A Long-Term Extension Trial From Late Phase II of SPM 962 in Patients With Restless Legs Syndrome (RLS)
An Open-label Long-term Extension Trial From Late Phase II of SPM 962 (243-07-003) in Patients With Restless Legs Syndrome
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ2
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:
- Subject completed the preceding trial 243-07-003 (NCT00666965)
Exclusion Criteria:
- Subject discontinued from the preceding trial 243-07-003 (NCT00666965)
- Subject had a serious adverse event which association with the investigational drug is not ruled out during trial 243-07-003
- Subject had a persistent serious adverse event at the baseline, which was observed and association with the investigational drug is ruled out during trial 243-07-003.
- Subject had persistent hallucination or delusion during trial 243-07-003.
- Subject had psychiatric conditions such as confusion, excitation, delirium, abnormal behaviour at the baseline.
- Subject had orthostatic hypotension or a systolic blood pressure (SBP) ≤ 100 mmHg and had a decrease of SBP from spine to standing position ≥ 30 mmHg at baseline.
- Subject had a history of epilepsy, convulsion etc. during trial 243-07-003.
- Subject developed serious ECG abnormality at the baseline.
- Subject had QTc-interval ≥ 500 msec at the baseline or subject had an increase of QTc-interval ≥ 60 msec from the baseline in the trial 243-07-003 and had a QTc-interval > 470 msec in female or > 450 msec in male at the baseline.
- Subject had a serum potassium level < 3.5 mEq/L at the end of the taper period in trial 243-07-003.
- Subject had a total bilirubin ≥ 3.0 mg/dL or AST(GOT) or ALT(GPT) greater than 2.5 times of the upper limit of the reference range (or ≥ 100 IU/L) at the end of the period in trial 243-07-003.
- Subject had BUN ≥ 30 mg/dL or serum creatinine ≥ 2.0 mg/dl at the end of the taper period in trial 243-07-003.
- Subject who planned pregnancy during the trial.
- Subject was judged to be inappropriate for this trial by the investigator for the reasons other than above.
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:なし
- 介入モデル:単一グループの割り当て
- 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 |
---|---|
実験的:SPM 962
Rotigotine transdermal patch
|
Tansdermal patch
他の名前:
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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 |
---|---|---|
The Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters
時間枠:Up to 54 weeks
|
The safety of the long-term SPM 962 treatment was examined based on the incidence and severity of adverse events, vital signs, and laboratory parameters. AEs of special interest (1-3) are defined as below:
|
Up to 54 weeks
|
Augmentation
時間枠:Up to 53 weeks
|
Augmentation is the main complication during long-term dopaminergic treatment of restless legs syndrome (RLS) and reflects an overall increase in RLS severity. Augmentation is clinically significant when at least one of the following occurs:
|
Up to 53 weeks
|
Change of the Pittsburgh Sleep Quality Index (PSQI) From Baseline to Each Visit
時間枠:Baseline, Up to 53 weeks
|
PSQI is a scale for assessing severity of sleep disorders.
The score ranges from 0 to 21. 0 indicates "no difficulty" and 21 indicates "severe difficulty".
A decrease in the scores means improvement.
|
Baseline, Up to 53 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Change of IRLS Sum Score From the Baseline to Each Visit
時間枠:Baseline, Up to 53 weeks
|
IRLS is a scale for assessing severity of restless legs syndrome symptoms. IRLS consists of ten questions. Each question is scored from 4 for the first (top) answer (usually 'very severe') to 0 for the last answer (usually none). The sum of the score of each question serves as the scale score. The scale scoring criteria are: Mild (score 1-10); Moderate (score 11-20); Severe (score 21-30); Very severe (score 31-40). A decrease in the scores means improvement. |
Baseline, Up to 53 weeks
|
Efficacy Rate in IRLS Sum Score
時間枠:Baseline, Up to 53 weeks
|
Efficacy rate (percentage of subjects with 50% decrease) (LOCF) in IRLS sum score.
|
Baseline, Up to 53 weeks
|
Change of Augmentation Severity Rating Scale (ASRS) Sum Score From Baseline to Each Visit
時間枠:Baseline, Up to 52 weeks
|
ASRS is a scale for assessing severity of augmentation. ASRS consists of 3 items (one item containing 4 sub-items). The sum of the score of each question serves as the scale score (each question score: 0-3, sum score 0-24). A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement. |
Baseline, Up to 52 weeks
|
Change of Short-Form 36-Item Health Survey (SF-36) From Baseline to Each Visit
時間枠:Baseline, Up to 53 weeks
|
SF-36 is a scale for assessing health status in clinical practice and research.
The scores of 36 questions are summarized into 7 sub-scales.
In each sub-scale which range is 0-100, a higher score indicates a better health status.
Thus a increase in the scores means improvement.
|
Baseline, Up to 53 weeks
|
協力者と研究者
出版物と役立つリンク
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。
SPM 962の臨床試験
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University of California, San Francisco完了血管疾患 | 変形性関節症 | 末梢動脈疾患 | 跛行 | 血管石灰化 | 跛行、間欠性 | 血管閉塞アメリカ
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University of North Carolina, Chapel HillMetagenics, Inc.; North Carolina Translational and Clinical Sciences Institute完了
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Queen Mary University of LondonMetagenics, Inc.わからない
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Cancer Intelligence Care Systems, Inc.Stella Pharma Corporation完了