Pregabalin in the Treatment of Essential Tremor
关键词
抽象
日期
| 最后验证: | 10/31/2015 |
| 首次提交: | 12/27/2007 |
| 提交的预估入学人数: | 03/25/2008 |
| 首次发布: | 03/27/2008 |
| 上次提交的更新: | 11/03/2015 |
| 最近更新发布: | 11/05/2015 |
| 实际学习开始日期: | 05/31/2006 |
| 预计主要完成日期: | 11/30/2008 |
| 预计完成日期: | 11/30/2008 |
状况或疾病
干预/治疗
Drug: 1
Drug: 2
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: 1 Pregabalin 75 mg bid to a maximum dose of 300 mg bid | Drug: 1 75 mg bid to 300 mg bid based on per subject tolerability |
| Placebo Comparator: 2 Placebo to 4 capsules bid | Drug: 2 up to 4 capsules bid as tolerated |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: 1. Subjects must be between the ages of 18 and 80 inclusive. 2. Each subject must have current manifestations of ET symptoms based on the Tremor Investigational Group (TRIG) criteria for definite or probable ET: - Moderate or severe tremor in head or arms for at least 3 years duration. - No present causes of enhanced physiologic tremor. - No recent exposure to tremorogenic drugs or drug withdrawal states. - No direct or indirect trauma to the nervous system within 3 months preceding the onset of tremor. - No historic or clinical evidence of psychogenic tremor origin. 3. Subjects with a history of seizures are eligible. 4. Subjects must be in generally good health as evidenced by previous medical history and clinical examination. 5. Patients will be allowed to take Beta-blockers but will not be allowed to take any other medication for tremor (primidone, topiramate, benzodiazepines, etc.) An evening dose of a benzodiazepine to improve sleep is acceptable. They must have been on a stable dose of any existing beta-blocker for 4 weeks prior to entry into the study and will not be allowed to change the dose of that medication throughout the controlled portion of the study. Any medication discontinued during screening in order to comply with these criteria must be stopped for 5 half-lives prior to study initiation. 6. Subjects must be accessible by telephone. 7. If the subject is a female of childbearing age, she must have had a hysterectomy, tubal ligation, otherwise be incapable of pregnancy, or have practiced one of the following methods of contraception for at least one month prior to study entry (or a negative urine pregnancy test within one week of study entry): - Hormonal contraceptives - Spermicide and barrier - Intrauterine device - Partner sterility 8. Prior to participation in this study, each subject must sign an informed consent. Exclusion Criteria: 1. Patients do not meet TRIG criteria for probable ET. 2. Subjects who are not able to abstain from alcohol for 24 hours prior to each evaluation. 3. Patients who can not maintain an identical dose of any medicine that may affect tremor during their entire study involvement. 4. Subjects who have exhibited any psychotic symptomatology. 5. Subjects who have known renal deficiencies. 6. Subjects who have been intolerant of pregabalin in the past 7. Prior surgical treatment for tremor. 8. Patients currently taking more than a single drug for ET. 9. Patients taking anti-seizure medications. 10. Breast feeding or pregnant females. |
结果
主要结果指标
1. Change from baseline in the overall TRS score obtained at the final evaluation (end of study). The overall TRS score will be derived from the three TRS subcecals giving a maximum score of 84 which will be converted to a 100 point scale. [baseline to completion]
次要成果指标
1. Nonparametric tests will be employed and exact p (2 tailed) values computed for the categorical dependent variables. [baseline to completion]
