Parkinson's Disease
Conditions
Keywords
dyskinesia, Parkinson's disease
Brief summary
The primary objective of the study is to evaluate the safety and tolerability of ADX48621 in Parkinson's disease patients following four weeks of dosing. The secondary objectives of the study include the evaluation of the efficacy of ADX48621 compared with placebo in reducing levodopa induced dyskinesia in patients with Parkinson's; the evaluation of the effect of ADX48621 on symptoms of Parkinson's disease and patient ability to function, and the evaluation of the effect of coadministration of ADX48621 on L-dopa efficacy.
Detailed description
First study of ADX48621 in male and female Parkinson's disease patients with levodopa-induced dyskinesia. Four weeks, double-blind, placebo-controlled dose titration from 50 mg once daily up to 100 mg three times daily, at the start of week 4. Safety and tolerability assessed by adverse events enquiry, heart rate and blood pressure, 12-lead ECG, haematology and biochemistry. Efficacy assessments include Abnormal Involuntary Movement Scale (AIMS), Unified Parkinson's Disease rating Scale (UPDRS) patient PD symptom diaries, Hospital Anxiety Depression Scale (HADS), patient and clinician global impression of change in PD and dyskinesia (PGIC and CGIC).
Interventions
DRUGADX48621
oral administration
DRUGPlacebo
oral administration
Sponsors
Addex Pharma S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* outpatient with idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnosis Criteria (UKPDSBBCDC) * experiences moderately disabling dyskinesia (screening visit UPDRS 33 score≥2) * has an mAIMS score at baseline ≥ 7 with a score ≥ 3 in at least one body area
Exclusion criteria
* surgical treatment for Parkinson's disease (e.g. Deep Brain Stimulation, within the last year or planned during the study) * unstable co-existing psychiatric disease including cognitive impairment that, according to the Investigator, could interfere with the conduct of the study * has a history of a significant medical condition that may affect the safety of the patient or preclude adequate participation in the study. * is pregnant or breast-feeding. Female patients who are of child-bearing potential must be using adequate contraceptive methods (e.g. oral contraceptive, double-barrier method, intra-uterine device, intra-muscular hormonal contraceptive), and have a negative pregnancy test at Screening Other protocol-defined inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with abnormal safety and tolerability assessment parameters | 4 weeks | Physical and neurological examination, heart rate and blood pressure, 12-lead ECG, hematology and biochemistry assessments, use of concomitant medications, adverse events and serious adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dyskinesia severity score measured by mAIMS | 4 weeks | — |
| Change in Parkinson's disease severity | 4 weeks | Patient diary at weeks 1, 2, 3 and 4, UPDRS Part III at weeks 2 and 4, UPDRS total score at week 4 |
| Patient-rated and clinician-rated global impression of change in dyskinesia and Parkinson's disease | 4 weeks | — |
Countries
Austria, France, Germany, United States
Outcome results
None listed