ट्रायल रडार AI | ||
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क्लिनिकल ट्रायल NCT01377922 के लिए Lambert Eaton Myasthenic Syndrome वर्तमान में पूर्ण है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें। | ||
एक परीक्षण फ़िल्टर मानदंडों से मेल खाता है
कार्ड दृश्य
A Phase 3 Study of Amifampridine Phosphate in Patients With Lambert Eaton Myasthenic Syndrome (LEMS) चरण III 38
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'अध्ययन समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल ट्रायल NCT01377922 का मुख्य उद्देश्य उपचार का अध्ययन करना था। यह चिकित्सकीय अध्ययन Lambert Eaton Myasthenic Syndrome से जुड़ा हुआ था और यह एक चरण III हस्तक्रियात्मक परीक्षण था। परीक्षण अब पूर्ण हो चुका है। इसकी शुरुआत 1 जून 2011 को हुई थी और इसमें कुल 38 प्रतिभागियों को शामिल किया गया था। कैटलिस्ट फार्मास्यूटिकल्स ने इस परीक्षण का नेतृत्व किया और यह 1 जुलाई 2016 को पूरा हुआ। ClinicalTrials.gov वेबसाइट पर यह जानकारी 4 जनवरी 2018 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
A Phase 3 study to evaluate the efficacy and safety of Amifampridine Phosphate in patients with Lambert-Eaton Myasthenic Syndrome (LEMS).
विस्तृत विवरण
This multicenter, double-blind, placebo-controlled, randomized (1:1) discontinuation study is a 4-part study designed to evaluate the efficacy and safety of multiple dose administration of amifampridine phosphate in patients with LEMS. Data from parts 2 and 3 (the double-blind parts of the study) are presented in this record.
आधिकारिक शीर्षक
A Phase 3, Double-blind, Placebo-controlled, Randomized Discontinuation Study Followed by Open-label Extension Evaluating Efficacy and Safety of Amifampridine Phosphate in Patients With Lambert-Eaton Myasthenic Syndrome (LEMS)
स्वास्थ्य स्थितियां
Lambert Eaton Myasthenic Syndromeअन्य अध्ययन आईडी
- LMS-002
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2011-06
अंतिम अद्यतन प्रकाशित
2018-01-04
अध्ययन की समाप्ति तिथि (अनुमानित)
2016-07
नामांकन (अनुमानित)
38
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
चरण III
स्थिति
पूर्ण
प्राथमिक उद्देश्य
उपचार
डिज़ाइन आवंटन
यादृच्छिक
हस्तक्षेप मॉडल
समानांतर
अंधकरण
दोहरा अंध
समूह/हस्तक्षेप
| प्रतिभागी समूह/शाखा | हस्तक्षेप/उपचार |
|---|---|
प्लेसबो तुलना समूहPlacebo Matching placebo tablets administered 3-4 times a day (to the individual patient's tablet count of active at baseline) over 2 weeks. | प्लेसबो Matching placebo tablets administered 3-4 times a day (to the individual patient's tablet count of active at baseline) over 2 weeks. |
प्रयोगात्मकAmifampridine Phosphate Amifampridine, 30-80 mg given 3-4 times per day with a maximum single dose of 20 mg (2 x 10 mg tablets), for 2 weeks. | Amifampridine Phosphate Amifampridine, 30-80 mg given 3-4 times per day with a maximum single dose of 20 mg (2 x 10 mg tablets), for 2 weeks. |
प्राथमिक परिणाम माप
द्वितीयक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Change From Baseline Quantitative Myasthenia Gravis (QMG) at 14 Days | The QMG is a physician-rated test including 13 assessments, including facial strength, swallowing, grip strength, and duration of time that limbs can be maintained in outstretched positions. Each of the 13 items is scored from 0 (none) to 3 (severe). The total score can range from 0 to 39. Increased QMG total score correlates to worsening symptoms of LEMS. | Assessment at Baseline and Day 14 |
Change in SGI Score | Subject Global Impression (SGI) is a measure of changes in subject's perception of change in overall wellbeing.
The patient is asked to use the 7-point scale below to rate their impression of the effects of the study medication during the preceding 3 days on their physical well being.
1. Terrible
2. Mostly dissatisfied
3. Mixed
4. Partially satisfied
5. Mostly satisfied
6. Pleased
7. Delighted | Assessment at Baseline and Day 14 |
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Change From Baseline Timed 25 Foot Walking Test (T25FW) at 14 Days | The T25FW test, a component of the Multiple Sclerosis Functional Composite, was a quantitative mobility and leg function performance test based on a timed 25-foot walk (National Multiple Sclerosis Society). The patient was directed to walk a clearly marked 25-foot course as quickly and safely as possible. Following a rest of at least 5 minutes, the timed 25-foot walk was repeated. Patients could use assistive devices, such as canes, crutches, or walkers.
All data were normalized to the number of feet per minute, so if the patient walked 25 feet in less than a minute, the result was a speed greater than 25 feet/minute.
The measurement for the T25FW test was the average speed, expressed in feet/minute, of the 2 completed walks. | Assessment at Baseline and Day 14 |
Change in CGI-I Score | The Investigator completed the 7-point CGI I, based on changes in symptoms, behavior, and functional abilities, at the protocol-specified time points compared to the patient's condition at Day 0.
1. = Very much improved
2. = Much improved
3. = Minimally improved
4. = No change
5. = Minimally worse
6. = Much worse
7. = Very much worse | Baseline and Day 14 |
पात्रता मानदंड
अध्ययन के लिए पात्र आयु
वयस्क, वृद्ध वयस्क
अध्ययन के लिए न्यूनतम आयु
18 Years
अध्ययन के लिए पात्र लिंग
सभी
Individuals eligible to participate in this study must meet all of the following inclusion criteria:
- ≥18 years of age
- Confirmed diagnosis of LEMS
- Normal respiratory function
- Normal swallowing function
- If receiving peripherally acting cholinesterase inhibitors a stable dose is required for at least 7 days prior to Screening.
- If receiving oral immunosuppressants a stable dose is required for at least 90 days prior to Screening.
- Negative pregnancy test for females of childbearing potential
- If sexually active, willing to use 2 acceptable methods of contraception
- Willing to perform all study procedures as physically possible.
- Willing and able to provide written informed consent after the nature of the study has been explained and prior to the start of any research-related procedures.
Individuals who meet any of the following exclusion criteria are not eligible to participate in the study:
- History of epilepsy or seizure.
- Known active brain metastasis.
- Use of Fampridine (4-aminopyridine), and any form of 3,4-diaminopyridine other than the IP provided, such as amifampridine base or Firdapse, during the study.
- Use of medications known to lower the epileptic threshold within 7 days or 5 half-lives.
- Use of medications which inhibit neuromuscular junction function within 7 days or 5 half-lives.
- Use of IVIG, plasmapheresis (plasma exchange), or immunoadsorption within 90 days
- Use of guanidine hydrochloride within 7 days
- Use of rituximab within 12 months
- History of drug allergy to any pyridine-containing substances or any amifampridine phosphate excipient(s).
- Use of any other investigational productwithin 30 days
- Treatment with a concomitant medication that prolongs the QT/QTc interval within 7 days or 5 half-lives.
- Treatment with sultopride (4-amino-N-\[(1-ethylpyrrolidin-2-yl)methyl\]-5-ethylsulfonyl-2-methoxybenzamide) within 7 days.
- An abnormal electrocardiogram (ECG).
- Documented history of arrhythmias.
- History of additional risk factors for torsade de pointes.
- Breastfeeding or pregnant or planning to become pregnant (self or partner) at any time during the study.
- Likely or expected to require treatment for cancer within 3 months (90 days) after entering.
- History of severe renal impairment or evidence of severe renal impairment
- Any condition that places the patient at high risk of poor treatment compliance or of not completing the study.
- History of uncontrolled asthma.
कोई संपर्क डेटा नहीं।
14 8 देशों में अध्ययन स्थान
Alabama
Birmingham, Alabama, 35233, United States
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Scottsdale, Arizona, 85258, United States
California
Los Angeles, California, 90095, United States
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Kansas
Kansas City, Kansas, 66160, United States
New York
New York, New York, 10032, United States
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Munich, Bavaria, D-80336, Germany
Berlin, D-10117, Germany
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