- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00365352
XP13512 vs. Placebo in Patients With Restless Legs Syndrome.
2013년 7월 15일 업데이트: XenoPort, Inc.
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of XP13512 in Patients With Restless Legs Syndrome.
The primary objective of this trial is to assess the efficacy of XP13512 taken once daily compared to placebo for the treatment of patients suffering from Restless Legs Syndrome (RLS).
연구 개요
상세 설명
This was a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of XP13512 in subjects with Restless Legs Syndrome (RLS).
Eligible subjects were randomized to receive 1 of 3 once daily oral doses of XP13512 1200 mg, XP13512 600 mg, or placebo.
The primary study objective was to compare the efficacy of XP13512 1200 mg taken once daily for 12 weeks versus placebo.
The secondary study objectives were to assess the efficacy of XP13512 600 mg taken once daily for the reatment of RLS and to assess the onset of treatment benefits and improvement in sleep, pain, mood, quality of life, and safety and tolerability of both XP13512 1200 mg and 600 mg.
연구 유형
중재적
등록 (실제)
325
단계
- 3단계
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Patients with primary RLS, based on the International RLS Study Diagnostic Criteria.
Exclusion Criteria:
- A sleep disorder (e.g., sleep apnea) that may significantly affect the assessment of RLS;
- Neurologic disease or movement disorder (e.g., diabetic neuropathy, Parkinson's Disease, Multiple Sclerosis, dyskinesias, and dystonias);
- Abnormal laboratory results, electrocardiogram (ECG) or physical findings;
- Pregnant or lactating women;
- Women of childbearing potential who are not practicing an acceptable method of birth control.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: XP13512 600MG
XP13512 600MG ONCE DAILY
|
XP13512 600MG ONCE DAILY
다른 이름들:
|
실험적: XP13512 1200MG
XP13512 1200MG ONCE DAILY
|
XP13512 1200MG ONCE DAILY
다른 이름들:
|
위약 비교기: Placebo
PLACEBO ONCE DAILY
|
PLACEBO ONCE DAILY
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change From Baseline in IRLS Rating Scale Total Score at Week 12 Using Last Observation Carried Forward (LOCF)
기간: Baseline and Week 12
|
The International Restless Legs Syndrome (IRLS) Rating scale is a measure of RLS disease severity.
The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS.
Ten items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants' mood, daily life, and activities.
The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe.
The scale assesses symptoms over the week prior to measurement.
|
Baseline and Week 12
|
Number of Participants With a Score of "Much Improved" or "Very Much Improved" on the Investigator-rated CGI-I Scale (Response) at (Week 12) Using LOCF
기간: Week 12
|
The investigator -rated Clinical Global Impression of Improvement (CGI-I) scale is an assessment designed to allow investigators to rate the change of a participant's disease severity over time based on a seven-point scale, with a score of 1 being "very much improved," a score of 2 being "much improved," a score of 3 being "minimally improved," a score of 4 being "no change," a score of 5 being "minimally improved,"a score of 6 being "much worse," and a score of 7 being "very much worse."
Participants with a response of "much improved" or "very much improved" were classified as responders.
|
Week 12
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change From Baseline to the End of Treatment (Week 12) in the IRLS Rating Scale Total Score Using LOCF
기간: Baseline (Day 1) and End of Treatment (Week 12)
|
The IRLS Rating scale is a measure of RLS disease severity.
The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS.
Items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants' mood, daily life, and activities.
The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe.
The scale assesses symptoms over the week prior to measurement.
|
Baseline (Day 1) and End of Treatment (Week 12)
|
Number of Participants Classsified as Responders on the Investigator-rated CGI-I Scale at Week 12 Using LOCF
기간: Week 12
|
The CGI-I scale is a standardized tool that is widely used in psychopharmacologic trials.
For the CGI-I, the investigator was asked to rate the participant's overall change in RLS symptoms from Baseline.
Scores ranged from 1 (very much improved) to 7 (very much worse).
Participants who were much improved (score of 2) or very much improved on the CGI-I scale at the end of treatment (Week 12) are classified as "Responders."
|
Week 12
|
Number of Participants Who Had an Onset of Response to Treatment at the End of Week 1 Based Upon the IRLS Rating Scale Total Score and the Investigator-rated CGI-I Using LOCF
기간: End of Week 1
|
The IRLS Rating scale is a measure of RLS disease severity.
Items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants' mood, daily life, and activities.
The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe.
Response was defined by an IRLS Rating Scale total score at the end of Week 1 < 15 and at least a 6-point reduction from the participant's Baseline score and an investigator-rated CGI-I response of "much improved" or "very much improved."
|
End of Week 1
|
The Time to Onset of the First Response to Treatment on the IRLS Rating Scale Total Score and the Investigator-rated CGI-I
기간: Baseline (Day 1) to End of Treatment (Week 12)
|
The Response was defined by an IRLS Rating Scale total score at the end of Week 1 < 15 and at least a 6-point reduction from the participant's Baseline score and an investigator-rated CGI-I response of much improved or very much improved.
The median time to onset is estimated using the product-limit estimation method.
|
Baseline (Day 1) to End of Treatment (Week 12)
|
Mean Change in the IRLS Rating Scale Total Score From Baseline at Week 12 by RLS Treatment History Using LOCF
기간: Baseline (Day 1) and Week 12
|
The IRLS Rating scale is a measure of RLS disease severity.
The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS.
Ten items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants' mood, daily life, and activities.
The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe.
The scale assesses symptoms over the week prior to measurement.
|
Baseline (Day 1) and Week 12
|
Change From Baseline in the IRLS Rating Scale Total Score at Week 12 by Baseline RLS Rating Scale Total Score Category (Baseline RLS Severity) Using LOCF
기간: Baseline (Day 1) and Week 12
|
The IRLS Rating scale is a measure of RLS disease severity.
The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS.
Ten items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants' mood, daily life, and activities.
The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe.
The scale assesses symptoms over the week prior to measurement.
|
Baseline (Day 1) and Week 12
|
Change From Baseline to the End of Week 1 in the IRLS Rating Scale Total Score Using LOCF
기간: Baseline and the End of Week 1
|
The IRLS Rating scale is a measure of RLS disease severity.
The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS.
Items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants' mood, daily life, and activities.
The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe.
The scale assesses symptoms over the week prior to measurement.
|
Baseline and the End of Week 1
|
Number of Participants Classified as Investigator-rated CGI-I Scale Responders at Week 12 by RLS Treatment History Using LOCF
기간: Basline and Week 12
|
The CGI-I scale is a standardized tool that is widely used in psychopharmacologic trials.
For the CGI-I, the investigator was asked to rate the participant's overall change in RLS symptoms from Baseline.
Scores ranged from 1 (very much improved) to 7 (very much worse).
Participants who were much improved (score of 2) or very much improved on the CGI-I scale at the end of treatment (Week 12) are classified as "Responders."
|
Basline and Week 12
|
Number of Total Responders to Treatment Based on the Investigator-Rated CGI of Improvement at the End of One Week of Treatment
기간: End of Week 1
|
The CGI-I scale is a standardized tool that is widely used in psychopharmacologic trials.
For the CGI-I, the investigator was asked to rate the participant's overall change in RLS symptoms from Baseline.
Scores ranged from 1 (very much improved) to 7 (very much worse).
Participants who were much improved (score of 2) or very much improved on the CGI-I scale at the end of treatment (Week 12) are classified as "Responders."
|
End of Week 1
|
Change From Baseline to the End of Treatment in Average Daily Total Sleep Time (Hours) Using LOCF
기간: Baseline to End of Treatment (Week 12)
|
Average daily total sleep time was derived from the Pittsburgh Sleep Diary (PghSD; an instrument with separate components to be completed [self-reported] at bedtime and waketime) as the mean of non-missing total sleep time over the 7 days before each visit, where total sleep time = [(wake up time - lights out time) - time to fall asleep - time awake during the night] in hours.
The change was calculated as the end of treatment (Week 12) value minus the Baseline value.
|
Baseline to End of Treatment (Week 12)
|
Change From Baseline to the End of Treatment in Average Daily Wake Time (Minutes) After Sleep Onset Using LOCF
기간: Baseline to End of Treatment (Week 12)
|
Average daily wake time after sleep onset was derived from the Pittsburgh Sleep Diary (PghSD) as the mean of non-missing total hours awake during the night after falling asleep over the 7 days before each visit.
The change was calculated as the end of treatment (Week 12) value minus the Baseline value.
|
Baseline to End of Treatment (Week 12)
|
Change From Baseline in the Average Daily RLS Pain Score at the End of Treatment (Week 12) for Participants With Pain at Baseline or the End of Week 12 Using LOCF
기간: Baseline and End of Treatment (Week 12)
|
The Daily RLS pain score was assessed by participants reporting whether they experienced any pain associated with RLS in the last 24 hours and rating their pain levels on an 11-point numerical rating scale, with 0 being no pain and 10 the most intense pain imaginable.
The assessment was performed for 7 days prior to Baseline and pre-defined study visits.
The change from baseline was calculated as the End of Treatment (Week 12) value minus the Baseline (Day 1) value.
|
Baseline and End of Treatment (Week 12)
|
Number of Participants Classified as Responders With at Least 30% and 50% Improvement in the Average Daily RLS Pain Score Using LOCF
기간: Week 12
|
The Mean Daily RLS pain was assessed by participants reporting whether they experienced any pain associated with RLS in the last 24 hours and rating their pain levels on an 11-point numerical rating scale, with 0 being no pain and 10 the most intense pain imaginable.
The assessment was performed for 7 days prior to Baseline and pre-defined visits A "Responder" is a participant with a score of "much improved" or "very much improved" on the investigator rated CGI I Scale at the end of treatment (Week 12 using LOCF).
|
Week 12
|
Change From Baseline in the Average Daily RLS Pain Score to Week 12 for Participants With a Baseline Pain Score of at Least 4 Using LOCF
기간: Baseline and Week 12
|
The Average Daily RLS pain was assessed by participants reporting whether they experienced any pain associated with RLS in the last 24 hours and rating their pain levels on an 11-point numerical rating scale, with 0 being no pain and 10 the most intense pain imaginable.
The assessment was performed for 7 days prior to Baseline and pre-defined visits.
The change from baseline was calculated as the End of Treatment (Week 12) value minus the Baseline (Day 1) value.
|
Baseline and Week 12
|
Number of Participants Classified as Responders to Treatment Based on the Participant-Rated CGI of Improvement at Week 1 and Week 12 (End of Treatment)
기간: Week 1 and Week 12
|
The CGI-I scale is a standardized tool that is widely used in psychopharmacologic trials.
For the CGI-I, the investigator was asked to rate the participant's overall change in RLS symptoms from Baseline.
Scores ranged from 1 (very much improved) to 7 (very much worse).
Participants who were much improved (score of 2) or very much improved on the CGI-I scale at the end of treatment (Week 12) are classified as "Responders."
|
Week 1 and Week 12
|
Number of Participants With a Rating of Excellent for the Overall Quality of Sleep in Past Week Measured by the Post-Sleep Questionnaire (PSQ) at the End of Treatment (Week 12) Using LOCF
기간: End of Treatment (Week 12)
|
The Post-Sleep Questionnaire (PSQ) was designed to evaluate overall sleep quality, ability to function, and RLS symptoms' interference with sleep over the past week.
Participants were asked to rate overall sleep quality (as either "Excellent," "Reasonable," or "Poor"), ability to function, number of nights with RLS symptoms, number of nights awakened by RLS symptoms, and the number of hours spent awake due to RLS symptoms over the past week.
|
End of Treatment (Week 12)
|
Number of Participants Who Indicated on the Mood Assessment That Their Mood Was Much Improved or Very Much Improved at Week 12 (End of Treatment) Using LOCF
기간: Week 12
|
The Mood Assessment is a non-disease-specific question surveying global change in a participant's overall mood.
Participants were asked to rate their overall change in mood since the start of the study by choosing a score in a range from 1 (Very Much Improved) to 7 (Very Much Worse).
The assessment was completed at Day 1 and the ends of Weeks 4, 8, and 12 or (Early Termination).
|
Week 12
|
Change From Baseline in the Profile of Mood State (POMS) Scale at Week 12 Using LOCF
기간: Baseline to End of Treatment (Week 12)
|
The Profile of Mood States (POMS) Brief Form contains 30 adjectives; each participant is asked to rate the degree to which each adjective describes themselves based on how they felt during the past week including the date on which the adjective was rated.
The possible ratings range from "0" (Not all all) to "4" (Extremely).
The Total Mood Disturbance Score (range of 0 to 120) is obtained by summing the values of six domains.
Higher scores indicate a more negative mood disturbance.
The POMS was completed at Baseline (Day 1), and at the end of Weeks 4, 8, and 12 (or Early Termination).
|
Baseline to End of Treatment (Week 12)
|
Change From Baseline in the Daytime Somnolence Score, an Item on the Medical Outcomes Study (MOS) Sleep Scale, at Week 12 Using LOCF
기간: Baseline and Week 12
|
The MOS Sleep Scale measures most constructs of sleep.
The scale has a battery of questions to measure specific aspects of sleep in participants with co-morbidities.
The four domains scored from the MOS Sleep Scale were "sleep disturbance,"' "sleep quantity,"' "sleep adequacy," and "daytime somnolence."
The scores of the daytime somnolence domain ranged from 1 to 100, with a high score indicating greater daytime somnolence.
The assessment was completed at Baseline (Day 1) and end of Weeks, 4, 8, and 12 (or end of Treatment).
|
Baseline and Week 12
|
Change From Baseline in the Sleep Disturbance Score, an Item on the MOS Sleep Scale, at Week 12 Using LOCF
기간: Baseline and Week 12
|
The MOS Sleep Scale measures most constructs of sleep.
The scale has a battery of questions to measure specific aspects of sleep in participants with co-morbidities.
The four domains scored from the MOS Sleep Scale were "sleep disturbance,"' "sleep quantity,"' "sleep adequacy," and "daytime somnolence."
The scores of the sleep disturbance domain ranged from 1 to 100, with a high score indicating greater impairment of sleep.
The assessment was completed at Baseline (Day 1) and end of Weeks, 4, 8, and 12 (or end of Treatment).
|
Baseline and Week 12
|
Change From Baseline in Sleep Adequacy, an Item on the MOS Sleep Scale, at Week 12 Using LOCF
기간: Basline and Week 12
|
The MOS Sleep Scale measures most constructs of sleep.
The scale has a battery of questions to measure specific aspects of sleep in participants with co-morbidities.
The four domains scored from the MOS Sleep Scale were "sleep disturbance,"' "sleep quantity,"' "sleep adequacy," and "daytime somnolence."
The scores of the sleep adequacy domain ranged from 1 to 100, with a high score indicating greater adequacy.
The assessment was completed at Baseline (Day 1) and end of Weeks, 4, 8, and 12 (or end of Treatment).
|
Basline and Week 12
|
Change From Baseline in Sleep Quantity, an Item on the MOS Sleep Scale, at Week 12 Using LOCF
기간: Baseline and Week 12
|
The MOS Sleep Scale measures most constructs of sleep.
The scale has a battery of questions to measure specific aspects of sleep in participants with co-morbidities.
The four domains scored from the MOS Sleep Scale were "sleep disturbance,"' "sleep quantity,"' "sleep adequacy," and "daytime somnolence."
The scores of the sleep quantity domain were measured in time (number of hours of sleep each night).
The assessment was completed at Baseline (Day 1) and end of Weeks, 4, 8, and 12 (or end of Treatment).
|
Baseline and Week 12
|
Change From Baseline in the Overall Life-Impact Score of the RLS Quality of Life (QoL) Questionnaire at Week 12 Using LOCF
기간: Baseline and Week 12
|
The Restless Legs Syndrome Quality of Life (RLS-QoL) questionnaire is a disease-specific, participant-rated questionnaire that assesses the impact of RLS on daily life, emotional well-being, social life, and work life of the participants.
The RLS-QoL Questionnaire is presented on a 0 (lowest possible score) to 100 (highest possible score) scale.
It was completed at Day 1 and at the end of Weeks 4, 8, and 12 (or Early Termination).
|
Baseline and Week 12
|
Number of Participants Experiencing No RLS Symptoms in Each of the Seven 4-hour Periods From the 24-hour RLS Record at Week 12 (End of Treatment)
기간: Week 12
|
RLS severity ratings were summarized in 6 non-overlapping 4-hour periods beginning at 8 AM.
A 4-hour period from 6 PM to 10 PM was also prospectively included to reflect the time frame when the most participants would experience their first symptoms of the day.
|
Week 12
|
Time to Onset of the First RLS Symptom From the 24-hour RLS Record Obtained at the End of Treatment (Week 12)
기간: Week 12
|
The time to onset of the first RLS symptoms from the 24-hour RLS Record is defined as the length of time from the start of the 24-hour assessment period (8:00 AM) to the time when 50% of participants experienced their first symptom.
|
Week 12
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Ahmed M, Hays R, Steven Poceta J, Jaros MJ, Kim R, Shang G. Effect of Gabapentin Enacarbil on Individual Items of the International Restless Legs Study Group Rating Scale and Post-sleep Questionnaire in Adults with Moderate-to-Severe Primary Restless Legs Syndrome: Pooled Analysis of 3 Randomized Trials. Clin Ther. 2016 Jul;38(7):1726-1737.e1. doi: 10.1016/j.clinthera.2016.05.008. Epub 2016 Jun 7.
- Avidan AY, Lee D, Park M, Jaros MJ, Shang G, Kim R. The Effect of Gabapentin Enacarbil on Quality of Life and Mood Outcomes in a Pooled Population of Adult Patients with Moderate-to-Severe Primary Restless Legs Syndrome. CNS Drugs. 2016 Apr;30(4):305-16. doi: 10.1007/s40263-016-0329-4.
- Ondo WG, Hermanowicz N, Borreguero DG, Jaros MJ, Kim R, Shang G. Effect of prior exposure to dopamine agonists on treatment with gabapentin enacarbil in adults with moderate-to-severe primary restless legs syndrome: pooled analyses from 3 randomized trials. J Clin Mov Disord. 2015 Mar 30;2:9. doi: 10.1186/s40734-015-0018-3. eCollection 2015.
- Lee DO, Ziman RB, Perkins AT, Poceta JS, Walters AS, Barrett RW; XP053 Study Group. A randomized, double-blind, placebo-controlled study to assess the efficacy and tolerability of gabapentin enacarbil in subjects with restless legs syndrome. J Clin Sleep Med. 2011 Jun 15;7(3):282-92. doi: 10.5664/JCSM.1074.
- Canafax DM, Bhanegaonkar A, Bharmal M, Calloway M. Validation of the post sleep questionnaire for assessing subjects with restless legs syndrome: results from two double-blind, multicenter, placebo-controlled clinical trials. BMC Neurol. 2011 Apr 28;11:48. doi: 10.1186/1471-2377-11-48.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2006년 8월 1일
기본 완료 (실제)
2007년 12월 1일
연구 완료 (실제)
2007년 12월 1일
연구 등록 날짜
최초 제출
2006년 8월 15일
QC 기준을 충족하는 최초 제출
2006년 8월 15일
처음 게시됨 (추정)
2006년 8월 17일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2013년 7월 22일
QC 기준을 충족하는 마지막 업데이트 제출
2013년 7월 15일
마지막으로 확인됨
2011년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 111460
- XP053 (기타 식별자: XenoPort, Inc.)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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Jazz Pharmaceuticals모병결절성 경화증 복합 환자의 발작 | Dravet Syndrome 참가자의 발작 | 레녹스-가스토 증후군 참가자의 발작미국
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Cure CMD모병Emery-Dreifuss 근이영양증 | 선천성 근무력증 증후군 | 림거들 근이영양증 | ITGA7(인테그린 알파-7) 결핍을 동반한 선천성 근이영양증 | 알파-디스트로글리칸병증(심각한 간질을 동반한 디스트로글리칸의 선천성 근이영양증 및 비정상적인 글리코실화) | 알파-디스트로글리칸병증(TRAPPC11 돌연변이로 인한 지방간 및 영아 발병 백내장을 동반한 선천성 근이영양증) | 알파-디스트로글리칸병증(디스트로글리칸의 저당화를 동반한 선천성 근이영양증) | 알파-디스트로글리칸병증(디스트로글리칸 및 간질의 저당화를 동반한 선천성 근이영양증) | 알파-디스트로글리칸병증(디스트로글리칸병증... 그리고 다른 조건미국
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Sanford HealthNational Ataxia Foundation; Beyond Batten Disease Foundation; Pitt Hopkins Research Foundation 그리고 다른 협력자들모병미토콘드리아 질병 | 색소 성 망막염 | 중증 근무력증 | 호산구성 위장염 | 다계통 위축 | 평활근육종 | 백질이영양증 | 항문 누공 | 척수소뇌성 운동실조증 3형 | 프리드라이히 실조증 | 케네디병 | 라임 병 | 혈구탐식림프조직구증 | 척수소뇌성 운동실조증 1형 | 척수소뇌성 운동실조증 2형 | 척수소뇌성 실조증 6형 | 윌리엄스 증후군 | 히르슈스프룽병 | 글리코겐 축적병 | 가와사키병 | 짧은 창자 증후군 | 저인산증 | 레버 선천성 흑암시 | 입내 | 심장이완불능증 | 다발성 내분비선 종양 | 레이 증후군 | 애디슨병 | 제2형 다발성내분비선종양 | 경피증 | 제1형 다발성내분비선종양 | 다발성 내분비선 종양 유형 2A | 다발성 내분비선 종양 유형 2B | 비정형 용혈성... 그리고 다른 조건미국, 호주
XP13512 600MG에 대한 임상 시험
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KalVista Pharmaceuticals, Ltd.모병유전성 혈관부종미국, 불가리아, 프랑스, 그리스, 이스라엘, 네덜란드, 스페인, 영국, 호주, 독일, 남아프리카, 슬로바키아, 오스트리아, 뉴질랜드, 루마니아, 캐나다, 일본
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Spinifex Pharmaceuticals Pty LtdSyneos Health빼는