Safety and Efficacy of Propranolol in the Treatment of Tardive Dyskinesia
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Change in the Abnormal Involuntary Movement Scale (AIMS) score.
研究概览
简要总结
Tardive dyskinesia (TD) is a disabling, embarrassing and often irreversible iatrogenic movement disorder that can occur in anyone exposed to drugs that block dopamine receptors, including first and second generation antipsychotics and antiemetic agents. There is no way to prevent TD except preventing exposure to the inciting agents and there are no approved symptomatic therapies. Propranolol is an FDA-approved β-blocker with limited data supporting its use as a treatment for TD.
The goal of this study is to determine the efficacy of propranolol in the treatment of TD in a double-blind, cross-over prospective manner. If propranolol is found to be an effective therapy, it will fulfill a great need in the treatment of TD with a medication that is known to be safe and inexpensive.
详细描述
Tardive dyskinesia (TD) is a disabling, embarrassing and often irreversible iatrogenic movement disorder that can occur in anyone exposed to drugs that block dopamine receptors, including first and second generation antipsychotics and antiemetic agents. There is no way to prevent TD except preventing exposure to the inciting agents and there are no approved symptomatic therapies. Propranolol is an FDA-approved β-blocker with limited data supporting its use as a treatment for TD.
The goal of this study is to determine the efficacy of propranolol in the treatment of TD in a double-blind, cross-over prospective manner. Patients with a diagnosis of TD will be randomized to propranolol or identical placebo. The patients will be treated for eight weeks, complete a one week washout and then crossed over for another eight weeks. Hence, the subjects will be their own controls. Participation in this pilot trial will provide placebo controlled blinded data that will assist in planning a larger phase II trial. If propranolol is found to be an effective therapy, it will fulfill a great need in the treatment of TD with a medication that is known to be safe and inexpensive.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-75 years
- •diagnosis of classical TD by a movement disorder expert for at least 6 months with a baseline score of at least 2 on two of the seven items on the AIMS severity scale
- •stable on medication (either on or off dopamine blocking agents) for at least six months.
排除标准
- •breastfeeding
- •unstable psychiatric disease
- •history of asthma or COPD
- •baseline heart rate less than 60
- •history of orthostatic hypertension or its presence at screening
- •history of congestive heart failure or unstable angina pectoris
- •resting SBP <100 and DBP < 60
- •AV-block II or III without pacemaker
- •history of diabetes mellitus
- •previous adverse effects from use of beta-blockers
- •current use of a β-blocker and the other following drugs: quinidine, amiodarone, propafenone, digoxin, verapamil, diltiazem, clonidine, and warfarin
- •tremor, dystonia, akathisia or other non-tardive movement disorder
- •any medical illness that precludes treatment with propranolol.
研究组 & 干预措施
Propranolol Hydrochloride
Two week up-titration to reach a total dose of 20mg per oral four times per day over the first two weeks then will remain on a stable dose for six weeks. The patients will be treated for eight weeks, complete a one week washout and then crossed over to another arm for eight weeks.
干预措施: Propranolol Hydrochloride (Drug)
Placebo Oral Tablet
Identical placebo. The patients will be treated for eight weeks, complete a one week washout and then crossed over to another arm for eight weeks.
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Change in the Abnormal Involuntary Movement Scale (AIMS) score.
时间窗: Visit 1, 3 4, 6, 7 (up to 18 weeks)
AIMS is a rating scale that scores each individual involuntary movement type at different body locations on a five-point anchored scale. For this study, items 1-7 represent the severity portion (rated 0-4) of the scale and will be used as the primary end point. This measure will be completed at the time of the visit by the enrolling physician. In addition, a standardized video documenting the motor portion of the AIMS will be completed at baseline and eight weeks for both segments of the study. These will be placed in a randomized order and scored using the AIMS severity scale by two blinded raters using consensus measures. A comparison of the change in score from placebo to active by the blinded video raters will be the primary outcome measure.
次要结局
- Change in the Clinical Global Impression of Severity (CGI-S) score.(Visit 1, 3 4, 6 (up to 18 weeks))
- Change in the Clinical Global Impression -Improvement (CGI-I) score.(Visit 3 and 6 (up to 18 weeks))
研究者
Jaime Hatcher-Martin
Asstant Professor
Emory University