurinesRandomized Controlled Trials as TopicAdenosine A2 Receptor AntagonistsAntiparkinson AgentsistradefyllineLevodopaPurinesAdenosine A2A receptor antagonistIstradefyllineLevodopaLevodopa doseParkinson’s disease

Identifiers

PMID35241003
PMCPMC8892732
OpenAlexW4214891384

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.