Evaluation of an Altered Peptide Ligand (NBI-5788) in Patients With Relapsing Multiple Sclerosis (MS)
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of NBI-5788 in Patients With Relapsing Multiple Sclerosis
We are studying this investigational drug treatment, comparing it with placebo, to evaluate whether it is effective in reducing the number of MRI lesions with a minimum number of side effects. The investigational drug will be administered in the clinic weekly for 5 injections (induction phase) then monthly for 8 additional injections (maintenance phase).
Approximately 150 male and female patients (100 active and 50 placebo), aged 18 to 55 years, with relapsing MS and at least one but no more than 10 total Gd-enhancing lesions on cranial MRI scans during the run-in phase will be randomized into this study.
調査の概要
詳細な説明
研究の種類
入学
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:
- Male or female, 18 to 55 years of age
- Diagnosed with relapsing multiple sclerosis, with at least one relapse in the last two years
- Females must not plan on becoming pregnant
- Females must either be post-menopausal, surgically incapable of bearing children, or practicing an acceptable method of birth control and willing to continue birth control until 30 days after the last dose of study drug
- Males must not intend to impregnate a partner during the study or for 30 days after the study and must also practice acceptable birth control with their partners
Exclusion Criteria:
- Significant long-lasting disease of the immune system other than multiple sclerosis
- Past or current medical disease (heart, liver, kidney, etc.) including severe asthma, cancer or advancing brain or spinal cord disorder
- Known or suspected long-lasting infectious disease including HIV, hepatitis B, or hepatitis C
- Treatment with certain steroid or hormone medications within 30 days before the pre-study MRI scan
- Treatment with other medications that suppress the immune system within 6 months before the pre-study MRI scan
- Certain treatments and medications are not allowed
- Laboratory and other tests will be performed to determine further eligibility
- History of drug or alcohol abuse in the last year
- History of medical or psychiatric condition that could pose a risk for participation in the study
- Females who are pregnant or breast feeding
- Participation in any other trial of an investigational agent within 90 days before the start of the study
- History of not following instructions with past therapy.
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:並列代入
- マスキング:ダブル
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
研究の完了
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
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- NBI-5788-0201
- MS APL
- Neurocrine
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。