ADX48621 for the Treatment of Levodopa Induced Dyskinesia in Patients With Parkinson's Disease
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson's Disease |
Drug: ADX48621 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of ADX48621 in the Treatment of Levodopa Induced Dyskinesia in Patients With Parkinson's Disease |
- Number of patients with abnormal safety and tolerability assessment parameters [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]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.
- Dyskinesia severity score measured by mAIMS [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Change in Parkinson's disease severity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 83 |
| Study Start Date: | April 2011 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: ADX48621 |
Drug: ADX48621
oral administration
Other Name: Dipraglurant
|
| Placebo Comparator: ADX48621 Matching Placebo |
Drug: Placebo
oral administration
Other Name: Placebo
|
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).
Eligibility| Ages Eligible for Study: | 30 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts 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 exclusion criteria may apply
Contacts and Locations
Show 25 Study Locations| Study Director: | Addex Pharma | Addex Pharma |
More Information
No publications provided
| Responsible Party: | Addex Pharma S.A. |
| ClinicalTrials.gov Identifier: | NCT01336088 History of Changes |
| Other Study ID Numbers: | ADX48621-201 |
| Study First Received: | April 4, 2011 |
| Last Updated: | July 13, 2012 |
| Health Authority: | United States: Food and Drug Administration Austria: Agency for Health and Food Safety France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Addex Pharma S.A.:
|
dyskinesia Parkinson's disease |
Additional relevant MeSH terms:
|
Dyskinesias Parkinson Disease Movement Disorders Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Neurodegenerative Diseases |
Levodopa Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013