Parkinson's DiseasePhase 4AMANDYSKNCT00632762
Long-Term Effects of Amantadine in Parkinsonian (AMANDYSK)
A Phase 4 study testing mantadix in people with Parkinson's Disease, run by University Hospital, Toulouse at 5 sites in France.
Trial summary
This is a French national trial, conducted using a double-blind, placebo-controlled, randomised design involving 7 centers and 80 patients of both sexes. The primary objective of the trial is to evaluate the effects of the interruption of a long term treatment (ex. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- mantadix
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 5 sitesFrance
- Study dates
- Nov 2007to Jan 2011
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or Male Patients with Idiopathic Parkinson's disease
- Presenting peak dose dyskinesias under levodopa therapy
- Patient receiving Amantadine for dyskinesia at a dose greater or equal to 200 mg/day (minimum dose at which one can observe anti dyskinetic effects) for at least 6 months.
- Patients between 30 and 80 years of age
- Patients having reported a subjective amelioration in their dyskinesias under Amantadine (at the beginning of their treatment with same)
- Patient with a Mini- Mental State Exam score > 24
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- Patient not presenting a cognitive problem that could impair the comprehension of the patient and their participation in the protocol (patient diaries)
- Receiving an anti-parkinsonian treatment at a stable dose for at least 2 months with the expectation that the treatment will remain unchanged throughout the course of the patients participation in the trial.
- Signed informed consent obtained
- Patient eligible for social security (specific requirement under french law)
Who cannot join
- Atypical parkinsonian syndrome (progressive supranuclear palsy, multi-system atrophy, etc)
- Patient with parkinsonian syndrome secondary to medication
- Patients presenting with dyskinesias whose severity allow an insufficient margin for observing any aggravation which follows a potential withdrawal of treatment (UPDRS 32+33 >6)
- Patients receiving treatment with Apokinon© injector pens (unless that treatment enters into a therapeutic schema at fixed hours)
- Patient presenting with dementia or an evolving dopaminergic psychosis
- Patient receiving neuroleptics or anticholinesterases
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- Patients having received functional surgery for their Parkinsons' Disease
- Patients pregnant or at risk of same
- Patients who are: wards of the state requirement under french law).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Hôpital d'Aix en Provence
Aix-en-Provence, 13616
CHU de Clermont-Ferrand
Clermont-Ferrand, 63003
CHU Timone
Marseille, 13385
Hôpital Haut-Lévêque
Nantes, 44095
CHU Pitié-Salpêtrière
Paris, 75013
About this study
Official title: Evaluation of the Long-term Effects of Amantadine in Parkinsonian's Suffering From Dyskinesia Induced by Levodopa: Study Randomised Double-blind, Placebo - Cessation of a Chronic Prescription. STUDY AMANDYSK.
This is a French national trial, conducted using a double-blind, placebo-controlled, randomised design involving 7 centers and 80 patients of both sexes.
The primary objective of the trial is to evaluate the effects of the interruption of a long term treatment (ex. Greater than 6 months) with Amantadine (prescribed as an antidyskinetic) in patients suffering from Parkinson disease being treated with Levodopa and suffering from mid dose dyskinesias.
Secondary objectives of the trial are the evaluation of the other effects of withdrawal of Amantadine on the same group of patients: motor fluctuations, vigilance, apathy, fatigue, certain cognitive aspects, the disappearance or development of undesirable side effects and quality of life.
Read the detailed description
The trial will involve the participation of the patients for a period of 3 months each. The two groups of patients to be studied are:
- a group who will continue their treatment with Amantadine with no modification to dosage;
- a group who will have their dosage of Amantadine progressively replaced over several days with a placebo (with the aim of avoiding a "brutal" withdrawal which has been associated with symptoms of hyperthermia in rare cases in the literature).
The trial visits are scheduled as such:
- weekly visits for the first 4 weeks, with a telephone call between each visit to assure that the withdrawal from Amantadine causes any problems.
- every 2 weeks from week 4 until week 8, with weekly telephone calls in between these visits.
- a telephone call in the 10th week followed by an end of study visit in week 12. In the event of an early withdrawal from the trial, and assuming that the patient gives their consent, a complete end of study visit will be performed prior to recommencing open label treatment with Amantadine in progressively increasing doses (100mg every 3 days until the pre-study dose is reached).
- Conditions
- Parkinson's Disease
- Being tested
- mantadix
- Keywords
- Amantadine benefit, 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.
mantadixDrug
dose greater or equal to 200 mg/day and progressively increasing doses (100mg every 3 days until the pre-study dose is reached).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Amantadine MANTADIX Receives: Drug: mantadix |
| 2 | Placebo comparator | placebo Receives: Drug: mantadix |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint is the variation in the sum of the items 32 and 33 (duration and severity of dyskinesias - maximum score = 8) evaluated using Part IV of the UPDRS scale
Measured: 3 months
Secondary outcomes (5)
The number of patient "responders"
Measured: 3 months
The number of premature withdrawals from the trial for reason of an aggravation of dyskinesias
Measured: 3 months
The AIMS scale
Measured: 3 months
The Clinical Global Impression Severity Scale
Measured: 3 months
Other "exploratory" secondary efficacy
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2008 (estimated)
- Study startNov 2007
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Investigators
- Olivier Rascol, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00632762
- Sponsor's protocol ID
- 06 008 01
- Acronym
- AMANDYSK
- Status last verified
- Apr 2011
- First submitted
- 20 Feb 2008
- Last updated
- 8 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Alves G, Wentzel-Larsen T, Larsen JP. Is fatigue an independent and persistent symptom in patients with Parkinson disease? Neurology. 2004 Nov 23;63(10):1908-11. doi: 10.1212/01.wnl.0000144277.06917.cc.
PubMed 15557510Bibbiani F, Oh JD, Kielaite A, Collins MA, Smith C, Chase TN. Combined blockade of AMPA and NMDA glutamate receptors reduces levodopa-induced motor complications in animal models of PD. Exp Neurol. 2005 Dec;196(2):422-9. doi: 10.1016/j.expneurol.2005.08.017. Epub 2005 Oct 3.
PubMed 16203001Chapuis S, Ouchchane L, Metz O, Gerbaud L, Durif F. Impact of the motor complications of Parkinson's disease on the quality of life. Mov Disord. 2005 Feb;20(2):224-30. doi: 10.1002/mds.20279.
PubMed 15384126
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Long-term Effects of Amantadine in Parkinsonian's Suffering From Dyskinesia Induced by Levodopa: Study Randomised Double-blind, Placebo - Cessation of a Chronic Prescription. STUDY AMANDYSK.
- ClinicalTrials.gov ID
- NCT00632762
- Acronym / sponsor ID
- AMANDYSK / 06 008 01
- Conditions
- Parkinson's Disease
- Keywords
- Amantadine benefit, Dyskinesia, Parkinson's disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 11 Mar 2008 (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.
This is a French national trial, conducted using a double-blind, placebo-controlled, randomised design involving 7 centers and 80 patients of both sexes.
The primary objective of the trial is to evaluate the effects of the interruption of a long term treatment (ex. Greater than 6 months) with Amantadine (prescribed as an antidyskinetic) in patients suffering from Parkinson disease being treated with Levodopa and suffering from mid dose dyskinesias.
Secondary objectives of the trial are the evaluation of the other effects of withdrawal of Amantadine on the same group of patients: motor fluctuations, vigilance, apathy, fatigue, certain cognitive aspects, the disappearance or development of undesirable side effects and quality of life.
Detailed description
The trial will involve the participation of the patients for a period of 3 months each. The two groups of patients to be studied are:
- a group who will continue their treatment with Amantadine with no modification to dosage;
- a group who will have their dosage of Amantadine progressively replaced over several days with a placebo (with the aim of avoiding a "brutal" withdrawal which has been associated with symptoms of hyperthermia in rare cases in the literature).
The trial visits are scheduled as such:
- weekly visits for the first 4 weeks, with a telephone call between each visit to assure that the withdrawal from Amantadine causes any problems.
- every 2 weeks from week 4 until week 8, with weekly telephone calls in between these visits.
- a telephone call in the 10th week followed by an end of study visit in week 12. In the event of an early withdrawal from the trial, and assuming that the patient gives their consent, a complete end of study visit will be performed prior to recommencing open label treatment with Amantadine in progressively increasing doses (100mg every 3 days until the pre-study dose is reached).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: mantadixAmantadine MANTADIX |
| 2 | Placebo comparator | Drug: mantadixplacebo |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Female or Male Patients with Idiopathic Parkinson's disease
- Presenting peak dose dyskinesias under levodopa therapy
- Patient receiving Amantadine for dyskinesia at a dose greater or equal to 200 mg/day (minimum dose at which one can observe anti dyskinetic effects) for at least 6 months.
- Patients between 30 and 80 years of age
- Patients having reported a subjective amelioration in their dyskinesias under Amantadine (at the beginning of their treatment with same)
Key exclusion criteria (9 listed)
- Atypical parkinsonian syndrome (progressive supranuclear palsy, multi-system atrophy, etc)
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 |
|---|---|---|
| mantadixdose greater or equal to 200 mg/day and progressively increasing doses (100mg every 3 days until the pre-study dose is reached). | Drug | 1, 2 |
Primary outcome
The primary efficacy endpoint is the variation in the sum of the items 32 and 33 (duration and severity of dyskinesias - maximum score = 8) evaluated using Part IV of the UPDRS scale
Time frame: 3 months
5 secondary outcomes
The number of patient "responders"
Time frame: 3 months
The number of premature withdrawals from the trial for reason of an aggravation of dyskinesias
Time frame: 3 months
The AIMS scale
Time frame: 3 months
The Clinical Global Impression Severity Scale
Time frame: 3 months
Other "exploratory" secondary efficacy
Time frame: 3 months
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 8 Apr 2011.
- Background: PubMed 15557510Alves G, Wentzel-Larsen T, Larsen JP. Is fatigue an independent and persistent symptom in patients with Parkinson disease? Neurology. 2004 Nov 23;63(10):1908-11. doi: 10.1212/01.wnl.0000144277.06917.cc.
- Background: PubMed 16203001Bibbiani F, Oh JD, Kielaite A, Collins MA, Smith C, Chase TN. Combined blockade of AMPA and NMDA glutamate receptors reduces levodopa-induced motor complications in animal models of PD. Exp Neurol. 2005 Dec;196(2):422-9. doi: 10.1016/j.expneurol.2005.08.017. Epub 2005 Oct 3.
- Background: PubMed 15384126Chapuis S, Ouchchane L, Metz O, Gerbaud L, Durif F. Impact of the motor complications of Parkinson's disease on the quality of life. Mov Disord. 2005 Feb;20(2):224-30. doi: 10.1002/mds.20279.
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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.
Olivier Rascol, MD principal investigator
University Hospital, Toulouse
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing mantadix in people with Parkinson's Disease, run by University Hospital, Toulouse at 5 sites in France.
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 10 inclusion and 9 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 8 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The primary efficacy endpoint is the variation in the sum of the items 32 and 33 (duration and severity of dyskinesias - maximum score = 8) evaluated using Part IV of the UPDRS scale (time frame: 3 months). 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 NCT00632762, which also lists 3 linked publications.
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 8 Apr 2011.