Study in Advanced Parkinson's Disease Patients With Predictable Motor Fluctuations
A Phase 2, Randomized, Open-Label, Crossover Study to Compare DM-1992, a Novel Gastric-Retentive Extended-Release Formulation of Levodopa/Carbidopa, to an Immediate-Release Carbidopa Tablet in Patients With Advanced Parkinson's Disease With Motor Fluctuations
The primary objective of this study is to explore the efficacy and tolerability of DM-1992 compared to a standard carbidopa/Levodopa Immediate-Release (CD/LD IR) tablet (Sinemet IR) as measured by:
- "ON" time with no dyskinesia or non-troublesome dyskinesia
- "OFF" time
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Alabama
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Birmingham、Alabama、アメリカ
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Arkansas
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Little Rock、Arkansas、アメリカ
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California
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Long Beach、California、アメリカ
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Illinois
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Chicago、Illinois、アメリカ
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Michigan
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Bingham Farms、Michigan、アメリカ
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Ohio
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Cincinnati、Ohio、アメリカ
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Texas
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Dallas、Texas、アメリカ
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Men and women at least 30 years and older at the time of informed consent with advanced idiopathic Parkinson's disease with predictable wearing-off motor fluctuations with Hoehn and Yahr Stage II-III when "on."
- Patients should be able to differentiate between the "ON" and "OFF" states with an average daily "OFF" time of ≥ 2.5 hours at study entry.
- On a stable daily dose of LD of ≥ 400 mg but ≤1600 mg for at least 1 month prior to the screening visit.
- Non CD/LD containing anti-Parkinson's medications should be kept at stable doses for 1 month prior to screening visit. Patients should be willing to keep their non LD containing medications consistently throughout the study duration.
- Female patients of childbearing potential should be abstinent or continuing to practice and willing to continue throughout the study with appropriate contraceptives (defined as Nova ring, oral, injected, transdermal patch, implanted, or barrier).
- Mini Mental State Examination (MMSE) ≥ 26 at screening visit.
- Able to provide informed consent and willing to sign Health Insurance Portability and Accountability Act (HIPAA) authorization.
- Able and willing to comply with the protocol, including availability for all scheduled study visits and blood sample collections. Must be under the observation of a competent care giver throughout the study participation.
Exclusion Criteria:
- Patients with atypical or drug-induced Parkinson's disease.
- Patients with a known history of hypersensitivity to levodopa or carbidopa.
- Patients who receive treatments with dopamine receptor blocking agents
- Patients with a history of seizures except of childhood febrile seizure.
- Patients with dementia.
- Patients with a significant history of GI diseases (severe inflammatory bowel disease, irritable bowel disease, dyspepsia, gastro-esophageal reflux disease etc.) in the past five years.
- Patients with any history of gastric surgery other than vagotomy and pyloroplasty.
- Patients with an immune-compromised state.
- Patients with clinically significant hepatic insufficiency with Child-Pugh total score of ≥ 5.
- Patients with a calculated creatinine clearance (Clcr) < 50 mL/min using the Cockcroft-Gault equation.
- Patients who have a difficulty swallowing tablets.
- Patient has participated in a clinical trial of an investigational drug or device within 30 days of the screening visit.
- Patients with any other serious medical condition that, in the opinion of the Investigator would jeopardize the safety of the patient or affect the validity of the study results.
研究計画
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:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:DM-1992
DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD)
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72.5mg carbidopa/230mg levodopa
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アクティブコンパレータ:Sinemet IR
An Immediate-release (IR) tablet containing 25mg carbidopa (CD) and 100mg levodopa (LD)
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Immediate-release tablet containing 25mg carbidopa and 100mg levodopa
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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 |
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The Primary Objective of This Study is to Explore the Efficacy and Tolerability of DM-1992 Compared to a Standard CD/LD IR Formulation as Measured by Percent "OFF" Time.
時間枠:Baseline and 10 days for each of the 2 study periods
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"OFF" indicates wearing off motor fluctuations before the next levodopa dose. Percent "OFF" time is calculated as the total "OFF" time divided by the total awake time for each day and multiplied by 100. Patient diary-every 30min while awake for 3days prior to initial Day1 as baseline & during the last 3days before Day10 for both treatments for dyskinesia state. Baseline is the average of the 3 days recorded in the patient diary prior to Day 1 of Period 1. End of Period is the average of the 3 days recorded in the patient diary prior to Day 10 in each period. Clinician-Assess efficacy at pre-dose, every 30min for Day1 and hourly for Day10 for dyskinesia state & motor fluctuations at clinic visits. |
Baseline and 10 days for each of the 2 study periods
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協力者と研究者
スポンサー
捜査官
- スタディディレクター:Rekha Sathyanarayana、Depomed
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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。
パーキンソン病の臨床試験
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Adelphi Values LLCBlueprint Medicines Corporation完了肥満細胞性白血病 (MCL) | 攻撃的な全身性肥満細胞症 (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | くすぶり全身性肥満細胞症 (SSM) | 無痛性全身性肥満細胞症 (ISM) ISM サブグループが完全に募集されましたアメリカ
DM-1992の臨床試験
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Neurovalens Ltd.University College Dublin; Clinical Trial Mentors; CS Lifescience積極的、募集していない
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Emory UniversityNational Institute of Nursing Research (NINR); Atlanta VA Medical Center; Atlanta Clinical and...完了
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National University, SingaporeTsao Foundation Singapore積極的、募集していない
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University of Southern California積極的、募集していない
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Diabetes Foundation, IndiaMinistry of Science and Technology, Indiaまだ募集していません糖尿病 | 前糖尿病 | ダイエット習慣