Botox Injection in Treatment of Chronic Migraine
Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Chronic Migraine. Safety Issues.
Chronic migraine is in many cases a most disabling condition. Chronic migraine is defined as headaches for at least 15 days per month, of which 8 days have typical migraine features. In many cases, oral drug treatment has little effect.
The parasympathetic nervous system acting through the sphenopalatine ganglion may be involved in several primary headaches, including migraine, by facilitating release of inflammatory substances in cerebral vessels. Botulinum toxin type A (BTA) inhibits excretion of acetylcholine resulting in blocking of nerve signals in the sphenopalatine ganglion.
The purpose of the present study is to evaluate a new technique with injection of BTA using an minimal invasive image guided procedure, for blocking of the sphenopalatine ganglion. The goal is to relieve the migraine symptoms and develop an alternate treatment for cases where oral drug treatments fail.
The main objective of the project is to determine the safety of this method of BTA injection in the area of the sphenopalatine ganglion by detecting adverse events. Secondary objectives are to measure changes in headache attack parameters with this novel method.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究場所
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Trondheim、ノルウェー
- Department of Neuroscience, Norwegian University of Science and Technology
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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:
- Informed and written consent
- Chronic migraine with or without aura defined in International Classification of Headache Disorders (ICHD)-3 criteria
- Failed at least 3 oral migraine prophylactic treatments
- Duration of migraine at least 1 year before inclusion
- Start of migraine before participant turned 50 years
- Participant can make a distinction between migraine and other types of headache
Exclusion Criteria:
- If the criteria for medication-overuse headache (MOH) is fulfilled
- Heart or lung disease
- Any kind of systematic or local disease or illness that may significantly increase the risk of complications for the procedure related to injection
- Psychiatric illness that hinders participation in the study
- Known pregnancy or breast feeding
- Inadequate use of contraceptives
- Overuse or abuse of opioids
- Abuse of medications, narcotics or alcohol
- Anomalies which hinder or impede the used method of injection
- Allergy or any other hypersensitivity reactions against marcain, lidocaine, xylocain or adrenalin, botulinum toxin type A, Botox or any of it's constituents or any other related medication
- Treatment with medication that can interact with botulinum toxin type A
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 |
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実験的：Botulinum Toxin
The patients will be injected with 25 IU of Botulinum Toxin Type A towards both the right and left sphenopalatine ganglion, a total of 50 IU.
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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 |
|---|---|---|
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Number of adverse events and number of participants with adverse events
時間枠：For the follow-up period of 3 months
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Number of adverse events and number of participants with adverse events after BTA injection in the area of the sphenopalatine ganglion and severity of adverse events by the method used.
Registration of any adverse events categorized by probable relationship to drug or the procedure.
Data obtained from the headache diaries as well as open questions during consultations.
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For the follow-up period of 3 months
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Number of headache days with moderate or severe intensity
時間枠：5-8 weeks
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measured from week 5 to week 8, in total during 4 weeks
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5-8 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of reponders
時間枠：12 weeks
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response is defined as ≥ 50% reduction in number of headache days with moderate or severe intensity per 4 weeks (week 1-4, week 5-8, week 9-12)
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12 weeks
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Days with moderate or severe headache per 4 weeks
時間枠：12 weeks
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week 1-4, week 5-8, week 9-12
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12 weeks
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Days without headache per 4 weeks
時間枠：12 weeks
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week 1-4, week 5-8, week 9-12
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12 weeks
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Hours with headache of moderate or severe headache per 4 weeks
時間枠：12 weeks
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week 1-4, week 5-8, week 9-12
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12 weeks
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協力者と研究者
捜査官
- 主任研究者：Erling A Tronvik, PhD, MD、Norwegian University of Science and Technology
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
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
- BTACM2014
- 2014-001852-43 (EudraCT番号)
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