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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01336088
Recruitment Status : Completed
First Posted : April 15, 2011
Last Update Posted : July 16, 2012
Information provided by (Responsible Party):
Addex Pharma S.A.

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: ADX48621 Drug: Placebo Phase 2

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : April 2011
Primary Completion Date : February 2012
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Levodopa
U.S. FDA Resources

Arm Intervention/treatment
Experimental: ADX48621 Drug: ADX48621
oral administration
Other Name: Dipraglurant
Placebo Comparator: ADX48621 Matching Placebo Drug: Placebo
oral administration

Primary Outcome Measures :
  1. Number of patients with abnormal safety and tolerability assessment parameters [ Time Frame: 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 Outcome Measures :
  1. Dyskinesia severity score measured by mAIMS [ Time Frame: 4 weeks ]
  2. Change in Parkinson's disease severity [ Time Frame: 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

  3. Patient-rated and clinician-rated global impression of change in dyskinesia and Parkinson's disease [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01336088

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Sponsors and Collaborators
Addex Pharma S.A.
Study Director: Addex Pharma Addex Pharma

Responsible Party: Addex Pharma S.A. Identifier: NCT01336088     History of Changes
Other Study ID Numbers: ADX48621-201
First Posted: April 15, 2011    Key Record Dates
Last Update Posted: July 16, 2012
Last Verified: July 2012

Keywords provided by Addex Pharma S.A.:
Parkinson's disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs