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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ADX48621
Placebo
Sponsored by
Addex Pharma S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring dyskinesia, Parkinson's disease

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Addex Investigator Site
  • Addex Investigator Site
  • Addex Investigator Site
  • Addex Investigator Site
  • Addex Investigator Site
  • Addex Investigator Site
  • Addex Investigator Site
  • Addex Investigator Site
  • Addex Investigator Site
  • Addex Investigator Site
  • Addex Investigator Site
  • Addex Investigator Site
  • Addex Investigator Site
  • Addex Investigator Site
  • Addex Investigator Site
  • Addex Investigator Site
  • Addex Investigator Site
  • Addex Investigator Site
  • Addex Investigator Site
  • Addex Investigator Site
  • Addex Investigator Site
  • Addex Investigator Site
  • Addex Investigator Site
  • Addex Investigator Site
  • Addex Investigator Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ADX48621

ADX48621 Matching Placebo

Arm Description

Outcomes

Primary Outcome Measures

Number of patients with abnormal safety and tolerability assessment parameters
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
Change in Parkinson's disease severity
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

Full Information

First Posted
April 4, 2011
Last Updated
July 13, 2012
Sponsor
Addex Pharma S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT01336088
Brief Title
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

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Addex Pharma S.A.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
dyskinesia, Parkinson's disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ADX48621
Arm Type
Experimental
Arm Title
ADX48621 Matching Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ADX48621
Other Intervention Name(s)
Dipraglurant
Intervention Description
oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral administration
Primary Outcome Measure Information:
Title
Number of patients with abnormal safety and tolerability assessment parameters
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Dyskinesia severity score measured by mAIMS
Time Frame
4 weeks
Title
Change in Parkinson's disease severity
Description
Patient diary at weeks 1, 2, 3 and 4, UPDRS Part III at weeks 2 and 4, UPDRS total score at week 4
Time Frame
4 weeks
Title
Patient-rated and clinician-rated global impression of change in dyskinesia and Parkinson's disease
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Addex Pharma
Organizational Affiliation
Addex Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Addex Investigator Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Addex Investigator Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Addex Investigator Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Addex Investigator Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Addex Investigator Site
City
Sunnyvale
State/Province
California
ZIP/Postal Code
94085
Country
United States
Facility Name
Addex Investigator Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Addex Investigator Site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Addex Investigator Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Addex Investigator Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Addex Investigator Site
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
Facility Name
Addex Investigator Site
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Addex Investigator Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Addex Investigator Site
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Facility Name
Addex Investigator Site
City
Innsbruck
Country
Austria
Facility Name
Addex Investigator Site
City
Bordeaux
Country
France
Facility Name
Addex Investigator Site
City
Clermont Ferrand
Country
France
Facility Name
Addex Investigator Site
City
Nantes
Country
France
Facility Name
Addex Investigator Site
City
Paris
Country
France
Facility Name
Addex Investigator Site
City
Toulouse
Country
France
Facility Name
Addex Investigator Site
City
Bochum
Country
Germany
Facility Name
Addex Investigator Site
City
Hanau
Country
Germany
Facility Name
Addex Investigator Site
City
Hannover
Country
Germany
Facility Name
Addex Investigator Site
City
Kassel
Country
Germany
Facility Name
Addex Investigator Site
City
Marburg
Country
Germany
Facility Name
Addex Investigator Site
City
Munich
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
31356217
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.
Results Reference
derived

Learn more about this trial

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

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