Acute Effects of Preladenant (SCH 420814) on Dyskinesia and Parkinsonism in Levodopa Treated Participants (P05550)
2018年10月9日 更新者：Merck Sharp & Dohme LLC
Acute Effects of SCH 420814 on Dyskinesia and Parkinsonism in Levodopa Treated Patients
This is a randomized, placebo-controlled, 3-period crossover, balanced, single-site, third party-blind study of preladenant (SCH 420814) in participants with Parkinson disease (PD) to be conducted in conformance with Good Clinical Practices.
This trial will investigate the effects of single doses of preladenant and placebo on the dyskinesia and antiparkinsonian actions of a levodopa infusion.
The study will examine 10 mg ("low dose") or 100 mg ("high dose") study drug, given as single, oral administrations in conjunction with intravenous (IV) levodopa infusion and oral carbidopa.
調査の概要
研究の種類
介入
入学 (実際)
12
段階
- フェーズ 1
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Participant must have a diagnosis of idiopathic PD based on history, exam and any relevant laboratory tests
- Participants must have been treated with levodopa for one or more years
- Participants must have motor fluctuations that can be measured as a 10% change in tapping speed between "on" and "off" and concurrent motor Unified PD Rating Scale (UPDRS) must also show a 20% improvement when "on"
- Participants must have dyskinesia when "on" measured as at least 2 in one or more body parts on scale using 0 (absent) to 4 (severe) for four limbs, trunk, neck and face (total 7 body parts and 28 points)
- Participant must be free of any clinically significant disease that would interfere with the study evaluations
- Female participants must be postmenopausal and/or surgically sterilized and have a negative serum pregnancy test at the screening visit and a negative urine or serum pregnancy test upon each admission to the study center
- Premenopausal, unsterilized female participants have to agree to use a medically accepted method of contraception
- Male participants must agree to use a medically accepted method of contraception as or abstain from sexual intercourse during the trial and for 2 months after stopping the medication.
Exclusion Criteria:
- Female participants who are pregnant, intend to become pregnant (within 3 months of ending the study), or are lactating
- Participants with dementia (mini-mental state examination [MMSE] <23), hallucinations, confusion, major psychiatric disorders, and unstable medical conditions
- Participants with any stable surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug
- Participants with a positive screen for drugs of abuse
- Participants who are positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV)
- Participants who are currently participating in another medical interventional clinical study or have participated in a medical interventional clinical study within 30 days and who have previously received this compound.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：SCH 420814 10 mg→SCH 420814 100 mg→Placebo
Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period.
The levodopa infusion was to be started at Hour 1 and was to run for 2 hours.
The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
|
one 10-mg capsule, orally, at hour 0 of treatment period
single oral dose of four SCH 420814 25-mg capsules at hour 0 of treatment period
Placebo capsule, oral, at hour 0 of treatment period
levodopa intravenous (IV) infusion (1 mg/kg body weight) was beginning 1 hour after study drug administration and continued for 2 hours
one 25-mg table, orally, at hours 0, 2 and 4 of each treatment period
|
|
実験的：SCH 420814 100 mg→Placebo→ SCH 420814 10 mg
Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period.
The levodopa infusion was to be started at Hour 1 and was to run for 2 hours.
The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
|
one 10-mg capsule, orally, at hour 0 of treatment period
single oral dose of four SCH 420814 25-mg capsules at hour 0 of treatment period
Placebo capsule, oral, at hour 0 of treatment period
levodopa intravenous (IV) infusion (1 mg/kg body weight) was beginning 1 hour after study drug administration and continued for 2 hours
one 25-mg table, orally, at hours 0, 2 and 4 of each treatment period
|
|
実験的：Placebo→SCH 420814 10 mg→SCH 420814 100 mg
Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period.
The levodopa infusion was to be started at Hour 1 and was to run for 2 hours.
The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
|
one 10-mg capsule, orally, at hour 0 of treatment period
single oral dose of four SCH 420814 25-mg capsules at hour 0 of treatment period
Placebo capsule, oral, at hour 0 of treatment period
levodopa intravenous (IV) infusion (1 mg/kg body weight) was beginning 1 hour after study drug administration and continued for 2 hours
one 25-mg table, orally, at hours 0, 2 and 4 of each treatment period
|
|
実験的：SCH 420814 10 mg→ Placebo→ SCH 420814 100 mg
Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period.
The levodopa infusion was to be started at Hour 1 and was to run for 2 hours.
The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
|
one 10-mg capsule, orally, at hour 0 of treatment period
single oral dose of four SCH 420814 25-mg capsules at hour 0 of treatment period
Placebo capsule, oral, at hour 0 of treatment period
levodopa intravenous (IV) infusion (1 mg/kg body weight) was beginning 1 hour after study drug administration and continued for 2 hours
one 25-mg table, orally, at hours 0, 2 and 4 of each treatment period
|
|
実験的：SCH 420814 100 mg→ SCH 420814 10 mg→Placebo
Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period.
The levodopa infusion was to be started at Hour 1 and was to run for 2 hours.
The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
|
one 10-mg capsule, orally, at hour 0 of treatment period
single oral dose of four SCH 420814 25-mg capsules at hour 0 of treatment period
Placebo capsule, oral, at hour 0 of treatment period
levodopa intravenous (IV) infusion (1 mg/kg body weight) was beginning 1 hour after study drug administration and continued for 2 hours
one 25-mg table, orally, at hours 0, 2 and 4 of each treatment period
|
|
実験的：Placebo→ SCH 420814 100 mg→SCH 420814 10 mg
Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period.
The levodopa infusion was to be started at Hour 1 and was to run for 2 hours.
The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
|
one 10-mg capsule, orally, at hour 0 of treatment period
single oral dose of four SCH 420814 25-mg capsules at hour 0 of treatment period
Placebo capsule, oral, at hour 0 of treatment period
levodopa intravenous (IV) infusion (1 mg/kg body weight) was beginning 1 hour after study drug administration and continued for 2 hours
one 25-mg table, orally, at hours 0, 2 and 4 of each treatment period
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean Peak Dyskinesia Score
時間枠：Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 of each treatment period
|
Dyskinesia was scored on a scale of 0 (absent), 1 (mild) , 2 (moderate), 3 (severe) and 4 (incapacitating) for seven body parts (face, neck, trunk, each arm and each leg) based on the worse dyskinesia noted during the entire measurement time.
Scores were assessed at Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0.
The dyskinesia score was the sum of the scores for the seven body parts.
The peak dyskinesia score was recorded for each participant regardless of what timepoint the score was achieved.
The total possible score for an individual at each timepoint could range from 0 to 28 with higher scores indicating greater effects of the dyskinesia.
The mean peak dyskinesia score was calculated using the individual peak values.
|
Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 of each treatment period
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean Peak Finger Tapping Score
時間枠：Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 of each treatment period
|
Tapping was measured with two manual counters with keys that were depressed to register a count.
The participant alternately tapped each counter using the index finger of the more affected hand for 60 seconds and was not allowed to use more than one finger to tap.
The participant was instructed to tap as rapidly as possible while being timed for 60 seconds.
The counts were recorded for the two counters at Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0.
The peak tapping score was recorded for each participant regardless of what timepoint the score was achieved.
The mean peak finger tapping score was calculated using the individual peak values.
|
Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 of each treatment period
|
|
Mean Peak Tremor Score
時間枠：Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 of each treatment period
|
Tremor was scored on a scale of 0 (absent), 1 (mild, 2 (moderate), 3 (severe) and 4 (incapacitating) for seven body parts (face, neck, trunk, each arm and each leg) based on the worse tremor observed during the time spent with participant while taking other study measurements(vital signs, drawing samples, performing the tapping and walking tasks).
Scores were assessed at Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0.
The tremor score was the sum of scores for seven body parts.
The peak tremor score was recorded for each participant regardless of what timepoint the score was achieved.
The total possible score for an individual at each timepoint could range from 0 to 28 with higher scores indicating more effects of the tremors.
The mean peak tremor score was calculated using the individual peak values.
|
Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 of each treatment period
|
|
Mean Peak Walking Speed
時間枠：Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 of each treatment period
|
Walking speed assessment began with the participant being seated in an armless chair.
Then while being timed, the participant stood up with their arms crossed on their chest and walked 6 meters, turned around, returned to the chair and sat.
Timing was stopped when the participant's buttocks hit the chair and the total time was recorded.
If the participant could not arise in 60 seconds, 60 seconds was entered in this line of the report form and the participant was tested again but allowed to push off to get out of the chair.
Sixty seconds was the maximum time allowed to complete the walking assessment, thus 60 seconds was recorded as the time if they could not complete the task within this time limit.
Walking speed was assessed at Hours 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7.0 and 8.
The peak walking speed was recorded for each participant regardless of what timepoint the score was achieved.
The mean peak walking speed was calculated using the individual peak values.
|
Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 of each treatment period
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2009年4月21日
一次修了 (実際)
2010年4月30日
研究の完了 (実際)
2010年5月14日
試験登録日
最初に提出
2009年2月13日
QC基準を満たした最初の提出物
2009年2月13日
最初の投稿 (見積もり)
2009年2月16日
学習記録の更新
投稿された最後の更新 (実際)
2018年11月7日
QC基準を満たした最後の更新が送信されました
2018年10月9日
最終確認日
2018年10月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- P05550
- MK-3814-023 (その他の識別子：Merck Study Number)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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