Clinical trial NCT01336088: ADX48621 for the Treatment of Levodopa Induced Dyskinesia in Patients With Parkinson's Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Keywords: dyskinesia
Parkinson's disease
Lead sponsor: Addex Pharma S.A.
Sponsor class: INDUSTRY
First posted: 2011-04-15
Enrollment: 83
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with abnormal safety and tolerability assessment parameters
timeFrame: 4 weeks
Secondary outcomes:
measure: Dyskinesia severity score measured by mAIMS
timeFrame: 4 weeks
measure: Change in Parkinson's disease severity
timeFrame: 4 weeks
measure: Patient-rated and clinician-rated global impression of change in dyskinesia and Parkinson's disease
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Addex Investigator Site
state: Alabama
city: Phoenix
country: United States
facility: Addex Investigator Site
state: Arizona
city: La Jolla
country: United States
facility: Addex Investigator Site
state: California
city: Los Angeles
country: United States
facility: Addex Investigator Site
state: California
city: Sunnyvale
country: United States
facility: Addex Investigator Site
state: California
city: New Haven
country: United States
facility: Addex Investigator Site
state: Connecticut
city: Boca Raton
country: United States
facility: Addex Investigator Site
state: Florida
city: Tampa
country: United States
facility: Addex Investigator Site
state: Florida
city: Chicago
country: United States
facility: Addex Investigator Site
state: Illinois
city: Southfield
country: United States
facility: Addex Investigator Site
state: Michigan
city: Commack
country: United States
facility: Addex Investigator Site
state: New York
city: Portland
country: United States
facility: Addex Investigator Site
state: Oregon
city: Kirkland
country: United States
facility: Addex Investigator Site
state: Washington
city: Innsbruck
country: Austria
facility: Addex Investigator Site
city: Bordeaux
country: France
facility: Addex Investigator Site
city: Clermont Ferrand
country: France
facility: Addex Investigator Site
city: Nantes
country: France
facility: Addex Investigator Site
city: Paris
country: France
facility: Addex Investigator Site
city: Toulouse
country: France
facility: Addex Investigator Site
city: Bochum
country: Germany
facility: Addex Investigator Site
city: Hanau
country: Germany
facility: Addex Investigator Site
city: Hannover
country: Germany
facility: Addex Investigator Site
city: Kassel
country: Germany
facility: Addex Investigator Site
city: Marburg
country: Germany
facility: Addex Investigator Site
city: Munich
country: Germany
facility: Addex Investigator Site
Study officials:
affiliation: Addex Pharma
name: Addex Pharma
role: STUDY_DIRECTOR
References:
citation: McFarthing K, Prakash N, Simuni T. CLINICAL TRIAL HIGHLIGHTS - DYSKINESIA. J Parkinsons Dis. 2019;9(3):449-465. doi: 10.3233/JPD-199002. No abstract available.