ADX48621 for the Treatment of Levodopa Induced Dyskinesia in Patients With Parkinson's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Addex Pharma S.A.
ClinicalTrials.gov Identifier:
NCT01336088
First received: April 4, 2011
Last updated: July 13, 2012
Last verified: July 2012
  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

Resource links provided by NLM:


Further study details as provided by Addex Pharma S.A.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01336088

  Show 25 Study Locations
Sponsors and Collaborators
Addex Pharma S.A.
Investigators
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 April 22, 2014