Parkinson's DiseasePhase 2NCT01336088
ADX48621 for the Treatment of Levodopa Induced Dyskinesia in Patients With Parkinson's Disease
A Phase 2 study testing ADX48621 in people with Parkinson's Disease, run by Addex Pharma S.A. at 25 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- ADX48621
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 25 sitesin 4 countries
- Study dates
- Apr 2011to Feb 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
25 sites in 4 countries.
25 sites in 4 countries
United States13 sites
Addex Investigator Site
Birmingham, Alabama, 35233
Addex Investigator Site
Boca Raton, Florida, 33612
Addex Investigator Site
Chicago, Illinois, 60612
Addex Investigator Site
Commack, New York, 11725
Addex Investigator Site
Kirkland, Washington, 98034
Addex Investigator Site
La Jolla, California, 92037
Addex Investigator Site
Los Angeles, California, 90033
Addex Investigator Site
New Haven, Connecticut, 06510
Addex Investigator Site
Phoenix, Arizona, 85013
Addex Investigator Site
Portland, Oregon, 97239
Addex Investigator Site
Southfield, Michigan, 48034
Addex Investigator Site
Sunnyvale, California, 94085
Addex Investigator Site
Tampa, Florida, 33606
Germany6 sites
Addex Investigator Site
Bochum
Addex Investigator Site
Hanau
Addex Investigator Site
Hanover
Addex Investigator Site
Kassel
Addex Investigator Site
Marburg
Addex Investigator Site
Munich
France5 sites
Addex Investigator Site
Bordeaux
Addex Investigator Site
Clermont-Ferrand
Addex Investigator Site
Nantes
Addex Investigator Site
Paris
Addex Investigator Site
Toulouse
About this study
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
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.
Read the 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).
- Conditions
- Parkinson's Disease
- Being tested
- ADX48621, Placebo
- Keywords
- dyskinesia, Parkinson's disease
- Medical subject headings
- Parkinson Disease, Dyskinesias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADX48621Drug
Also called Dipraglurant
oral administration
PlaceboDrug
oral administration
| Study group | Role | What they receive |
|---|---|---|
| ADX48621 | Experimental | Not described Receives: Drug: ADX48621 |
| ADX48621 Matching Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (3)
Dyskinesia severity score measured by mAIMS
Measured: 4 weeks
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
Measured: 4 weeks
Patient-rated and clinician-rated global impression of change in dyskinesia and Parkinson's disease
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Addex Pharma S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Addex Pharma, Study director, Addex Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01336088
- Sponsor's protocol ID
- ADX48621-201
- Status last verified
- Jul 2012
- First submitted
- 4 Apr 2011
- Last updated
- 16 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31356217
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01336088
- Acronym / sponsor ID
- ADX48621-201
- Conditions
- Parkinson's Disease
- Keywords
- dyskinesia, Parkinson's disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Addex Pharma S.A.Industry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 15 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADX48621 | Experimental | Drug: ADX48621 |
| ADX48621 Matching Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADX48621Also: Dipraglurantoral administration | Drug | ADX48621 |
| Placebooral administration | Drug | ADX48621 Matching Placebo |
Primary outcome
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.
3 secondary outcomes
Dyskinesia severity score measured by mAIMS
Time frame: 4 weeks
Change in Parkinson's disease severity
Time frame: 4 weeks
Patient-rated and clinician-rated global impression of change in dyskinesia and Parkinson's disease
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2012.
- Derived from this study: PubMed 31356217McFarthing 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Addex Pharma study director
Addex Pharma
25 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ADX48621 in people with Parkinson's Disease, run by Addex Pharma S.A. at 25 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Germany, France, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with abnormal safety and tolerability assessment parameters (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01336088, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2012.