計劃書編號27937
試驗已結束
2009-08-01 - 2012-12-31
Phase III
終止收納6
ICD-10G20
巴金森氏症
ICD-10G21.4
血管性巴金森氏症
ICD-9332.0
震顫麻痺
A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine
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試驗申請者
艾昆緯股份有限公司
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試驗委託 / 贊助單位名稱
Merck Serono S.A. – Geneva
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臨床試驗規模
多國多中心
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更新日期
2026/02/01
試驗主持人及試驗醫院
實際收案人數
0 終止收納
實際收案人數
0 終止收納
適應症
巴金森病
試驗目的
目標：
目標在於評估 safinamide (50-100 mg/day) 相較於安慰劑，作為接受穩定劑量 levopoda，對於罹患運動機能障礙的原發性帕金森氏症 (PD) 患者附加治療的長期安全性與藥效。
主要目標
主要目標是在「on」階段使用運動障礙評分量表，評估基準點到第 78 週的運動障礙變化，並比較 safinamide (50-100 mg/day) 與安慰劑。
次要目標
次要目標是評估基準點到第 78 週的運動機能、運動功能、日常活動、生活品質變化、整體臨床狀態變化、levodopa 劑量變化，以及認知能力。
藥品名稱
錠劑
主成份
Safinamide
劑型
110
劑量
50 and 100
評估指標
Endpoints:
Primary
• Dyskinesia Rating Scale score during the “on” phase change from baseline to W78
Secondary
• Daily “on” time (“on” time without dyskinesia plus “on” time with minor dyskinesia), as
measured by diary cards, change from baseline to W78
• Daily “off” time, as measured by diary cards, change from baseline to W78
• UPDRS Section III score during the “on” phase, change from baseline to W78
• UPDRS Section II score during the “on” phase, change from baseline to W78
• CGI - Change scale score, change from Day 0 of Trial 27919 to W78
• CGI - Severity scale score, change from baseline to W78
• Percent change in levodopa dose, change from baseline to W78
• EQ-5D score, change from baseline to W78
• PDQ-39 score, change from baseline to W78
• Cogtest® PD battery test score, change from baseline to W78
Primary
• Dyskinesia Rating Scale score during the “on” phase change from baseline to W78
Secondary
• Daily “on” time (“on” time without dyskinesia plus “on” time with minor dyskinesia), as
measured by diary cards, change from baseline to W78
• Daily “off” time, as measured by diary cards, change from baseline to W78
• UPDRS Section III score during the “on” phase, change from baseline to W78
• UPDRS Section II score during the “on” phase, change from baseline to W78
• CGI - Change scale score, change from Day 0 of Trial 27919 to W78
• CGI - Severity scale score, change from baseline to W78
• Percent change in levodopa dose, change from baseline to W78
• EQ-5D score, change from baseline to W78
• PDQ-39 score, change from baseline to W78
• Cogtest® PD battery test score, change from baseline to W78
主要納入條件
Inclusion Criteria:
To be eligible for inclusion into this trial, the subjects must fulfill all of the following
criteria:
1. The subject completed 24 weeks of trial 27919.
2. The subject successfully completed all trial requirements in trial 27919.
3. If female, they must be either post-menopausal for at least 2 years, surgically sterilized
or have undergone hysterectomy or, if of child bearing potential they must be willing to
avoid pregnancy by using an adequate method of contraception as described in Section
6.4.9 for four weeks prior to, during and four weeks after the last dose of study
medication. For the purposes of this trial, women of childbearing potential are defined
as: “All female subjects after puberty unless they are post-menopausal for at least two
years, are surgically sterile or are sexually inactive”.
4. Subject is willing and able to participate in the trial and has provided written, informed
consent.
5. Be able to maintain an accurate and complete diary (18-hour), with the help of a
caregiver, recording “on” time, “on” time with minor dyskinesia, “on” time with
troublesome dyskinesia, “off” time and time asleep.
Exclusion Criteria:
To be eligible for inclusion in this trial the subjects must not meet any of the following
criteria:
1. If female, the subject is pregnant or lactating.
2. The subject experienced a clinically significant adverse effect during trial 27919 that
could put the subject at risk according to the investigator’s opinion.
3. The subject has shown clinically significant deterioration during participation in
trial 27919.
4. Motor deterioration during trial 27919 that requires upward titration of existing antiparkinsonian
medication or the initiation of an additional anti-parkinsonian medication.
5. The investigator deems it is not in the subject’s best interest to participate to trial 27937.
6. Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family
members who suffer(ed) from such.
To be eligible for inclusion into this trial, the subjects must fulfill all of the following
criteria:
1. The subject completed 24 weeks of trial 27919.
2. The subject successfully completed all trial requirements in trial 27919.
3. If female, they must be either post-menopausal for at least 2 years, surgically sterilized
or have undergone hysterectomy or, if of child bearing potential they must be willing to
avoid pregnancy by using an adequate method of contraception as described in Section
6.4.9 for four weeks prior to, during and four weeks after the last dose of study
medication. For the purposes of this trial, women of childbearing potential are defined
as: “All female subjects after puberty unless they are post-menopausal for at least two
years, are surgically sterile or are sexually inactive”.
4. Subject is willing and able to participate in the trial and has provided written, informed
consent.
5. Be able to maintain an accurate and complete diary (18-hour), with the help of a
caregiver, recording “on” time, “on” time with minor dyskinesia, “on” time with
troublesome dyskinesia, “off” time and time asleep.
Exclusion Criteria:
To be eligible for inclusion in this trial the subjects must not meet any of the following
criteria:
1. If female, the subject is pregnant or lactating.
2. The subject experienced a clinically significant adverse effect during trial 27919 that
could put the subject at risk according to the investigator’s opinion.
3. The subject has shown clinically significant deterioration during participation in
trial 27919.
4. Motor deterioration during trial 27919 that requires upward titration of existing antiparkinsonian
medication or the initiation of an additional anti-parkinsonian medication.
5. The investigator deems it is not in the subject’s best interest to participate to trial 27937.
6. Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family
members who suffer(ed) from such.
主要排除條件
Inclusion Criteria:
To be eligible for inclusion into this trial, the subjects must fulfill all of the following
criteria:
1. The subject completed 24 weeks of trial 27919.
2. The subject successfully completed all trial requirements in trial 27919.
3. If female, they must be either post-menopausal for at least 2 years, surgically sterilized
or have undergone hysterectomy or, if of child bearing potential they must be willing to
avoid pregnancy by using an adequate method of contraception as described in Section
6.4.9 for four weeks prior to, during and four weeks after the last dose of study
medication. For the purposes of this trial, women of childbearing potential are defined
as: “All female subjects after puberty unless they are post-menopausal for at least two
years, are surgically sterile or are sexually inactive”.
4. Subject is willing and able to participate in the trial and has provided written, informed
consent.
5. Be able to maintain an accurate and complete diary (18-hour), with the help of a
caregiver, recording “on” time, “on” time with minor dyskinesia, “on” time with
troublesome dyskinesia, “off” time and time asleep.
Exclusion Criteria:
To be eligible for inclusion in this trial the subjects must not meet any of the following
criteria:
1. If female, the subject is pregnant or lactating.
2. The subject experienced a clinically significant adverse effect during trial 27919 that
could put the subject at risk according to the investigator’s opinion.
3. The subject has shown clinically significant deterioration during participation in
trial 27919.
4. Motor deterioration during trial 27919 that requires upward titration of existing antiparkinsonian
medication or the initiation of an additional anti-parkinsonian medication.
5. The investigator deems it is not in the subject’s best interest to participate to trial 27937.
6. Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family
members who suffer(ed) from such.
To be eligible for inclusion into this trial, the subjects must fulfill all of the following
criteria:
1. The subject completed 24 weeks of trial 27919.
2. The subject successfully completed all trial requirements in trial 27919.
3. If female, they must be either post-menopausal for at least 2 years, surgically sterilized
or have undergone hysterectomy or, if of child bearing potential they must be willing to
avoid pregnancy by using an adequate method of contraception as described in Section
6.4.9 for four weeks prior to, during and four weeks after the last dose of study
medication. For the purposes of this trial, women of childbearing potential are defined
as: “All female subjects after puberty unless they are post-menopausal for at least two
years, are surgically sterile or are sexually inactive”.
4. Subject is willing and able to participate in the trial and has provided written, informed
consent.
5. Be able to maintain an accurate and complete diary (18-hour), with the help of a
caregiver, recording “on” time, “on” time with minor dyskinesia, “on” time with
troublesome dyskinesia, “off” time and time asleep.
Exclusion Criteria:
To be eligible for inclusion in this trial the subjects must not meet any of the following
criteria:
1. If female, the subject is pregnant or lactating.
2. The subject experienced a clinically significant adverse effect during trial 27919 that
could put the subject at risk according to the investigator’s opinion.
3. The subject has shown clinically significant deterioration during participation in
trial 27919.
4. Motor deterioration during trial 27919 that requires upward titration of existing antiparkinsonian
medication or the initiation of an additional anti-parkinsonian medication.
5. The investigator deems it is not in the subject’s best interest to participate to trial 27937.
6. Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family
members who suffer(ed) from such.
試驗計畫預計收納受試者人數
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台灣人數
36 人
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全球人數
416 人
