A clinical trial to see if ADS-5102 is safe and effective in people with drug induced abnormal movements in Parkinson's disease
- Conditions
- Treatment of levodopa-induced dyskinesia in subjects with Parkinson's diseaseMedDRA version: 18.0Level: PTClassification code 10013916Term: DyskinesiaSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2014-003738-24-ES
- Lead Sponsor
- Adamas Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 72
1. Signed a current IRB/REC/IEC-approved informed consent form;
2. Male or female subjects between 30 and 85 years of age, inclusive;
3. Ambulatory or ambulatory-aided (e.g. walker or cane) ability while ON, such that the subject can complete study assessments;
4. Knowledgeable and reliable caregiver/study partner, if appropriate, to accompany the subject to study visits and assist in completion of study instruments, as needed and allowed;
5. Following diary training, the subject is willing and able to understand and complete the 24-hour PD home diary (trained caregiver/study partner assistance allowed);
6. Parkinson?s disease, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria;
7. On a stable regimen of antiparkinson?s medications for at least 30 days prior to screening, including a levodopa preparation administered not less than three times daily, and willing to continue the same doses and regimens during study participation;
8. A score of at least 2 on part IV, item 4.2 (functional impact of dyskinesias) of the Unified Parkinson?s Disease Rating Scale (MDS-UPDRS), at screening and at Baseline/Day 1/Week 0;
9. Using the 48-hour PD home diaries completed just prior to Baseline/Day 1/Week 0 (baseline), at least 2 half-hour time periods between 9 am and 4 pm of each 24-hour period are indicated as ?ON with troublesome dyskinesia?;
10. Any other current and allowed prescription/non-prescription medications and/or nutritional supplements taken regularly must have been at a stable dose and regimen for at least 30 days prior to screening, and subject must be willing to continue the same doses and regimens during study participation (this criterion does not apply to medications that are being taken pre-study only on an as-needed basis);
11. If taking an antidepressant, must be on a stable dose for at least 30 days prior to randomization.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36
1. History of exclusively diphasic, off state, myoclonic, dystonic, or akathetic dyskinesia without peak dose dyskinesia;
2. History of neurosurgical intervention related to PD (e.g. deep brain stimulation);
3. History of other neurological disease that, in the opinion of the investigator, would affect motor function or cognition, including, but not limited to Alzheimer?s dementia, Huntington?s disease, Lewy body dementia, frontotemporal dementia, corticobasal degeneration, progressive supranuclear palsy, multiple system atrophy, motor or sensory dysfunction secondary to stroke or brain trauma, or multi-infarct dementia with lacunae;
4. History of clinically significant hallucinations (visual, auditory, or any other type) due to levodopa, dopamine agonist, underlying PD or other/unknown cause, within 1 year prior to screening;
5. History of sensory impairments (e.g., hearing, vision) that, in the opinion of the investigator, would impair the subject?s ability to complete study assessments, or presence of untreated angle closure glaucoma;
6. History of alcohol or substance dependence or abuse within 2 years prior to screening;
7. History of seizures within 2 years prior to screening;
8. History of stroke or TIA within 2 years prior to screening;
9. History of myocardial infarction, or NYHA Functional Classification of Heart Failure Class 3 or 4 within 2 years prior to screening;
10. Any clinically significant ECG abnormalities, including any findings of abnormal ventricular conduction or rhythm other than isolated PVCs or first degree AV block;
11. History of cancer within 5 years prior to screening, with the following exceptions: adequately treated non-melanomatous skin cancers, localized bladder cancer, non-metastatic prostate cancer, in situ cervical cancer, or other definitively treated cancer that is considered cured;
12. Presence of cognitive impairment, as evidenced by a MMSE score of less than 24 during screening;
13. Hoehn and Yahr Stage 5;
14. Presence of an acute or chronic major psychiatric disorder or symptom (e.g. suicidal ideation) that, in the opinion of the investigator, would affect the subject?s ability to complete study assessments, or which would not be in the subject?s best interest to participate in the study;
15. Presence of orthostatic hypotension at screening: a decrease in systolic blood pressure (at least 20 mm Hg) or diastolic blood pressure (at least 10 mm Hg) within 3 minutes of the subject standing up, compared to pressures obtained while sitting;
16. Any of the following:
? Hemoglobin < 10 g/dL
? WBC <3.0 x 1e9/L
? Neutrophils <1.5 x 1e9/L
? Lymphocytes < 0.5 x 1e9/L
? Platelets <100 x 1e9/L
? AST and/or ALT > 2 times the upper limit of normal;
17. Estimated GFR < 50 mL/min/1.73m2 (calculated using MDRD);
18. Inability to swallow oral capsules, or a history of gastrointestinal malabsorption that would preclude the use of oral medication;
19. If female, is pregnant or lactating;
20. If a sexually active female, is not surgically sterile or at least 2 years postmenopausal, or does not agree to utilize a highly effective hormonal method of contraception (an IUD, or vasectomized male partner is also acceptable), in combination with a barrier method, from screening through at least 4 weeks after the completion of study treatment;
21.Use of amantadine within 30 days prior to screening, or documented inability to tolerate or lack of response to prior amantadine treatment for LID, or history of suicidal ideatio
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method